Mebeverine Hydrochloride IBS, 135mg film-coated Tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEBEVERINE HYDROCHLORIDE

Available from:

Morningside Healthcare Limited

ATC code:

A03AA04

INN (International Name):

MEBEVERINE HYDROCHLORIDE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

MEBEVERINE HYDROCHLORIDE 135 milligram(s)

Prescription type:

OTC

Therapeutic area:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Authorization status:

Authorised

Authorization date:

2019-03-01

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MEBEVERINE HYDROCHLORIDE IBS 135MG FILM-COATED TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has
told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
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.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 14 days.
WHAT IS IN THIS LEAFLET
1. What Mebeverine Tablets are and what they are used for
2. What you need to know before you take Mebeverine Tablets
3. How to take Mebeverine Tablets
4. Possible side effects
5. How to store Mebeverine Tablets
6. Contents of the pack and other information
1. WHAT MEBEVERINE TABLETS ARE AND WHAT THEY ARE USED FOR
Mebeverine
Hydrochloride
IBS
135
mg
Film-coated
Tablets
contain
the
active
ingredient
mebeverine hydrochloride. This belongs to a group of medicines called
antispasmodics.
This medicine is used to treat symptoms of irritable bowel syndrome
(IBS).
This 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 and pain.
The main symptoms of irritable bowel syndrome (IBS) include:
•
stomach pain and spasm
•
feeling bloated and having wind
•
having diarrhoea (with or without constipation)
•
small, hard, pellet-like or ribbon-like stools (faeces)
These symptoms may vary from person to person.
Talk to your doctor if you develop new symptoms or if these symptoms
continue for more than 14
days.
YOUR DIET AND LIFESTYLE CAN ALSO HELP TREAT IBS:
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How you

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mebeverine Hydrochloride IBS 135mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 135mg mebeverine hydrochloride.
Excipient with known effect:
Each film-coated tablet contains 97 mg lactose monohydrate equivalent
to
92.15 mg of lactose (see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablet.
White to off-white, round film-coated tablets debossed with M135 on
one side
and plain on other side with 10mm diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of Irritable Bowel Syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ _
Duration of use is not limited.
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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. If
symptoms
persist for more than 2 weeks, consult your doctor.
Warning: Do not exceed the stated dose.
_Paediatric population: _
Mebeverine hydrochloride 135 mg film-coated tablets are not
recommended
for use in children and adolescents below 18 years, 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 film-coated tablets should be swallowed with a sufficient amount
of water
(at
least
100
ml
water).
Tablets
should
not
be
chewed
because
of
the
unpleasant taste.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4
SPECIAL WARNINGS