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Superceded Text: June 2010
Updated text: October 2010
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 291.0mg ciprofloxacin hydrochloride equivalent to 250mg Ciprofloxacin.
For a full list of excipients, see Section 6.1.
Each film-coated tablet contains 250 mg ciprofloxacin (as hydrochloride)
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL form
Film-coated tablet, round, white to slightly yellow, marked with the 'Bayer Cross' on one side and CIP 250 on the reverse.
Film-coated tablet
Round, nearly white to slightly yellowish tablets marked with “CIP score 250” on one side and a Bayer cross on the reverse side.
The tablets can be divided into equal halves.
6.1 List of excipients
Each tablet core contains:
microcrystalline cellulose,
maize starch,
crospovidone,
silica, colloidal anhydrous,
magnesium stearate.
The tablet film-coat consists of a mixture of:
hypromellose 2910,
Macrogol 4000,
titanium dioxide (E171).
Tablet core :
Cellulose microcrystalline
Crospovidone
Maize starch
Magnesium stearate
Silica colloidal anhydrous
Film-coat :
Hypromellose
Macrogol 4000
Titanium dioxide (E171)
6.4 Special precautions for storage
No special storage precautions are necessary.
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Blister strips in cardboard outers comprising:
a) 250µm, 40g/m2 PVC/PVDC foil with 20µm hard aluminium backing foil.
Pack sizes 10, 20, 100 tablets.
b) 300µm polypropylene foil with 20µm hard aluminium backing foil with a 3.5g/m2 heat seal polypropylene coating.
Pack sizes: 10, 20, 100 tablets.
Not all pack sizes may be marketed.
One of the following primary packaging materials is used:
Transparent colourless or white opaque PVC/PVDC/Aluminum blister
Transparent colourless or white opaque PP/Aluminum blister
Aluminum/Aluminum blister
Pack sizes of 6, 8, 10, 12, 14, 16, 20, 28, 50, 100, 160 or 500 film-coated tablets
10. DATE OF REVISION OF THE TEXT
June 2010
September 2010