Mebeverine hydrochloride 135 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mebeverine hydrochloride

Available from:

Azure Pharmaceuticals Ltd

ATC code:

A03AA04

INN (International Name):

Mebeverine hydrochloride

Dosage:

135 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

mebeverine

Authorization status:

Marketed

Authorization date:

2019-11-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEBEVERINE HYDROCHLORIDE 135 MG FILM-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.

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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mebeverine hydrochloride 135 mg Film-coated Tablets are and what
they are used for
2.
What you need to know before you take Mebeverine hydrochloride 135 mg
Film-coated Tablets
3.
How to take Mebeverine hydrochloride 135 mg Film-coated Tablets
4.
Possible side effects
5.
How to store Mebeverine hydrochloride 135 mg Film-coated Tablets
6.
Contents of the pack and other information
1.
WHAT MEBEVERINE HYDROCHLORIDE 135 MG FILM-COATED TABLETS ARE AND WHAT
THEY ARE USED FOR
Mebeverine hydrochloride 135 mg Film-coated Tablets contain the active
substance 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 by relaxing muscles of the
gut.
The main symptoms of irritable bowel syndrome (IBS) include:

Stomach pain and spasm

Persistent diarrhoea, or alternating

Summary of Product characteristics

Health Products Regulatory Authority
25 November 2019
CRN009500
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mebeverine hydrochloride 135 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 135 mg of Mebeverine hydrochloride.
Excipients with known effect: Each tablet contains 97 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White colored, circular biconvex shaped, film-coated tablets, plain on
both the sides.
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
Posology
The film-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.
Duration of use is not limited.
If one or more doses are missed, the patient should continue with the
next dose as prescribed; the missed dose(s) should not
be taken in addition to the regular dose.
_Adults (including the elderly):_
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.
_Warning:_ Do not exceed the stated dose.
_Paediatric Population:_
Mebeverine coated tablets are not recommended for use in children and
adolescents below 18, due to insufficient data on
safety and efficacy.
_ _
_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.
Method of administration
For oral administration.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Health Products Re