Colofac 135 mg Tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Mebeverine hydrochloride

Tersedia dari:

Mylan IRE Healthcare Limited

Kode ATC:

A03AA; A03AA04

INN (Nama Internasional):

Mebeverine hydrochloride

Dosis:

135 milligram(s)

Bentuk farmasi:

Coated tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Synthetic anticholinergics, esters with tertiary amino group; mebeverine

Status otorisasi:

Marketed

Tanggal Otorisasi:

1983-02-07

Karakteristik produk

Health Products Regulatory Authority
20 November 2020
CRN00C1LQ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Colofac 135 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mebeverine Hydrochloride 135mg
Excipients with known effect: also includes Lactose monohydrate 97.0
mg per tablet and Sucrose 79.0 mg per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated Tablet.
White, circular, sugar coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in the management of irritable bowel syndrome, (particularly
gastrointestinal spasm).
4.2 POSOLOGY AND 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.
Adults and children over 10 years:
One tablet three times a day preferably 20 minutes before meals.
Duration of use is not limited. However, after a period of several
weeks when the desired effect has been obtained, the dosage
may be gradually reduced.
In case of missed dose(s), the patient should continue with the next
dose as prescribed; do not take the missed dose(s) in
addition to the regular dose.
Children under 10 years:
Colofac should not be used in children aged 3 years and younger as no
clinical data are available. For children from 3-10 years
Colofac 135mg tablets should not be used due to the high content of
the active substance.
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.
4.3 CONTRAINDICATIONS
Hypersensitivityto the active substance or to anyof the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
20 November 2020
CRN00C1LQ
Page 2 of 5