Mebeverine hydrochloride 135mg Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEBEVERINE HYDROCHLORIDE

Available from:

Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland

ATC code:

A03AA04

INN (International Name):

MEBEVERINE HYDROCHLORIDE 135 mg

Pharmaceutical form:

COATED TABLET

Composition:

MEBEVERINE HYDROCHLORIDE 135 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Authorization status:

Authorised

Authorization date:

2016-08-18

Patient Information leaflet

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6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEBEVERINE HYDROCHLORIDE 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.
-
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 this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE
IS AND WHAT IT IS USED FOR
This medicine contains an active substance called Mebeverine
hydrochloride, which
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 passes down food, 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)
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•
small, hard, pellet-like or ribbon-like stools (faeces)
These symptoms may vary from person to person.
Talk to your doctor if these symptoms do not improve after a while, if
you develop new
symptom

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mebeverine hydrochloride 135 mg coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 135 mg of mebeverine hydrochloride.
Excipient with known effect: Also contains 121.50 mg of lactose
monohydrate
and 60.00 mg of sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Coated tablet
Round, white to off-white, sugar coated tablets, plain on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of irritable bowel syndrome and other
conditions usually included in this grouping, such as: chronic
irritable colon,
spastic constipation, mucous colitis, spastic colitis. Mebeverine is
effectively
used to treat the symptoms of these conditions, such as: colicky
abdominal
pain and cramps, persistent, non-specific diarrhoea (with or without
alternating
constipation) and flatulence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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.
_Paediatric Population _
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This medicine is 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 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.
Duration of use is not limited.
If one or more doses are missed, the patient should continue with the
next dose
as prescribed; the misse