Colofac Retard 200mg Hard Capsules, Modified Release

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

MEBEVERINE HYDROCHLORIDE

MAH:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC_code:

A03AA04

INN:

MEBEVERINE HYDROCHLORIDE 200 mg

pharmaceutical_form:

PROLONGED-RELEASE CAPSULE

composition:

MEBEVERINE HYDROCHLORIDE 200 mg

prescription_type:

POM

therapeutic_area:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

authorization_status:

Authorised

authorization_date:

2007-05-16

PIL

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v3/July 2017
Colofac Retard, 200 mg, 30 capsules
20 JUN 2019
14:45
Leaflet (Insert)
3945
FRONT
1885830
400540739
N.A.
N.A.
1
P. Process
Black U
1
10 pt
10 pt
1885830
1
MA1187/00901
Malta
Mylan Laboratories SAS
(Chatillon sur Chalaronne - FR)
Flat - 158X315mm - SPE 97885
50071606
N.A.
Helvetica Neue
N.A.
Flat 158x315mm
Cutting Die
(not printed)
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. 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.
In this leaflet:
1. What Colofac is and what it is used for
2. What you need to know before you take
Colofac
3. How to take Colofac
4. Possible side effects
5. How to store Colofac
6. Contents of the pack and other information
1. What Colofac is and what it is used for
The
name
of
your
medicine
is
Colofac
Retard 200 mg. It contains a medicine called
mebeverine hydrochloride. This belongs to a
group of medicines called anti-spasmodics,
which act on your 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. This medicine works
by relieving the spasm and pain.
Colofac is used to:
Relieve
the
symptoms
of
irritable
bowel
syndrome (IBS). These symptom

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Colofac Retard 200 mg, hard capsules, modified release
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One modified release capsule, hard, contains 200 mg mebeverine
hydrochloride.
For the full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Opaque white, hard gelatine capsule of size no. 1, with standard
imprint 245.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults and children over 10 years _
Symptomatic treatment of the irritable bowel syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
For oral use
The capsules should be swallowed with a sufficient amount of water (at
least 100 ml water). They should not
be chewed because the coating is intended to ensure a prolonged
release mechanism (see 5.2)
_ _
_Adults and children over 10 years: _
One capsule of 200 mg twice daily, to be given one in the morning and
one in the evening.
_ _
There are no safety risks for a duration of use up to 1 year. When the
desired effect has been reached, the
dose can be gradually decreased after a couple of weeks.
In case of one or more dose(s) is (are) missed, the patient should
continue with the next dose as prescribed;
the missed dose(s) is (are) not to be taken in addition to the regular
dose.
_Children _
Colofac Retard should not be used in children aged below 10 years
because safety and effectiveness have not
been established for this group.
_ _
_Elderly, renal and/or hepatic impaired patients _
No posology studies in elderly, renal and/or hepatic impaired patients
have been performed.
_ _
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
(see section 6.1).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not applicable
2
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
_ _
No interactions of mebeverine are known.
4.6
FERTILITY, PREGNANCY AND LACTATION
_ _
_Pregnancy _
There are no or limited amount of data from the use of mebeverine in
pregnant women.
Animal studies are ins