INTRAROSA Pessary Ref.[7593] Active ingredients: Prasterone

Posology

The recommended dose is 6.5 mg prasterone (one pessary) administered once daily, at bedtime.

For the treatment of postmenopausal symptoms, Intrarosa should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk.

If a dose is forgotten, it should be taken as soon as the patient remembers. However, if the next dose is due in less than 8 hours, the patient should skip the missed pessary. Two pessaries should not be used to make up for a forgotten dose.

Special populations

Elderly

No dose adjustment is considered necessary in elderly women.

Patients with renal and/or hepatic impairment

Since Intrarosa acts locally in the vagina, no dosage adjustment is needed for postmenopausal women having renal or hepatic impairment or any other systemic anomaly or disease.

Paediatric population There is no relevant use of Intrarosa in female children of any age group for the indication of vulvar and vaginal atrophy due to menopause.

Method of administration

Vaginal use.

Intrarosa can be inserted in the vagina with the finger or with an applicator provided within the identified pack.

The pessary should be inserted in the vagina as far as it can comfortably go without force.

If inserted with an applicator, the following steps should be followed:

1. The applicator should be activated (by pulling back the plunger) before use.
2. The flat end of the pessary should be placed into the open end of the activated applicator.
3. The applicator should be inserted into the vagina as far as it can comfortably go without force.
4. The plunger of the applicator should be pressed to release the pessary.
5. The applicator should then be withdrawn and disassembled, and the two pieces of the applicator should be rinsed for 30 seconds under running water before wiping with paper towel and reassembled. The applicator should be kept in a clean place until next use.
6. Each applicator should be discarded after one week of usage (two extra applicators are provided).

In the event of overdose, vaginal douching is recommended.

3 years.

Store below 30°C.

Do not freeze.

Blister composed of an outer layer of PVC and an inner layer of LDPE.

Applicator made of LDPE and 1% colorant (Titanium dioxide).

28 pessaries are packed in a carton with 6 applicators.

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