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COLOFAC 135 MG TABLETS

Active substance: MEBEVERINE HYDROCHLORIDE

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Package leaflet: Information for the user

Colofac® 135mg Tablets/Mebeverine hydrochloride
135 mg Tablets
(mebeverine hydrochloride)
This product is known by the above names but will be referred to as
Colofac 135mg Tablets in this leaflet.
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 Colofac 135 mg Tablets are and what they are used for
2. Before you take Colofac 135 mg Tablets
3. How to take Colofac 135 mg Tablets
4. Possible side effects
5. How to store Colofac 135 mg Tablets
6. Further information
1. What Colofac 135 mg Tablets are and what they are used for
Colofac 135 mg 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.
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)
These symptoms may vary from person to person.
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 135 mg Tablets
Do not take Colofac 135 mg 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.
Take special care with Colofac 135 mg 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.
Taking Colofac 135 mg Tablets with food and drink
You can drink alcohol while you are taking Colofac 135 mg 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 Colofac
135 mg 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
135 mg 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 135 mg Tablets
How to take Colofac 135 mg 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 135 mg Tablets to take
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.
Do not give Colofac 135 mg Tablets to children or adolescents
younger than 18 years.
If you take more Colofac 135 mg Tablets than you should
If you or someone else takes too many Colofac 135 mg
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 135 mg 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 135 mg 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.

If your doctor stops your treatment, return unused tablets to a
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. What Colofac 135 mg Tablets contain
What Colofac 135 mg Tablets contain
Each tablet contains 135 mg mebeverine hydrochloride.
The tablets also contain lactose monohydrate, potato starch
povidone, talc, magnesium stearate, sucrose, gum arabic, beeswax,
carnauba wax and gelatin.
What Colofac 135 mg Tablets look like and contents of the pack
Colofac 135 mg Tablets are white, round, sugar coated and
unmarked.
Each pack contains 60 or 100 tablets.
Manufacturer: Recipharm Parets, S.L.
Ramon y Cajal, 2
08150 Parets del Valles (Barcelona)
Procured within the EU.

4. Possible side effects
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
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 national reporting system
listed below.
In the UK:
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 135 mg Tablets
• Keep out of the reach and sight of children.
• 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.
• Do not store your tablets above 25°C.
• Keep them in their original container.

Product Licence holder: Ecosse Pharmaceuticals Limited
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited
3 Young Place, East Kilbride G75 0TD.
PL 19065/0493

POM

This leaflet was last revised 29/06/2015
Colofac® is available in other formats.
If you are visually impaired and require this information in another
format, please call the Regulatory department on 01355 574450.
E0493/1
Colofac® is a registered trade mark of Abbott Products operations AG

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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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