al study in rats, reduced viability of the offspring was observed at doses that were toxic to the dams.
6. Pharmaceutical particulars
6.1 List of excipients
Tablet core:
Microcrystalline cellulose
Croscarmellose sodium
Lactose monohydrate
Hypromellose
Sodium laurilsulfate
Magnesium stearate
Film-coat:
Macrogol 3350
Hypromellose
Titanium dioxide (E171)
Iron oxide red (E172)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
PP/Aluminium foil blisters in cartons of 10, 14, 28 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1, or 100 x 1 or in multipacks containing 100 (10 packs of 10 x 1) film-coated tablets.
HDPE bottles of 100 film-coated tablets with a PP screw cap.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorisation holder
Bayer Pharma AG
13342 Berlin
Germany
8. Marketing authorisation number(s)
EU/1/08/472/017-021, EU/1/08/472/024, EU/1/08/472/037, EU/1/08/472/039.
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 30 September 2008
Date of latest renewal: 22 May 2013
10. Date of revision of the text
September 2016
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
