COLOFAC 135 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-04-2024
Summary of Product characteristics
(SPC)
25-09-2015
Active ingredient:
MEBEVERINE HYDROCHLORIDE
Available from:
BGP Products Ltd
ATC code:
A03AA04
INN (International Name):
MEBEVERINE HYDROCHLORIDE
Dosage:
135 Milligram
Pharmaceutical form:
Tablets
Administration route:
Oral use
Units in package:
100 tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Manufactured by:
Abbott Healthcare SAS
Therapeutic group:
Synthetic anticholinergics, esters with tertiary amino group
Therapeutic area:
Synthetic anticholinergics, esters with tertiary amino group
Therapeutic indications:
For use in the management of irritable bowel syndrome, (particularly gastrointestinal spasm).
Authorization status:
Authorised
Authorization date:
2015-03-27
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
medi
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colofac 135 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mebeverine Hydrochloride 135mg
Excipients with known effect: also includes Lactose monohydrate 97.0 mg per tablet and Sucrose 79.0 mg per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated Tablet.
White, circular, sugar coated tablet.
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 substan
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