Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
bazedoxifene
Pfizer Europe MA EEIG
G03XC02
bazedoxifene
Sex hormones and modulators of the genital system,
Osteoporosis, Postmenopausal
Conbriza is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. A significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy on hip fractures has not been established.When determining the choice of Conbriza or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.
Revision: 15
Authorised
2009-04-17
24 B. PACKAGE LEAFLET 25 Package Leaflet: Information for the patient CONBRIZA 20 mg film-coated tablets bazedoxifene Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What CONBRIZA is and what it is used for 2. What you need to know before you take CONBRIZA 3. How to take CONBRIZA 4. Possible side effects 5. How to store CONBRIZA 6. Contents of the pack and other information 1. What CONBRIZA is and what it is used for CONBRIZA contains the active substance bazedoxifene, and is a medicine that belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs). It is used for the treatment of osteoporosis in women after they have reached menopause, when they are at an increased risk of fractures. It works by slowing or stopping the thinning of bone in these women. This medicine should not be used for the treatment of osteoporosis in men. 2. What you need to know before you take CONBRIZA Do not take CONBRIZA if you are allergic to bazedoxifene or any of the other ingredients of this medicine (listed in section 6). if you have or have had a blood clot (for example, in the blood vessels in your legs, lungs, or eyes). if you are pregnant or could still become pregnant. This medicine may cause harm to your unborn child if taken during pregnancy. if you have any unexplained vaginal bleeding. This must be investigated by your doctor. if you have active uterine cancer. Warnings and precautions Talk to your doctor or pharmacist before taking CONBRIZA Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CONBRIZA 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg bazedoxifene. Excipient with known effect Each film-coated tablet contains 142.8 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off-white, capsule-shaped, film-coated tablet debossed on one side with “WY20”. The tablet is approximately 1.5 cm in length. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications CONBRIZA is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. A significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy on hip fractures has not been established. When determining the choice of CONBRIZA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1). 4.2 Posology and method of administration Posology The recommended dose of CONBRIZA is one tablet once daily, at any time of day, with or without food (see section 5.2). Doses higher than 20 mg are not recommended because there is no demonstrable increased efficacy and higher doses may be associated with additional risk (see section 5.1). Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate. Special populations Renal impairment Bazedoxifene has not been sufficiently evaluated in patients with severe renal impairment; caution should be used in this population (see sections 4.4 and 5.2). No dose adjustment is required for mild or moderate renally impaired patients. 3 Hepatic impairment Safety and efficacy of bazedoxifene have not been evaluated in patients with hepatic impairment; use in this population is not recommended (see sections 4.4 and 5. Przeczytaj cały dokument