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DUSPATALIN 135MG TABLETS

Active substance(s): MEBEVERINE HYDROCHLORIDE

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Colofac® 135mg Tablets / Duspatalin® 135mg Tablets / Mebeverine Hydrochloride 135mg Tablets
(mebeverine hydrochloride)
Your medicine is known by one of the above names, but will be referred to as
Colofac 135mg Tablets throughout this:
Patient Information 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

1) What Colofac 135mg Tablets are and what they are used for
Colofac Tablets 135 mg 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)

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.
If the above applies to you (or you are not sure), talk to your doctor or
pharmacist before taking this medicine.
Taking Colofac 135mg Tablets with food and drink
You can drink alcohol while you are taking Colofac 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 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.

These symptoms may vary from person to person.

3) How to take Colofac 135mg Tablets
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.

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
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 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.



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 contains
Each sugar coated tablet contains 135mg of the active ingredient mebeverine
hydrochloride.
Colofac 135mg Tablets also contain lactose monohydrate, sucrose, potato
starch, povidone, talc, magnesium stearate, acacia, gelatin and carnauba
wax.
What Colofac 135mg Tablets looks like and contents of the pack
The tablets are round, white, sugar coated with no markings.
Colofac 135mg Tablets are available as blister packs of 60 tablets.
PL10383/1271

How to stop taking Colofac 135mg Tablets
Do not stop taking the tablets without talking to your doctor, even if you feel
better.

POM

If you have any further questions on the use of this product, ask your doctor
or pharmacist.

Who makes and repackages your medicine:
Your medicine is Manufactured by Recipharm Parets S.L., Ramon y Cajal, 2,
08150 Parets de Valles Barcelona, Spain.. Procured from within the EU and
repackaged by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS

4) Possible side effects

Leaflet date: 27.08.2015

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 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 all medicines 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.
Do not store above 25°C.

If your doctor stops your treatment, return unused tablets to a
pharmacist.
If the tablets become discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.

Colofac and Duspatalin are registered trademarks of Abbott Healthcare
Products B.V., Weesp, The Netherlands.

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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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