Seoularoxifen Hydrochloride Tablets

Adult dose

Administer 60 mg orally once a day as Roxifen Hydrochloride.

This medication may increase the risk of thrombosis in the blood, so patients with a history of thrombosis or those at high risk of thrombosis should use it with caution. If a prolonged immobile state occurs, treatment with this drug should be discontinued, and therapy can be resumed when the condition improves and the patient can move again. Since this drug is primarily processed in the liver, it is safe not to use it in patients with poor liver function. The efficacy and safety of this drug have not been confirmed in premenopausal women, and it is not used in this population. Caution is needed as postmenopausal women with a high risk of cardiovascular disease or stroke may have an increased risk of death due to stroke. This drug should not be used for the prevention of cardiovascular disease, and concomitant use with systemic estrogen is not recommended. Women who are pregnant or may become pregnant, and women who are breastfeeding should not take this drug. It should also not be administered to patients with a history of thrombosis, liver dysfunction, unexplained uterine bleeding, or symptoms of endometrial cancer. Patients who are in a prolonged immobile state or have antiphospholipid syndrome should also avoid this medication. Patients with genetic issues such as lactose intolerance should not take this drug. Patients with high triglyceride levels in the blood or severely impaired kidney function should use this drug with caution. During treatment, side effects such as facial flushing, leg cramps, cold symptoms, peripheral edema may occur, and there is also a risk of thrombosis, so caution is advised. Patients with breast cancer or a history of breast cancer should consult a specialist before taking this drug, and if breast abnormalities occur during use, further examination is necessary. This drug is not intended for use in men and does not relieve menopausal symptoms. It is advisable to supplement calcium and vitamin D if intake is insufficient, and improvements in smoking or drinking habits are recommended. This drug generally has fewer interactions with other medications, but caution may be necessary when used in combination with specific drugs. Taking this medication during pregnancy can harm the fetus, thus women planning to become pregnant or who are pregnant should not use it. There has been no confirmation of safety and efficacy in children, so it is not used in this population. In the event of overdose, symptoms such as leg cramps and dizziness may occur, and immediate consultation with healthcare professionals is necessary. This drug should be kept out of reach of children and not transferred to other containers.

Serious side effects

• Deep vein thrombosis
• pulmonary embolism
• retinal vein thrombosis
• superficial venous thrombophlebitis
• arterial thromboembolism
• retinal vein occlusion
• stroke
• death related to deep vein thrombosis
• thrombocytopenia
• elevated blood pressure

Mild side effects

Vasodilation (facial flushing), leg cramps, cold symptoms, peripheral edema, decreased platelet count, gastrointestinal symptoms (nausea, vomiting, abdominal pain, dyspepsia), headache, rash, breast symptoms (pain, swelling, tenderness), vaginal bleeding, itching, palpitations, fever, malaise, sweating, muscle pain, insomnia, perineal pain, weight gain, arthritis, rheumatic symptoms, pain, fatigue, feelings of tightness, chest discomfort, skin lesions, anxiety, weight loss, seizures,

This medication should be stored in a sealed container to prevent air from entering, and it should be kept in a cool place between 15 to 30 degrees Celsius. This will help maintain the drug’s effectiveness and prevent degradation.

Appearance

White oval film-coated tablets

Package unit

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