COLOFAC MR 200MG CAPSULES

Active substance: MEBEVERINE HYDROCHLORIDE

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Assessed against the UK PIL dated August 2011

By mcdermottc at 11:04 am, Dec 15, 2011

Mock UpCOLOFAC

PACKAGE LEAFLET: INFORMATION FOR THE USER

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MR 200mg CAPSULES

(mebeverine hydrochloride)
This medicine is available as the above name but will be referred to as Colofac MR
throughout the following:
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 gets 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 MR is and what it is used for
2. Before you take Colofac MR
3. How to take Colofac MR
4. Possible side effects
5. How to store Colofac MR
6. Further information

1. WHAT COLOFAC MR IS AND WHAT IT IS USED FOR
Colofac MR is a capsule containing Mebeverine hydrochloride. This belongs to a group
of medicines call antispasmodics.
This medicine is used to treat the symptoms of irritable bowel syndrome (IBS).
This 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 to 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 or pharmacist 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 to 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 doctor or 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 MR
Do not take Colofac MR if:
• You are allergic to mebeverine hydrochloride or any of the other capsule ingredients
(see section 6 for a list of ingredients)
• You have ‘paralytic ileus’ (a lack of the rhythmic squeezing in the gut or intestine).
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 MR
Check with your doctor or pharmacist before taking your medicine if:
• You have ‘porphyria’ (a metabolism problem)
• You have developed new symptoms or your symptoms have become worse.
• You have liver or kidney problems.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist
before taking this medicine.
Taking Colofac MR with food and drink
You can drink alcohol while you are taking Colofac MR.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
You should talk to your doctor or pharmacist before taking Colofac MR if you are
pregnant or might become pregnant. There is only limited information about the safety
of Mebeverine for pregnant woman. Your doctor may advice you to stop taking Colofac
MR before you become pregnant or as soon as you know you are pregnant. Colofac
MR 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.
3. HOW TO TAKE COLOFAC MR
Always take Colofac MR as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
• Try to take the capsule 20 minutes before a meal - some people find their symptoms
to be strongest after they have eaten.
• Swallow the capsule whole with a drink of water. Do not chew the capsule.

How much Colofac MR to take
Adults (including the elderly)
• The normal starting dose is one capsule twice a day.
Children
• This medicine is not recommended for use in children
If you take more Colofac MR than you should
If you or someone else takes too much Colofac MR (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 MR
If you miss a capsule, take it when you remember. However, if it is nearly time for the
next dose, skip the missed dose and carry on as normal with the next dose. Do not take
a double dose to make up for a forgotten dose.
If you stop taking Colofac MR
Do not stop taking Colofac MR without talking to your doctor, even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Colofac MR can cause side effects (unwanted effects or reactions),
but not everyone gets them.
Allergic reactions such as:
• swelling of your face, lips or tongue
• a red skin rash, itching, inflamed skin.
If you notice any of the above, stop taking this medicine and see your doctor straight
away.
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.
5. HOW TO STORE COLOFAC MR
• Store Colofac MR in the original package.
• Do not store above 25°C. Do not refrigerate or freeze.
• Do not take Colofac MR after the expiry date.
• Keep all medicines where children cannot see or reach them.
• If the capsules become discoloured or show signs of any deterioration, you should
seek the advice of 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 is in Colofac MR?
Each modified release capsule contains 200mg of mebeverine hydrochloride as the
active ingredient.
The capsules also contain magnesium stearate, glycerol triacetate, Eudragit E30D, talc,
hypromellose 2910 and Eudragit L30D. The capsule shell contains gelatin, titanium
dioxide (E171).
Colofac MR are white, opaque and imprinted “245“ with a Solvay logo.
The capsule shell is printed with black printing ink.
Colofac MR is available in blister packs of 30 or 60 capsules.
PLPI 15814/0950

Colofac MR 200mg Capsules

POM

The product is made by Solvay Pharmaceuticals, 01400 Châtillon-sur-Chalaronne,
France and procured from within the EU and repackaged by the product licence holder:
OPD Laboratories Limited, Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision date (ref) 30.11.2011
Colofac is a registered Trademark of Solvay Pharmaceuticals B.V.

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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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