Raloxifene Teva

Due to the nature of this disease process, raloxifene is intended for long term use. Generally calcium and vitamin D supplements are advised in women with a low dietary intake.

Elderly:

No dose adjustment is necessary for the elderly. 3). In patients with moderate and mild renal impairment, raloxifene should be used with caution. 4).

Paediatric population:

Raloxifene should not be used in children of any age. There is no relevant use of Raloxifene in the paediatric population. Method of administration Oral administration. The tablet can be taken at any time of the day without regard to meals.

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a. 4), which occurred in less than 1% of treated patients. b. Tabulated summary of adverse reactions The table below gives the adverse reactions and frequencies observed in treatment and prevention studies involving over 13,000 postmenopausal women along with adverse reactions arising from postmarketing reports.

The duration of the treatment in these studies ranged from 6 to 60 months. The majority of adverse reactions have not usually required cessation of therapy. The frequencies for postmarketing reports were calculated from placebo-controlled clinical trials (comprising a total of 15,234 patients, 7,601 on raloxifene 60 mg and 7,633 on placebo) in postmenopausal women with osteoporosis, or established coronary heart disease (CHD) or increased risk for CHD, without comparison to the frequencies of adverse events in the placebo assignment groups.

1 % of 584 placebo-treated patients. 1 % of 2,576 placebo treated patients. The following convention has been used for the classification of the adverse reactions: 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) very rare (< 1/10,000), not known (cannot be estimated from the available data).

Blood and lymphatic system disorders Uncommon:

Thrombocytopeniaa Nervous system disorders Common: Headache, including migrainea Uncommon: Fatal strokes Vascular disorders Very common: Vasodilation (hot flushes) Uncommon: Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial vein thrombophlebitis, Arterial thromboembolic reactionsa Gastrointestinal disorders Very common: Gastrointestinal symptomsa such as nausea, vomiting, abdominal pain, dyspepsia Skin and subcutaneous tissue disorders Common: Rasha Musculoskeletal and connective tissue disorders 6 Common: Leg cramps Reproductive system and breast disorders Common: Mild breast symptomsa such as pain, enlargement and tenderness General disorders and administration site conditions Very common: Flu syndrome Common: Peripheral oedema Investigations Very common: Increased blood pressurea aTerm(s) included based on postmarketing experience.

Raloxifene is associated with an increased risk for venous thromboembolic events that is similar to the reported risk associated with current use of hormone replacement therapy. The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.

Raloxifene should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation. Discontinuation should happen as soon as possible in case of the illness, or from 3 days before the immobilisation occurs.

Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile. In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.

However, there was an increase in death due to stroke in women assigned to raloxifene. 2 per 1000 women per year for raloxifene. This finding should be considered when prescribing raloxifene for postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischemic attack or atrial fibrillation.

There is no evidence of endometrial proliferation. Any uterine bleeding during raloxifene therapy is unexpected and should be fully investigated by a specialist. The two most frequent diagnoses associated with uterine bleeding during raloxifene treatment were endometrial atrophy and benign endometrial polyps.

3 % in women who received placebo treatment. Raloxifene is metabolised primarily in the liver. 5 times the controls. The increase correlated with total bilirubin concentrations. Until safety and efficacy have been evaluated further in patients with hepatic insufficiency, the use of raloxifene is not recommended in this patient population.

1. Must not be used in women with child bearing potential. Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis. Hepatic impairment including cholestasis.

Severe renal impairment. Unexplained uterine bleeding. Raloxifene should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.