RIFINAH Coated tablet Ref.[10703] Active ingredients: Isoniazid Rifampicin Rifampicin and Isoniazid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Rifinah 150/100 mg Tablets.

Pharmaceutical Form

Coated tablet.

Cyclamen, smooth, shiny, round, curved sugar coated tablet.

Qualitative and quantitative composition

Active substances (per tablet):

Rifampicin 150 mg

Isoniazid 100 mg

Excipients with known effect (per tablet):

Sucrose 110.06 mg

For a full list of excipients, see section 6.1.

Active Ingredient Description
Isoniazid

Isoniazid is used mainly in the treatment of pulmonary tuberculosis but it appears to be effective also in the treatment of extrapulmonary lesions, including meningitis and genito-urinary disease.

Rifampicin

Rifampicin is an active bactericidial antituberculosis drug which is particularly active against the rapidly growing extracellular organisms and also has bactericidial activity intracellularly. Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.

Rifampicin and Isoniazid

Rifampicin and isoniazid are active bactericidial antituberculosis drugs which are particularly active against the rapidly growing extracellular organisms and also have bactericidal activity intracellularly. Rifampicin has activity against slow- and intermittently-growing M. tuberculosis. Isoniazid acts against actively growing tubercle bacilli.

List of Excipients

Tablet core:

Sodium lauryl sulphate
Calcium stearate
Sodium carboxymethylcellulose
Magnesium stearate
Microcrystalline cellulose
Magnesium carbonate – light
Carnauba wax
Colophony
Beeswax white
Hard paraffin

Sugar coating:

Acacia
Gelatin
Kaolin
Talc
Titanium dioxide (E171)
Colloidal silicon dioxide
Polyvinylpyrollidone K30
Sucrose
Erythrosine (E127)

Pack sizes and marketing

Blister packs of 84 tablets (4 week calendar packs) in cardboard cartons.

Blister material is PVC/PVDC and aluminium foil/PVC.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0041

Date of First Authorisation: 15 December 1974
Date of latest renewal: 26 January 2005

Drugs

Drug Countries
RIFINAH Spain, France, Hong Kong, Ireland, Malta, Netherlands, New Zealand, United Kingdom, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.