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MEBEVERINE HYDROCHLORIDE 135MG TABLETS

Active substance(s): MEBEVERINE HYDROCHLORIDE

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Previously assessed against UK PIL dated July 2015

Add/Amend: To correct the
manufacturer address in the reason
Colofac® 135mg tablets
box and annotations on the label and
(mebeverine hydrochloride)
leaflet to 'Route de Belleville, Lieu dit
Maillard, 01400 Chatillon-surTaking Colofac 135mg
tablets with food
and drinkNo other
Read all of this leaflet carefully before you start taking this
Chalaronne,
France'.
medicine.
You can drink alcohol while you are taking Colofac 135mg tablets.
changes approved.
• Keep this leaflet. You may need to read it again.
By Nabeela Farooq at 3:19 pm, May 16, 2016

Patient Information Leaflet

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects becomes serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Colofac 135mg tablets are and what they are used for
2) Before you take Colofac 135mg tablets
3) How to take Colofac 135mg tablets
4) Possible side effects
5) How to store Colofac 135mg tablets
6) Further information
1) WHAT COLOFAC 135MG TABLETS ARE AND WHAT THEY
ARE USED FOR

Colofac 135mg tablets contain mebeverine hydrochloride. This belongs
to a group of medicines called antispasmodics.
This medicine is used to treat symptoms of irritable bowel syndrome
(IBS) and similar problems such as chronic irritable colon, spastic
constipation, mucous colitis and spastic colitis.
Irritable bowel syndrome (IBS) is a very common condition which causes
spasm and pain in the gut or intestine.
The intestine is a long muscular tube which food passes down so it can
be digested. If the intestine goes into spasm and squeezes too tightly,
you get pain. The way this medicine works is by relieving the spasm, pain
and other symptoms of IBS.

Taking other medicines
No interactions with other medicines are known.

Pregnancy and breast-feeding
You should talk to your doctor or pharmacist before taking Colofac
135mg tablets if you are pregnant or might become pregnant. There is
only limited information about the safety of mebeverine for pregnant
women. Your doctor may advise you to stop taking Colofac tablets before
you become pregnant or as soon as you know you are pregnant. Colofac
tablets should not be used during breast-feeding.
Driving and using machines
This medicine is not likely to affect you being able to drive or use any
tools or machines.
Important information about some of the ingredients of
Colofac 135mg tablets
This medicine contains lactose and sucrose (types of sugar). If you have
been told by your doctor that you cannot tolerate or digest some sugars
(have an intolerance to some sugars), talk to your doctor before taking
this medicine.
3) HOW TO TAKE COLOFAC 135MG TABLETS
How to take Colofac 135mg tablets
• Try to take the tablet twenty minutes before a meal - some people find
their symptoms to be strongest after they have eaten.
• Swallow the tablet whole with water. Do not chew the tablet.
How many Colofac 135mg tablets to take

The main symptoms of irritable bowel syndrome (IBS) include:
• stomach pain and spasm
• feeling bloated and having wind
• having diarrhoea (with or without constipation)
• small, hard, pellet-like or ribbon-like stools (faeces)

Adults and the elderly:
• Take 1 tablet 3 times a day
• The number of tablets you take can be lowered if your symptoms
improve
• Do not take more than 3 tablets per day.

These symptoms may vary from person to person.

Do not give Colofac 135mg tablets to children or adolescents younger
than 18 years.

Talk to your doctor if these symptoms do not improve after a while, if you
develop new symptoms or you are concerned about your symptoms.
Your diet and lifestyle can also help treat IBS:
How you restrict your diet depends on the way IBS affects you. If you find
that certain foods bring on the symptoms, then it makes sense not to eat
them. A high fibre diet may help, but ask your pharmacist for more
information.
Some people find that learning to relax can help to lessen their
symptoms of IBS. You may find it helpful to set aside a few moments
each day to relax and gently unwind.
2) BEFORE YOU TAKE COLOFAC 135MG TABLETS
Do not take Colofac 135mg tablets if:
• You are allergic to any of the tablet ingredients (see section 6 for a list
of ingredients).
If any of the above applies to you, do not take this medicine and talk to
your doctor or pharmacist.

If you take more Colofac 135mg tablets than you should
If you or someone else takes too many Colofac 135mg tablets (an
overdose), talk to a doctor or go to a hospital straight away. Take the
medicine pack with you.
If you forget to take Colofac 135mg tablets
If you miss a tablet, take it as soon as you remember. However, if it is
nearly time for the next dose, skip the missed dose. Do not take a double
dose to make up for a forgotten dose.
How to stop taking Colofac 135mg tablets
Do not stop taking the tablets without talking to your doctor, even if you
feel better.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Most people will not have problems, but some may get some side effects
(unwanted effects or reactions).

Take special care with Colofac 135mg tablets
Check with your doctor or pharmacist before taking your medicine if:
• You have developed new symptoms or your symptoms have become
worse.
• You have liver or kidney problems.

If you get any of these serious side effects, stop taking the tablets.
See a doctor at once:
• Difficulty in breathing, swelling of face, neck, tongue or throat (severe
allergic reactions).

If the above applies to you (or you are not sure), talk to your doctor or
pharmacist before taking this medicine.

These other effects are less serious. If they bother you talk to a
pharmacist:
• Skin rash, red itchy skin.

Previously assessed against UK PIL dated July 2015

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 COLOFAC 135MG TABLETS





Keep out of the sight and reach of children.
Do not store above 30oC.
Store in the original package to protect from light.
Do not use the tablets after the expiry date which is printed on the
carton and blister pack.
• The expiry date refers to the last day of that month.
• If the tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
• 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) FURTHER INFORMATION

What Colofac 135mg tablets contain
Each tablet contains 135mg mebeverine hydrochloride.
The other ingredients are: lactose monohydrate, starch (potato or maize),
povidone, talc, magnesium stearate, sucrose, gelatin, acacia and
carnauba wax.
What Colofac 135mg tablets look like and contents of the pack
Colofac 135mg tablets are white, round, unmarked, sugar-coated tablets.
Colofac 135mg tablets are available in printed cartons of 100 tablets in
blister packs.
Manufactured by Mylan Laboratories SAS, Route de Belleville,
Lieu dit Maillard, 01400 Châtillon-sur-Chalaronne, France.
Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0536

POM

Leaflet dated 10th February 2016
Leaflet coded XXXXXXXXXX
Colofac® is a registered trademark of BGP Products Operations GmbH.

Previously assessed against UK PIL dated July 2015

Patient Information Leaflet

Mebeverine hydrochloride 135mg tablets
Read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects becomes serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Mebeverine hydrochloride 135mg tablets are and what they
are used for
2) Before you take Mebeverine hydrochloride 135mg tablets
3) How to take Mebeverine hydrochloride 135mg tablets
4) Possible side effects
5) How to store Mebeverine hydrochloride 135mg tablets
6) Further information
1) WHAT MEBEVERINE HYDROCHLORIDE 135MG TABLETS
ARE AND WHAT THEY ARE USED FOR

Mebeverine hydrochloride 135mg tablets contain mebeverine
hydrochloride. This belongs to a group of medicines called
antispasmodics.
This medicine is used to treat symptoms of irritable bowel syndrome
(IBS) and similar problems such as chronic irritable colon, spastic
constipation, mucous colitis and spastic colitis.
Irritable bowel syndrome (IBS) is a very common condition which causes
spasm and pain in the gut or intestine.
The intestine is a long muscular tube which food passes down so it can
be digested. If the intestine goes into spasm and squeezes too tightly,
you get pain. The way this medicine works is by relieving the spasm, pain
and other symptoms of IBS.

Taking Mebeverine hydrochloride 135mg tablets with food and drink
You can drink alcohol while you are taking Mebeverine hydrochloride
135mg tablets.
Taking other medicines
No interactions with other medicines are known.
Pregnancy and breast-feeding
You should talk to your doctor or pharmacist before taking Mebeverine
hydrochloride 135mg tablets if you are pregnant or might become
pregnant. There is only limited information about the safety of
mebeverine for pregnant women. Your doctor may advise you to stop
taking Mebeverine hydrochloride tablets before you become pregnant or
as soon as you know you are pregnant. Mebeverine hydrochloride tablets
should not be used during breast-feeding.
Driving and using machines
This medicine is not likely to affect you being able to drive or use any
tools or machines.
Important information about some of the ingredients of
Mebeverine hydrochloride 135mg tablets
This medicine contains lactose and sucrose (types of sugar). If you have
been told by your doctor that you cannot tolerate or digest some sugars
(have an intolerance to some sugars), talk to your doctor before taking
this medicine.
3) HOW TO TAKE MEBEVERINE HYDROCHLORIDE 135MG
TABLETS

How to take Mebeverine hydrochloride 135mg tablets
• Try to take the tablet twenty minutes before a meal - some people find
their symptoms to be strongest after they have eaten.
• Swallow the tablet whole with water. Do not chew the tablet.
How many Mebeverine hydrochloride 135mg tablets to take

The main symptoms of irritable bowel syndrome (IBS) include:
• stomach pain and spasm
• feeling bloated and having wind
• having diarrhoea (with or without constipation)
• small, hard, pellet-like or ribbon-like stools (faeces)

Adults and the elderly:
• Take 1 tablet 3 times a day
• The number of tablets you take can be lowered if your symptoms
improve
• Do not take more than 3 tablets per day.

These symptoms may vary from person to person.

Do not give Mebeverine hydrochloride 135mg tablets to children or
adolescents younger than 18 years.

Talk to your doctor if these symptoms do not improve after a while, if you
develop new symptoms or you are concerned about your symptoms.
Your diet and lifestyle can also help treat IBS:
How you restrict your diet depends on the way IBS affects you. If you find
that certain foods bring on the symptoms, then it makes sense not to eat
them. A high fibre diet may help, but ask your pharmacist for more
information.
Some people find that learning to relax can help to lessen their
symptoms of IBS. You may find it helpful to set aside a few moments
each day to relax and gently unwind.
2) BEFORE YOU TAKE MEBEVERINE HYDROCHLORIDE 135MG
TABLETS

Do not take Mebeverine hydrochloride 135mg tablets if:
• You are allergic to any of the tablet ingredients (see section 6 for a list
of ingredients).

If you take more Mebeverine hydrochloride 135mg tablets than you
should
If you or someone else takes too many Mebeverine hydrochloride 135mg
tablets (an overdose), talk to a doctor or go to a hospital straight away.
Take the medicine pack with you.
If you forget to take Mebeverine hydrochloride 135mg tablets
If you miss a tablet, take it as soon as you remember. However, if it is
nearly time for the next dose, skip the missed dose. Do not take a double
dose to make up for a forgotten dose.
How to stop taking Mebeverine hydrochloride 135mg tablets
Do not stop taking the tablets without talking to your doctor, even if you
feel better.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS

If any of the above applies to you, do not take this medicine and talk to
your doctor or pharmacist.
Take special care with Mebeverine hydrochloride 135mg tablets
Check with your doctor or pharmacist before taking your medicine if:
• You have developed new symptoms or your symptoms have become
worse.
• You have liver or kidney problems.
If the above applies to you (or you are not sure), talk to your doctor or
pharmacist before taking this medicine.

Most people will not have problems, but some may get some side effects
(unwanted effects or reactions).
If you get any of these serious side effects, stop taking the tablets.
See a doctor at once:
• Difficulty in breathing, swelling of face, neck, tongue or throat (severe
allergic reactions).
These other effects are less serious. If they bother you talk to a
pharmacist:
• Skin rash, red itchy skin.

Previously assessed against UK PIL dated July 2015

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 MEBEVERINE HYDROCHLORIDE 135MG
TABLETS






Keep out of the sight and reach of children.
Do not store above 30oC.
Store in the original package to protect from light.
Do not use the tablets after the expiry date which is printed on the
carton and blister pack.
• The expiry date refers to the last day of that month.
• If the tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
• 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) FURTHER INFORMATION

What Mebeverine hydrochloride 135mg tablets contain
Each tablet contains 135mg mebeverine hydrochloride.
The other ingredients are: lactose monohydrate, starch (potato or maize),
povidone, talc, magnesium stearate, sucrose, gelatin, acacia and
carnauba wax.
What Mebeverine hydrochloride 135mg tablets look like and
contents of the pack
Mebeverine hydrochloride 135mg tablets are white, round, unmarked,
sugar-coated tablets.
Mebeverine hydrochloride 135mg tablets are available in printed cartons
of 100 tablets in blister packs.
Manufactured by Mylan Laboratories SAS, Route de Belleville,
Lieu dit Maillard, 01400 Châtillon-sur-Chalaronne, France.
Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL 33532/0536
Leaflet dated 10th February 2016
Leaflet coded XXXXXXXXXX

POM

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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