Colofac 135mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MEBEVERINE HYDROCHLORIDE

Available from:

Imbat Limited

ATC code:

A03AA

INN (International Name):

MEBEVERINE HYDROCHLORIDE

Dosage:

135 milligram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Synthetic anticholinergics, esters with tertiary amino group

Authorization status:

Authorised

Authorization date:

2009-08-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
COLOFAC 135 MG TABLETS
(mebeverine hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

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 only. Do not pass
it on to others. It may harm them, even if their signs of
illness are the same as yours. If you get any side effects,
talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Colofac is and what it is used for
2.
What you need to know before you take Colofac
3.
How to take Colofac
4.
Possible side effects
5.
How to store Colofac
6.
Contents of the pack and other information
1.
WHAT COLOFAC IS AND WHAT IT IS USED FOR
WHAT COLOFAC IS
The name of your medicine is Colofac 135 mg tablets (called
Colofac in this leaflet). Colofac contains a medicine called
mebeverine hydrochloride. This belongs to a group of medicines
called antispasmodics, which act on your 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. This medicine works by relieving the
spasm and pain.
WHAT COLOFAC IS USED FOR
Colofac is used to relieve the symptoms of irritable bowel
syndrome (IBS). These symptoms vary from person to person but
can include:

stomach pain and cramps

feeling bloated and having wind

diarrhoea, constipation or a combination of both

small, hard, pellet-like or ribbon-like stools (faeces).
Colofac is also used to relieve cramps and pain in your stomach or
gut caused by other medical conditions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
COLOFAC
DO NOT TAKE COLOFAC

if you are allergic to mebeverine hydrochloride or any of the
other ingredients of this medicine(listed in Section 6).
Do not take Colofac if the above applies

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colofac 135mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mebeverine Hydrochloride 135 mg.
Excipients: also includes lactose and sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated-tablet.
_Product imported from the UK:_
White, round, sugar-coated tablet with no markings.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in the management of irritable bowel syndrome, (particularly
gastrointestinal spasm).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
The coated tablets should be swallowed with a sufficient amount of
water (at least 100 ml water). They should not be
chewed because of the unpleasant taste.
Adults and children over 10 years:
One tablet three times a day preferably 20 minutes before meals.
Duration of use is not limited. However, after a period of several
weeks when the desired effect has been obtained, the
dosage may be gradually reduced.
In case of missed dose(s), the patient should continue with the next
dose as prescribed; do not take the missed dose(s)
in addition to the regular dose.
Children under 10 years:
Colofac should not be used in children aged 3 years and younger as no
clinical data are available. For children from 3-
10 years Colofac 135mg tablets should not be used due to the high
content of the active substance.
Special population
No posology studies in elderly, renal and/or hepatic impaired patients
have been performed. No specific risk for
elderly, renal and/or hepatic impaired patients could be identified
from available post-marketing data. No dosage
adjustment is deemed necessary in elderly, renal and/or hepatic
impaired patients.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
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