MEBECON 135 Milligram Coated Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
20-04-2024
Summary of Product characteristics
(SPC)
20-04-2024
Active ingredient:
MEBEVERINE HYDROCHLORIDE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
MEBEVERINE HYDROCHLORIDE
Dosage:
135 Milligram
Pharmaceutical form:
Coated Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2013-04-30
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEBECON 135 MG COATED 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
or nurse.
• 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 or
nurse. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Mebecon is and what it is used for
2. What you need to know before you take Mebecon
3. How to take Mebecon
4. Possible side effects
5. How to store Mebecon
6. Contents of the pack and other information
1. WHAT MEBECON IS AND WHAT IT IS USED FOR
WHAT MEBECON IS
The name of your medicine is Mebecon 135 mg coated tablets_ _(called
Mebecon in this
leaflet). Mebecon 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 MEBECON IS USED FOR
Mebecon 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).
Mebecon 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 MEBECON
DO NOT TAKE MEBECON:
• if you a
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mebecon 135 mg Coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains Mebeverine hydrochloride 135 mg.
Excipients: also includes Lactose monohydrate 97.0 mg per tablet and sucrose 79.0 mg per tablet.
For a 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
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 100ml 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.
After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced.
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:
Mebecon should not be used in children aged 3 years and younger as no clinical data is available for this age group. For
children from 3 – 10 years mebeverine 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
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