KLACID Film-coated tablet Ref.[49803] Active ingredients: Clarithromycin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Product name and form

Klacid 250 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

A yellow, ovaloid, film-coated tablet.

Qualitative and quantitative composition

Each tablet contains 250 mg 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

Tablet core:

Croscarmellose sodium
Starch, pregelatinised
Cellulose, microcrystalline
Silicon dioxide
Povidone
Stearic acid
Magnesium stearate
Talc
Quinoline Yellow Aluminium Lake (E104)

Tablet coat:

Hypromellose,
Hydroxyproplycellulose
Propylene glycol
Sorbitan oleate
Titanium dioxide (E171)
Sorbic acid
Vanillin
Quinoline yellow Aluminium Lake (E104)

Pack sizes and marketing

2, 14, 56 tablets in PVC/PVdC Al blister pack. The blisters are packaged in a carton with a pack insert. Not all pack sizes may be marketed.

Marketing authorization holder

Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Marketing authorization dates and numbers

PA2010/004/001

Date of first authorisation: 20th November 1989
Date of last renewal: 20th November 2009

Drugs

Drug Countries
KLACID Austria, Australia, Germany, Estonia, Spain, Finland, Hong Kong, Ireland, Israel, Italy, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, South Africa

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