Raloxifene Hydrochloride 60 mg Tablet

Adult dosage

Administer 60 mg orally once daily as Raloxifene Hydrochloride.

This medication may increase the risk of venous thromboembolism, therefore patients with a risk of thrombosis should carefully weigh the risks and benefits before taking it. Since this medication is primarily metabolized in the liver, patients with impaired liver function should either avoid taking this medication or have their liver function monitored regularly. Its effectiveness and safety in premenopausal women have not been established, so it is not recommended for use in these individuals. For menopausal women at high risk for cardiovascular disease, this medication may affect the incidence of myocardial infarction or stroke, so caution is especially needed in those with a history of stroke. This medication is not used for the prevention of cardiovascular disease, and concurrent use with other hormone therapies is not recommended. Women who are pregnant or may become pregnant and breastfeeding mothers should avoid this medication due to potential harm to the fetus or baby. Patients with a history of thrombosis, liver dysfunction, unexplained uterine bleeding, symptoms of endometrial cancer, long-term immobility, or antiphospholipid syndrome should not use this medication. Patients who had elevated triglycerides due to oral estrogen therapy should have their blood triglyceride levels monitored periodically during treatment with this medication. Common side effects may include facial flushing, cold symptoms, leg cramps, peripheral edema, nausea, vomiting, abdominal pain, indigestion, migraines, rash, mild breast symptoms, vaginal bleeding, itching, palpitations, fever, weakness, sweating, muscle pain, insomnia, perineal pain, weight gain, arthritis, rheumatic pain, fatigue, tightness, chest tightness, skin lesions, anxiety, weight loss, seizures, and taste disturbances. Patients should consult a healthcare provider if any abnormal symptoms occur, as there is a risk of thrombosis. If uterine bleeding occurs during use, professional evaluation is necessary, and appropriate examinations should be conducted if any abnormal symptoms appear in the breasts. This medication is not to be used by men and does not alleviate menopausal symptoms. It is advisable to take calcium and vitamin D supplements if these nutrients are deficient, and to improve lifestyle habits if one smokes or consumes alcohol. This medication has no significant interaction with specific antacids, but it is not advisable to take it with medications like cholestyramine. Additionally, careful monitoring of coagulation status is necessary when used in combination with anticoagulants like warfarin. Severe adverse effects due to overdose have not been reported, but leg cramps and dizziness may occur, so the prescribed dosage should be followed. Caution is needed when administering this medication to children or the elderly, especially since its safety has not been established in children. This medication should be stored out of reach of children and not transferred to another container for safety.

Serious side effects

• Venous thromboembolism
• pulmonary embolism
• retinal vein thrombosis
• superficial thrombophlebitis
• arterial thromboembolism
• retinal vein occlusion
• stroke
• death related to venous thromboembolism
• thrombocytopenia
• increased blood pressure

Mild side effects

• Vasodilation (flushing)
• leg cramps
• cold symptoms
• peripheral edema
• nausea
• vomiting
• abdominal pain
• indigestion
• migraine
• rash

This medication should be stored in a tightly sealed container to avoid exposure to air. It is best kept at room temperature between 15°C and 30°C, not too hot or too cold.

Appearance

White oval film-coated tablet

Package unit

14 tablets (14 tablets/PTP packaging x 1), 28 tablets (14 tablets/PTP packaging x 2)