Medication info

Daewoong Raloxifene Hydrochloride Tablet 60 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Raloxifene Hydrochloride›Strength being verified
Manufacturer / importer
(주)대웅제약
Appearance
White oval film-coated tablet
Packaging
14 tablets/PTP [14 tablets/PTP packaging x 1], 28 tablets/PTP [14 tablets/PTP packaging x 2]
Approval status
Approval withdrawn

MFDS item code 202002216 · Approved 2020.03.31

This product's status changed to Approval withdrawn on 2023.03.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women
Who uses it
Adults
Adult dosage
Administer 60 mg orally once daily as Raloxifene Hydrochloride.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Treatment and prevention of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication is used for the treatment and prevention of osteoporosis in postmenopausal women. It helps to increase bone density, strengthen bones, and reduce the risk of fractures. Thus, it is effective in maintaining healthy bones and preventing complications arising from osteoporosis.

Dosage and Administration

Adult dosage

Administer 60 mg orally once daily as Raloxifene Hydrochloride.

Precautions

This medication may increase the risk of blood clots in the blood, so it should be discontinued if immobilization lasts for a long time. Caution is necessary in patients with impaired liver function as the concentration of this medication can increase, and regular liver function tests should be conducted. It is not advisable for premenopausal women as safety has not been confirmed. Postmenopausal women with cardiovascular disease or high risk may increase the risk of stroke when taking this medication, so careful judgment is required. Women who are pregnant, potentially pregnant, or breastfeeding should not take this medication, as it may be harmful to the fetus or baby. Patients with a history of thrombosis, liver disorders, unexplained uterine bleeding, or endometrial cancer should also avoid using this medication. Patients with high triglycerides or poor kidney function should exercise caution when using this medication. During use, facial flushing or leg cramps may occur, as well as cold symptoms or swelling. When used with other medications, there may be interactions, and consultation with a doctor or pharmacist is recommended. This medication is used for the treatment of osteoporosis, and it is advisable to take it with calcium and vitamin D. Improving smoking and drinking habits can be beneficial. It should not be used by pregnant, breastfeeding women, children, or men, and there is no special caution needed for the elderly. In case of overdose, dizziness or leg cramps may occur, so immediate consultation with medical personnel is necessary. Store this medication out of reach of children, and do not transfer it 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
  • venous thromboembolism
  • arterial thromboembolism
  • retinal vein occlusion
  • stroke
  • death related to deep vein thrombosis
  • thrombocytopenia
Show 2 more
  • increased blood pressure
  • headaches including migraine.

Mild side effects

Vasodilation (facial flushing), leg cramps, cold symptoms, peripheral edema, nausea, vomiting, abdominal pain, indigestion, headache, rash, breast symptoms (pain, swelling, and tenderness), vaginal bleeding, facial swelling, heartburn, constipation, itching, palpitations, fever, fatigue, sweating, myalgia, insomnia, perineal pain, weight gain, arthritis, rheumatism-like symptoms, pain, fatigue, tightness, chest discomfort, skin lesions, anxiety, weight loss, cramps, vision problems.

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 air and moisture from entering. It is recommended to keep the medication at a temperature between 15 to 30 degrees Celsius, avoiding extremes of heat or cold, to maintain its effectiveness.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

14 tablets/PTP [14 tablets/PTP packaging x 1], 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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.