Conbriza

2). 1). Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate. 2). No dose adjustment is required for mild or moderate renally impaired patients. 2). 2). Paediatric population There is no relevant use of bazedoxifene in the paediatric population.

Method of administration Oral use.

Summary of the safety profile The safety of CONBRIZA has been evaluated in two multicentre, double-blind, randomised, placebo- and active-control, Phase 3 trials: 7,492 evaluable postmenopausal women in a three-year osteoporosis treatment trial (1,886 women received bazedoxifene 20 mg; 1,872 women received bazedoxifene 40 mg; 1,849 women received raloxifene; 1,885 women received placebo) and 1,583 evaluable postmenopausal women in a 2-year osteoporosis prevention trial (321 women received bazedoxifene 10 mg; 322 women received bazedoxifene 20 mg; 319 women received bazedoxifene 40 mg; 311 women received raloxifene; 310 women received placebo).

The majority of adverse reactions occurring during the clinical trials were mild to moderate in severity and did not lead to discontinuation of therapy. The most frequent drug-related adverse reactions in double-blind, randomised studies were hot flushes and muscle spasms (includes leg cramps).

Tabulated list of adverse reactions The safety data in the following table are derived from both clinical trials and spontaneous post-marketing reporting. Adverse reactions are categorised according to the following frequencies: very common ( 1/10); common ( 1/100 to  1/10); uncommon ( 1/1,000 to  1/100); rare ( 1/10,000 to  1/1,000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. System organ class Very common Common Uncommon Frequency not known (cannot be estimated from available data) Immune system disorders Hypersensitivity Nervous system disorders Somnolence Eye disorders Retinal vein thrombosis* Vision disorders/Ocular events# Cardiac disorders Palpitations Vascular disorders Hot flush Deep vein thrombosis*, thrombophlebitis superficial 6 System organ class Very common Common Uncommon Frequency not known (cannot be estimated from available data) Respiratory, thoracic and mediastinal disorders Pulmonary embolism* Gastrointestinal disorders Dry mouth Skin and subcutaneous tissue disorders Urticaria, rash, pruritus Musculoskeletal and connective tissue disorders Muscle spasms (includes leg cramps) General disorders and administration site conditions Oedema peripheral Investigations Blood triglycerides increased, alanine aminotransferase increased, aspartate aminotransferase increased.

Use of CONBRIZA is not recommended in women at an increased risk for venous thromboembolic events. CONBRIZA is associated with an increased risk of venous thromboembolism (VTE). 69 compared to placebo. 1). The risk factors associated with VTE cases in clinical trials included: advanced age, obesity, immobilisation, surgery, major trauma and malignancy.

, post-surgical recovery, prolonged bed rest), and therapy should be resumed only after the patient is fully ambulatory. In addition, women taking CONBRIZA should be advised to move about periodically during prolonged travel. Bazedoxifene has not been studied in premenopausal women.

Its safety in premenopausal women has not been established, and its use is not recommended in this population. There is no evidence of endometrial proliferation. Any uterine bleeding during CONBRIZA therapy is unexpected and should be fully investigated.

4 mmol/litre). 1). The safety of CONBRIZA in patients with breast cancer has not been studied. No data are available on the concomitant use with agents used in the treatment of early or advanced breast cancer. Therefore, bazedoxifene is not recommended for treatment or prevention of breast cancer.

4 Bazedoxifene has not been sufficiently evaluated in patients with severe renal impairment; caution should be used in this population. 3-fold increase in area under the curve (AUC) [on average] compared with controls. 2). Excipients with known effect CONBRIZA contains lactose.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

1. Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. CONBRIZA is only indicated for use in postmenopausal women. 3). Unexplained uterine bleeding. Patients with signs or symptoms of endometrial cancer; safety in this patient group has not been adequately studied.