RIMACTANE Capsule Ref.[49654] Active ingredients: Rifampicin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

Product name and form

Rimactane 300 mg Capsules.

Pharmaceutical Form

Capsules.

Opaque, two-piece, hard gelatine capsule, reddish-brown in colour, marked with ‘NG 300’.

Qualitative and quantitative composition

The active ingredient is 3-(4-Methyl-1-piperazinyliminomethyl) rifamycin SV.

One capsule contains 300 mg rifampicin Ph. Eur.

For the full list of excipients, see section 6.1.

Active Ingredient Description
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.

List of Excipients

The capsules contain:

Calcium stearate
Lactose
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide yellow (E172)
Iron oxide black (E172)
Gelatine
Shellac glaze
Propylene glycol (E1520)
mmonium hydroxide (E527)

Pack sizes and marketing

The capsules are opaque, two-piece, hard gelatine capsule size 1, reddish-brown in colour, marked with the monogram NG on each half and the code 300, and come in securitainers of 100 and PVC/PE/PVdC blister packs of 60.

Marketing authorization holder

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

Marketing authorization dates and numbers

PL 04520/0043

1 February 2000

Drugs

Drug Countries
RIMACTANE Hong Kong, Malta, United Kingdom, South Africa

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