PREMIQUE Modified release tablet Ref.[27876] Active ingredients: Estrogens, conjugated Medroxyprogesterone

Posology

Adults

Premique Low Dose is taken in a continuous combined 28-day regimen of one tablet daily with no break between packs.

In women who are not taking hormone replacement therapy or women who switch from another continuous combined hormone replacement therapy product, treatment may be started on any convenient day. In women transferring from a sequential hormone replacement therapy regimen, treatment should begin the day following completion of the prior regimen.

For treatment of postmenopausal symptoms: Take one tablet per day.

Breakthrough bleeding and spotting may occur in the early stages of Premique Low Dose therapy. If breakthrough bleeding persists and endometrial abnormality has been ruled out, a higher dose of treatment or cyclic therapy should be considered as an alternative.

The lowest dose and regimen that will control symptoms should be chosen.

Maintenance / Continuation / Extended treatment

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see section 4.4) should be used. Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary.

The benefits of the lower risk of endometrial hyperplasia and endometrial cancer due to adding a progestogen should be weighed against the increased risk of breast cancer (see sections 4.4 and 4.8).

Forgotten tablet: If a tablet is forgotten, it should be taken as soon as the patient remembers, therapy should then be continued as before. If more than one tablet has been forgotten only the most recent tablet should be taken, the patient should not take double the usual dose to make up for missed tablets.

Missed pills may cause breakthrough bleeding.

Elderly

There are no special dosage requirements for elderly patients, but, as with all medicines, the lowest effective dose should be used.

Paediatric population

Not recommended.

Method of administration

Premique is taken orally.

Symptoms of overdosage of estrogen-containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in females. There is no specific antidote, and further treatment should be symptomatic.

2 years.

Do not store above 25°C. Keep blister in the outer carton to protect from light.

Blister pack, consisting of a polyvinyl chloride (PVC)/Aclar film and aluminum foil with heat seal coating containing 28 tablets. Each carton contains 28 tablets (1 blister pack) or 84 tablets (3 blister packs).

Not all pack sizes may be marketed.

No special requirements.