COLOFAC MR CAPSULES

Active substance: MEBEVERINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
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.

000-0000A

COLOFAC® MR CAPSULES
(Mebeverine Hydrochloride)
Patient Information Leaflet

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.

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.
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 things 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.

DATE:
28/01/14

DT
ARTWORKER:

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)
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 developed new symptoms or your symptoms have become worse.
• You have liver or kidney problems.

DATE OF PROOF:

Q.A.
APPROVED:
PRE-PRESS NO.:

05-0440

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.

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

TO UK PIL DATED MARCH 2013
REPORTING OF SIDE EFFECTS

6464/0977A
CODE:

CUSTOMER: Waymade
PRODUCT: Colofac mr caps

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 women. Your doctor
may advise 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.

Colour
Swatch

Black

WARNING!

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.

DATE:

CUSTOMER
APPROVED:

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.

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.

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

Notes:

This product is known by the above name but will usually be referred to as Colofac MR throughout 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

PROOF HISTORY:
v.1 - waymade - 28/01/14

Leaflet Flat Size = 148 x 317

27mm

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.

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
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 capsules. See a doctor at once:
• Difficulty in breathing, swelling of face, neck, tongue or throat (severe allergic reactions)

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

DATE:

CUSTOMER
APPROVED:

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

By reporting side effects you can help provide more information on the safety of this medicine.



DATE:




28/01/14

6. Further information
Your medicine is called Colofac MR capsules.
Each capsule contains 200mg of the active ingredient mebeverine hydrochloride in a
modified release formulation and has a white cap marked ‘S’ and a white body marked ‘245’.



TO UK PIL DATED MARCH 2013
REPORTING OF SIDE EFFECTS

6464/0977A

Colofac MR capsules also contain the following inactive ingredients:
Eudragit E30D, talc, hypromellose, Eudragit L30D, magnesium stearate, triacetin, black printing ink, gelatin
and titanium dioxide (E171).

CODE:

DT



DATE OF PROOF:

ARTWORKER:

CUSTOMER: Waymade
PRODUCT: Colofac MR capsules

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:



5. How to store Colofac MR
Keep out of the sight and reach of children.
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 MR capsules should not be stored above 25°C, and they should be kept in their original
container.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe
disposal. Only keep the capsules if your doctor tells you to.
If the capsules 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 waste water or household waste. Ask your doctor or
pharmacist how to dispose of medicines no longer required. These measures will help to protect
the environment.

Colofac MR capsules are available as blister packs of 30 and 60 capsules.
POM

PL No: 6464/0977

This product is manufactured by Abbott Healthcare SAS, F 01400 Châtillon-sur-Chalaronne, France 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.) 28.01.2014
Colofac® is a registered trademark of Abbott Healthcare Products B.V.

Colour
Swatch

Black

WARNING!

Leaflet Flat Size = 148 x 317

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

Adults (including the elderly)
• The normal starting dose is one capsule twice a day.

PROOF HISTORY:
v.1 - waymade - 28/01/14

Notes:

How much Colofac MR to take

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.

27mm

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.

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.

Hide
(web2)