MEDOFLOXINE Film-coated tablet Ref.[50420] Active ingredients: Ofloxacin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Medofloxine 200 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White, round, convex film- coated tablets, with diameter of nucleus 9.5 mm.

For oral administration.

Qualitative and quantitative composition

Each film-coated tablet contains 200mg of ofloxacin.

Excipient with known effect: lactose.

Each film-coated tablet contains 74 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ofloxacin

Ofloxacin is a quinolone-carboxylic acid derivative with a wide range of antibacterial activity against both Gram-negative and Gram-positive organisms. The primary mode of action of the quinolones is the specific inhibition of bacterial DNA gyrase. This enzyme is required for DNA replication, transcription, repair and recombination.

List of Excipients

Medofloxine also contain croscarmellose sodium, povidone, lactose, microcrystalline cellulose, magnesium stearate, hydroxypropylmethyl cellulose, titanium dioxide (E171) and polyethylene glycol.

Pack sizes and marketing

Blisters of polyvinylchloride film and aluminium foil. Blister, with patient information leaflet, in a cardboard carton.

Packs of ten (10) and twenty (20) film-coated tablets are available.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

13357

First authorization: 22/04/1991
Renewal authorization: 15/07/2013

Drugs

Drug Countries
MEDOFLOXINE Cyprus, Estonia

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