New Avesta Tablet (Leroxifen Hydrochloride)

Adult dosage

As Leroxifen Hydrochloride, orally administer 60 mg once daily.

This medication may increase the risk of thrombosis in the blood; therefore, patients with a history of thrombosis or those at high risk for thrombosis should consult their doctor before taking it. For patients with poor liver function, the safety and efficacy of this medication have not been adequately confirmed, so it is advisable to avoid taking it in cases of liver impairment. The use of this medication has not been approved for premenopausal women and is recommended only for postmenopausal women. Postmenopausal women with cardiovascular diseases or those at high risk for cardiovascular diseases should be cautious, as taking this medication may increase the risk of stroke. This medication should not be used for the prevention of cardiovascular diseases, and no beneficial effects on the cardiovascular system have been proven. It is not recommended to take this medication in conjunction with systemic estrogens. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication, as it may pose risks to the fetus or nursing infant. This medication should be avoided by patients with a history of venous thromboembolism, liver impairment, unclear causes of uterine bleeding, symptoms of endometrial cancer, patients who are immobile for extended periods, and those with antiphospholipid syndrome. This medication contains lactose and should not be administered to patients with lactose intolerance. Patients with a history of hypertriglyceridemia or severe renal impairment should be closely monitored when taking this medication. During treatment, side effects such as vasodilation symptoms (flushing), leg cramps, cold symptoms, peripheral edema, nausea, vomiting, abdominal pain, dyspepsia, headache (including migraine), rash, mild breast symptoms (pain, tenderness, swelling), vaginal bleeding, facial swelling, heartburn, constipation, itching, palpitations, fever, fatigue, sweating, myalgia, insomnia, perineal pain, weight gain, arthralgia, rheumatic-like pain, malaise, chest tightness, skin lesions, anxiety, and weight loss may occur, and any unusual symptoms should be reported to a doctor immediately. It is advisable to supplement with calcium and vitamin D if intake is insufficient, and lifestyle improvements are necessary for those with smoking and drinking habits. Potential drug interactions may occur, so patients taking other medications should inform their doctor or pharmacist before use. This medication is not to be used in children or males, and should only be used in the elderly if safety and efficacy have been confirmed. In case of overdose, appropriate treatment based on symptoms is required; there is no specific antidote for this medication. When storing, keep it out of the reach of children and do not transfer it to another container.

Serious side effects

• Deep vein thrombosis
• pulmonary embolism
• retinal vein thrombosis
• superficial venous thrombophlebitis
• stroke
• cardiovascular disorders
• thrombocytopenia
• arterial thromboembolism
• retinal vein occlusion
• death related to deep vein thrombosis

Mild side effects

Vasodilation (facial flushing), leg cramps, cold symptoms, peripheral edema, nausea, vomiting, abdominal pain, dyspepsia, headache (including migraine), rash, mild breast symptoms (pain, swelling, tenderness), vaginal bleeding, facial swelling, heartburn, constipation, itching, palpitations, fever, weakness, sweating, myalgia, insomnia, perineal pain, weight gain, arthralgia, rheumatic-like pain, fatigue, malaise, chest tightness, skin lesions, anxiety, weight loss,

This medication should be stored in a tightly sealed container to prevent air or moisture ingress, and it is best kept in a cool place between 15 degrees and 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy for a longer period.

Appearance

White oval film-coated tablet

Package unit

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