Mebeverine hydrochloride 135mg Coated Tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

MEBEVERINE HYDROCHLORIDE

Tillgänglig från:

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

ATC-kod:

A03AA04

INN (International namn):

MEBEVERINE HYDROCHLORIDE 135 mg

Läkemedelsform:

COATED TABLET

Sammansättning:

MEBEVERINE HYDROCHLORIDE 135 mg

Receptbelagda typ:

OTC

Terapiområde:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Bemyndigande status:

Authorised

Tillstånd datum:

2016-08-18

Bipacksedel

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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.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist have 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 2 week
s.
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).
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)
•
small, hard, pellet-like or ribbon-like stools (faeces)
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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
symptoms or you are concerned about your symptoms.

Produktens egenskaper

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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 relief of Irritable Bowel Syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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 135 mg tablets are not recommended for use in children and
adolescents below 18, due to insufficient data on safety and efficacy.
_Special Population_
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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 missed dose(s) should not be taken in addition to
the regular
dose.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed
in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If any of the following apply, do not use mebeverine. It may not be
the right
treatment for you. See your doctor as soon as possi