ARTHROSIN EC 500

PACKAGE LEAFLET: INFORMATION FOR THE USER

NAPROXEN
250 mg & 500 mg
GASTRO-RESISTANT
TABLETS

Read all of this leaflet carefully before you start taking
this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET
1. What Naproxen Tablets is and what it is
used for
2. What you need to know before you take
Naproxen Tablets
3. How to take Naproxen Tablets
4. Possible side effects
5. How to store Naproxen Tablets
6. Contents of the pack and other information

1. WHAT NAPROXEN TABLETS IS AND
WHAT IT IS USED FOR
Naproxen is a Non-Steroidal Anti-Inflammatory Drug (NSAID)
used to reduce pain and swelling in joint, bone or muscle
diseases (e.g. rheumatoid arthritis, osteoarthritis, gout,
ankylosing spondylitis or musculoskeletal disorders).
You must talk to a doctor if you do not feel better or if you feel
worse.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE NAPROXEN TABLETS
Do not take Naproxen Gastro-resistant tablets
 If you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6 of this leaflet)
 If you are allergic to other NSAIDs (e.g. ibuprofen, aspirin)
 If you have or have had a serious heart condition
 If you are in the last three months of your pregnancy
 If you have or have had repeated ulcers or bleeding in the
stomach or intestines
 If you have or have had problems with your liver or
kidneys.
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine
if you
 are planning a pregnancy or are having problems
becoming pregnant, as this medicine may make it more
difficult to become pregnant
 are elderly, have ulcerative colitis or Crohn’s disease, as
there is a higher risk of stomach problems (e.g. ulcers or
bleeding)
 have blood clotting problems or are taking medicines to
stop your blood clotting
 have asthma, other breathing problems, lumps in your
nose (polyps) or have had a skin rash, facial swelling or a
blocked or runny nose after taking another NSAID
 have been told that you have Systemic Lupus
Erythematosus (a condition where your immune system
attacks itself).
Medicines such as Naproxen Gastro-resistant tablets may be
linked to a small increased risk of heart attack or stroke. Any
risk is more likely with high doses or prolonged treatment. Do
not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you
might be at risk of these conditions (e.g. if you have high blood

pressure, diabetes or high cholesterol or are a smoker) you
should discuss your treatment with your doctor or pharmacist.
Children
Do not give this medicine to children under 5 years old.
Other medicines and Naproxen Tablets
Tell your doctor or pharmacist if you are taking, or have
recently taken, or might take any other medicines, even
medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines, as they may affect how this
medicine works:
 Aspirin or other NSAIDs for pain and swelling or
Probenecid to treat gout
 Methotrexate to treat cancer
 Medicines to stop your blood clotting such as warfarin
 Medicines for high blood pressure or heart failure
 Diuretics (water tablets) like furosemide
 Medicines to suppress the immune system such as
Tacrolimus or steroid hormones
 Medicines called Sulphonamides or Quinolone antibiotics
to treat bacterial infections
 Zidovudine to treat viral infections
 Digoxin to treat heart failure
 Lithium for mental health problems
 Medicines called Selective Serotonin Re-uptake Inhibitors
(SSRIs) for depression
 Phenytoin for epilepsy
 Medicines to increase urine production
 Mifepristone for abortion
 Bisphosphonates
 Colestyramine.
If you go into hospital or have treatment for other conditions,
tell the doctor that you are taking Naproxen Gastro-resistant
tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine if you are in the last three months of
your pregnancy. Avoid these tablets if you are in first six
months of your pregnancy.
Breast-feeding
If you are breast-feeding unless your doctor has advised you
to take them.
Fertility
Naproxen may make it more difficult to become pregnant.
Driving and using machines
Naproxen Gastro-resistant tablets may cause dizziness,
drowsiness, tiredness, problems with your vision, depressed
or difficulty sleeping. If affected do not drive or operate
machinery.
Naproxen Gastro-resistant tablets contains lactose
If you know you have an intolerance to lactose contact your
doctor before taking this medicine.

3. HOW TO TAKE NAPROXEN TABLETS
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.
Do not crush or chew the tablets.
Swallow them whole with a glass of water.
Dosage
Your doctor will decide your dose, as it depends on your
condition.
The recommended dose is:
Adults:
Rheumatoid arthritis, osteoarthritis and ankylosing
spondylitis - Typical dose is 500-1000 mg daily, taken in two
divided doses at 12 hour intervals. If 1 g is needed this can be
given as two 500mg doses or as a single dose.
Severe night-time pain and morning stiffness - Typical
dose is 750-1000 mg per day.
Gout - Typical dose is 750 mg, then 250 mg every 6 - 8 hours
until the attack has passed.
Musculoskeletal disorders and period pain - Typical dose
is 500 mg then 250 mg every 6 - 8 hours. Maximum daily dose
is 1250 mg.

Elderly and patients with liver and kidney problems:
Require smaller doses. Follow your doctor’s advice.
Children over 5 years of age:
Juvenile rheumatoid arthritis - The usual dose is 10 mg/kg
bodyweight a day, split into two doses at 12 hour intervals.
Naproxen tablets should not be used in children under 16
years of age for any other condition.
If you take more Naproxen Gastro-resistant tablets than
you should
Contact your doctor or pharmacist immediately. Show them
the package.
If you forget to take Naproxen Gastro-resistant tablets
Don’t worry, just take your next scheduled dose at the correct
time. Do not take a double dose to make up for forgotten
dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you get any of the following serious side effects STOP
TAKING Naproxen and tell your doctor immediately or go
to the nearest hospital emergency department:
Serious stomach or gut problems, signs include:
 Bleeding from the stomach, seen as vomit which has
blood in it, or bits that look like coffee grounds.
 Bleeding from your back passage (anus), seen as
passing black sticky bowel motions (stools) or bloody
diarrhoea.
 Ulcers or holes forming in your stomach or gut sometimes
fatal particularly in elderly. Signs include upset stomach,
stomach pain, fever, feeling or being sick.
 Problems with your pancreas. Signs include severe
stomach pain which spreads to your back.
 Worsening of ulcerative colitis or Crohn’s disease, seen
as pain, diarrhoea, vomiting and weight loss.
Allergic reactions which may cause asthma, difficulty
breathing, swelling of throat, face, hands or feet, skin rashes,
blisters or itching.
Severe skin rashes signs include blistering of skin when
exposed to sunlight (porphyria cutanea tarda) seen most on
arms face and hands.
Liver problems signs include yellowing of your skin or the
whites of your eyes (jaundice).
Feeling tired, loss of appetite, feeling or being sick and pale
coloured stools (hepatitis) and problems (including hepatitis),
shown in blood tests.
Heart attack signs include chest pain which may spread to
your neck and shoulders and down your left arm.
Stroke signs include muscle weakness and numbness. This
may only be on one side of your body. A suddenly altered
sense of smell, taste, hearing or vision, confusion.
Meningitis signs include fever, feeling or being sick, a stiff
neck, headache, depression, vertigo, drowsiness, sensitivity
to bright light and confusion (most likely in people with
autoimmune conditions such as ‘systemic lupus
erythematosus’).
Other possible side effects
Stomach and gut
 Heartburn, indigestion, stomach ache, feeling sick or
being sick, constipation, diarrhoea, wind.
Blood
 Blood problems, like anaemia or changes to the numbers
of white blood cells.
Mental illness
 Having difficulty sleeping or changes in your patterns of
dreaming.
 Depression.
 Confusion or seeing and possibly hearing things that are
not there (hallucinations).
Nervous system
 Headache.
 Fits or seizures, feeling dizzy or light-headed or sleepy.
 Pins and needles or numbness of your hands and feet.
 Difficulty with your memory or concentration.
Eyes and ears
 Changes to your eyesight, eye pain.
 Changes to your hearing, including ringing in the ears
(tinnitus) and hearing loss.

 Dizziness that causes problems with your balance.
Heart and circulation
 Swelling of your hands, feet or legs (oedema), this may
be with chest pains, tiredness, shortness of breath
(cardiac failure).
 A fluttering feeling in your heart (palpitations), slow heart
beat or high blood pressure.
 Problems with the way your heart pumps blood around
the body or damage to your blood vessels. Signs may
include tiredness, shortness of breath, feeling faint,
general pain.
Chest
 Difficulty breathing, including shortness of breath,
wheezing or coughing.
 Pneumonia or swelling of your lungs.
Skin and hair
 Skin rashes including redness, hives, pimples and blisters
on your body and face.
 Bruising, itching, sweating, skin being more sensitive to
the sun or hair loss.
Urinary
 Blood in your water (urine) or kidney problems.
Other
Thirst, fever, feeling tired or generally unwell, a sore mouth or
mouth ulcers, problems for women in getting pregnant,
‘Systemic lupus erythematosus’ (SLE). Signs include fever,
rash, problems with your kidneys and joint pain.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects 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.

5. HOW TO STORE NAPROXEN TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original container and
keep the container tightly closed.
Do not use this medicine after the expiry date, which is stated
on the package. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Naproxen Gastro-resistant tablets contains
The active ingredient in this medicine is naproxen. The other
ingredients are lactose, potato starch, povidone, glycerol,
sodium starch glycollate, magnesium stearate, eudragit L
12.5 and L30D, triacetin, talc, polyethylene glycol and
simethicone emulsion.
What Naproxen Gastro-resistant tablets looks like and
contents of the pack
Naproxen 250 mg Gastro-resistant tablets are oval white
tablets with no markings. Naproxen 500 mg Gastro-resistant
tablets are oblong white tablets with a break line engraved on
one side.
The tablets come in blisters packs and containers of 8, 20, 56,
60, 84, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus
Manufacturer
Haupt Pharma Berlin GmbH,
Moosrosenstraße 7, 12347 Berlin, Germany
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last amended in 06/2017
CL0144-0145/O/PIL1/CL3

PACKAGE LEAFLET: INFORMATION FOR THE USER

NAPROXEN
250 mg & 500 mg
GASTRO-RESISTANT
TABLETS

Read all of this leaflet carefully before you start taking
this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET
1. What Naproxen Tablets is and what it is
used for
2. What you need to know before you take
Naproxen Tablets
3. How to take Naproxen Tablets
4. Possible side effects
5. How to store Naproxen Tablets
6. Contents of the pack and other information

1. WHAT NAPROXEN TABLETS IS AND
WHAT IT IS USED FOR
Naproxen is a Non-Steroidal Anti-Inflammatory Drug (NSAID)
used to reduce pain and swelling in joint, bone or muscle
diseases (e.g. rheumatoid arthritis, osteoarthritis, gout,
ankylosing spondylitis or musculoskeletal disorders).
You must talk to a doctor if you do not feel better or if you feel
worse.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE NAPROXEN TABLETS
Do not take Naproxen Gastro-resistant tablets
 If you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6 of this leaflet)
 If you are allergic to other NSAIDs (e.g. ibuprofen, aspirin)
 If you have or have had a serious heart condition
 If you are in the last three months of your pregnancy
 If you have or have had repeated ulcers or bleeding in the
stomach or intestines
 If you have or have had problems with your liver or
kidneys.
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine
if you
 are planning a pregnancy or are having problems
becoming pregnant, as this medicine may make it more
difficult to become pregnant
 are elderly, have ulcerative colitis or Crohn’s disease, as
there is a higher risk of stomach problems (e.g. ulcers or
bleeding)
 have blood clotting problems or are taking medicines to
stop your blood clotting
 have asthma, other breathing problems, lumps in your
nose (polyps) or have had a skin rash, facial swelling or a
blocked or runny nose after taking another NSAID
 have been told that you have Systemic Lupus
Erythematosus (a condition where your immune system
attacks itself).
Medicines such as Naproxen Gastro-resistant tablets may be
linked to a small increased risk of heart attack or stroke. Any
risk is more likely with high doses or prolonged treatment. Do
not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you
might be at risk of these conditions (e.g. if you have high blood

pressure, diabetes or high cholesterol or are a smoker) you
should discuss your treatment with your doctor or pharmacist.
Children
Do not give this medicine to children under 5 years old.
Other medicines and Naproxen Tablets
Tell your doctor or pharmacist if you are taking, or have
recently taken, or might take any other medicines, even
medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines, as they may affect how this
medicine works:
 Aspirin or other NSAIDs for pain and swelling or
Probenecid to treat gout
 Methotrexate to treat cancer
 Medicines to stop your blood clotting such as warfarin
 Medicines for high blood pressure or heart failure
 Diuretics (water tablets) like furosemide
 Medicines to suppress the immune system such as
Tacrolimus or steroid hormones
 Medicines called Sulphonamides or Quinolone antibiotics
to treat bacterial infections
 Zidovudine to treat viral infections
 Digoxin to treat heart failure
 Lithium for mental health problems
 Medicines called Selective Serotonin Re-uptake Inhibitors
(SSRIs) for depression
 Phenytoin for epilepsy
 Medicines to increase urine production
 Mifepristone for abortion
 Bisphosphonates
 Colestyramine.
If you go into hospital or have treatment for other conditions,
tell the doctor that you are taking Naproxen Gastro-resistant
tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine if you are in the last three months of
your pregnancy. Avoid these tablets if you are in first six
months of your pregnancy.
Breast-feeding
If you are breast-feeding unless your doctor has advised you
to take them.
Fertility
Naproxen may make it more difficult to become pregnant.
Driving and using machines
Naproxen Gastro-resistant tablets may cause dizziness,
drowsiness, tiredness, problems with your vision, depressed
or difficulty sleeping. If affected do not drive or operate
machinery.
Naproxen Gastro-resistant tablets contains lactose
If you know you have an intolerance to lactose contact your
doctor before taking this medicine.

3. HOW TO TAKE NAPROXEN TABLETS
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.
Do not crush or chew the tablets.
Swallow them whole with a glass of water.
Dosage
Your doctor will decide your dose, as it depends on your
condition.
The recommended dose is:
Adults:
Rheumatoid arthritis, osteoarthritis and ankylosing
spondylitis - Typical dose is 500-1000 mg daily, taken in two
divided doses at 12 hour intervals. If 1 g is needed this can be
given as two 500mg doses or as a single dose.
Severe night-time pain and morning stiffness - Typical
dose is 750-1000 mg per day.
Gout - Typical dose is 750 mg, then 250 mg every 6 - 8 hours
until the attack has passed.
Musculoskeletal disorders and period pain - Typical dose
is 500 mg then 250 mg every 6 - 8 hours. Maximum daily dose
is 1250 mg.

Elderly and patients with liver and kidney problems:
Require smaller doses. Follow your doctor’s advice.
Children over 5 years of age:
Juvenile rheumatoid arthritis - The usual dose is 10 mg/kg
bodyweight a day, split into two doses at 12 hour intervals.
Naproxen tablets should not be used in children under 16
years of age for any other condition.
If you take more Naproxen Gastro-resistant tablets than
you should
Contact your doctor or pharmacist immediately. Show them
the package.
If you forget to take Naproxen Gastro-resistant tablets
Don’t worry, just take your next scheduled dose at the correct
time. Do not take a double dose to make up for forgotten
dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you get any of the following serious side effects STOP
TAKING Naproxen and tell your doctor immediately or go
to the nearest hospital emergency department:
Serious stomach or gut problems, signs include:
 Bleeding from the stomach, seen as vomit which has
blood in it, or bits that look like coffee grounds.
 Bleeding from your back passage (anus), seen as
passing black sticky bowel motions (stools) or bloody
diarrhoea.
 Ulcers or holes forming in your stomach or gut sometimes
fatal particularly in elderly. Signs include upset stomach,
stomach pain, fever, feeling or being sick.
 Problems with your pancreas. Signs include severe
stomach pain which spreads to your back.
 Worsening of ulcerative colitis or Crohn’s disease, seen
as pain, diarrhoea, vomiting and weight loss.
Allergic reactions which may cause asthma, difficulty
breathing, swelling of throat, face, hands or feet, skin rashes,
blisters or itching.
Severe skin rashes signs include blistering of skin when
exposed to sunlight (porphyria cutanea tarda) seen most on
arms face and hands.
Liver problems signs include yellowing of your skin or the
whites of your eyes (jaundice).
Feeling tired, loss of appetite, feeling or being sick and pale
coloured stools (hepatitis) and problems (including hepatitis),
shown in blood tests.
Heart attack signs include chest pain which may spread to
your neck and shoulders and down your left arm.
Stroke signs include muscle weakness and numbness. This
may only be on one side of your body. A suddenly altered
sense of smell, taste, hearing or vision, confusion.
Meningitis signs include fever, feeling or being sick, a stiff
neck, headache, depression, vertigo, drowsiness, sensitivity
to bright light and confusion (most likely in people with
autoimmune conditions such as ‘systemic lupus
erythematosus’).
Other possible side effects
Stomach and gut
 Heartburn, indigestion, stomach ache, feeling sick or
being sick, constipation, diarrhoea, wind.
Blood
 Blood problems, like anaemia or changes to the numbers
of white blood cells.
Mental illness
 Having difficulty sleeping or changes in your patterns of
dreaming.
 Depression.
 Confusion or seeing and possibly hearing things that are
not there (hallucinations).
Nervous system
 Headache.
 Fits or seizures, feeling dizzy or light-headed or sleepy.
 Pins and needles or numbness of your hands and feet.
 Difficulty with your memory or concentration.
Eyes and ears
 Changes to your eyesight, eye pain.
 Changes to your hearing, including ringing in the ears
(tinnitus) and hearing loss.

 Dizziness that causes problems with your balance.
Heart and circulation
 Swelling of your hands, feet or legs (oedema), this may
be with chest pains, tiredness, shortness of breath
(cardiac failure).
 A fluttering feeling in your heart (palpitations), slow heart
beat or high blood pressure.
 Problems with the way your heart pumps blood around
the body or damage to your blood vessels. Signs may
include tiredness, shortness of breath, feeling faint,
general pain.
Chest
 Difficulty breathing, including shortness of breath,
wheezing or coughing.
 Pneumonia or swelling of your lungs.
Skin and hair
 Skin rashes including redness, hives, pimples and blisters
on your body and face.
 Bruising, itching, sweating, skin being more sensitive to
the sun or hair loss.
Urinary
 Blood in your water (urine) or kidney problems.
Other
Thirst, fever, feeling tired or generally unwell, a sore mouth or
mouth ulcers, problems for women in getting pregnant,
‘Systemic lupus erythematosus’ (SLE). Signs include fever,
rash, problems with your kidneys and joint pain.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects 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.

5. HOW TO STORE NAPROXEN TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original container and
keep the container tightly closed.
Do not use this medicine after the expiry date, which is stated
on the package. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Naproxen Gastro-resistant tablets contains
The active ingredient in this medicine is naproxen. The other
ingredients are lactose, potato starch, povidone, glycerol,
sodium starch glycollate, magnesium stearate, eudragit L
12.5 and L30D, triacetin, talc, polyethylene glycol and
simethicone emulsion.
What Naproxen Gastro-resistant tablets looks like and
contents of the pack
Naproxen 250 mg Gastro-resistant tablets are oval white
tablets with no markings. Naproxen 500 mg Gastro-resistant
tablets are oblong white tablets with a break line engraved on
one side.
The tablets come in blisters packs and containers of 8, 20, 56,
60, 84, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
84 Pembroke Road, London, W8 6NX, UK
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last amended in 06/2017
CL0144-0145/O/PIL2/CL3

PACKAGE LEAFLET: INFORMATION FOR THE USER

ARTHROSIN EC
250 mg & 500 mg
GASTRO-RESISTANT
TABLETS
Naproxen

Read all of this leaflet carefully before you start taking
this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET
1. What Arthrosin EC Tablets is and what it is
used for
2. What you need to know before you take
Arthrosin EC Tablets
3. How to take Arthrosin EC Tablets
4. Possible side effects
5. How to store Arthrosin EC Tablets
6. Contents of the pack and other information

1. WHAT ARTHROSIN EC TABLETS IS
AND WHAT IT IS USED FOR
Arthrosin EC is a Non-Steroidal Anti-Inflammatory Drug
(NSAID) used to reduce pain and swelling in joint, bone or
muscle diseases (e.g. rheumatoid arthritis, osteoarthritis, gout,
ankylosing spondylitis or musculoskeletal disorders).
You must talk to a doctor if you do not feel better or if you feel
worse.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ARTHROSIN EC TABLETS
Do not take Arthrosin EC Gastro-resistant tablets
 If you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6 of this leaflet)
 If you are allergic to other NSAIDs (e.g. ibuprofen, aspirin)
 If you have or have had a serious heart condition
 If you are in the last three months of your pregnancy
 If you have or have had repeated ulcers or bleeding in the
stomach or intestines
 If you have or have had problems with your liver or
kidneys.
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine if
you
 are planning a pregnancy or are having problems
becoming pregnant, as this medicine may make it more
difficult to become pregnant
 are elderly, have ulcerative colitis or Crohn’s disease, as
there is a higher risk of stomach problems (e.g. ulcers or
bleeding)
 have blood clotting problems or are taking medicines to
stop your blood clotting
 have asthma, other breathing problems, lumps in your
nose (polyps) or have had a skin rash, facial swelling or a
blocked or runny nose after taking another NSAID
 have been told that you have Systemic Lupus
Erythematosus (a condition where your immune system
attacks itself).
Medicines such as Arthrosin EC Gastro-resistant tablets may be
linked to a small increased risk of heart attack or stroke. Any
risk is more likely with high doses or prolonged treatment. Do
not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you
might be at risk of these conditions (e.g. if you have high blood
pressure, diabetes or high cholesterol or are a smoker) you
should discuss your treatment with you.r doctor or pharmacist.

Children
Do not give this medicine to children under 5 years old.
Other medicines and Arthrosin EC Tablets
Tell your doctor or pharmacist if you are taking, or have
recently taken, or might take any other medicines, even
medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any
of the following medicines, as they may affect how this
medicine works:
 Aspirin or other NSAIDs for pain and swelling or
Probenecid to treat gout
 Methotrexate to treat cancer
 Medicines to stop your blood clotting such as warfarin
 Medicines for high blood pressure or heart failure
 Diuretics (water tablets) like furosemide
 Medicines to suppress the immune system such as
Tacrolimus or steroid hormones
 Medicines called Sulphonamides or Quinolone antibiotics
to treat bacterial infections
 Zidovudine to treat viral infections
 Digoxin to treat heart failure
 Lithium for mental health problems
 Medicines called Selective Serotonin Re-uptake Inhibitors
(SSRIs) for depression
 Phenytoin for epilepsy
 Medicines to increase urine production
 Mifepristone for abortion
 Bisphosphonates
 Colestyramine.
If you go into hospital or have treatment for other conditions,
tell the doctor that you are taking Arthrosin EC Gastro-resistant
tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine if you are in the last three months of
your pregnancy. Avoid these tablets if you are in first six
months of your pregnancy.
Breast-feeding
If you are breast-feeding unless your doctor has advised you to
take them.
Fertility
Arthrosin EC may make it more difficult to become pregnant.
Driving and using machines
Arthrosin EC Gastro-resistant tablets may cause dizziness,
drowsiness, tiredness, problems with your vision, depressed
or difficulty sleeping. If affected do not drive or operate
machinery.
Arthrosin EC Gastro-resistant tablets contains lactose
If you know you have an intolerance to lactose contact your
doctor before taking this medicine.

3. HOW TO TAKE ARTHROSIN EC TABLETS
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.
Do not crush or chew the tablets.
Swallow them whole with a glass of water.
Dosage
Your doctor will decide your dose, as it depends on your
condition.
The recommended dose is:
Adults:
Rheumatoid arthritis, osteoarthritis and ankylosing
spondylitis - Typical dose is 500-1000 mg daily, taken in two
divided doses at 12 hour intervals. If 1 g is needed this can be
given as two 500mg doses or as a single dose.
Severe night-time pain and morning stiffness - Typical
dose is 750-1000 mg per day.
Gout - Typical dose is 750 mg, then 250 mg every 6 - 8 hours
until the attack has passed.
Musculoskeletal disorders and period pain - Typical dose is
500 mg then 250 mg every 6 - 8 hours. Maximum daily dose is
1250 mg.
Elderly and patients with liver and kidney problems:
Require smaller doses. Follow your doctor’s advice.

Children over 5 years of age:
Juvenile rheumatoid arthritis - The usual dose is 10 mg/kg
bodyweight a day, split into two doses at 12 hour intervals.
Arthrosin EC tablets should not be used in children under 16
years of age for any other condition.
If you take more Arthrosin EC Gastro-resistant tablets
than you should
Contact your doctor or pharmacist immediately. Show them
the package.
If you forget to take Arthrosin EC Gastro-resistant tablets
Don’t worry, just take your next scheduled dose at the correct
time. Do not take a double dose to make up for forgotten dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you get any of the following serious side effects STOP
TAKING Arthrosin EC and tell your doctor immediately or
go to the nearest hospital emergency department:
Serious stomach or gut problems, signs include:
 Bleeding from the stomach, seen as vomit which has
blood in it, or bits that look like coffee grounds.
 Bleeding from your back passage (anus), seen as passing
black sticky bowel motions (stools) or bloody diarrhoea.
 Ulcers or holes forming in your stomach or gut sometimes
fatal particularly in elderly. Signs include upset stomach,
stomach pain, fever, feeling or being sick.
 Problems with your pancreas. Signs include severe
stomach pain which spreads to your back.
 Worsening of ulcerative colitis or Crohn’s disease, seen as
pain, diarrhoea, vomiting and weight loss.
Allergic reactions which may cause asthma, difficulty
breathing, swelling of throat, face, hands or feet, skin rashes,
blisters or itching
Severe skin rashes signs include blistering of skin when
exposed to sunlight (porphyria cutanea tarda) seen most on
arms face and hands.
Liver problems signs include yellowing of your skin or the
whites of your eyes (jaundice).
Feeling tired, loss of appetite, feeling or being sick and pale
coloured stools (hepatitis) and problems (including hepatitis),
shown in blood tests.
Heart attack signs include chest pain which may spread to
your neck and shoulders and down your left arm.
Stroke signs include muscle weakness and numbness. This
may only be on one side of your body. A suddenly altered
sense of smell, taste, hearing or vision, confusion.
Meningitis signs include fever, feeling or being sick, a stiff
neck, headache, depression, vertigo, drowsiness, sensitivity to
bright light and confusion (most likely in people with
autoimmune conditions such as ‘systemic lupus
erythematosus’).
Other possible side effects
Stomach and gut
 Heartburn, indigestion, stomach ache, feeling sick or being
sick, constipation, diarrhoea, wind.
Blood
 Blood problems, like anaemia or changes to the numbers
of white blood cells.
Mental illness
 Having difficulty sleeping or changes in your patterns of
dreaming.
 Depression.
 Confusion or seeing and possibly hearing things that are
not there (hallucinations).
Nervous system
 Headache.
 Fits or seizures, feeling dizzy or light-headed or sleepy.
 Pins and needles or numbness of your hands and feet.
 Difficulty with your memory or concentration.
Eyes and ears
 Changes to your eyesight, eye pain.
 Changes to your hearing, including ringing in the ears
(tinnitus) and hearing loss.
 Dizziness that causes problems with your balance.
Heart and circulation
 Swelling of your hands, feet or legs (oedema), this may be
with chest pains, tiredness, shortness of breath (cardiac
failure).

 A fluttering feeling in your heart (palpitations), slow heart
beat or high blood pressure.
 Problems with the way your heart pumps blood around the
body or damage to your blood vessels. Signs may include
tiredness, shortness of breath, feeling faint, general pain.
Chest
 Difficulty breathing, including shortness of breath,
wheezing or coughing.
 Pneumonia or swelling of your lungs.
Skin and hair
 Skin rashes including redness, hives, pimples and blisters
on your body and face.
 Bruising, itching, sweating, skin being more sensitive to
the sun or hair loss.
Urinary
 Blood in your water (urine) or kidney problems.
Other
Thirst, fever, feeling tired or generally unwell, a sore mouth or
mouth ulcers, problems for women in getting pregnant,
‘Systemic lupus erythematosus’ (SLE). Signs include fever,
rash, problems with your kidneys and joint pain.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects 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.

5. HOW TO STORE ARTHROSIN EC
TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original container and
keep the container tightly closed.
Do not use this medicine after the expiry date, which is stated
on the package. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Arthrosin EC Gastro-resistant tablets contains
The active ingredient in this medicine is naproxen. The other
ingredients are lactose, potato starch, povidone, glycerol,
sodium starch glycollate, magnesium stearate, eudragit L 12.5
and L30D, triacetin, talc, polyethylene glycol and simethicone
emulsion.
What Arthrosin EC Gastro-resistant tablets looks like and
contents of the pack
Arthrosin EC 250 mg Gastro-resistant tablets are oval white
tablets with no markings. Arthrosin EC 500 mg
Gastro-resistant tablets are oblong white tablets with a break
line engraved on one side.
The tablets come in blisters packs and containers of 8, 20, 56,
60, 84, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus
Manufacturer
Haupt Pharma Berlin GmbH,
Moosrosenstraße 7, 12347 Berlin, Germany
DDSA Pharmaceuticals Limited,
84 Pembroke Road, London, W8 6NX, UK
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last amended in 06/2017
CL0144-0145/O/PIL1-Br1/CL3
CL0144-0145/O/PIL2-Br1/CL3

PACKAGE LEAFLET: INFORMATION FOR THE USER

NYCOPREN
250 mg & 500 mg
GASTRO-RESISTANT
TABLETS
Naproxen

Read all of this leaflet carefully before you start taking
this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET
1. What Nycopren Tablets is and what it is
used for
2. What you need to know before you take
Nycopren Tablets
3. How to take Nycopren Tablets
4. Possible side effects
5. How to store Nycopren Tablets
6. Contents of the pack and other information

1. WHAT NYCOPREN TABLETS IS AND
WHAT IT IS USED FOR
Nycopren is a Non-Steroidal Anti-Inflammatory Drug (NSAID)
used to reduce pain and swelling in joint, bone or muscle
diseases (e.g. rheumatoid arthritis, osteoarthritis, gout,
ankylosing spondylitis or musculoskeletal disorders).
You must talk to a doctor if you do not feel better or if you feel
worse.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE NYCOPREN TABLETS
Do not take Nycopren Gastro-resistant tablets
 If you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6 of this leaflet)
 If you are allergic to other NSAIDs (e.g. ibuprofen, aspirin)
 If you have or have had a serious heart condition
 If you are in the last three months of your pregnancy
 If you have or have had repeated ulcers or bleeding in the
stomach or intestines
 If you have or have had problems with your liver or
kidneys.
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine if
you
 are planning a pregnancy or are having problems
becoming pregnant, as this medicine may make it more
difficult to become pregnant
 are elderly, have ulcerative colitis or Crohn’s disease, as
there is a higher risk of stomach problems (e.g. ulcers or
bleeding)
 have blood clotting problems or are taking medicines to
stop your blood clotting
 have asthma, other breathing problems, lumps in your
nose (polyps) or have had a skin rash, facial swelling or a
blocked or runny nose after taking another NSAID
 have been told that you have Systemic Lupus
Erythematosus (a condition where your immune system
attacks itself).
Medicines such as Nycopren Gastro-resistant tablets may be
linked to a small increased risk of heart attack or stroke. Any
risk is more likely with high doses or prolonged treatment. Do
not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you
might be at risk of these conditions (e.g. if you have high blood
pressure, diabetes or high cholesterol or are a smoker) you
should discuss your treatment with you.r doctor or pharmacist.

Children
Do not give this medicine to children under 5 years old.
Other medicines and Nycopren Tablets
Tell your doctor or pharmacist if you are taking, or have
recently taken, or might take any other medicines, even
medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any
of the following medicines, as they may affect how this
medicine works:
 Aspirin or other NSAIDs for pain and swelling or
Probenecid to treat gout
 Methotrexate to treat cancer
 Medicines to stop your blood clotting such as warfarin
 Medicines for high blood pressure or heart failure
 Diuretics (water tablets) like furosemide
 Medicines to suppress the immune system such as
Tacrolimus or steroid hormones
 Medicines called Sulphonamides or Quinolone antibiotics
to treat bacterial infections
 Zidovudine to treat viral infections
 Digoxin to treat heart failure
 Lithium for mental health problems
 Medicines called Selective Serotonin Re-uptake Inhibitors
(SSRIs) for depression
 Phenytoin for epilepsy
 Medicines to increase urine production
 Mifepristone for abortion
 Bisphosphonates
 Colestyramine.
If you go into hospital or have treatment for other conditions,
tell the doctor that you are taking Nycopren Gastro-resistant
tablets.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine if you are in the last three months of
your pregnancy. Avoid these tablets if you are in first six
months of your pregnancy.
Breast-feeding
If you are breast-feeding unless your doctor has advised you to
take them.
Fertility
Nycopren may make it more difficult to become pregnant.
Driving and using machines
Nycopren Gastro-resistant tablets may cause dizziness,
drowsiness, tiredness, problems with your vision, depressed
or difficulty sleeping. If affected do not drive or operate
machinery.
Nycopren Gastro-resistant tablets contains lactose
If you know you have an intolerance to lactose contact your
doctor before taking this medicine.

3. HOW TO TAKE NYCOPREN TABLETS
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.
Do not crush or chew the tablets.
Swallow them whole with a glass of water.
Dosage
Your doctor will decide your dose, as it depends on your
condition.
The recommended dose is:
Adults:
Rheumatoid arthritis, osteoarthritis and ankylosing
spondylitis - Typical dose is 500-1000 mg daily, taken in two
divided doses at 12 hour intervals. If 1 g is needed this can be
given as two 500mg doses or as a single dose.
Severe night-time pain and morning stiffness - Typical
dose is 750-1000 mg per day.
Gout - Typical dose is 750 mg, then 250 mg every 6 - 8 hours
until the attack has passed.
Musculoskeletal disorders and period pain - Typical dose is
500 mg then 250 mg every 6 - 8 hours. Maximum daily dose is
1250 mg.
Elderly and patients with liver and kidney problems:
Require smaller doses. Follow your doctor’s advice.

Children over 5 years of age:
Juvenile rheumatoid arthritis - The usual dose is 10 mg/kg
bodyweight a day, split into two doses at 12 hour intervals.
Nycopren tablets should not be used in children under 16
years of age for any other condition.
If you take more Nycopren Gastro-resistant tablets than
you should
Contact your doctor or pharmacist immediately. Show them
the package.
If you forget to take Nycopren Gastro-resistant tablets
Don’t worry, just take your next scheduled dose at the correct
time. Do not take a double dose to make up for forgotten dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you get any of the following serious side effects STOP
TAKING Nycopren and tell your doctor immediately or go
to the nearest hospital emergency department:
Serious stomach or gut problems, signs include:
 Bleeding from the stomach, seen as vomit which has
blood in it, or bits that look like coffee grounds.
 Bleeding from your back passage (anus), seen as passing
black sticky bowel motions (stools) or bloody diarrhoea.
 Ulcers or holes forming in your stomach or gut sometimes
fatal particularly in elderly. Signs include upset stomach,
stomach pain, fever, feeling or being sick.
 Problems with your pancreas. Signs include severe
stomach pain which spreads to your back.
 Worsening of ulcerative colitis or Crohn’s disease, seen as
pain, diarrhoea, vomiting and weight loss.
Allergic reactions which may cause asthma, difficulty
breathing, swelling of throat, face, hands or feet, skin rashes,
blisters or itching.
Severe skin rashes signs include blistering of skin when
exposed to sunlight (porphyria cutanea tarda) seen most on
arms face and hands.
Liver problems signs include yellowing of your skin or the
whites of your eyes (jaundice).
Feeling tired, loss of appetite, feeling or being sick and pale
coloured stools (hepatitis) and problems (including hepatitis),
shown in blood tests.
Heart attack signs include chest pain which may spread to
your neck and shoulders and down your left arm.
Stroke signs include muscle weakness and numbness. This
may only be on one side of your body. A suddenly altered
sense of smell, taste, hearing or vision, confusion.
Meningitis signs include fever, feeling or being sick, a stiff
neck, headache, depression, vertigo, drowsiness, sensitivity to
bright light and confusion (most likely in people with
autoimmune conditions such as ‘systemic lupus
erythematosus’).
Other possible side effects
Stomach and gut
 Heartburn, indigestion, stomach ache, feeling sick or being
sick, constipation, diarrhoea, wind.
Blood
 Blood problems, like anaemia or changes to the numbers
of white blood cells.
Mental illness
 Having difficulty sleeping or changes in your patterns of
dreaming.
 Depression.
 Confusion or seeing and possibly hearing things that are
not there (hallucinations).
Nervous system
 Headache.
 Fits or seizures, feeling dizzy or light-headed or sleepy.
 Pins and needles or numbness of your hands and feet.
 Difficulty with your memory or concentration.
Eyes and ears
 Changes to your eyesight, eye pain.
 Changes to your hearing, including ringing in the ears
(tinnitus) and hearing loss.
 Dizziness that causes problems with your balance.
Heart and circulation
 Swelling of your hands, feet or legs (oedema), this may be
with chest pains, tiredness, shortness of breath (cardiac
failure).

 A fluttering feeling in your heart (palpitations), slow heart
beat or high blood pressure.
 Problems with the way your heart pumps blood around the
body or damage to your blood vessels. Signs may include
tiredness, shortness of breath, feeling faint, general pain.
Chest
 Difficulty breathing, including shortness of breath,
wheezing or coughing.
 Pneumonia or swelling of your lungs.
Skin and hair
 Skin rashes including redness, hives, pimples and blisters
on your body and face.
 Bruising, itching, sweating, skin being more sensitive to
the sun or hair loss.
Urinary
 Blood in your water (urine) or kidney problems.
Other
Thirst, fever, feeling tired or generally unwell, a sore mouth or
mouth ulcers, problems for women in getting pregnant,
‘Systemic lupus erythematosus’ (SLE). Signs include fever,
rash, problems with your kidneys and joint pain.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects 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.

5. HOW TO STORE NYCOPREN TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original container and
keep the container tightly closed.
Do not use this medicine after the expiry date, which is stated
on the package. The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Nycopren Gastro-resistant tablets contains
The active ingredient in this medicine is naproxen. The other
ingredients are lactose, potato starch, povidone, glycerol,
sodium starch glycollate, magnesium stearate, eudragit L 12.5
and L30D, triacetin, talc, polyethylene glycol and simethicone
emulsion.
What Nycopren Gastro-resistant tablets looks like and
contents of the pack
Nycopren 250 mg Gastro-resistant tablets are oval white
tablets with no markings. Nycopren 500 mg Gastro-resistant
tablets are oblong white tablets with a break line engraved on
one side.
The tablets come in blisters packs and containers of 8, 20, 56,
60, 84, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus
Manufacturer
Haupt Pharma Berlin GmbH,
Moosrosenstraße 7, 12347 Berlin, Germany
DDSA Pharmaceuticals Limited,
84 Pembroke Road, London, W8 6NX, UK
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last amended in 06/2017
CL0144-0145/O/PIL1-Br2/CL3
CL0144-0145/O/PIL2-Br2/CL3