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28 X 2.5 mg
The dosage is one tablet per day. 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 should be used.
A separate progestogen 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.
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.
Older people: No dose adjustment is necessary for the elderly.
Paediatric population: There is no relevant use of Livial in the paediatric population.
Method of administration: Oral use.
Complaints resulting from the natural or artificial menopause.
Treatment of oestrogen deficiency symptoms in postmenopausal women, more than one year after menopause. Women above 60 years of age should only start with Livial treatment when they are intolerant of, or contraindicated for, other medicinal products approved for the treatment of oestrogen deficiency symptoms.
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.
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.
– 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 oestrogen-dependent malignant tumours (e.g. endometrial cancer).
– Undiagnosed genital bleeding.
– Untreated endometrial hyperplasia.
– Previous or current venous thromboembolism (deep venous thrombosis,
– Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin
– 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(s) or to any of the excipients.
As with conventional HRT and SERMs, risk/benefit should be weighed in consultation with the patient with a risk factor of VTE. If VTE develops after initiating therapy, the drug should be discontinued.
See prescribing information for full details.
Change of body weight, dizziness, rash, pruritus, seborrhoeic dermatosis, increased facial hair growth, headache, migraine, visual disturbances (including blurred vision), gastrointestinal upset, abdominal pain, depression, edema, effects on the musculoskeletal system such as arthralgia or myalgia and changes in liver function parameters. There have been reports of endometrial hyperplasia and endometrial cancer in patients treated with tibolone although a causal relationship has not been established.
Since Livial may increase blood fibrinolytic activity, it may enhance the effect of
anticoagulants. This effect has been demonstrated with warfarin. Caution should therefore be exercised during the simultaneous use of Livial and anticoagulants, especially when starting or stopping concurrent Livial treatment. If necessary, the dose of warfarin should be adjusted.
There is limited information regarding pharmacokinetic interactions with tibolone. An in vivo study showed that simultaneous treatment of tibolone affects pharmacokinetics of the cytochrome P450 3A4 substrate midazolam to a moderate extent. Based on this, drug interactions with other CYP3A4 substrates might be expected.
Compounds that induce CYP3A4 activity such as barbiturates, carbamazepine,
hydantoins and rifampicin may enhance the metabolism of tibolone and thus affect its therapeutic effect.
Herbal preparations containing St.John’s wort (Hypericum Perforatum) may induce the metabolism of oestrogens and progestogens via CYP3A4. Clinically, an increased metabolism of oestrogens and progestogens may lead to decreased effect and changes in the uterine bleeding profile.
Pregnancy and Lactation
Pregnancy: Livial is contraindicated during pregnancy. If pregnancy occurs during medication with Livial, treatment should be withdrawn immediately. For Livial no clinical data on exposed pregnancies are available.
Studies in animals have shown reproductive toxicity. The potential risk
for humans is unknown.
Breast-feeding: Livial is contraindicated during breast-feeding.
The acute toxicity of tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur, even when several tablets are taken simultaneously. In cases of acute overdose, nausea, vomiting and vaginal bleeding in females may occur. No specific antidote is known. Symptomatic treatment can be given if necessary.