Medication info
Riseprel Plus Tablets

Riseprel Plus Tablets

Prescription medicationTablet경구
Ingredient · strength
Risedronate Sodium 2.5 Hydrate›40.162mg / 1 tabletCholecalciferol Concentrate Powder›56mg / 1 tablet
Manufacturer / importer
(주)휴비스트제약
Appearance
Light orange oval film-coated tablets
Packaging
4 tablets (4 tablets/PTP*1)
Approval status
Active

MFDS item code 201700623 · Approved 2017.02.06 · Insurance code 628800970

Summary

Main use
Treatment and prevention of postmenopausal osteoporosis in women and men
Who takes it
Adults · Children
Adult dose
Adults: Take 1 tablet of this medication orally once a week. Since food can interfere with absorption, take it at least 30 minutes before breakfast or at least 2 hours before or after taking food or drinks. Take with a sufficient amount of plain water (170–230 mL) in an upright position, and do not chew or suck on it. Do not lie down for at least 30 minutes after taking.
Child dose
Safety and effectiveness for pediatric and adolescent patients have not been established, so dosing instructions are not specified.

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Treatment and prevention of postmenopausal osteoporosis in women and men

  • Osteoporosis
View approved original text

This medication is used for the treatment and prevention of osteoporosis in postmenopausal women and men.

How to take

Adult dose

Adults: Take 1 tablet of this medication orally once a week. Since food can interfere with absorption, take it at least 30 minutes before breakfast or at least 2 hours before or after taking food or drinks. Take with a sufficient amount of plain water (170–230 mL) in an upright position, and do not chew or suck on it. Do not lie down for at least 30 minutes after taking.

Child dose

Safety and effectiveness for pediatric and adolescent patients have not been established, so dosing instructions are not specified.

Precautions

This medication may irritate the upper gastrointestinal mucosa, potentially causing issues such as esophagitis or esophageal ulcers. It should be taken with a sufficient amount of water, and patients should not lie down for at least 30 minutes after taking the medication. If difficulties swallowing occur or symptoms such as pain behind the sternum or heartburn appear, discontinue use immediately and consult a physician. This medication should not be administered to patients with esophageal dysfunction or severe renal impairment. Additionally, patients with allergies to the ingredients of this medication or certain genetic metabolic disorders should also refrain from taking it. During treatment, it is advisable not to take this medication together with other drugs or foods containing calcium, magnesium, iron, etc., and to adhere strictly to the timing and method of administration. It is important to ensure adequate intake of calcium and vitamin D while taking this medication, and supplements should be taken according to a physician's instructions if necessary. This medication is used for the treatment of osteoporosis and may cause side effects such as dyspepsia, myalgia, arthralgia, headache, and skin rash. Serious side effects such as osteonecrosis of the jaw, severe esophageal damage, and liver function abnormalities may occur rarely, so caution is required. Women who are pregnant or breastfeeding should consult a physician about taking this medication and may need to stop taking the medication or discontinue breastfeeding if necessary. In case of overdose, symptoms of hypocalcemia may arise due to low serum calcium levels, and if symptoms are suspected, immediate medical attention is required. Keep this medication out of reach of children, and do not transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

  • Severe allergic reactions such as hives, significant swelling (edema), chest tightness, difficulty breathing, and paleness.
  • Severe skin reaction with high fever accompanied by severe rash, blisters, peeling skin, and pain in the oral/ocular mucosa.
  • Esophagitis, esophageal ulcer, esophageal erosion, and rarely, esophageal obstruction or perforation.
  • Liver dysfunction and jaundice.
  • Severe neurological symptoms such as sudden and severe headache, seizures, confusion, vision changes, and paralysis.

Mild side effects

Mild to moderate adverse reactions similar to those in the placebo group have mainly been reported, including nausea, diarrhea, gastritis, abdominal pain, headache, myalgia, arthralgia, fatigue, pruritus, rash, pharyngitis, rhinitis, pneumonia, increased cough, urinary tract infection, cystitis, insomnia, depression, dizziness, anxiety, nausea, constipation, dyspepsia, vomiting, and elevated blood pressure.

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

Storage

This medication should be stored in a sealed container to protect it from air or moisture. It should be kept at room temperature, neither too high nor too low, ideally between 1°C and 30°C.

Appearance and packaging

Appearance

Light orange oval film-coated tablets

Package unit

4 tablets (4 tablets/PTP*1)

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.