Mebeverine Hydrochloride, 135mg film coated Tablet

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

MEBEVERINE HYDROCHLORIDE

Tillgänglig från:

Aspire Pharma (Malta) Limited Trident Park, Notabile Gardens No. 2, Level 3, Mdina Road Central Business District Birkirkara CBD2010 , Malta

ATC-kod:

A03AA04

INN (International namn):

MEBEVERINE HYDROCHLORIDE 135 mg

Läkemedelsform:

FILM-COATED TABLET

Sammansättning:

MEBEVERINE HYDROCHLORIDE 135 mg

Receptbelagda typ:

POM

Terapiområde:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Bemyndigande status:

Authorised

Tillstånd datum:

2019-03-01

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEBEVERINE HYDROCHLORIDE 135MG FILM-COATED TABLETS
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 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 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) 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.
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 these symptoms do not improve after a while, if

Produktens egenskaper

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mebeverine Hydrochloride 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.
(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
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
Page 2 of 8
POSOLOGY
_ _
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.
_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