MEBEVERINE HYDROCHLORIDE 135MG TABLETS

Active substance: MEBEVERINE HYDROCHLORIDE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

COLOFAC® 135mg TABLETS/
MEBEVERINE HYDROCHLORIDE 135mg TABLETS
(Mebeverine Hydrochloride)
Patient Information Leaflet

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
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BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

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 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

PROOF HISTORY:
v.1 - waymade - 30/01/14

Leaflet Flat Size = 148 x 317

27mm

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.

WARNING!

Irritable bowel syndrome (IBS) is a very common condition which causes spasm and pain in the gut or
intestine.

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)

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CUSTOMER
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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.

Q.A.
APPROVED:

DATE:

DT

30/01/14

ARTWORKER:

DATE OF PROOF:

PRE-PRESS NO.:

05-0440

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 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.
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.

64640908A
CODE:

UK PIL DATED MARCH 2013
REPORTING OF SIDE EFFECTS

Colofac 135mg Tabs

Taking Colofac 135mg Tablets with food and drink
You can drink alcohol while you are taking Colofac 135mg Tablets.

PRODUCT:

CUSTOMER: Waymade

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

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 135mg Tablets before you become pregnant or as
soon as you know you are pregnant. Colofac 135mg 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.

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WARNING!

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

These symptoms may vary from person to person.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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

WARNING!

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 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.



DATE:
30/01/14




6. Further Information
Your medicine is called Colofac 135mg tablets/Mebeverine hydrochloride 135mg tablets.

DATE OF PROOF:

Each tablet contains 135mg of the active ingredient mebeverine hydrochloride in a white, round,
sugar-coated, unmarked tablet.

64640908A
CODE:

UK PIL DATED MARCH 2013
REPORTING OF SIDE EFFECTS

Colofac 135mg Tabs

Colofac 135mg tablets/Mebeverine hydrochloride 135mg tablets also contain the following inactive
ingredients:
Lactose monohydrate, sucrose, potato starch, magnesium stearate, povidone, talc, gum arabic, gelatin, bees
wax and carnauba wax.

PRODUCT:

ARTWORKER:

DT

Q.A.
APPROVED:
CUSTOMER: Waymade

PRE-PRESS NO.:

05-0440




5. How to store Colofac 135mg Tablets
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to
the last day of that month.
Colofac 135mg tablets should not be stored above 25°C, and they should be kept in their original
container.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist before taking them.
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.

Colofac 135mg tablets/Mebeverine hydrochloride 135mg tablets are available as blister packs of 60, 90, 100
and 120 tablets.
POM

PL No: 6464/0908

This product is manufactured by Abbott Healthcare S.A., Barcelona, Spain and Recipharm Parets S.L.,
Barcelona, Spain and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 30.01.2014
Colofac® is a registered trademark of Solvay Pharmaceuticals B.V.

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Black

WARNING!

DATE:

CUSTOMER
APPROVED:

If any side effects becomes severe, or you notice any side effect not listed here, please tell your
pharmacist or doctor.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

How many Colofac 135mg 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.

PROOF HISTORY:
v.1 - waymade - 30/01/14

Leaflet Flat Size = 148 x 317

27mm

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.

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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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