CLARITHROMYCIN Film-coated tablets

Active ingredients: Clarithromycin

Product name and form

Clarithromycin 250 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Light yellow coloured, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘62’ on the other side. The size is 15.1 mm x 7.1 mm.

Qualitative and quantitative composition

Each film-coated tablet contains 250 mg of clarithromycin.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

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:

Microcrystalline cellulose
Croscarmellose sodium
Silica, colloidal anhydrous
Magnesium stearate
Povidone (K-30)

Coating:

Hypromellose
Propylene glycol
Titanium dioxide (E171)
Hydroxypropyl cellulose
Vanillin
Sorbic acid
Iron oxide yellow (E172)

Pack sizes and marketing

Clarithromycin 250 mg tablets are available in clear PVC /PVdC/Aluminium blister packs of: 7, 12, 14 and 21 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0413

12/05/2014