Presentation and Status in Health Basket
Film Coated Tablets
One tablet is taken daily. Each blister is for 28 days of treatment.
Additional information on special populations
Children and adolescents: Angeliq is not indicated for use in children and adolescents.
Geriatric patients: There are no data suggesting a need for dosage adjustment in elderly patients. InFor full details on women aged 65 years or older seeSpecial precautions.
Patients with hepatic impairment: In women with mild or moderate hepatic impairment, drospirenone is well tolerated. Angeliq is contraindicated in women with severe hepatic disease.
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. Angeliq is contraindicated in women with severe renal disease.
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women more than 1 year post menopause. Prevention of postmenopausal osteoporosis in women with an increased risk of future osteoporotic fractures.
Prior to starting therapy or occurring during therapy: Undiagnosed genital bleeding; known past or suspected cancer of the breast; known or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer); previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism). Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction); present or past liver tumors (benign or malignant); acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal. Severe renal insufficiency or acute renal failure, severe hypertriglyceridemia. Pregnancy and lactation, diabetes mellitus, known hypersensitivity to the active substances or to any of the excipients.
For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk. Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.
Medical examination/follow-up: Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse. Investigations, including appropriate imaging tools, e.g mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Conditions which need supervision: If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with Angeliq, in particular: Leiomyoma (uterine fibroids) or endometriosis, Risk factors for, thromboembolic disorders (see below), Risk factors for estrogen dependent tumours, e.g. 1st degree heredity for breast cancer, Hypertension, Liver disorders (e.g. liver adenoma), Diabetes mellitus with or without vascular involvement, Cholelithiasis, Migraine or (severe) headache, Systemic lupus erythematosus, A history of endometrial hyperplasia (see below), Epilepsy, Asthma, Otosclerosis.
Reasons for immediate withdrawal of therapy: Therapy should be discontinued in case a contra-indication is discovered and in the following situations: Jaundice or deterioration in liver function, Significant increase in blood pressure, New onset of migraine-type headache, Pregnancy.
Endometrial hyperplasia and carcinoma: In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when estrogens are administered alone for prolonged periods. The reported increase in endometrial cancer risk among estrogen-only users varies from 2- to 12-fold greater compared with non-users, depending on the duration of treatment and estrogen dose. After stopping treatment risk may remain elevated for at least 10 years. The addition of a progestogen cyclically for at least 12 days per month/28 day cycle or continuous combined estrogen-progestogen therapy in non-hysterectomised women prevents the excess risk associated with estrogen-only HRT. Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Breast cancer: The overall evidence suggests an increased risk of breast cancer in women taking combined estrogen-progestogen and possibly also estrogen-only HRT, that is dependent on the duration of taking HRT. The randomised placebo-controlled trial, the Women’s Health Initiative study (WHI), and epidemiological studies are consistent in finding an increased risk of breast cancer in women taking combined estrogen-progestogen for HRT that becomes apparent after about3 years. The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment. HRT, especially estrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Ovarian cancer: Long-term (at least 5-10 years) use of estrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies. It is uncertain whether long-term use of combined HRT confers a different risk than estrogenonly products. Pregnancy and lactation: If pregnancy occurs during medicdbation, treatment should be discontinued promptly. Should not be used during lactation.
Abdominal pain or bloating, asthenia, pain in an extremity. Nausea, headache, mood swings, hot flushes, nervousness. Benign breast neoplasms, breast enlargement. Enlarged uterine fibroids, cervix neoplasm, leukorrhea. Benign and malignant estrogen-dependent neoplasms, venous thromboembolism, myocardial infarction and stroke. Gall bladder disease, skin and subcutaneous disorders.
For full details see prescribing information.
Anticonvulsants (e.g. phenobarbital, phenytoin, carbamezapine), anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz). Ritonavir, nelfinavir, St. John”s wort, cimetidine, ketoconazole.
For full details see prescribing information.
Pregnancy and Lactation
Pregnancy: Angeliq is not indicated during pregnancy. If pregnancy occurs during medication with Angeliq, treatment should be discontinued promptly. No clinical data on exposed pregnancies are available for drospirenone. Animal studies have shown reproductive toxicity. The potential risk for humans is unknown. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to combinations of estrogens with other progestogens have not indicated a teratogenic or foetotoxic effect.
Lactation: Angeliq is not indicated during lactation.
In clinical studies in male volunteers doses up to 100 mg of drospirenone were well tolerated. Based on general experience with combined oral contraceptives, symptoms that may possibly occur are nausea and vomiting and – in young girls and some women – vaginal bleeding. There are no specific antidotes, and, therefore, treatment should be symptomatic.