PROFLOXIN Film-coated tablet Ref.[50282] Active ingredients: Ciprofloxacin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, Ireland

Product name and form

Profloxin 250 mg film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

White or yellowish 11 mm round biconvex, film-coated tablets. Scored on both sides and side wall scored, marked C250 on one side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

One film-coated tablet contains ciprofloxacin hydrochloride equivalent to 250 mg ciprofloxacin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ciprofloxacin

Ciprofloxacin is a fluoroquinolone antibacterial agent. The bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.

List of Excipients

Microcrystalline cellulose
Crospovidone
Colloidal anhydrous silica
Magnesium stearate
Hypromellose
Macrogol 400
Titanium dioxide (E171)

Pack sizes and marketing

Blister strips consisting of 250 microM clear PVC and 20 microM hard temper aluminium foil contained in a carton.

Pack sizes: 5, 10, 12, 20, 30, 50, 60, 90 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, Ireland

Marketing authorization dates and numbers

PA0126/203/001

Date of first authorisation: 28th January 2005
Date of last renewal: 28th January 2010

Drugs

Drug Countries
PROFLOXIN Ireland, Malta, South Africa

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