ACTIVELLE TABLET [SIN10960P]

Product Info

ACTIVELLE TABLET

[SIN10960P]

4.1 Therapeutic indications
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with more than 1 year since last menses.

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.

The experience of treating women older than 65 years is limited.

4.2 Posology and method of administration
Activelle^® is a continuous combined HRT product intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be used.

A switch to a higher dose combination product could be indicated if the response after 3 months is insufficient for symptom relief.

In women with amenorrhoea and not taking HRT or women in transition from another continuous combined HRT product, treatment with Activelle^® may be started on any convenient day. In women in transition from a sequential HRT regimen, treatment should start right after their withdrawal bleeding has ended.

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 may increase the likelihood of breakthrough bleeding and spotting.

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 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 previous 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

• Known hypersensitivity to the active substances or to any of the excipients

• Porphyria