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Women who do not take hormone replacement therapy (HRT) or women who change from another continuous combined product may start treatment at any time. Women changing from a cyclic, sequential combined HRT regimen, treatment should begin the day following completion of the prior regimen.
One tablet is taken daily. Each blister is for 28 days of treatment.
The tablets are to be swallowed whole with some liquid irrespective of food intake. 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. If 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, vaginal bleeding may occur.
For treatment of post menopausal symptoms, the lowest effective dose should be used.
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.
Additional information on special populations
Children and adolescents
Angeliq is not indicated for use in children and adolescents.
There are no data suggesting a need for dosage adjustment in elderly patients. In women aged 65 years or older, see section 4.4.
Patients with hepatic impairment
In women with mild or moderate hepatic impairment, drospirenone is well tolerated (see section 5.2. Pharmacokinetic properties). Angeliq is contraindicated in women with severe hepatic disease (see section 4.3).
Patients with renal impairment
In women with mild or moderate renal impairment, a slight increase of drospirenone exposure was observed but is not expected to be of clinical relevance (see section 5.2). Angeliq is contraindicated in women with severe renal disease (see section 4.3).
• Undiagnosed genital bleeding
• Known, past or suspected cancer of the breast
• Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer)
• Untreated endometrial hyperplasia
• Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
• 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
• Known thrombophilic disorders (e.g. protein C protein S, or antithrombin deficiency, see section 4.4
• Severe renal insufficiency or acute renal failure
• Known hypersensitivity to the active substances or to any of the excipients
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