Colofac IBS 135mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Mebeverine hydrochloride

Prieinama:

Viatris UK Healthcare Ltd

ATC kodas:

A03AA04

INN (Tarptautinis Pavadinimas):

Mebeverine hydrochloride

Dozė:

135mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 01020000; GTIN: 5012781015871

Prekės savybės

OBJECT 1
COLOFAC IBS
Summary of Product Characteristics Updated 26-Aug-2016 | Mylan
Products Limited
1. Name of the medicinal product
Colofac IBS
Boots IBS Relief 135mg Coated Tablets
2. Qualitative and quantitative composition
Mebeverine hydrochloride 135mg.
Excipients with known effect : Lactose and Sucrose
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Coated tablets (Tablets).
Round white sugar coated tablets, with no superficial markings.
4. Clinical particulars
4.1 Therapeutic indications
For the symptomatic relief of Irritable Bowel Syndrome.
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.
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.
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_
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
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
Since Mebeverine coated tablets contain lactose, patients with rare
hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not take this medicine.
The coated