PROGYLUTON Coated tablets Ref.[50731] Active ingredients: Estradiol Norgestrel

Progyluton is a cyclic HRT product. One tablet is to be taken orally once a day for 21 days, followed by a 7-day tablet free interval. Therefore each new pack is started after a 28 day cycle. The white tablets should be taken from days 1 to 11 followed by the brown tablets from days 12 to 21. It is recommended that the tablets are taken at the same time every day.

For initiation and continuation of treatment of peri- and post-menopausal symptoms the lowest effective dose for the shortest duration (see also ‘Special warnings and special precautions for use’) should be used.

For women still having periods, the first tablet should be taken on the 5th day of their menstrual period. If menstruation has stopped, or is infrequent or sporadic, then the first tablet can be taken any time.

If the patient is being transferred from a continuous HRT product, the patient may start Progyluton on any convenient day. For those transferring from a cyclic or sequential product, Progyluton should be started following completion of the previous regimen.

If a tablet is missed, it should be taken as soon as possible, unless it is more than 12 hours late. In this case the missed tablet should be left in the pack and the next tablet taken at the right time. Missing a dose may result in breakthrough bleeding or spotting.

Unless there is a previous diagnosis of endometriosis, it is not recommended that progestogencontaining HRT be given to hysterectomised women.

Children and adolescents

Progyluton is not indicated for use in children and adolescents.

Geriatric patients

There are no data suggesting a need for dosage adjustment in women aged 65 years or older (see section 4.4 Special warnings and precautions for use).

Patients with renal impairment

Progyluton has not been specifically studied in renally impaired patients. Available data do not suggest a need for dosage adjustment in this patient population.

Hepatic insufficiency

Progyluton has not been tested in patients with hepatic insufficiency. Progyluton is contraindicated in women with serious hepatic conditions.

Owing to the low acute toxicity of the active substances estradiol valerate and norgestrel no acute intoxication risk is likely, even if a multiple of the therapeutically required dose is ingested by mistake on one occasion.

An acute overdose may be accompanied by headaches, nausea, vomiting, feeling of tightness in the chest and uterine bleeding.

With chronic overdosage an increase in undesirable effects and heightened risks as described in the section “Special warnings and special precautions for use” can be expected.

No specific antidote exists. Symptomatic treatment must be provided if necessary.

The expiry date of the product is indicated on the packaging materials.

Keep out of reach of children.

Do not store above 25°C.

Calendar pack containing 1 × 21 coated tablets (B).