Basic Information
ESTROFEM TABLET 2 mg
TABLET, FILM COATED
Regulatory Information
SIN06009P
June 3, 1991
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
XG03CA03
Company Information
Active Ingredients
Strength: 2 mg
Detailed Information
Contraindications
**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.
Indication Information
**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.