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CIPROFLOXACIN Film-coated tablet (2019)

Active ingredients: Ciprofloxacin

Product Name and Form

Ciprofloxacin 250 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet.

White, round film-coated tablets debossed with “250” on one side and plain on the other side.

Qualitative and Quantitative Composition

Each film-coated tablet contains Ciprofloxacin hydrochloride equivalent to Ciprofloxacin 250 mg.

For the full list of excipients, see section 6.1.

Chemical substance
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

Core tablet:

Microcrystalline cellulose
Maize starch
Magnesium stearate
Talc
Colloidal anhydrous silica
Sodium starch glycollate (Type A)

Film-coating:

Hypromellose
Titanium dioxide (E171)
Macrogol 400
Talc

Pack sizes and Marketing

The tablets are available in blisters comprising of:

  • PVdC coated PVC as blister forming material with aluminium foil backing or
  • Cold form blister laminate (Structure from outer to inner side: oriented polyamide/aluminium foil/hard PVC films) with a backing of aluminium foil coated with heat seal lacquer.

Packs of 1, 8, 10, 14, 16, 20, 28, 32 and 100 tablets per carton are available.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Ranbaxy (UK) Limited, 5th floor, Hyde Park, Hayes 3, 11 Millington Road, Hayes, UB3 4AZ, United Kingdom

15 December 2000

Marketing authorization number:

PL 14894/0022