IMVAGGIS Pessary Ref.[49986] Active ingredients: Estriol

Posology

During the first 3 weeks of treatment one pessary is administered daily. Thereafter a maintenance dose of 1 pessary twice a week is recommended.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used (see also section 4.4).

For estrogen products for vaginal application of which the systemic exposure to the estrogen is very low, it is not recommended to add a progestagen (but see section 4.4).

Method of administration and duration of treatment

The pessary should be introduced deeply into the vagina, preferably in the evening before going to bed.

Missed dose

During daily use within the first 3 weeks of treatment

If a missed dose is not realized before the next day, it should not be replaced. In that case the usual dosing schedule should be resumed.

During twice-weekly use

If the administration of the medicinal product has been forgotten at a scheduled date during the twice-weekly maintenance treatment, the missed dose should be administered as soon as possible.

Toxicity for estriol is very low. Overdose of IMVAGGIS 0.03 mg pessary by vaginal application is very unlikely. Symptoms that may occur in the case of a high dose is accidentally ingested are nausea, vomiting and vaginal bleeding in females. There is no known antidote. If necessary, a symptomatic treatment should be instituted.

3 years.

Do not store above 25°C.

Aluminium/laminated PE strips with pessaries packed in a cardboard carton.

Pack sizes with 10, 15, 20, 24 and 30 pessaries.

Not all pack sizes may be marketed.

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