PREMARIN Coated tablet Ref.[8089] Active ingredients: Estrogens, conjugated

Adults

Premarin is an estrogen only HRT.

Treatment of Postmenopausal Symptoms

Premarin 0.3-1.25mg daily is the usual starting dose for women without a uterus. Continuous administration is recommended.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see section 4.4) should be used. Treatment to control menopausal symptoms should be initiated with Premarin 0.3mg. If symptoms are not adequately controlled, higher doses of Premarin may be prescribed. Once treatment is established the lowest effective dose necessary for the relief of symptoms should be used. Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary.

Prevention of postmenopausal osteoporosis:

When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.

The minimum effective dose is 0.625mg daily for most patients. (see section 5.1).

Starting or Changing Treatment

In women who are not taking hormone replacement therapy or women who switch from a 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.

Concomitant progestogen use for women with a uterus

In women with a uterus, where the addition of a progestogen is necessary it should be added for at least 12-14 days every 28 day cycle to reduce the risk to the endometrium.

Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.

The benefits of the lower risk of endometrial hyperplasia and endometrial cancer due to adding 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 in women with a uterus.

Elderly

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

Paediatric population

Safety and effectiveness in pediatric patients have not been established. Estrogen treatment of prepubertal girls induces premature breast development and vaginal cornification, and may induce uterine bleeding.

Since large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, hormonal therapy should not be started before epiphyseal closure has occurred in order not to compromise final growth.

Method of administration

For Oral administration

Tablets should be taken whole; do not divide, crush, chew, or dissolve tablets in mouth.

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.

Blister pack consisting of a PVC/Aclar/PVC and a hard tempered aluminium foil lid containing 28 tablets.

One carton pack contains 3 blisters.

Securitainers containing 100 tablets. PVC/Aluminium foil blisters containing 21 tablets.

Not applicable.