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Drug Registration File (French to English)

5.3 Preclinical safety data

Toxicological studies were conducted on each constituent and their association.

Acute toxicity studies indicate that there is no special risk in the event of accidental ingestion of a high dose of the contraceptive.

Repeated administration studies do not show any particular risk in humans. Long-term toxicity studies do not indicate any carcinogenic potential. However, it is known that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.

Embryotoxicity and teratogenicity studies and studies of the reproductive system do not show any particular risks. Even if oestroprogestagens have been used correctly, it is very important to stop treatment immediately if it is discovered that a pregnancy has started.

6. Pharmaceutical Particulars

6.1 Incompatibilities

6.2 Shelf life

Two years.

6.3 Special precautions for storage

To be stored at a temperature less than 25°C, away from light and humidity.

6.4 Nature and contents of container

21 tablets in a thermoformed blister pack (PVC/aluminum): box of 1.

21 tablets in a thermoformed blister pack (PVC/aluminum): box of 3.

6.5 Instructions for use/handling

Not to be left within the reach of children.

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