ZAFRILLA Tablet Ref.[50403] Active ingredients: Dienogest

Posology

The dosage of Zafrilla is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. The tablet can be taken with or without food.

Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption.

Treatment can be started on any day of the menstrual cycle.

Any hormonal contraception needs to be stopped prior to initiation of Zafrilla. If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method).

Management of missed tablets

The efficacy of Zafrilla may be reduced in the event of missed tablets, vomiting and/or diarrhoea (if occuring within 3‑4 hours after tablet taking). In the event of one or more missed tablets, the woman should take one tablet only, as soon as she remembers, and should then continue the next day at her usual time. A tablet not absorbed due to vomiting or diarrhoea should likewise be replaced by one tablet.

Additional information on special populations

Paediatric population

Zafrilla is not indicated in children prior to menarche.

The safety and efficacy of dienogest 2 mg tablet was investigated in an uncontrolled clinical trial over 12 months in 111 adolescent women (12 ‑ <18) with clinically suspected or confirmed endometriosis (see sections 4.4 and 5.1).

Elderly

There is no relevant indication for use of Zafrilla in the geriatric population.

Hepatic impairment

Zafrilla is contraindicated in patients with present or past severe hepatic disease (see section 4.3).

Renal impairment

There are no data suggesting the need for a dosage adjustment in patients with renal impairment.

Method of administration

For oral use.

Acute toxicity studies performed with dienogest did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic dose. There is no specific antidote. A daily intake of 20‑30 mg dienogest (10 to 15 times higher dose than in {(Invented) name}) over 24 weeks of use was very well tolerated.

3 years.

Store in the original package in order to protect from light.

This medicinal product does not require any special temperature storage conditions.

28, 84, 168 Zafrilla 2 mg tablets are packaged in green, hard PVC//Al calendar blisters in folded carton box.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.