KLERIMED Film coated tablet Ref.[28162] Active ingredients: Clarithromycin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Klerimed 250mg film-coated tablet.

Klerimed 500mg film-coated tablet.

Pharmaceutical Form

Film coated tablets.

250mg: yellow, oval shaped, convex tablets, scored on one side, film-coated, with dimensions 14 × 8 mm.

500mg: yellow, oval shaped convex tablets film-coated tablets with diameter of nucleus 19.0 × 10.0 mm.

Qualitative and quantitative composition

Each tablet contains 250mg or 500 of 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

Croscarmellose
Cellulose microcrystalline
Silicon dioxide
Povidone
Stearic acid
Magnesium stearate
Talc
Hypromellose
Propylene glycol
Sorbitan oleate
Vanilla
Quinolline yellow (E104)
Titanium dioxide (E171)
Hydroxy propyl cellulose
Sorbic acid

Pack sizes and marketing

Tablets are packed into PVC/PVDC-Al blisters. Boxes of 14, 16 and 20 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

Klerimed tablets 250 mg: 19927
Klerimed tablets 500 mg: 19195

Klerimed tablets 250 mg: 20.12.2005 / 22.08.2011
Klerimed tablets 500 mg: 29.3.2001 / 28.03.2014

Drugs

Drug Countries
KLERIMED Cyprus, Estonia, Hong Kong, Lithuania, Malta, Romania, Singapore

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