RIFASYNT Hard gelatin capsule Ref.[28306] Active ingredients: Rifampicin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Rifasynt 150 mg capsules.

Rifasynt 300 mg capsules.

Pharmaceutical Form

Rifasynt 150 mg: Hard gelatin capsules, scarlet – scarlet size 2, for oral administration.

Rifasynt 300 mg: Hard gelatin capsules, scarlet – scarlet size 1, for oral administration.

Qualitative and quantitative composition

Each capsule contains either 150 mg or 300 mg of rifampicin.

Excipients with known effect: lactose monohydrate.

For the full list of excipients, see section 6.1.

Each 150mg capsule contains lactose monohydrate 23.0mg.

Each 300mg capsule contains lactose monohydrate 28.0mg.

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

Rifasynt 150 mg capsules also contain lactose monohydrate, croscarmellose sodium and magnesium stearate. The capsule shells contain gelatin, erythrosine (E127), indigo carmine (E132) and titanium dioxide (E171).

Rifasynt 300 mg capsules also contain lactose monohydrate, croscarmellose sodium and magnesium stearate. The capsule shells contain gelatin, erythrosine (E127), indigo carmine (E132) and titanium dioxide (E171).

Pack sizes and marketing

Capsules are available packed in aluminium foil – polyvinylchloride film blisters.

Rifasynt 150mg caps: Cartons containing 8, 10 and 100 capsules are available.

Rifasynt 300mg caps: Cartons containing 8, 20, 100 capsules and hospital packs of 1000 capsules are available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Rifasynt 150mg caps: 8533
Rifasynt 300mg caps: 7238

Rifasynt 150mg caps: 30/10/1982
Rifasynt 300mg caps: 14/12/1979

Drugs

Drug Countries
RIFASYNT Cyprus, Estonia, Hong Kong, Malta

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