LIVIAL TABLET 2.5 MG [SIN05423P]

Product Info

LIVIAL TABLET 2.5 MG

[SIN05423P]

4.1 Therapeutic indications

• Treatment of estrogen deficiency symptoms in postmenopausal women, more than one year after menopause.

For all women the decision to prescribe Livial should be based on an assessment of the individual patient’s overall risks and, particularly in the over 60s, should include consideration of the risk of stroke (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

The dosage is one tablet per day. No dose adjustment is necessary for the elderly.

The tablets should be swallowed with some water or other drink, 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 separate progestagen should not be added with Livial treatment.

Starting Livial

Women experiencing a natural menopause should commence treatment with Livial at least 12 months after their last natural bleed. In case of a surgical menopause, treatment with Livial may commence immediately.

Any irregular/unscheduled vaginal bleeding, either on or off HRT, should be investigated to exclude malignancy before starting Livial (see section 4.3).

Switching from a sequential or continuous combined HRT preparation

If changing from a sequential HRT preparation, treatment with Livial should start the day following completion of the prior regimen. If changing from a continuous-combined HRT preparation, treatment can start at any time.

Missed dose

A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue. In the latter case, the missed dose should be skipped and the next dose should be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting.

4.3 Contraindications

• Pregnancy and lactation

• Known, past or suspected breast cancer – Livial increased the risk of breast cancer recurrence in a placebo-controlled trial

• Known or suspected estrogen-dependent malignant tumors (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)

• Any history of arterial thromboembolic disease (e.g. angina, myocardial infarction, stroke or TIA)

• 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 substance or to any of the excipients

• Porphyria