Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women with more than one year post menopause.
Experience of treating women older than 65 years is limited.
Women who do not take hormone replacement therapy (HRT) or women who change from another continuous combined HRT product may start treatment at any time.
Women changing from a continuous sequential HRT regimen should begin the day following completion of the prior regimen.
Women changing from a cyclic HRT regimen should begin the day after the treatment-free period.
One tablet is taken daily. Each blister pack contains tablets for 28 days of treatment.
For oral use.
The tablets are to be swallowed whole with some liquid. Treatment is continuous, which means that the next pack follows immediately without a break. The tablets should preferably be taken at the same time every day. In case a tablet is forgotten it should be taken as soon as possible. If more than 24 hours have elapsed no extra tablet needs to be taken. If several tablets are forgotten, bleeding may occur. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used.
Velbienne is contraindicated for use in children and adolescents.
There is no data that would lead to an adjustment of the dosage in older patients. In women aged 65 or older, see section 4.4.
Velbienne has not been specifically studied in patients with hepatic impairment. Velbienne is contraindicated in women with severe hepatic diseases (see section 4.3).
Velbienne has not been specifically studied in renally impaired patients.. Available data do not suggest a need for dosage adjustment in this patient population.
Acute toxicity studies indicated that, even in the case of inadvertent intake of a multiple of the therapeutic dose, no acute toxicity risk is to be expected. Overdose may cause nausea and vomiting and withdrawal bleeding may occur in some women. There is no specific antidote.
3 years.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
Blister of PVC/PVDC/aluminium.
Supplied in cartons containing 28, 3 × 28, or 6 × 28 coated tablets.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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