WOCKHARDT DUAL ACTION PAIN CONTROL TABLETS
Active substance(s): ASPIRIN / CAFFEINE
3rd fold
(26.25mm)
2nd fold
(26.25mm)
1st fold
(26.25mm)
Neutral code not required on the leaflet artworks.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Extra Power Pain Control Caplets
Aspirin, Paracetamol and Caffeine
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Extra
Power Pain Control Caplets carefully to get the best results from them.
- Keep this leaflet. You may need to read it again while you are receiving your
treatment.
- If you have any further questions, please ask your pharmacist.
- You must contact a doctor if your symptoms worsen or do not improve after 3 days.
- If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Extra Power Pain Control Caplets are and what they are used for
2. Before you take Extra Power Pain Control Caplets
3. How to take Extra Power Pain Control Caplets
4. Possible side effects
5. How to store Extra Power Pain Control Caplets
6. Further information
4th fold
(26.25mm)
1. What Extra Power Pain Control Caplets are and what they are used for
These caplets contain a combination of aspirin (pain relief and anti-inflammatory),
paracetamol (a painkiller) and caffeine (a mild stimulant).
Extra Power Pain Control Caplets are used for relief from mild to moderate pain
including headache, migraine, neuralgia, toothache, sore throat, period pains; and
symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis,
muscular aches and pains, joint swelling and stiffness, influenza, feverishness and
feverish colds.
(26.25mm)
16th fold
(26.25mm)
15th fold
(26.25mm)
14th fold
(26.25mm)
13th fold
(26.25mm)
12th fold
(26.25mm)
11th fold
(26.25mm)
10th fold
9th fold
(26.25mm)
8th fold
(26.25mm)
7th fold
(26.25mm)
6th fold
(26.25mm)
5th fold
(26.25mm)
2. Before you take Extra Power Pain Control Caplets
You should not take Extra Power Pain Control Caplets if you:
• are allergic (hypersensitive) to aspirin or any other non-steroidal anti-inflammatory
drugs (NSAIDs), paracetamol, caffeine or any of the other ingredients in Extra Power
Pain Control Caplets (see section 6, Further information). Symptoms may include
rhinitis (runny nose, itchy rash, swollen face, mouth
or tongue or asthma attack.
• have had ulcers of the stomach or small intestine
(peptic ulcer disease)
• suffer from haemophilia, any other blood clotting
disorders or are taking any medicines to prevent
blood clotting
• suffer from gout.
Talk to your doctor or pharmacist before taking
Extra Power Pain Control Caplets if you:
• suffer from kidney disease or liver disease,
particularly if caused by alcohol
• suffer from alcoholism
• suffer from asthma, particularly if your asthma is worsened by aspirin
• if you have nasal polyps (inflamed swellings inside the nose)
• if you suffer from indigestion (dyspepsia)
• if you have an infection
• if you are a woman trying to conceive
• suffer from heart disease and/or high blood pressure
• suffer from diabetes
• suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme
deficiency that can cause anaemia)
• are dehydrated.
Caution should be exercised when taking paracetamol products prior to (less than
72 hours before) or at the same time as intravenous busulfan.
Your blood, kidney and liver should be monitored during prolonged use as blood,
kidney and liver disorders may develop.
This medicine contains paracetamol; do not take with any other
paracetamol-containing products at the same time. Aspirin can increase the
time it takes your blood to clot; you should not take this medicine several
days before any scheduled surgery appointments.
This medicine should not be given to children under 16 years unless
specifically advised by your doctor (e.g. to treat Kawasaki’s disease), due to
the association between aspirin and Reye’s syndrome, a very rare disease
that can cause damage to the brain, liver and could be fatal.
This product belongs to a group of medicines which may impair the fertility in
women. This effect is reversible on stopping the medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. The following
medicines can affect or be affected by Extra Power Pain Control Caplets:
• medicines used to treat bacterial infections (e.g. quinolones such as enoxacin,
pipemidic acid and ciprofloxacin, sulphonamide antibiotics and isoniazid used to
treat tuberculosis)
• medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital,
primodone, sodium valporate). If you take sodium valproate with this medicine
you may increase the likelihood of bleeding
• medicines used to treat depression (e.g. fluvoxamine), Selective Serotonin
Re-uptake Inhibitors (SSRIs) such as venlafaxine): if taken with aspirin products
you may increase the likelihood of bleeding
• medicines used to treat asthma (e.g. theophylline or zafirlukast)
• medicine used to thin the blood and stop the blood clotting (anticoagulants- e.g.
warfarin, heparin, streptokinase, clopidogrel and ticlopidine): if you take one of
these medicines with aspirin products you may increase the likelihood of bleeding
• medicines used to treat water retention (diuretics - e.g. spironolactone and
acetazolamide)
• medicines used to treat high blood pressure (ACE Inhibitors, Angiotensin-II
Receptor Antagonists and calcium channel blockers e.g. verapamil): taken with
aspirin products these medicines may not be as effective and you may suffer from
kidney problems
• medicines used to treat gout (e.g. probenecid or sulfinpyrazone). Phenylbutazone
may reduce the effect of aspirin products.
• metoclopramide and domperidone (used to treat sickness and nausea)
• oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT
• diflunisal (an anti-inflammatory painkiller)
• colestyramine (used to treat high cholesterol and in diseases of the intestine and
liver)
• disulfiram (used to treat alcoholism)
• lithium (used to treat manic depression/bipolar disorder)
• mexilitine (used to treat abnormal heart rhythms)
• fluconazole or terbinafine (used to treat fungal infections)
• clozapine (an antipsychotic used to treat schizophrenia)
• diuretics such as hydrochlorothiazide
• ephedrine, a stimulant used in dietary supplements such as Ma Huang
• thiopental (used as an anaesthetic)
• kaolin (used to treat Diarrhoea)
• methotreaxate (used to treat arthritis and cancers)
• benzodiazepine medicines (sedatives e.g. diazepam)
• phenylpropanolamine (a decongestant)
• non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. indometacin or fenoprofen)
• insulin and oral anti-diabetic medicines
• corticosteroids. If you suddenly stop taking corticosteroids you may develop
aspirin poisoning
• vitamin C
• gold compounds
• mifepristone used as an emergency contraceptive. Wait 8-12 days after
taking mifepristone before taking any aspirin products
103206/7
pg1/2
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Process
Black
Extra Power Pain Control - 16 Caplets
Wockhardt UK
FP2711; FP2792; FP2838; FP3969
L1
(w)128 x (h)420mm
2285
215322
9 pt.
XPower_16Caplet_Lit_103206-7.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
17th September, 2012
R 1st PDF sent on - 19TH OCT. 2012
R 2nd PDF sent on - 6TH NOV. 2012
R 3rd PDF sent on - 4TH DEC. 2012
R 4th PDF sent on - 30TH JAN. 2013
R 5th PDF sent on - 13TH FEB. 2013
R 6th PDF sent on - 10TH JULY 2013
R 7th PDF sent on - 2ND SEPT. 2013
R 8th PDF sent on - 14TH JAN. 2014
R 9th PDF sent on - 3RD FEB. 2014
R 10th PDF sent on- 2ND APRIL 2014
R 11th PDF sent on- 30TH MAY 2014
R 12th PDF sent on- 7TH OCT. 2014
R 13th PDF sent on- 20TH NOV. 2014
R 14th PDF sent on- 28TH JAN. 2015
R 15th PDF sent on- 28TH JAN. 2015
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends • Updated new Wockhardt logo
• Text font size increased to 9pt.
• Dimensions changed to 128 x 420mm
(Dimensions changed to accomodate bigger text font size)
• Pharmacode placed on 6th fold & 8mm from cutting edge
1st fold
(26.25mm)
2nd fold
(26.25mm)
3rd fold
(26.25mm)
4th fold
(26.25mm)
Always follow the instructions on the carton. If you are not sure then ask your doctor
or pharmacist for advice. Swallow caplets whole with a glass of water.
Adults, elderly and children over 16 years
• 1 to 2 caplets every 4-6 hours as required
• The dose should not be taken more frequently than every four hours
• do not take more than 8 caplets in 24 hours
• do not exceed the recommended dose
• if symptoms persist see your doctor
• do not take for more than 3 days unless you have been told to do so by your
doctor.
Take the caplets with or immediately after food to reduce the risk of getting stomach
and bowel irritation.
Do not give to children aged under 16 years, unless specifically advised by
your doctor.
If you take more Extra Power Pain Control Caplets than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Symptoms of an overdose include vomiting, dehydration, tinnitus, vertigo,
headache, nausea, dizziness, restlessness, heart failure, breathing failure,
deafness, sweating, warm extremities with racing pulse, increased breathing rate
and hyperventilation.
If you forget to take Extra Power Pain Control Caplets
If you forget a dose, take another as soon as you remember. If it is almost time for
your next dose, then do not take the missed dose at all. NEVER take a double dose
to make up for the one missed.
5th fold
3. How to take Extra Power Pain Control Caplets
(26.25mm)
• Cilostazol (for leg pain that occurs when walking due to poor circulation): the dose
of aspirin should not be greater than 80mg a day
• intravenous busulfan (used in chemotherapy to treat cancer).
Pregnancy and breast-feeding
This medicine should not be taken during pregnancy or whilst breast-feeding. Ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machinery
Extra Power Pain Control Caplets do not affect your ability to drive or use
machinery.
6th fold
7th fold
(26.25mm)
8th fold
(26.25mm)
9th fold
(26.25mm)
(26.25mm)
10th fold
(26.25mm)
11th fold
Like all medicines, Extra Power Pain Control Caplets
can cause side effects, although not everybody gets
them.
As can happen with any medicine, a few people may
develop a serious side effect. If you experience any
of the following, stop taking the medicine
immediately, and see your doctor or pharmacist:
• allergic reactions which may be • Stevens-Johnson
• Toxic epidermal
severe such as skin rash,
syndrome (symptoms
necrolysis (a severe
peeling of the skin, itching,
include fever, rash, sore skin problem with
swollen red areas of the skin,
mouth and eyes, joint
shedding of the
sometimes with shortness of
and muscle aches).
upper layer).
breath or swelling of the mouth,
lips, tongue, throat or face.
• Vomiting of blood and/or blood in
the faeces, which may result in stomach
and gut ulcers or haemorrhage.
Side effects that have been reported with Extra Power Pain Control Caplets are:
• rash
• worsening of asthma
• tremor
• anxiety
• sleep disturbance
• restlessness
• slight blood loss which may
• blood in the urine
• excitement
result in iron-deficiency
anaemia during long term use • diarrhoea
• palpitations
• changes in blood cells
• irregular heart beat
• acid reflux
• irritability
• insomnia
• stomach irritation
• increased frequency
• lumps (cysts) in
• very rare cases of
to urinate
the breasts
serious sin
reactions have
been reported
• tinnutus
• deafness
• anaemia
• indigestion
• feeling or being sick
• irritation in the nose
• asthma attacks
• liver problems
• swelling of tissues
Stomach and bowel irritation may be reduced by taking the tablets with or
immediately after food.
The use of this medicine over a long time can cause kidney problems. If you
experience any side effects or feel that the medicine is affecting you badly tell your
doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting
side effects you can help provide more information on the safety of this medicine.
(26.25mm)
4. Possible side effects
GSL
103206/7
215322
pg2/2
(26.25mm)
(26.25mm)
13th fold
(26.25mm)
14th fold
(26.25mm)
Please be ready to give the following information:
Product name
Reference number
Extra Power Pain Control Caplets
29831/0164
This is a service provided by the Royal National Institute of Blind People.
Leaflet Prepared: January 2015
15th fold
What Extra Power Pain Control Caplets contain
The active ingredients are: aspirin 300mg, paracetamol 200mg and caffeine 45mg.
The other ingredients are: povidone, hydroxypropylcellulose, stearic acid,
microcrystalline cellulose, maize starch, pregelatinised starch, hydroxypropyl
methylcellulose 5cPs, hydroxypropyl methylcellulose 15cPs, macrogol 4000.
What Extra Power Pain Control Caplets look like and the contents of the pack
Extra Power Pain Control Caplets are white, coated, capsule shaped tablets.
Extra Power Pain Control Caplets are available from on general sale in blister pack
sizes of 12 and 16 caplets.
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North,
Wrexham LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
free of charge: 0800 198 5000 (UK Only).
(26.25mm)
6. Further information
16th fold
Keep out of the reach and sight of children.
• Extra Power Pain Control Caplets should be stored in a dry place below 25°C
• Store in the original container to protect from light; do not transfer to another container
• Extra Power Pain Control Caplets should not be taken after the expiry date on the
carton; the expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help protect the environment.
12th fold
5. How to store Extra Power Pain Control Caplets
(26.25mm)
16th fold
(26.25mm)
15th fold
(26.25mm)
14th fold
(26.25mm)
13th fold
(26.25mm)
12th fold
(26.25mm)
11th fold
(26.25mm)
10th fold
9th fold
(26.25mm)
8th fold
(26.25mm)
7th fold
(26.25mm)
6th fold
(26.25mm)
5th fold
(26.25mm)
4th fold
(26.25mm)
3rd fold
(26.25mm)
2nd fold
(26.25mm)
1st fold
(26.25mm)
Neutral code not required on the leaflet artworks.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tesco Extra Power Pain Control Tablets
Aspirin, Paracetamol and Caffeine
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take
Extra Power Pain Control Tablets carefully to get the best results from them.
− Keep this leaflet. You may need to read it again while you are receiving your
treatment.
− If you have any further questions, please ask your pharmacist.
− You must contact a doctor if your symptoms worsen or do not improve after 3 days.
− If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Tesco Extra Power Pain Control Tablets. In the rest
of this leaflet it is called Extra Power Pain Control Tablets.
In this leaflet:
1. What Extra Power Pain Control Tablets are and what they are used for
2. Before you take Extra Power Pain Control Tablets
3. How to take Extra Power Pain Control Tablets
4. Possible side effects
5. How to store Extra Power Pain Control Tablets
6. Further information
1. What Extra Power Pain Control Tablets are and what they are used for
The name of your medicine is Extra Power Pain Control Tablets. These tablets
contain a combination of aspirin (pain relief and anti-inflammatory), paracetamol (a
painkiller) and caffeine (a mild stimulant).
Extra Power Pain Control Tablets are used to relieve the symptoms of the common
cold and flu; including fever, and sore throats and are also used to relieve mild to
moderate pain including, headache, period pains, and pains associated with the
joints and muscles.
2. Before you take Extra Power Pain Control Tablets
You should not take Extra Power Pain Control Tablets if you:
• are allergic (hypersensitive) to aspirin or any other non-steroidal anti-inflammatory
drugs (NSAIDs), paracetamol, caffeine or any of
the other ingredients in Extra Power Pain Control
Tablets (see section 6, Further information).
Symptoms may include rhinitis (runny nose, itchy
rash, swollen face, mouth or tongue or asthma
attack
• have had ulcers of the stomach or small intestine
(peptic ulcer disease)
• suffer from haemophilia, any other blood clotting
disorders or are taking any medicines to prevent
blood clotting
• suffer from gout.
Talk to your doctor or pharmacist before taking Extra Power Pain Control
Tablets if you:
• suffer from kidney disease or liver disease, particularly if caused by alcohol
• suffer from alcoholism
• suffer from asthma, particularly if your asthma is worsened by aspirin
• suffer from heart disease and/or high blood pressure
• if you have nasal polyps (inflamed swellings inside the nose)
• if you suffer from indigestion
• if you have an infection
• if you are a woman trying to conceive
• suffer from diabetes
• suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme
deficiency that can cause anaemia)
• are dehydrated.
Caution should be exercised when taking paracetamol products prior to (less than
72 hours before) or at the same time as intravenous busulfan.
Your blood, kidney and liver should be monitored during prolonged use as blood,
kidney and liver disorders may develop.
This medicine contains paracetamol; do not take with any other
paracetamol-containing products at the same time. Aspirin can increase the
time it takes your blood to clot; you should not take this medicine several
days before any scheduled surgery appointments.
This medicine should not be given to children under 16 years unless
specifically advised by your doctor (e.g to treat Kawasaki’s disease), due to
the association between aspirin and Reye’s syndrome, a very rare disease
that can cause damage to the brain, liver and could be fatal.
The product belongs to a group of medicines which may impair the fertility in
women. This effect is reversible on stopping the medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without prescription. The following
medicines can affect or be affected by Extra Power Pain Control Tablets:
• medicines used to treat bacterial infections (e.g. quinolone, such as enoxacin,
pipemidic acid and ciprofloxacin, sulphonamide antibiotics and isoniazid used to
treat tuberculosis)
• medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital,
primodone, sodium valporate)
• medicines used to treat depression (e.g. fluvoxamine), Selective Serotonin
Re-uptake Inhibitors (SSRIs) such as venlafaxine): if taken with aspirin products
you may increase the likelihood of bleeding.
• medicines used to treat asthma ( e.g. theophylline or zafirlukast)
• medicine used to thin the blood and stop the blood clotting (anticoagulants- e.g.
warfarin, heparin, streptokinase, clopidogrel and ticlopidine): if you take one of
these medicines with aspirin products you may increase the likelihood of bleeding
• medicines used to treat water retention (diuretics - e.g. spironolactone and
acetazolamide)
• medicines used to treat high blood pressure (ACE Inhibitors, Angiotensin-II
Receptor Antagonists and calcium channel blockers e.g. verapamil): taken with
aspirin products these medicines may not be as effective and you may suffer from
kidney problems
• medicines used to treat gout (e.g. probenecid or sulfinpyrazone). Phenylbutazone
may reduce the effect of aspirin products.
• metoclopramide and domperidone (used to treat sickness and nausea)
• oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT
• diflunisal (an anti-inflammatory painkiller)
• colestyramine (used to treat high cholesterol and in diseases of the intestine and liver)
• disulfaram (used to treat alcoholism)
• lithium (used to treat manic depression/bipolar disorder)
• mexilitine (used to treat abnormal heart rhythms)
• thiopental (used as an anaesthetic)
• kaolin (used to treat Diarrhoea)
• methotreaxate (used to treat arthritis and cancers)
• benzodiazepine medicines (sedatives e.g. diazepam)
• phenylpropanolamine (a decongestant)
• non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. indometacin or fenoprofen)
• insulin and oral anti-diabetic medicines
• corticosteroids. If you suddenly stop taking corticosteroids you may develop
aspirin poisoning
• vitamin C
• gold compounds
• mifepristone used as an emergency contraceptive. Wait 8-12 days after
taking mifepristone before taking any aspirin products.
107195/2
pg1/2
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Process
Black
Extra Power Pain Control - 16 Caplets (TESCO)
Wockhardt UK
FP3969
Daman (Bhimpore)
(w)128 x (h)420mm
2461
220346
9 pt.
XPower_16Caplet_Lit_107195-2.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
7th & 8th October, 2014
R 1st PDF sent on - 8TH OCT. 2014
R 2nd PDF sent on - 21ST NOV. 2014
R 3rd PDF sent on - 28TH JAN. 2015
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends
• Pharmacode positioned at 8mm from the cutting edge
1st fold
(26.25mm)
2nd fold
(26.25mm)
3rd fold
(26.25mm)
4th fold
(26.25mm)
Always follow the instructions on the label. If you are not sure then ask your doctor
or pharmacist for advice. Swallow tablets whole with a glass of water.
Adults, elderly and children over 16 years
• 1 to 2 tablets every 4-6 hours as required
• do not take more than 8 tablets in 24 hours
• do not exceed the recommended dose
• if symptoms persist see your doctor
• do not take for more than 3 days unless you have been told to do so by your
doctor.
Take the tablets with or immediately after food to reduce the risk of getting stomach
and bowel irritation.
Do not give to children aged under 16 years, unless specifically advised by
your doctor.
If you take more Extra Power Pain Control Tablets than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Symptoms of an overdose include vomiting, dehydration, tinnitus, vertigo,
headache, nausea, dizziness, restlessness, heart failure, breathing failure,
deafness, sweating, warm extremities with racing pulse, increased breathing rate
and hyperventilation.
If you forget to take Extra Power Pain Control Tablets
If you forget a dose, take another as soon as you remember. If it is almost time for
your next dose, then do not take the missed dose at all. NEVER take a double dose
to make up for the one missed.
5th fold
3. How to take Extra Power Pain Control Tablets
(26.25mm)
• Cilostazol (for leg pain that occurs when walking due to poor circulation): the dose
of aspirin should not be greater than 80mg a day
• intravenous busulfan (used in chemotherapy to treat cancer).
Pregnancy and breast-feeding
This medicine should not be taken during pregnancy or whilst breast-feeding. Ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machinery
Extra Power Pain Control Tablets do not affect your ability to drive and use machinery.
6th fold
7th fold
(26.25mm)
8th fold
(26.25mm)
9th fold
(26.25mm)
(26.25mm)
10th fold
(26.25mm)
11th fold
Keep out of reach and sight of children.
• Extra Power Pain Control Tablets should be stored in a dry place below 25°C
• Store in the original container to protect from light; do not transfer to another
container
• Extra Power Pain Control Tablets should not be taken after the expiry date on the
label; the expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask you
pharmacist how to dispose of medicines no longer required. These measures will
help protect the environment.
(26.25mm)
5. How to store Extra Power Pain Control Tablets
12th fold
Like all medicines, Extra Power Pain Control Tablets
can cause side effects, although not everybody gets
them.
As can happen with any medicine, a few people may
develop an allergic reaction. If you experience any
of the following, stop taking the medicine
immediately, and see your doctor or pharmacist:
• allergic reactions which may be severe such as
skin rash, peeling of the skin, itching, swollen red areas of the skin, sometimes
with shortness of breath or swelling of the mouth, lips, tongue, throat or face.
• Stevens-Johnson syndrome (symptoms include fever, rash, sore mouth and eyes,
joint and muscle aches).
• Toxic epidermal necrolysis (a severe skin problem with shredding of the upper layer).
• Vomiting blood and/or blood in the faeces, which may result in stomach and gut
ulcers or haemorrhage.
Side effects that have been reported with Extra Power Pain Control Tablets are:
• rash
• worsening of asthma
• tremor
• anxiety
• sleep disturbance
• restlessness
• excitement
• palpitations
• changes in blood cells
• irregular heart beat
• stomach irritation
• anaemia
• indigestion
• diarrhoea
• blood in the urine
• irritation in the nose
• feeling or being sick
• asthma attacks
• liver problems
• swelling of tissues
• tinnutus
• slight blood loss which • acid reflux may result in
• increased frequency
iron-deficiency anaemia
to urinate
during long term use
• insomnia
• lumps (cysts) in the breasts • very rare cases of
serious sin reactions
• deafness
• irritability
have been reported.
Stomach and bowel irritation may be reduced by taking the tablets with or
immediately after food.
The use of this medicine over a long time can cause kidney problems. If you
experience any side effects or feel that the medicine is affecting you badly tell your
doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting
side effects you can help provide more information on the safety of this medicine.
(26.25mm)
4. Possible side effects
This is a service provided by the Royal National Institute of Blind People.
Leaflet Prepared: January 2015
GSL
107195/2
220346
pg2/2
(26.25mm)
(26.25mm)
14th fold
(26.25mm)
15th fold
(26.25mm)
Please be ready to give the following information:
Product name
Reference number
Extra Power Pain Control Tablets
29831/0164
16th fold
What Extra Power Pain Control Tablets contain
The active ingredients are: aspirin 300mg, paracetamol 200mg and caffeine 45mg.
The other ingredients are: povidone, hydroxypropylcellulose, stearic acid,
microcrystalline cellulose, maize starch, pregelatinised starch, hydroxypropyl
methylcellulose 5cPs, hydroxypropyl methylcellulose 15cPs, macrogol 4000.
What Extra Power Pain Control Tablets look like and the contents of the pack
Extra Power Pain Control Tablets are white, coated, capsule shaped tablets.
Extra Power Pain Control Tablets are available from on general sale in blister pack
sizes of 12 and 16 tablets.
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North,
Wrexham LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
free of charge:
0800 198 5000 (UK Only).
13th fold
6. Further information
3rd fold
(26.25mm)
2nd fold
(26.25mm)
1st fold
(26.25mm)
Neutral code not required on the leaflet artworks.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Wockhardt Dual Action Pain Control Tablets
Aspirin, Paracetamol and Caffeine
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take
Wockhardt Dual Action Pain Control Tablets carefully to get the best results from them.
- Keep this leaflet. You may need to read it again while you are receiving your treatment.
- If you have any further questions, please ask your pharmacist.
- You must contact a doctor if your symptoms worsen or do not improve after 3
days.
- If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Wockhardt Dual Action Pain Control Tablets. In the
rest of the leaflet it is called Dual Action Pain Control Tablets.
In this leaflet:
1. What Dual Action Pain Control Tablets are and what they are used for
2. Before you take Dual Action Pain Control Tablets
3. How to take Dual Action Pain Control Tablets
4. Possible side effects
5. How to store Dual Action Pain Control Tablets
6. Further information
2. Before you take Dual Action Pain Control Tablets
(26.25mm)
16th fold
(26.25mm)
15th fold
(26.25mm)
14th fold
(26.25mm)
13th fold
(26.25mm)
12th fold
(26.25mm)
11th fold
(26.25mm)
10th fold
9th fold
(26.25mm)
8th fold
(26.25mm)
7th fold
(26.25mm)
6th fold
(26.25mm)
5th fold
4th fold
(26.25mm)
These tablets contain a combination of aspirin (pain relief and anti-inflammatory),
paracetamol (a painkiller) and caffeine (a mild stimulant).
Dual Action Pain Control Tablets are used for relief from mild to moderate pain
including headache, migraine, neuralgia, toothache, sore throat, period pains; and
symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis,
muscular aches and pains, joint swelling and stiffness, influenza, feverishness and
feverish colds.
(26.25mm)
1. What Dual Action Pain Control Tablets are and what they are used for
You should not take Dual Action Pain Control Tablets if you:
• are allergic (hypersensitive) to aspirin or any other non-steroidal anti-inflammatory
drugs (NSAIDs), paracetamol, caffeine or any of the
other ingredients in Dual Action Pain Control Tablets
(see section 6, Further information). Symptoms
may include rhinitis (runny nose, itchy rash,
swollen face, mouth or tongue or asthma attack.
• have had ulcers of the stomach or small intestine
(peptic ulcer disease)
• suffer from haemophilia, any other blood clotting
disorders or are taking any medicines to prevent
blood clotting
• suffer from gout.
Talk to your doctor or pharmacist before taking Dual Action Pain Control
Tablets if you:
• suffer from kidney disease or liver disease, particularly if caused by alcohol
• suffer from alcoholism
• suffer from asthma, particularly if your asthma is worsened by aspirin
• if you have nasal polyps (inflamed swellings inside the nose)
• if you suffer from indigestion (dyspepsia)
• if you have an infection
• if you are a woman trying to conceive
• suffer from heart disease and/or high blood pressure
• suffer from diabetes
• suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme
deficiency that can cause anaemia)
• are dehydrated.
Caution should be exercised when taking paracetamol products prior to (less than
72 hours before) or at the same time as intravenous busulfan.
Your blood, kidney and liver should be monitored during prolonged use as blood,
kidney and liver disorders may develop.
This medicine contains paracetamol; do not take with any other
paracetamol-containing products at the same time. Aspirin can increase the
time it takes your blood to clot; you should not take this medicine several
days before any scheduled surgery appointments.
This medicine should not be given to children under 16 years unless
specifically advised by your doctor (e.g. to treat Kawasaki’s disease), due to
the association between aspirin and Reye’s syndrome, a very rare disease
that can cause damage to the brain, liver and could be fatal.
This product belongs to a group of medicines which may impair the fertility in
women. This effect is reversible on stopping the medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. The following
medicines can affect or be affected by Dual Action Pain Control Tablets:
• medicines used to treat bacterial infections (e.g. quinolones such as enoxacin,
pipemidic acid and ciprofloxacin, sulphonamide antibiotics and isoniazid used to
treat tuberculosis)
• medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital,
primodone, sodium valporate). If you take sodium valproate with this medicine
you may increase the likelihood of bleeding
• medicines used to treat depression (e.g. fluvoxamine), Selective Serotonin
Re-uptake Inhibitors (SSRIs) such as venlafaxine): if taken with aspirin products
you may increase the likelihood of bleeding
• medicines used to treat asthma ( e.g. theophylline or zafirlukast)
• medicine used to thin the blood and stop the blood clotting (anticoagulants- e.g.
warfarin, heparin, streptokinase, clopidogrel and ticlopidine): if you take one of
these medicines with aspirin products you may increase the likelihood of bleeding
• medicines used to treat water retention (diuretics - e.g. spironolactone and
acetazolamide)
• medicines used to treat high blood pressure (ACE Inhibitors, Angiotensin-II
Receptor Antagonists and calcium channel blockers e.g. verapamil): taken with
aspirin products these medicines may not be as effective and you may suffer from
kidney problems
• medicines used to treat gout (e.g. probenecid or sulfinpyrazone).
Phenylbutazone may reduce the effect of aspirin products.
• metoclopramide and domperidone (used to treat sickness and nausea)
• oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT
• diflunisal (an anti-inflammatory painkiller)
• colestyramine (used to treat high cholesterol and in diseases of the intestine and liver)
• disulfiram (used to treat alcoholism)
• lithium (used to treat manic depression/bipolar disorder)
• mexilitine (used to treat abnormal heart rhythms)
• thiopental (used as an anaesthetic)
• kaolin (used to treat Diarrhoea)
• fluconazole or terbinafine (used to treat fungal infections)
• clozapine (an antipsychotic used to treat schizophrenia)
• diuretics such as hydrochlorothiazide
• ephedrine, a stimulant used in dietary supplements such as Ma Huang
• methotreaxate (used to treat arthritis and cancers)
• benzodiazepine medicines (sedatives e.g. diazepam)
• phenylpropanolamine (a decongestant)
• non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. indometacin or fenoprofen)
• insulin and oral anti-diabetic medicines
• corticosteroids. If you suddenly stop taking corticosteroids you may develop
aspirin poisoning
• vitamin C
• gold compounds
105021/4
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Process
Black
Dual Action Pain Control Tablets - 16tab
Wockhardt UK
FP3523
L1
(w)128mm x (h)420mm
2351
216520
9 pt.
Dual Action Tablets_Lit_105021-4.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
13th & 14th June, 2013
R 1st PDF sent on
R 2nd PDF sent on
R 3rd PDF sent on
R 4th PDF sent on
R 5th PDF sent on
R 6th PDF sent on
- 10TH JULY 2013
- 14TH JAN. 2014
- 3RD FEB. 2014
- 7TH OCT. 2014
- 20TH NOV. 2014
- 28TH JAN. 2015
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends • Updated new Wockhardt logo
• Text font size increased to 9pt.
• Dimensions changed to 128 x 420mm
(Dimensions changed to accomodate bigger text font size)
• Pharmacode placed on 6th fold & 8mm from cutting edge
pg1/2
1st fold
(26.25mm)
2nd fold
(26.25mm)
3rd fold
(26.25mm)
4th fold
(26.25mm)
5th fold
(26.25mm)
6th fold
(26.25mm)
7th fold
(26.25mm)
8th fold
(26.25mm)
9th fold
(26.25mm)
Like all medicines, Dual Action Pain Control Tablets can
cause side effects, although not everybody gets them.
As can happen with any medicine, a few people may
develop a serious side effect. If you experience any
of the following, stop taking the medicine
immediately, and see your doctor or pharmacist:
• Allergic reactions which may be severe such as skin rash, peeling of the skin,
itching, swollen red areas of the skin, sometimes with shortness of breath or
swelling of the mouth, lips, tongue, throat or face.
• Stevens-Johnson syndrome (symptoms include fever, rash, sore mouth and eyes,
joint and muscle aches).
• Toxic epidermal necrolysis (a severe skin problem with shedding of the upper layer).
• Vomiting of blood and/or blood in the faeces, which may result in stomach and gut
ulcers or haemorrhage.
Side effects that have been reported with Dual Action Pain Control Tablets are:
• rash
• worsening of asthma • tremor
• anxiety
• sleep disturbance
• restlessness
• slight blood loss which may
• blood in the urine
• excitement
result in iron-deficiency
anaemia during long term use • diarrhoea
• palpitations
• changes in blood cells
• irregular heart beat
• acid reflux
• irritability
• insomnia
• tinnitus
• deafness
• very rare cases of
• increased frequency
serious skin reactions to urinate
have been reported
• lumps (cysts) in
• stomach irritation
• anaemia
the breasts
• indigestion
• feeling or being sick • irritation in the nose
• asthma attacks
• liver problems
• swelling of tissues
Stomach and bowel irritation may be reduced by taking the tablets with or
immediately after food.
The use of this medicine over a long time can cause kidney problems. If you
experience any side effects or feel that the medicine is affecting you badly tell your
doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting
side effects you can help provide more information on the safety of this medicine.
(26.25mm)
4. Possible side effects
10th fold
Always follow the instructions on the carton. If you are not sure then ask your doctor
or pharmacist for advice. Swallow tablets whole with a glass of water.
Adults, elderly and children over 16 years
• 1 to 2 tablets every 4-6 hours as required
• The dose should not be taken more frequently than every four hours
• do not take more than 8 tablets in 24 hours
• do not exceed the recommended dose
• if symptoms persist see your doctor
• do not take for more than 3 days unless you have been told to do so by your doctor.
Take the tablets with or immediately after food to reduce the risk of getting stomach
and bowel irritation.
Do not give to children aged under 16 years, unless specifically advised by
your doctor.
If you take more Dual Action Pain Control Tablets than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Symptoms of an overdose include vomiting, dehydration, tinnitus, vertigo,
headache, nausea, dizziness, restlessness, heart failure, breathing failure,
deafness, sweating, warm extremities with racing pulse, increased breathing rate
and hyperventilation.
If you forget to take Dual Action Pain Control Tablets
If you forget a dose, take another as soon as you
remember. If it is almost time for your next dose, then
do not take the missed dose at all. NEVER take a
double dose to make up for the one missed.
(26.25mm)
3. How to take Dual Action Pain Control Tablets
11th fold
• mifepristone used as an emergency contraceptive. Wait 8-12 days after taking
mifepristone before taking any aspirin products
• Cilostazol (for leg pain that occurs when walking due to poor circulation): the dose
of aspirin should not be greater than 80mg a day
• intravenous busulfan (used in chemotherapy to treat cancer).
Pregnancy and breast-feeding
This medicine should not be taken during pregnancy or whilst breast-feeding. Ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machinery
Dual Action Pain Control Tablets do not affect your ability to drive or use machinery.
105021/4
216520
pg2/2
(26.25mm)
(26.25mm)
13th fold
(26.25mm)
14th fold
(26.25mm)
15th fold
What Dual Action Pain Control Tablets contain
The active ingredients are: aspirin 300mg, paracetamol 200mg and caffeine 45mg.
The other ingredients are: povidone, hydroxypropylcellulose, stearic acid,
microcrystalline cellulose, maize starch, pregelatinised starch, hydroxypropyl
methylcellulose 5cPs, hydroxypropyl methylcellulose 15cPs, macrogol 4000.
What Dual Action Pain Control Tablets look like and the contents of the pack
Dual Action Pain Control Tablets are white, coated, capsule shaped tablets.
Dual Action Pain Control Tablets are available from on general sale in blister pack
sizes of 12 and 16 caplets.
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North,
Wrexham LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
free of charge: 0800 198 5000 (UK Only).
Please be ready to give the following information:
Product name
Reference number
Wockhardt Dual Action Pain Control Caplets
29831/0164
This is a service provided by the Royal National Institute of Blind People.
Leaflet Prepared: January 2015
(26.25mm)
6. Further information
16th fold
Keep out of the reach and sight of children.
• Dual Action Pain Control Tablets should be stored in a dry place below 25°C
• Store in the original container to protect from light; do not transfer to another container
• Dual Action Pain Control Tablets should not be taken after the expiry date on the
carton; the expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help protect the environment.
12th fold
5. How to store Dual Action Pain Control Tablets
(26.25mm)
2nd fold
(26.25mm)
1st fold
(26.25mm)
Neutral code not required on the leaflet artworks.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Extra Power Pain Control Caplets
Aspirin, Paracetamol and Caffeine
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Extra
Power Pain Control Caplets carefully to get the best results from them.
- Keep this leaflet. You may need to read it again while you are receiving your
treatment.
- If you have any further questions, please ask your pharmacist.
- You must contact a doctor if your symptoms worsen or do not improve after 3 days.
- If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Extra Power Pain Control Caplets are and what they are used for
2. Before you take Extra Power Pain Control Caplets
3. How to take Extra Power Pain Control Caplets
4. Possible side effects
5. How to store Extra Power Pain Control Caplets
6. Further information
4th fold
(26.25mm)
1. What Extra Power Pain Control Caplets are and what they are used for
These caplets contain a combination of aspirin (pain relief and anti-inflammatory),
paracetamol (a painkiller) and caffeine (a mild stimulant).
Extra Power Pain Control Caplets are used for relief from mild to moderate pain
including headache, migraine, neuralgia, toothache, sore throat, period pains; and
symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis,
muscular aches and pains, joint swelling and stiffness, influenza, feverishness and
feverish colds.
(26.25mm)
16th fold
(26.25mm)
15th fold
(26.25mm)
14th fold
(26.25mm)
13th fold
(26.25mm)
12th fold
(26.25mm)
11th fold
(26.25mm)
10th fold
9th fold
(26.25mm)
8th fold
(26.25mm)
7th fold
(26.25mm)
6th fold
(26.25mm)
5th fold
(26.25mm)
2. Before you take Extra Power Pain Control Caplets
You should not take Extra Power Pain Control Caplets if you:
• are allergic (hypersensitive) to aspirin or any other non-steroidal anti-inflammatory
drugs (NSAIDs), paracetamol, caffeine or any of the other ingredients in Extra Power
Pain Control Caplets (see section 6, Further information). Symptoms may include
rhinitis (runny nose, itchy rash, swollen face, mouth
or tongue or asthma attack.
• have had ulcers of the stomach or small intestine
(peptic ulcer disease)
• suffer from haemophilia, any other blood clotting
disorders or are taking any medicines to prevent
blood clotting
• suffer from gout.
Talk to your doctor or pharmacist before taking
Extra Power Pain Control Caplets if you:
• suffer from kidney disease or liver disease,
particularly if caused by alcohol
• suffer from alcoholism
• suffer from asthma, particularly if your asthma is worsened by aspirin
• if you have nasal polyps (inflamed swellings inside the nose)
• if you suffer from indigestion (dyspepsia)
• if you have an infection
• if you are a woman trying to conceive
• suffer from heart disease and/or high blood pressure
• suffer from diabetes
• suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme
deficiency that can cause anaemia)
• are dehydrated.
Caution should be exercised when taking paracetamol products prior to (less than
72 hours before) or at the same time as intravenous busulfan.
Your blood, kidney and liver should be monitored during prolonged use as blood,
kidney and liver disorders may develop.
This medicine contains paracetamol; do not take with any other
paracetamol-containing products at the same time. Aspirin can increase the
time it takes your blood to clot; you should not take this medicine several
days before any scheduled surgery appointments.
This medicine should not be given to children under 16 years unless
specifically advised by your doctor (e.g. to treat Kawasaki’s disease), due to
the association between aspirin and Reye’s syndrome, a very rare disease
that can cause damage to the brain, liver and could be fatal.
This product belongs to a group of medicines which may impair the fertility in
women. This effect is reversible on stopping the medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. The following
medicines can affect or be affected by Extra Power Pain Control Caplets:
• medicines used to treat bacterial infections (e.g. quinolones such as enoxacin,
pipemidic acid and ciprofloxacin, sulphonamide antibiotics and isoniazid used to
treat tuberculosis)
• medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital,
primodone, sodium valporate). If you take sodium valproate with this medicine
you may increase the likelihood of bleeding
• medicines used to treat depression (e.g. fluvoxamine), Selective Serotonin
Re-uptake Inhibitors (SSRIs) such as venlafaxine): if taken with aspirin products
you may increase the likelihood of bleeding
• medicines used to treat asthma (e.g. theophylline or zafirlukast)
• medicine used to thin the blood and stop the blood clotting (anticoagulants- e.g.
warfarin, heparin, streptokinase, clopidogrel and ticlopidine): if you take one of
these medicines with aspirin products you may increase the likelihood of bleeding
• medicines used to treat water retention (diuretics - e.g. spironolactone and
acetazolamide)
• medicines used to treat high blood pressure (ACE Inhibitors, Angiotensin-II
Receptor Antagonists and calcium channel blockers e.g. verapamil): taken with
aspirin products these medicines may not be as effective and you may suffer from
kidney problems
• medicines used to treat gout (e.g. probenecid or sulfinpyrazone). Phenylbutazone
may reduce the effect of aspirin products.
• metoclopramide and domperidone (used to treat sickness and nausea)
• oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT
• diflunisal (an anti-inflammatory painkiller)
• colestyramine (used to treat high cholesterol and in diseases of the intestine and
liver)
• disulfiram (used to treat alcoholism)
• lithium (used to treat manic depression/bipolar disorder)
• mexilitine (used to treat abnormal heart rhythms)
• fluconazole or terbinafine (used to treat fungal infections)
• clozapine (an antipsychotic used to treat schizophrenia)
• diuretics such as hydrochlorothiazide
• ephedrine, a stimulant used in dietary supplements such as Ma Huang
• thiopental (used as an anaesthetic)
• kaolin (used to treat Diarrhoea)
• methotreaxate (used to treat arthritis and cancers)
• benzodiazepine medicines (sedatives e.g. diazepam)
• phenylpropanolamine (a decongestant)
• non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. indometacin or fenoprofen)
• insulin and oral anti-diabetic medicines
• corticosteroids. If you suddenly stop taking corticosteroids you may develop
aspirin poisoning
• vitamin C
• gold compounds
• mifepristone used as an emergency contraceptive. Wait 8-12 days after
taking mifepristone before taking any aspirin products
103206/7
pg1/2
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Process
Black
Extra Power Pain Control - 16 Caplets
Wockhardt UK
FP2711; FP2792; FP2838; FP3969
L1
(w)128 x (h)420mm
2285
215322
9 pt.
XPower_16Caplet_Lit_103206-7.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
17th September, 2012
R 1st PDF sent on - 19TH OCT. 2012
R 2nd PDF sent on - 6TH NOV. 2012
R 3rd PDF sent on - 4TH DEC. 2012
R 4th PDF sent on - 30TH JAN. 2013
R 5th PDF sent on - 13TH FEB. 2013
R 6th PDF sent on - 10TH JULY 2013
R 7th PDF sent on - 2ND SEPT. 2013
R 8th PDF sent on - 14TH JAN. 2014
R 9th PDF sent on - 3RD FEB. 2014
R 10th PDF sent on- 2ND APRIL 2014
R 11th PDF sent on- 30TH MAY 2014
R 12th PDF sent on- 7TH OCT. 2014
R 13th PDF sent on- 20TH NOV. 2014
R 14th PDF sent on- 28TH JAN. 2015
R 15th PDF sent on- 28TH JAN. 2015
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends • Updated new Wockhardt logo
• Text font size increased to 9pt.
• Dimensions changed to 128 x 420mm
(Dimensions changed to accomodate bigger text font size)
• Pharmacode placed on 6th fold & 8mm from cutting edge
1st fold
(26.25mm)
2nd fold
(26.25mm)
3rd fold
(26.25mm)
4th fold
(26.25mm)
Always follow the instructions on the carton. If you are not sure then ask your doctor
or pharmacist for advice. Swallow caplets whole with a glass of water.
Adults, elderly and children over 16 years
• 1 to 2 caplets every 4-6 hours as required
• The dose should not be taken more frequently than every four hours
• do not take more than 8 caplets in 24 hours
• do not exceed the recommended dose
• if symptoms persist see your doctor
• do not take for more than 3 days unless you have been told to do so by your
doctor.
Take the caplets with or immediately after food to reduce the risk of getting stomach
and bowel irritation.
Do not give to children aged under 16 years, unless specifically advised by
your doctor.
If you take more Extra Power Pain Control Caplets than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Symptoms of an overdose include vomiting, dehydration, tinnitus, vertigo,
headache, nausea, dizziness, restlessness, heart failure, breathing failure,
deafness, sweating, warm extremities with racing pulse, increased breathing rate
and hyperventilation.
If you forget to take Extra Power Pain Control Caplets
If you forget a dose, take another as soon as you remember. If it is almost time for
your next dose, then do not take the missed dose at all. NEVER take a double dose
to make up for the one missed.
5th fold
3. How to take Extra Power Pain Control Caplets
(26.25mm)
• Cilostazol (for leg pain that occurs when walking due to poor circulation): the dose
of aspirin should not be greater than 80mg a day
• intravenous busulfan (used in chemotherapy to treat cancer).
Pregnancy and breast-feeding
This medicine should not be taken during pregnancy or whilst breast-feeding. Ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machinery
Extra Power Pain Control Caplets do not affect your ability to drive or use
machinery.
6th fold
7th fold
(26.25mm)
8th fold
(26.25mm)
9th fold
(26.25mm)
(26.25mm)
10th fold
(26.25mm)
11th fold
Like all medicines, Extra Power Pain Control Caplets
can cause side effects, although not everybody gets
them.
As can happen with any medicine, a few people may
develop a serious side effect. If you experience any
of the following, stop taking the medicine
immediately, and see your doctor or pharmacist:
• allergic reactions which may be • Stevens-Johnson
• Toxic epidermal
severe such as skin rash,
syndrome (symptoms
necrolysis (a severe
peeling of the skin, itching,
include fever, rash, sore skin problem with
swollen red areas of the skin,
mouth and eyes, joint
shedding of the
sometimes with shortness of
and muscle aches).
upper layer).
breath or swelling of the mouth,
lips, tongue, throat or face.
• Vomiting of blood and/or blood in
the faeces, which may result in stomach
and gut ulcers or haemorrhage.
Side effects that have been reported with Extra Power Pain Control Caplets are:
• rash
• worsening of asthma
• tremor
• anxiety
• sleep disturbance
• restlessness
• slight blood loss which may
• blood in the urine
• excitement
result in iron-deficiency
anaemia during long term use • diarrhoea
• palpitations
• changes in blood cells
• irregular heart beat
• acid reflux
• irritability
• insomnia
• stomach irritation
• increased frequency
• lumps (cysts) in
• very rare cases of
to urinate
the breasts
serious sin
reactions have
been reported
• tinnutus
• deafness
• anaemia
• indigestion
• feeling or being sick
• irritation in the nose
• asthma attacks
• liver problems
• swelling of tissues
Stomach and bowel irritation may be reduced by taking the tablets with or
immediately after food.
The use of this medicine over a long time can cause kidney problems. If you
experience any side effects or feel that the medicine is affecting you badly tell your
doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting
side effects you can help provide more information on the safety of this medicine.
(26.25mm)
4. Possible side effects
GSL
103206/7
215322
pg2/2
(26.25mm)
(26.25mm)
13th fold
(26.25mm)
14th fold
(26.25mm)
Please be ready to give the following information:
Product name
Reference number
Extra Power Pain Control Caplets
29831/0164
This is a service provided by the Royal National Institute of Blind People.
Leaflet Prepared: January 2015
15th fold
What Extra Power Pain Control Caplets contain
The active ingredients are: aspirin 300mg, paracetamol 200mg and caffeine 45mg.
The other ingredients are: povidone, hydroxypropylcellulose, stearic acid,
microcrystalline cellulose, maize starch, pregelatinised starch, hydroxypropyl
methylcellulose 5cPs, hydroxypropyl methylcellulose 15cPs, macrogol 4000.
What Extra Power Pain Control Caplets look like and the contents of the pack
Extra Power Pain Control Caplets are white, coated, capsule shaped tablets.
Extra Power Pain Control Caplets are available from on general sale in blister pack
sizes of 12 and 16 caplets.
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North,
Wrexham LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
free of charge: 0800 198 5000 (UK Only).
(26.25mm)
6. Further information
16th fold
Keep out of the reach and sight of children.
• Extra Power Pain Control Caplets should be stored in a dry place below 25°C
• Store in the original container to protect from light; do not transfer to another container
• Extra Power Pain Control Caplets should not be taken after the expiry date on the
carton; the expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help protect the environment.
12th fold
5. How to store Extra Power Pain Control Caplets
(26.25mm)
16th fold
(26.25mm)
15th fold
(26.25mm)
14th fold
(26.25mm)
13th fold
(26.25mm)
12th fold
(26.25mm)
11th fold
(26.25mm)
10th fold
9th fold
(26.25mm)
8th fold
(26.25mm)
7th fold
(26.25mm)
6th fold
(26.25mm)
5th fold
(26.25mm)
4th fold
(26.25mm)
3rd fold
(26.25mm)
2nd fold
(26.25mm)
1st fold
(26.25mm)
Neutral code not required on the leaflet artworks.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tesco Extra Power Pain Control Tablets
Aspirin, Paracetamol and Caffeine
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take
Extra Power Pain Control Tablets carefully to get the best results from them.
− Keep this leaflet. You may need to read it again while you are receiving your
treatment.
− If you have any further questions, please ask your pharmacist.
− You must contact a doctor if your symptoms worsen or do not improve after 3 days.
− If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Tesco Extra Power Pain Control Tablets. In the rest
of this leaflet it is called Extra Power Pain Control Tablets.
In this leaflet:
1. What Extra Power Pain Control Tablets are and what they are used for
2. Before you take Extra Power Pain Control Tablets
3. How to take Extra Power Pain Control Tablets
4. Possible side effects
5. How to store Extra Power Pain Control Tablets
6. Further information
1. What Extra Power Pain Control Tablets are and what they are used for
The name of your medicine is Extra Power Pain Control Tablets. These tablets
contain a combination of aspirin (pain relief and anti-inflammatory), paracetamol (a
painkiller) and caffeine (a mild stimulant).
Extra Power Pain Control Tablets are used to relieve the symptoms of the common
cold and flu; including fever, and sore throats and are also used to relieve mild to
moderate pain including, headache, period pains, and pains associated with the
joints and muscles.
2. Before you take Extra Power Pain Control Tablets
You should not take Extra Power Pain Control Tablets if you:
• are allergic (hypersensitive) to aspirin or any other non-steroidal anti-inflammatory
drugs (NSAIDs), paracetamol, caffeine or any of
the other ingredients in Extra Power Pain Control
Tablets (see section 6, Further information).
Symptoms may include rhinitis (runny nose, itchy
rash, swollen face, mouth or tongue or asthma
attack
• have had ulcers of the stomach or small intestine
(peptic ulcer disease)
• suffer from haemophilia, any other blood clotting
disorders or are taking any medicines to prevent
blood clotting
• suffer from gout.
Talk to your doctor or pharmacist before taking Extra Power Pain Control
Tablets if you:
• suffer from kidney disease or liver disease, particularly if caused by alcohol
• suffer from alcoholism
• suffer from asthma, particularly if your asthma is worsened by aspirin
• suffer from heart disease and/or high blood pressure
• if you have nasal polyps (inflamed swellings inside the nose)
• if you suffer from indigestion
• if you have an infection
• if you are a woman trying to conceive
• suffer from diabetes
• suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme
deficiency that can cause anaemia)
• are dehydrated.
Caution should be exercised when taking paracetamol products prior to (less than
72 hours before) or at the same time as intravenous busulfan.
Your blood, kidney and liver should be monitored during prolonged use as blood,
kidney and liver disorders may develop.
This medicine contains paracetamol; do not take with any other
paracetamol-containing products at the same time. Aspirin can increase the
time it takes your blood to clot; you should not take this medicine several
days before any scheduled surgery appointments.
This medicine should not be given to children under 16 years unless
specifically advised by your doctor (e.g to treat Kawasaki’s disease), due to
the association between aspirin and Reye’s syndrome, a very rare disease
that can cause damage to the brain, liver and could be fatal.
The product belongs to a group of medicines which may impair the fertility in
women. This effect is reversible on stopping the medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without prescription. The following
medicines can affect or be affected by Extra Power Pain Control Tablets:
• medicines used to treat bacterial infections (e.g. quinolone, such as enoxacin,
pipemidic acid and ciprofloxacin, sulphonamide antibiotics and isoniazid used to
treat tuberculosis)
• medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital,
primodone, sodium valporate)
• medicines used to treat depression (e.g. fluvoxamine), Selective Serotonin
Re-uptake Inhibitors (SSRIs) such as venlafaxine): if taken with aspirin products
you may increase the likelihood of bleeding.
• medicines used to treat asthma ( e.g. theophylline or zafirlukast)
• medicine used to thin the blood and stop the blood clotting (anticoagulants- e.g.
warfarin, heparin, streptokinase, clopidogrel and ticlopidine): if you take one of
these medicines with aspirin products you may increase the likelihood of bleeding
• medicines used to treat water retention (diuretics - e.g. spironolactone and
acetazolamide)
• medicines used to treat high blood pressure (ACE Inhibitors, Angiotensin-II
Receptor Antagonists and calcium channel blockers e.g. verapamil): taken with
aspirin products these medicines may not be as effective and you may suffer from
kidney problems
• medicines used to treat gout (e.g. probenecid or sulfinpyrazone). Phenylbutazone
may reduce the effect of aspirin products.
• metoclopramide and domperidone (used to treat sickness and nausea)
• oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT
• diflunisal (an anti-inflammatory painkiller)
• colestyramine (used to treat high cholesterol and in diseases of the intestine and liver)
• disulfaram (used to treat alcoholism)
• lithium (used to treat manic depression/bipolar disorder)
• mexilitine (used to treat abnormal heart rhythms)
• thiopental (used as an anaesthetic)
• kaolin (used to treat Diarrhoea)
• methotreaxate (used to treat arthritis and cancers)
• benzodiazepine medicines (sedatives e.g. diazepam)
• phenylpropanolamine (a decongestant)
• non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. indometacin or fenoprofen)
• insulin and oral anti-diabetic medicines
• corticosteroids. If you suddenly stop taking corticosteroids you may develop
aspirin poisoning
• vitamin C
• gold compounds
• mifepristone used as an emergency contraceptive. Wait 8-12 days after
taking mifepristone before taking any aspirin products.
107195/2
pg1/2
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Process
Black
Extra Power Pain Control - 16 Caplets (TESCO)
Wockhardt UK
FP3969
Daman (Bhimpore)
(w)128 x (h)420mm
2461
220346
9 pt.
XPower_16Caplet_Lit_107195-2.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
7th & 8th October, 2014
R 1st PDF sent on - 8TH OCT. 2014
R 2nd PDF sent on - 21ST NOV. 2014
R 3rd PDF sent on - 28TH JAN. 2015
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends
• Pharmacode positioned at 8mm from the cutting edge
1st fold
(26.25mm)
2nd fold
(26.25mm)
3rd fold
(26.25mm)
4th fold
(26.25mm)
Always follow the instructions on the label. If you are not sure then ask your doctor
or pharmacist for advice. Swallow tablets whole with a glass of water.
Adults, elderly and children over 16 years
• 1 to 2 tablets every 4-6 hours as required
• do not take more than 8 tablets in 24 hours
• do not exceed the recommended dose
• if symptoms persist see your doctor
• do not take for more than 3 days unless you have been told to do so by your
doctor.
Take the tablets with or immediately after food to reduce the risk of getting stomach
and bowel irritation.
Do not give to children aged under 16 years, unless specifically advised by
your doctor.
If you take more Extra Power Pain Control Tablets than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Symptoms of an overdose include vomiting, dehydration, tinnitus, vertigo,
headache, nausea, dizziness, restlessness, heart failure, breathing failure,
deafness, sweating, warm extremities with racing pulse, increased breathing rate
and hyperventilation.
If you forget to take Extra Power Pain Control Tablets
If you forget a dose, take another as soon as you remember. If it is almost time for
your next dose, then do not take the missed dose at all. NEVER take a double dose
to make up for the one missed.
5th fold
3. How to take Extra Power Pain Control Tablets
(26.25mm)
• Cilostazol (for leg pain that occurs when walking due to poor circulation): the dose
of aspirin should not be greater than 80mg a day
• intravenous busulfan (used in chemotherapy to treat cancer).
Pregnancy and breast-feeding
This medicine should not be taken during pregnancy or whilst breast-feeding. Ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machinery
Extra Power Pain Control Tablets do not affect your ability to drive and use machinery.
6th fold
7th fold
(26.25mm)
8th fold
(26.25mm)
9th fold
(26.25mm)
(26.25mm)
10th fold
(26.25mm)
11th fold
Keep out of reach and sight of children.
• Extra Power Pain Control Tablets should be stored in a dry place below 25°C
• Store in the original container to protect from light; do not transfer to another
container
• Extra Power Pain Control Tablets should not be taken after the expiry date on the
label; the expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask you
pharmacist how to dispose of medicines no longer required. These measures will
help protect the environment.
(26.25mm)
5. How to store Extra Power Pain Control Tablets
12th fold
Like all medicines, Extra Power Pain Control Tablets
can cause side effects, although not everybody gets
them.
As can happen with any medicine, a few people may
develop an allergic reaction. If you experience any
of the following, stop taking the medicine
immediately, and see your doctor or pharmacist:
• allergic reactions which may be severe such as
skin rash, peeling of the skin, itching, swollen red areas of the skin, sometimes
with shortness of breath or swelling of the mouth, lips, tongue, throat or face.
• Stevens-Johnson syndrome (symptoms include fever, rash, sore mouth and eyes,
joint and muscle aches).
• Toxic epidermal necrolysis (a severe skin problem with shredding of the upper layer).
• Vomiting blood and/or blood in the faeces, which may result in stomach and gut
ulcers or haemorrhage.
Side effects that have been reported with Extra Power Pain Control Tablets are:
• rash
• worsening of asthma
• tremor
• anxiety
• sleep disturbance
• restlessness
• excitement
• palpitations
• changes in blood cells
• irregular heart beat
• stomach irritation
• anaemia
• indigestion
• diarrhoea
• blood in the urine
• irritation in the nose
• feeling or being sick
• asthma attacks
• liver problems
• swelling of tissues
• tinnutus
• slight blood loss which • acid reflux may result in
• increased frequency
iron-deficiency anaemia
to urinate
during long term use
• insomnia
• lumps (cysts) in the breasts • very rare cases of
serious sin reactions
• deafness
• irritability
have been reported.
Stomach and bowel irritation may be reduced by taking the tablets with or
immediately after food.
The use of this medicine over a long time can cause kidney problems. If you
experience any side effects or feel that the medicine is affecting you badly tell your
doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting
side effects you can help provide more information on the safety of this medicine.
(26.25mm)
4. Possible side effects
This is a service provided by the Royal National Institute of Blind People.
Leaflet Prepared: January 2015
GSL
107195/2
220346
pg2/2
(26.25mm)
(26.25mm)
14th fold
(26.25mm)
15th fold
(26.25mm)
Please be ready to give the following information:
Product name
Reference number
Extra Power Pain Control Tablets
29831/0164
16th fold
What Extra Power Pain Control Tablets contain
The active ingredients are: aspirin 300mg, paracetamol 200mg and caffeine 45mg.
The other ingredients are: povidone, hydroxypropylcellulose, stearic acid,
microcrystalline cellulose, maize starch, pregelatinised starch, hydroxypropyl
methylcellulose 5cPs, hydroxypropyl methylcellulose 15cPs, macrogol 4000.
What Extra Power Pain Control Tablets look like and the contents of the pack
Extra Power Pain Control Tablets are white, coated, capsule shaped tablets.
Extra Power Pain Control Tablets are available from on general sale in blister pack
sizes of 12 and 16 tablets.
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North,
Wrexham LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
free of charge:
0800 198 5000 (UK Only).
13th fold
6. Further information
3rd fold
(26.25mm)
2nd fold
(26.25mm)
1st fold
(26.25mm)
Neutral code not required on the leaflet artworks.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Wockhardt Dual Action Pain Control Tablets
Aspirin, Paracetamol and Caffeine
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take
Wockhardt Dual Action Pain Control Tablets carefully to get the best results from them.
- Keep this leaflet. You may need to read it again while you are receiving your treatment.
- If you have any further questions, please ask your pharmacist.
- You must contact a doctor if your symptoms worsen or do not improve after 3
days.
- If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Wockhardt Dual Action Pain Control Tablets. In the
rest of the leaflet it is called Dual Action Pain Control Tablets.
In this leaflet:
1. What Dual Action Pain Control Tablets are and what they are used for
2. Before you take Dual Action Pain Control Tablets
3. How to take Dual Action Pain Control Tablets
4. Possible side effects
5. How to store Dual Action Pain Control Tablets
6. Further information
2. Before you take Dual Action Pain Control Tablets
(26.25mm)
16th fold
(26.25mm)
15th fold
(26.25mm)
14th fold
(26.25mm)
13th fold
(26.25mm)
12th fold
(26.25mm)
11th fold
(26.25mm)
10th fold
9th fold
(26.25mm)
8th fold
(26.25mm)
7th fold
(26.25mm)
6th fold
(26.25mm)
5th fold
4th fold
(26.25mm)
These tablets contain a combination of aspirin (pain relief and anti-inflammatory),
paracetamol (a painkiller) and caffeine (a mild stimulant).
Dual Action Pain Control Tablets are used for relief from mild to moderate pain
including headache, migraine, neuralgia, toothache, sore throat, period pains; and
symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis,
muscular aches and pains, joint swelling and stiffness, influenza, feverishness and
feverish colds.
(26.25mm)
1. What Dual Action Pain Control Tablets are and what they are used for
You should not take Dual Action Pain Control Tablets if you:
• are allergic (hypersensitive) to aspirin or any other non-steroidal anti-inflammatory
drugs (NSAIDs), paracetamol, caffeine or any of the
other ingredients in Dual Action Pain Control Tablets
(see section 6, Further information). Symptoms
may include rhinitis (runny nose, itchy rash,
swollen face, mouth or tongue or asthma attack.
• have had ulcers of the stomach or small intestine
(peptic ulcer disease)
• suffer from haemophilia, any other blood clotting
disorders or are taking any medicines to prevent
blood clotting
• suffer from gout.
Talk to your doctor or pharmacist before taking Dual Action Pain Control
Tablets if you:
• suffer from kidney disease or liver disease, particularly if caused by alcohol
• suffer from alcoholism
• suffer from asthma, particularly if your asthma is worsened by aspirin
• if you have nasal polyps (inflamed swellings inside the nose)
• if you suffer from indigestion (dyspepsia)
• if you have an infection
• if you are a woman trying to conceive
• suffer from heart disease and/or high blood pressure
• suffer from diabetes
• suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme
deficiency that can cause anaemia)
• are dehydrated.
Caution should be exercised when taking paracetamol products prior to (less than
72 hours before) or at the same time as intravenous busulfan.
Your blood, kidney and liver should be monitored during prolonged use as blood,
kidney and liver disorders may develop.
This medicine contains paracetamol; do not take with any other
paracetamol-containing products at the same time. Aspirin can increase the
time it takes your blood to clot; you should not take this medicine several
days before any scheduled surgery appointments.
This medicine should not be given to children under 16 years unless
specifically advised by your doctor (e.g. to treat Kawasaki’s disease), due to
the association between aspirin and Reye’s syndrome, a very rare disease
that can cause damage to the brain, liver and could be fatal.
This product belongs to a group of medicines which may impair the fertility in
women. This effect is reversible on stopping the medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. The following
medicines can affect or be affected by Dual Action Pain Control Tablets:
• medicines used to treat bacterial infections (e.g. quinolones such as enoxacin,
pipemidic acid and ciprofloxacin, sulphonamide antibiotics and isoniazid used to
treat tuberculosis)
• medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital,
primodone, sodium valporate). If you take sodium valproate with this medicine
you may increase the likelihood of bleeding
• medicines used to treat depression (e.g. fluvoxamine), Selective Serotonin
Re-uptake Inhibitors (SSRIs) such as venlafaxine): if taken with aspirin products
you may increase the likelihood of bleeding
• medicines used to treat asthma ( e.g. theophylline or zafirlukast)
• medicine used to thin the blood and stop the blood clotting (anticoagulants- e.g.
warfarin, heparin, streptokinase, clopidogrel and ticlopidine): if you take one of
these medicines with aspirin products you may increase the likelihood of bleeding
• medicines used to treat water retention (diuretics - e.g. spironolactone and
acetazolamide)
• medicines used to treat high blood pressure (ACE Inhibitors, Angiotensin-II
Receptor Antagonists and calcium channel blockers e.g. verapamil): taken with
aspirin products these medicines may not be as effective and you may suffer from
kidney problems
• medicines used to treat gout (e.g. probenecid or sulfinpyrazone).
Phenylbutazone may reduce the effect of aspirin products.
• metoclopramide and domperidone (used to treat sickness and nausea)
• oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT
• diflunisal (an anti-inflammatory painkiller)
• colestyramine (used to treat high cholesterol and in diseases of the intestine and liver)
• disulfiram (used to treat alcoholism)
• lithium (used to treat manic depression/bipolar disorder)
• mexilitine (used to treat abnormal heart rhythms)
• thiopental (used as an anaesthetic)
• kaolin (used to treat Diarrhoea)
• fluconazole or terbinafine (used to treat fungal infections)
• clozapine (an antipsychotic used to treat schizophrenia)
• diuretics such as hydrochlorothiazide
• ephedrine, a stimulant used in dietary supplements such as Ma Huang
• methotreaxate (used to treat arthritis and cancers)
• benzodiazepine medicines (sedatives e.g. diazepam)
• phenylpropanolamine (a decongestant)
• non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. indometacin or fenoprofen)
• insulin and oral anti-diabetic medicines
• corticosteroids. If you suddenly stop taking corticosteroids you may develop
aspirin poisoning
• vitamin C
• gold compounds
105021/4
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Process
Black
Dual Action Pain Control Tablets - 16tab
Wockhardt UK
FP3523
L1
(w)128mm x (h)420mm
2351
216520
9 pt.
Dual Action Tablets_Lit_105021-4.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
13th & 14th June, 2013
R 1st PDF sent on
R 2nd PDF sent on
R 3rd PDF sent on
R 4th PDF sent on
R 5th PDF sent on
R 6th PDF sent on
- 10TH JULY 2013
- 14TH JAN. 2014
- 3RD FEB. 2014
- 7TH OCT. 2014
- 20TH NOV. 2014
- 28TH JAN. 2015
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Non-Regulatory
Changes in detail: • Regulatory text amends • Updated new Wockhardt logo
• Text font size increased to 9pt.
• Dimensions changed to 128 x 420mm
(Dimensions changed to accomodate bigger text font size)
• Pharmacode placed on 6th fold & 8mm from cutting edge
pg1/2
1st fold
(26.25mm)
2nd fold
(26.25mm)
3rd fold
(26.25mm)
4th fold
(26.25mm)
5th fold
(26.25mm)
6th fold
(26.25mm)
7th fold
(26.25mm)
8th fold
(26.25mm)
9th fold
(26.25mm)
Like all medicines, Dual Action Pain Control Tablets can
cause side effects, although not everybody gets them.
As can happen with any medicine, a few people may
develop a serious side effect. If you experience any
of the following, stop taking the medicine
immediately, and see your doctor or pharmacist:
• Allergic reactions which may be severe such as skin rash, peeling of the skin,
itching, swollen red areas of the skin, sometimes with shortness of breath or
swelling of the mouth, lips, tongue, throat or face.
• Stevens-Johnson syndrome (symptoms include fever, rash, sore mouth and eyes,
joint and muscle aches).
• Toxic epidermal necrolysis (a severe skin problem with shedding of the upper layer).
• Vomiting of blood and/or blood in the faeces, which may result in stomach and gut
ulcers or haemorrhage.
Side effects that have been reported with Dual Action Pain Control Tablets are:
• rash
• worsening of asthma • tremor
• anxiety
• sleep disturbance
• restlessness
• slight blood loss which may
• blood in the urine
• excitement
result in iron-deficiency
anaemia during long term use • diarrhoea
• palpitations
• changes in blood cells
• irregular heart beat
• acid reflux
• irritability
• insomnia
• tinnitus
• deafness
• very rare cases of
• increased frequency
serious skin reactions to urinate
have been reported
• lumps (cysts) in
• stomach irritation
• anaemia
the breasts
• indigestion
• feeling or being sick • irritation in the nose
• asthma attacks
• liver problems
• swelling of tissues
Stomach and bowel irritation may be reduced by taking the tablets with or
immediately after food.
The use of this medicine over a long time can cause kidney problems. If you
experience any side effects or feel that the medicine is affecting you badly tell your
doctor or pharmacist immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting
side effects you can help provide more information on the safety of this medicine.
(26.25mm)
4. Possible side effects
10th fold
Always follow the instructions on the carton. If you are not sure then ask your doctor
or pharmacist for advice. Swallow tablets whole with a glass of water.
Adults, elderly and children over 16 years
• 1 to 2 tablets every 4-6 hours as required
• The dose should not be taken more frequently than every four hours
• do not take more than 8 tablets in 24 hours
• do not exceed the recommended dose
• if symptoms persist see your doctor
• do not take for more than 3 days unless you have been told to do so by your doctor.
Take the tablets with or immediately after food to reduce the risk of getting stomach
and bowel irritation.
Do not give to children aged under 16 years, unless specifically advised by
your doctor.
If you take more Dual Action Pain Control Tablets than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Symptoms of an overdose include vomiting, dehydration, tinnitus, vertigo,
headache, nausea, dizziness, restlessness, heart failure, breathing failure,
deafness, sweating, warm extremities with racing pulse, increased breathing rate
and hyperventilation.
If you forget to take Dual Action Pain Control Tablets
If you forget a dose, take another as soon as you
remember. If it is almost time for your next dose, then
do not take the missed dose at all. NEVER take a
double dose to make up for the one missed.
(26.25mm)
3. How to take Dual Action Pain Control Tablets
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• mifepristone used as an emergency contraceptive. Wait 8-12 days after taking
mifepristone before taking any aspirin products
• Cilostazol (for leg pain that occurs when walking due to poor circulation): the dose
of aspirin should not be greater than 80mg a day
• intravenous busulfan (used in chemotherapy to treat cancer).
Pregnancy and breast-feeding
This medicine should not be taken during pregnancy or whilst breast-feeding. Ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machinery
Dual Action Pain Control Tablets do not affect your ability to drive or use machinery.
105021/4
216520
pg2/2
(26.25mm)
(26.25mm)
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(26.25mm)
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(26.25mm)
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What Dual Action Pain Control Tablets contain
The active ingredients are: aspirin 300mg, paracetamol 200mg and caffeine 45mg.
The other ingredients are: povidone, hydroxypropylcellulose, stearic acid,
microcrystalline cellulose, maize starch, pregelatinised starch, hydroxypropyl
methylcellulose 5cPs, hydroxypropyl methylcellulose 15cPs, macrogol 4000.
What Dual Action Pain Control Tablets look like and the contents of the pack
Dual Action Pain Control Tablets are white, coated, capsule shaped tablets.
Dual Action Pain Control Tablets are available from on general sale in blister pack
sizes of 12 and 16 caplets.
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North,
Wrexham LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call,
free of charge: 0800 198 5000 (UK Only).
Please be ready to give the following information:
Product name
Reference number
Wockhardt Dual Action Pain Control Caplets
29831/0164
This is a service provided by the Royal National Institute of Blind People.
Leaflet Prepared: January 2015
(26.25mm)
6. Further information
16th fold
Keep out of the reach and sight of children.
• Dual Action Pain Control Tablets should be stored in a dry place below 25°C
• Store in the original container to protect from light; do not transfer to another container
• Dual Action Pain Control Tablets should not be taken after the expiry date on the
carton; the expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help protect the environment.
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5. How to store Dual Action Pain Control Tablets
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Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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