PROGYNOVA 1mg Coated tablet Ref.[27703] Active ingredients: Estradiol

Posology

Progynova is an oestrogen-only product.

One tablet of Progynova 1 mg to be taken daily. It does not matter at what time of day the woman takes her tablet, but once she has selected a particular time she should keep to it every day. Treatment is continuous, which means that the next pack follows immediately without a break.

For initiation and continuation of treatment of menopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used. Treatment to control menopausal symptoms should be initiated with Progynova 1 mg. If considered necessary, Progynova 2 mg should be used. Once treatment is established the lowest effective does necessary for relief of symptoms should be used.

In women with an intact uterus, a progestogen should be added to Progynova for at least 12-14 days each month/28 day cycle. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.

How to start Progynova 1 mg

If the woman has an intact uterus and is still menstruating, a combination regimen with Progynova and a progestogen, commencing with the oestrogen phase, should begin on the first day of bleeding. If the menstrual periods are very infrequent or if amenorrhoea is established, she may start at any time provided, if appropriate, pregnancy has been excluded (see section 4.6).

In women transferring from a continuous combined HRT product, treatment with Progynova may be started on any day.

In women transferring from cyclic or continuous sequential HRT regimens the woman should complete the cycle and then change to Progynova without a break in therapy.

Missed or lost tablets

If the woman forgets to take a tablet at the usual time, she may take it within the following 12 hours. If the woman is more than 12 hours late the forgotten tablet should not be taken and the remaining tablets taken at the usual time on the right days. A missed dose may lead to breakthrough bleeding or spotting.

Paediatric population

Not recommended for children

Method of administration

The tablets can be taken with or without food. The tablets should be swallowed whole with a glass of water or milk. The tablets should be taken at the same time each day.

Overdose may cause nausea and vomiting and withdrawal bleeding may occur in some women. There are no specific antidotes and treatment should be symptomatic.

5 years.

None.

Container consists of aluminium foil and PVC blister strips packed in a cardboard carton.

Presentation: Carton containing memo-packs of either 1 × 28 tablets or 3 × 28 tablets.

None.