Medication info
Entirabin Tablets 60 mg (Raloxifene Hydrochloride)

Entirabin Tablets 60 mg (Raloxifene Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Raloxifene Hydrochloride›60mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
White oval film-coated tablets
Packaging
28 tablets/PTP [(14 tablets/PTP packaging x 2)]
Approval status
Active

MFDS item code 201906182 · Approved 2019.08.30

Summary

Main use
Treatment and prevention of postmenopausal osteoporosis
Who takes it
Adults
Adult dose
Administer 60 mg of Raloxifene Hydrochloride orally once daily.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Treatment and prevention of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

This medication is used to treat and prevent osteoporosis that may occur in postmenopausal women.

How to take

Adult dose

Administer 60 mg of Raloxifene Hydrochloride orally once daily.

Precautions

This medication may increase the risk of blood clots in the bloodstream, so it should be used with caution in patients with a history of thrombosis or those at high risk of thrombosis. As this medication is primarily metabolized in the liver, it is not recommended for patients with poor liver function, and any signs of liver dysfunction should be closely monitored. It is not used in premenopausal women as its safety and efficacy have not been established. In postmenopausal women with heart disease or high cardiovascular risk, this medication does not help prevent cardiovascular disease and may slightly increase the risk of stroke, so caution is advised. Pregnant women, women who may become pregnant, and nursing mothers should not use this medication as it may be harmful to the fetus or infant. This medication should not be administered to patients with specific genetic disorders, liver dysfunction, unexplained uterine bleeding, or signs of endometrial cancer. In patients who are immobile for a long time, the risk of thrombosis increases, so the use of this medication should be discontinued. Possible side effects during treatment include leg cramps, facial flushing, cold symptoms, peripheral edema, nausea, vomiting, abdominal pain, dyspepsia, increased blood pressure, headache, rash, breast symptoms (pain, swelling, tenderness), facial flushing, vaginal bleeding, facial swelling, heartburn, constipation, itching, palpitations, fever, weakness, sweating, muscle pain, insomnia, perineal pain, weight gain, arthritis, rheumatic-like pain, fatigue, discomfort, chest tightness, skin lesions, anxiety, weight loss, and When taken with other medications, there may be interactions, particularly if taken with drugs affecting blood coagulation; therefore, blood tests should be conducted to monitor conditions. This medication is used for the treatment and prevention of osteoporosis in postmenopausal women, and adequate intake of calcium and vitamin D is recommended. It is not used in children or men, and it is also safe and effective in the elderly, but must be taken under a doctor's guidance. In cases of overdose, dizziness or leg cramps may occur, so it is crucial to adhere to the prescribed dosage and notify healthcare providers immediately of any adverse symptoms. This medication should be kept out of reach of children and not transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial venous thrombophlebitis, stroke, death related to deep vein thrombosis and pulmonary embolism, thrombocytopenia, arterial thromboembolism, retinal vein occlusion, migraine including headache

Mild side effects

Vasodilation (flushing), leg cramps, cold symptoms, peripheral edema, nausea, vomiting, abdominal pain, dyspepsia, increased blood pressure, headache, rash, breast symptoms (pain, swelling, tenderness), facial flushing, vaginal bleeding, facial swelling, heartburn, constipation, itching, palpitations, fever, weakness, sweating, muscle pain, insomnia, perineal pain, weight gain, arthritis, rheumatic-like pain, fatigue, discomfort, chest tightness, skin lesions, anxiety, weight loss,

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The storage temperature should be maintained between 15 degrees and 30 degrees Celsius. This will help to preserve the medication's effectiveness.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

28 tablets/PTP [(14 tablets/PTP packaging x 2)]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.