RIFAREN Capsule Ref.[28197] Active ingredients: Rifampicin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Remedica Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Rifaren 150 mg capsules.

Rifaren 300 mg capsules.

Pharmaceutical Form

Capsules.

Rifaren 150 mg capsules: Red/Light blue capsules.

Rifaren 300 mg capsules: Reddish brown/Reddish brown capsules.

Qualitative and quantitative composition

Rifaren 150 mg capsules:

Each Rifaren 150 mg capsule contains 150 mg rifampicin.

Rifaren 300 mg capsules:

Each Rifaren 300 mg capsule contains 300 mg rifampicin.

Excipients with known effect:

Rifaren 150 mg capsules:

Each Rifaren 150 mg capsule contains 60.9 mg lactose.

Rifaren 300 mg capsules:

Each Rifaren 300 mg capsule contains 101.46 mg lactose.

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

Rifaren 150 mg tablets

Capsule content:

Microcrystalline cellulose
Sodium starch glycolate
Lactose
Starch
Povidone
Colloidal silicon dioxide
Sodium lauryl sulphate
Magnesium stearate
Talc

Capsule shell:

Body:

Indigo carmine E132
Titanium dioxide E171
Gelatin

Cap:

Erythrosine E127
Red iron oxide E172
Titanium dioxide E171
Yellow iron oxide E172
Gelatin

Rifaren 300 mg tablets

Capsule content:

Microcrystalline cellulose
Sodium starch glycolate
Lactose
Starch
Povidone
Colloidal silicon dioxide
Sodium lauryl sulphate
Magnesium stearate
Talc

Capsule shell:

Body:

Erythrosine E127
Red iron oxide E172
Titanium dioxide E171
Yellow iron oxide E172
Gelatin

Cap:

Erythrosine E127
Red iron oxide E172
Titanium dioxide E171
Yellow iron oxide E172
Gelatin

Pack sizes and marketing

Rifaren 150 mg capsules:

PVC/Aluminium blisters. Pack-sizes of 20, 100 and 1000 capsules.

PP containers with PE closure. Pack-sizes of 100 and 1000 capsules.

Rifaren 300 mg capsules:

PVC/Aluminium blisters. Pack-sizes of 20, 100 and 1000 capsules.

PP containers with PE closure. Pack-sizes of 100 and 1000 capsules.

Not all pack-sizes may be marketed.

Marketing authorization holder

Remedica Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Rifaren 150 mg capsules: 9029
Rifaren 300 mg capsules: 12369

Rifaren 150 mg capsules:

Date of first authorization: 15 September 1983
Date of latest renewal: 02 November 2009

Rifaren 300 mg capsules:

Date of first authorization: 06 July 1989
Date of latest renewal: 30 September 2011

Drugs

Drug Countries
RIFAREN Cyprus, Singapore

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