OMNIC XL 400MICROGRAMS TABLETS

Package leaflet: Information for the user

Flomaxtra® XL 400micrograms tablets
(tamsulosin hydrochloride)
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, pharmacist or
nurse.
This medicine has been prescribed for you. 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Flomaxtra® XL 400micrograms tablets but it
will be referred to as Flomaxtra XL throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Flomaxtra XL is and what it is used for
What you need to know before you use Flomaxtra XL
How to use Flomaxtra XL
Possible side effects
How to store Flomaxtra XL
Contents of the pack and other information

Children and adolescents
Do not give this medicine to children or adolescents under 18 years
because it does not work in this population.
Other medicines and Flomaxtra XL
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. This is because Flomaxtra XL can affect
the way that some other medicines work and some other medicines can
affect the way that Flomaxtra XL works.
In particular tell your doctor or pharmacist if you are taking:
Medicines to lower your blood pressure such as verapamil and
diltiazem
Medicines to treat HIV such as ritonavir or indinavir.
Medicines to treat a fungal infection such as ketaconazole or
itraconazole
Other alpha blockers such as doxazosin, indoramin, prazosin or
alfuzosin
Erythromycin, an antibiotic used to treat infections
Please inform your doctor that you are on Flomaxtra XL before any
operation or dental procedure as there is a potential that your medicine
may interfere with the effects of the anaesthetic.

1. What Flomaxtra XL is and what it is used for

Pregnancy, breast-feeding and fertility
Flomaxtra XL is not indicated for use in women.

What is Flomaxtra XL
Flomaxtra XL contains the active substance tamsulosin hydrochloride. It
acts by relaxing the muscles in the prostate and urethra (the tube that
carries urine to the outside), and lets urine pass more readily through the
urethra and aids urination.

In men, abnormal ejaculation has been reported (ejaculation disorder). This
means that the semen does not leave the body via the urethra, but instead
goes into the bladder (retrograde ejaculation) or the ejaculation volume is
reduced or absent (ejaculation failure). This phenomenon is harmless.

In the prostate gland, bladder and urethra there are specialised cells
containing alpha1A-receptors that cause the muscles in the urethra to
tighten. Flomaxtra XL is an alpha1A-adrenoceptor blocker, which reduces
the action of these specialised cells and relaxes the muscles making it
easier to pass water.

Driving and using machines
There is no information available on whether Flomaxtra XL affects the
ability to drive or to operate machinery or equipment. However, it is known
that Flomaxtra XL may cause drowsiness, blurred vision, dizziness and
fainting. If you suffer from these do not drive or operate machinery.

What Flomaxtra XL is used for
Flomaxtra XL is used to treat the symptoms associated with benign
prostatic hyperplasia (BPH) which is enlargement of the prostate gland.
These symptoms include difficulty in starting to pass water, frequent trips to
the toilet to pass water, a feeling of not completely emptying the bladder
and having to get up several times in the night to pass water.

3. How to take Flomaxtra XL

2. What you need to know before you use Flomaxtra XL
Do not use Flomaxtra XL if you
are allergic to tamsulosin or any of the other ingredients of
Flomaxtra XL (listed in Section 6´)
have a severe liver condition
have ever fainted or felt dizzy when suddenly sitting or standing
up. Dizziness can sometimes occur when taking Flomaxtra XL,
particularly if you are also taking other alpha1- blockers. If you do feel
weak or dizzy make sure you sit or lie down straight away until the
symptoms have disappeared.
Warnings and precautions
Talk to your doctor before using Flomaxtra XL
If you have kidney problems
If you are undergoing or have been scheduled for eye surgery because
of cloudiness of the lens (cataract) or increased pressure in the eye
(glaucoma).
Please inform your eye specialist that you have previously used, are
using or are planning to use tamsulosin hydrochloride. The specialist
can then take appropriate precautions with respect to medication and
surgical techniques to be used. Ask your doctor whether or not you
should postpone or temporarily stop taking this medicine when
undergoing eye surgery because of a cloudy lens (cataract) or
increased pressure in the eye (glaucoma).

Always take this medicine exactly as your doctor, pharmacist or nurse has
told you. Check with your doctor, pharmacist or nurse if you are not sure.
The recommended dose for adults and the elderly is one tablet each day. It
can be taken with or without food. Swallow the tablet whole. Do not crunch
or chew. Your doctor may want to examine you from time to time whilst you
are taking this medicine.
If you take more Flomaxtra XL than you should
If you have taken too many tablets, contact your doctor immediately or go
to the nearest hospital casualty department taking any remaining
medication and this patient information leaflet with you.
If you forget to take Flomaxtra XL
You may take your tablet later the same day if you have forgotten to take it
earlier. If you have missed a day, just continue to take your daily tablet
from the next day. Do not take a double dose to make up for a missed
dose.
If you have any further questions on the use of this product, ask your
doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking this medicine and consult your doctor immediately if any
of the following occur – you may need medical treatment.
Rare (affects less than 1 in 1000 people)
Swelling of the face, throat or tongue with breathing problems linked to
allergy

Very rare (affects less than 1 in 10,000 people)
Persistent painful erection usually unrelated to sexual activity.
Rash, inflammation and blistering of the skin and/or mucous
membranes of the lips, eyes, mouth, nasal passages or genitals
(Stevens-Johnson syndrome).
Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia,
tachycardia), difficult breathing (dyspnoea).
The following side effects have also been reported:
Common (affects less than 1 in 10 people)
dizziness
abnormal ejaculation (ejaculation disorder). This means that semen
does not leave the body via the urethra, but instead goes into the
bladder (retrograde ejaculation) or the ejaculation volume is reduced or
absent (ejaculation failure). This phenomenon is harmless.
Uncommon (affects less than 1 in 100 people)
weakness
headache
runny or blocked nose
dizziness as you sit or stand up
palpitations (rapid or irregular heart beat)
gastro-intestinal symptoms such as nausea and vomiting (feeling or
being sick), diarrhoea or constipation
hypersensitivity reactions such as rash, itching, redness, local swelling
and breathing problems
Rare (affects less than 1 in 1000 people)
fainting
Not known (frequency cannot be estimated from the available data):
blurred vision
impaired vision
nose bleeds (epistaxis)
serious skin rashes (erythema multiforme, dermatitis exfoliative)
dry mouth
As with other medicines of this type, drowsiness, blurred vision or swelling
of the hands and feet can occur.
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.

5. How to store Flomaxtra XL
Keep out of the sight and reach of children.
Do not use Flomaxtra XL after the expiry date printed on the pack. The
expiry date refers to the last day of that month.
If the tablets become discoloured or show any other signs of
deterioration, you should consult your pharmacist who will advise you
what to do.
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 to protect the environment.

6. Contents of the pack and other information
What Flomaxtra XL contains
Your medicine is called Flomaxtra XL tablets.
Each film-coated, prolonged-release tablet contains 400micrograms
tamsulosin hydrochloride.
Flomaxtra XL tablets also contain the following inactive ingredients:
macrogol 7000000, macrogol 8 000, magnesium stearate, colloidal silica
anhydrous, butylhydroxytoluene, hypromellose, and yellow iron oxide
(E172).
What Flomaxtra XL looks like and contents of the pack
Flomaxtra XL are round, mustard yellow tablets marked ‘04’ on one side
and plain on the reverse.
Flomaxtra XL tablets are available as blister packs of 30 tablets.
Manufactured by: Astellas Pharma A/S, Naverland 4, 2600 Glostrup,
Denmark.
Procured from within the EU and repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Flomaxtra® XL 400micrograms tablets
PL 18799/2778
Leaflet date: 18.11.2015

POM

Package leaflet: Information for the user

Omnic® XL 400micrograms tablets
(tamsulosin hydrochloride)
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, pharmacist or
nurse.
This medicine has been prescribed for you. 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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Omnic® XL 400micrograms tablets but it will
be referred to as Omnic XL throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Omnic XL is and what it is used for
What you need to know before you use Omnic XL
How to use Omnic XL
Possible side effects
How to store Omnic XL
Contents of the pack and other information

Children and adolescents
Do not give this medicine to children or adolescents under 18 years
because it does not work in this population.
Other medicines and Omnic XL
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. This is because Omnic XL can affect the
way that some other medicines work and some other medicines can affect
the way that Omnic XL works.
In particular tell your doctor or pharmacist if you are taking:
Medicines to lower your blood pressure such as verapamil and
diltiazem
Medicines to treat HIV such as ritonavir or indinavir.
Medicines to treat a fungal infection such as ketaconazole or
itraconazole
Other alpha blockers such as doxazosin, indoramin, prazosin or
alfuzosin
Erythromycin, an antibiotic used to treat infections
Please inform your doctor that you are on Omnic XL before any operation
or dental procedure as there is a potential that your medicine may interfere
with the effects of the anaesthetic.

1. What Omnic XL is and what it is used for

Pregnancy, breast-feeding and fertility
Omnic XL is not indicated for use in women.

What is Omnic XL
Omnic XL contains the active substance tamsulosin hydrochloride. It acts
by relaxing the muscles in the prostate and urethra (the tube that carries
urine to the outside), and lets urine pass more readily through the urethra
and aids urination.

In men, abnormal ejaculation has been reported (ejaculation disorder). This
means that the semen does not leave the body via the urethra, but instead
goes into the bladder (retrograde ejaculation) or the ejaculation volume is
reduced or absent (ejaculation failure). This phenomenon is harmless.

In the prostate gland, bladder and urethra there are specialised cells
containing alpha1A-receptors that cause the muscles in the urethra to
tighten. Omnic XL is an alpha1A-adrenoceptor blocker, which reduces the
action of these specialised cells and relaxes the muscles making it easier
to pass water.

Driving and using machines
There is no information available on whether Omnic XL affects the ability to
drive or to operate machinery or equipment. However, it is known that
Omnic XL may cause drowsiness, blurred vision, dizziness and fainting. If
you suffer from these do not drive or operate machinery.

What Omnic XL is used for
Omnic XL is used to treat the symptoms associated with benign prostatic
hyperplasia (BPH) which is enlargement of the prostate gland. These
symptoms include difficulty in starting to pass water, frequent trips to the
toilet to pass water, a feeling of not completely emptying the bladder and
having to get up several times in the night to pass water.

3. How to take Omnic XL

2. What you need to know before you use Omnic XL
Do not use Omnic XL if you
are allergic to tamsulosin or any of the other ingredients of Omnic
XL (listed in Section 6´)
have a severe liver condition
have ever fainted or felt dizzy when suddenly sitting or standing
up. Dizziness can sometimes occur when taking Omnic XL, particularly
if you are also taking other alpha1- blockers. If you do feel weak or
dizzy make sure you sit or lie down straight away until the symptoms
have disappeared.
Warnings and precautions
Talk to your doctor before using Omnic XL
If you have kidney problems
If you are undergoing or have been scheduled for eye surgery because
of cloudiness of the lens (cataract) or increased pressure in the eye
(glaucoma).
Please inform your eye specialist that you have previously used, are
using or are planning to use tamsulosin hydrochloride. The specialist
can then take appropriate precautions with respect to medication and
surgical techniques to be used. Ask your doctor whether or not you
should postpone or temporarily stop taking this medicine when
undergoing eye surgery because of a cloudy lens (cataract) or
increased pressure in the eye (glaucoma).

Always take this medicine exactly as your doctor, pharmacist or nurse has
told you. Check with your doctor, pharmacist or nurse if you are not sure.
The recommended dose for adults and the elderly is one tablet each day. It
can be taken with or without food. Swallow the tablet whole. Do not crunch
or chew. Your doctor may want to examine you from time to time whilst you
are taking this medicine.
If you take more Omnic XL than you should
If you have taken too many tablets, contact your doctor immediately or go
to the nearest hospital casualty department taking any remaining
medication and this patient information leaflet with you.
If you forget to take Omnic XL
You may take your tablet later the same day if you have forgotten to take it
earlier. If you have missed a day, just continue to take your daily tablet
from the next day. Do not take a double dose to make up for a missed
dose.
If you have any further questions on the use of this product, ask your
doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking this medicine and consult your doctor immediately if any
of the following occur – you may need medical treatment.
Rare (affects less than 1 in 1000 people)
Swelling of the face, throat or tongue with breathing problems linked to
allergy

Very rare (affects less than 1 in 10,000 people)
Persistent painful erection usually unrelated to sexual activity.
Rash, inflammation and blistering of the skin and/or mucous
membranes of the lips, eyes, mouth, nasal passages or genitals
(Stevens-Johnson syndrome).
Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia,
tachycardia), difficult breathing (dyspnoea).
The following side effects have also been reported:
Common (affects less than 1 in 10 people)
dizziness
abnormal ejaculation (ejaculation disorder). This means that semen
does not leave the body via the urethra, but instead goes into the
bladder (retrograde ejaculation) or the ejaculation volume is reduced or
absent (ejaculation failure). This phenomenon is harmless.
Uncommon (affects less than 1 in 100 people)
weakness
headache
runny or blocked nose
dizziness as you sit or stand up
palpitations (rapid or irregular heart beat)
gastro-intestinal symptoms such as nausea and vomiting (feeling or
being sick), diarrhoea or constipation
hypersensitivity reactions such as rash, itching, redness, local swelling
and breathing problems
Rare (affects less than 1 in 1000 people)
fainting
Not known (frequency cannot be estimated from the available data):
blurred vision
impaired vision
nose bleeds (epistaxis)
serious skin rashes (erythema multiforme, dermatitis exfoliative)
dry mouth
As with other medicines of this type, drowsiness, blurred vision or swelling
of the hands and feet can occur.
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.

5. How to store Omnic XL
Keep out of the sight and reach of children.
Do not use Omnic XL after the expiry date printed on the pack. The
expiry date refers to the last day of that month.
If the tablets become discoloured or show any other signs of
deterioration, you should consult your pharmacist who will advise you
what to do.
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 to protect the environment.

6. Contents of the pack and other information
What Omnic XL contains
Your medicine is called Omnic XL tablets.
Each film-coated, prolonged-release tablet contains 400micrograms
tamsulosin hydrochloride.
Omnic XL tablets also contain the following inactive ingredients: macrogol
7000000, macrogol 8 000, magnesium stearate, colloidal silica anhydrous,
butylhydroxytoluene, hypromellose, and yellow iron oxide (E172).
What Omnic XL looks like and contents of the pack
Omnic XL are round, mustard yellow tablets marked ‘04’ on one side and
plain on the reverse.
Omnic XL tablets are available as blister packs of 30 tablets.
Manufactured by: Astellas Pharma A/S, Naverland 4, 2600 Glostrup,
Denmark.
Procured from within the EU and repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Omnic® XL 400micrograms tablets
PL 18799/2778
Leaflet date: 18.11.2015

POM