An increased number of intrauterine deaths were observed in rats given extremely high doses. Notwithstanding, reproduction studies in mice, rats, rabbits and dogs, overall yielded no evidence of teratogenicity, embryotoxicity, or of any impairment of fertility or perinatal development.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

 Hydroxyethyl cellulose

Povidone

Talc

Magnesium stearate

Sucrose

Acacia

Macrogol 6000

Erythrosine (E127)

Titanium dioxide (E171)

6.2 Incompatibilities

 None known.

6.3 Shelf life

 3 years

6.4 Special precautions for storage

 Do not store above 25°C. Store in original package

6.5 Nature and contents of container

 Blister packs (Aluminium/PVC) containing 100 tablets

6.6 Special precautions for disposal and other handling

 No special requirements.

7. MARKETING AUTHORISATION HOLDER

 Sanofi-aventis Ireland Ltd.,

Citywest Business Campus,

Dublin 24.

8. MARKETING AUTHORISATION NUMBER(S)

 PA 540/80/3

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 7 March 1977 / 7 March 2007

10. DATE OF REVISION OF THE TEXT

 August 2010.