OFLOXACIN Film-coated tablet Ref.[7840] Active ingredients: Ofloxacin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Product name and form

Ofloxacin 200 mg Tablets.

Pharmaceutical Form

Film-coated tablet.

White biconvex capsule-shaped, film-coated tablet marked ‘OF’ breakline ‘200’ on one side and ‘G’ on the reverse.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 200 mg of ofloxacin.

Excipient with known effect: Each film-coated tablet also contains 96.00 mg of lactose, anhydrous.

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

Tablet core:

Maize starch
Lactose, anhydrous
Hydroxypropylcellulose
Croscarmellose sodium
Magnesium stearate

Film-coating:

Hypromellose
Titanium dioxide (E171)
Macrogol 400
Talc

Pack sizes and marketing

Aluminium PVC/PVDC blisters and polypropylene bottles with polyethylene tamper evident closure (with optional polyethylene ullage filler).

Obtainable in the following pack sizes: 3, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 30, 50, 100, 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Marketing authorization dates and numbers

PL 04569/0549

28 February 2002 / 11 June 2007

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