Colofac Retard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEBEVERINE HYDROCHLORIDE

Available from:

BGP Products BV

ATC code:

A03AA04

INN (International Name):

MEBEVERINE HYDROCHLORIDE

Pharmaceutical form:

PROLONGED-RELEASE CAPSULE

Composition:

MEBEVERINE HYDROCHLORIDE 200 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Authorization status:

Authorised

Summary of Product characteristics

Page 1 of 5
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.
2
_ _
_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
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 stud