OFLOXIN Film-coated tablet Ref.[50389] Active ingredients: Ofloxacin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Codal-Synto Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus

Product name and form

Ofloxin 200mg film-coated tablets.

Ofloxin 400mg film-coated tablets.

Pharmaceutical Form

Film coated tablet.

Ofloxin 200mg: White, round, convex film- coated tablets, with diameter of nucleus 9.5 mm.

Ofloxin 400mg: White, oblong, convex film- coated tablets, with dimensions of nucleus 17.5 × 8mm.

For oral administration.

Qualitative and quantitative composition

Ofloxin 200mg film coated tablets: Each tablet contains 200mg of ofloxacin.

Ofloxin 400mg film coated tablets: Each tablet contains 400mg of ofloxacin.

Excipient with known effect: lactose.

Each 200mg tablet contains 74mg lactose.

Each 400mg tablet contains 128mg 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

Ofloxin 200mg and 400mg film coated tablets contain croscarmellose sodium, povidone, lactose, microcrystalline cellulose, magnesium stearate, hydroxypropylmethyl cellulose, titanium dioxide and polyethylene glycol.

Ofloxin 400mg film coated tablets also contain talc.

Pack sizes and marketing

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

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

Marketing authorization holder

Codal-Synto Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Ofloxin 200mg film coated tablets: 14408

Ofloxin 400mg film coated tablets: 19793

Ofloxin 200mg film coated tablets: 07 October1993 / 15 February 2011

Ofloxin 400mg film coated tablets: 29 December 2005 / 12 June 2012

Drugs

Drug Countries
OFLOXIN Cyprus, Estonia, Lithuania, Romania

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