ESTROFEM TABLET 1 MG [SIN09922P]

Product Info

ESTROFEM TABLET 1 MG

[SIN09922P]

4.1 Therapeutic indications
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women.
Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.
Estrofem® is particularly for women who have been hysterectomised and therefore do not require combined oestrogen/progestagen therapy.
The experience of treating women older than 65 years is limited.

4.2 Posology and method of administration
Estrofem® is an oestrogen-only product for hormonal replacement. Estrofem® is administered orally, one tablet daily without interruption, and should not be administered to women with an intact uterus unless combined with a suitable progestagen for at least 12–14 days every month/28 day cycle. 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

A switch to a higher dose or a lower dose of Estrofem® could be indicated if the response after three months is insufficient for satisfactory symptom relief or if the tolerability is not satisfactory.
Prevention of bone mineral content loss is normally achieved with 1–2 mg estradiol daily, therefore higher doses are not usually used for long term prophylaxis of osteoporosis.

In women without a uterus, Estrofem® may be started on any convenient day.
In women with a uterus who present amenorrhoea and are being transferred from a sequential HRT, Estrofem® may be initiated on day 5 of bleeding and only in combination with a progestagen for at least 12–14 days; if transferred from a continuous-combined HRT, Estrofem® along with a progestin, may be started on any convenient day. The progestagen type and dose should provide sufficient inhibition of the oestrogen induced endometrial proliferation (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours have passed, the tablet should be discarded. Forgetting a dose for women with a uterus may increase the likelihood of breakthrough bleeding and spotting. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women.

4.3 Contraindications

• Known, past or suspected breast cancer

• Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)

• Undiagnosed genital bleeding

• Untreated endometrial hyperplasia

• Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)

• Known thrombophilic disease disorders (e.g. protein C, protein S or antithrombin deficiency (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information))

• Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction)

• Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Porphyria.