CLAREM Film-coated tablet Ref.[28238] Active ingredients: Clarithromycin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Clarem 250 mg film-coated tablets.

Clarem 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Clarem 250 mg film-coated tablets: Yellow, parallel, capsule shaped, film-coated tablets with Remedica’s logo on both sides.

Clarem 500 mg film-coated tablets: Yellow, oval, film-coated tablets, scored on one side and embossed with “CL500” on the other side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Clarem 250 mg film-coated tablets: Each film-coated tablet contains 250 mg clarithromycin.

Clarem 500 mg film-coated tablets: Each film-coated tablet contains 500 mg clarithromycin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Clarithromycin

Clarithromycin is a semi-synthetic derivative of erythromycin A. It exerts its antibacterial action by selectively binding to the 50s ribosomal sub-unit of susceptible bacteria preventing translocation of activated amino acids. It inhibits the intracellular protein synthesis of susceptible bacteria.

List of Excipients

Core:

Povidone
Cellulose, microcrystalline
Sodium starch glycolate (Type A)
Silica, colloidal anhydrous
Magnesium stearate

Coating:

Hypromellose
Macrogol 400
Titanium Dioxide
Talc
Quinoline yellow aluminium lake E104
Orange liquid

Pack sizes and marketing

Clarem 250 mg film-coated tablets: PVC-PVDC/Aluminium blisters. Pack sizes of 14 and 100 film-coated tablets.

Clarem 500 mg film-coated tablets: PVC-PVDC/Aluminium blisters. Pack sizes of 14 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Clarem 250 mg film-coated tablets: 19180
Clarem 500 mg film-coated tablets: 19181

Clarem 250 mg film-coated tablets:

Date of first authorization: 12 March 2001
Date of latest renewal: 29 March 2013

Clarem 500 mg film-coated tablets:

Date of first authorization: 13 March 2001
Date of latest renewal: 29 March 2013

Drugs

Drug Countries
CLAREM Cyprus, Hong Kong

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