Medication info
Reset tablet (Risedronate sodium hydrate 2.5)

Reset tablet (Risedronate sodium hydrate 2.5)

Prescription medicationTablet경구
Ingredient · strength
Risedronate Sodium 2.5 Hydrate›40.2mg / 1 tablet
Manufacturer / importer
(주)셀릭스
Appearance
Yellow oval film-coated tablet
Packaging
4 tablets (4 tablets/PTP×1)
Approval status
Active

MFDS item code 200713906 · Approved 2007.12.31 · Insurance code 646202490

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women and men
Who takes it
Adults · Children
Adult dose
Risedronate sodium: 35 mg taken orally once a week. Food can interfere with absorption, so take at least 30 minutes before breakfast or at least 2 hours before or after food or beverages during the day. Take it with a sufficient amount of plain water (170-230 mL) while in an upright position, and do not chew or suck the tablet. Do not lie down for at least 30 minutes after taking. If a patient forgets to take the medication on the scheduled day, they should take it the next morning when they remember. The next dose should then be taken as originally scheduled. Do not take two tablets on the same day.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

Treatment and prevention of osteoporosis in postmenopausal women and men

  • Osteoporosis
View approved original text

This medication is primarily used for the treatment and prevention of osteoporosis in postmenopausal women. It is also effective in treating osteoporosis in men. Osteoporosis is a condition that causes bones to weaken and increases the risk of fractures. This medication helps enhance bone health, preventing and treating fractures due to osteoporosis, making it a good choice for maintaining and strengthening bone health.

How to take

Adult dose

Risedronate sodium: 35 mg taken orally once a week. Food can interfere with absorption, so take at least 30 minutes before breakfast or at least 2 hours before or after food or beverages during the day. Take it with a sufficient amount of plain water (170-230 mL) while in an upright position, and do not chew or suck the tablet. Do not lie down for at least 30 minutes after taking. If a patient forgets to take the medication on the scheduled day, they should take it the next morning when they remember. The next dose should then be taken as originally scheduled. Do not take two tablets on the same day.

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established.

Precautions

This medication may irritate the gastric mucosa, so individuals with upper gastrointestinal disorders such as Barrett's esophagus, dysphagia, esophageal diseases, gastritis, duodenitis, or ulcers should take it with caution. If symptoms such as dysphagia, odynophagia, pain behind the chest, or heartburn occur during use, discontinue immediately and consult a doctor. When taking the medication, it must be taken with plenty of water (170-230 mL), and one should not lie down for at least 30 minutes after taking it. Patients with mental disorders or those who may have difficulty following medication instructions should take this medication under medical supervision. Individuals with esophageal strictures or achalasia, hypocalcemia, severe renal impairment, pregnant or breastfeeding women, and those with lactose intolerance should not take this medication. If calcium and vitamin D are deficient, they must be supplemented before taking this medication, and patients receiving long-term corticosteroid treatment should also ensure calcium and vitamin D intake is adequate. This medication can interfere with the absorption when taken with foods or drugs containing calcium, magnesium, iron, aluminum, etc., so it should be taken at least 30 minutes before meals. Rare side effects such as osteonecrosis of the jaw have been reported, so it's important to maintain good oral hygiene and consult with a doctor before dental treatment if necessary. There is a risk of atypical femoral fractures, so if there is pain in the thigh or groin, immediate medical attention is needed. Symptoms such as fever, muscle pain, joint pain, dyspepsia, nausea, diarrhea may occur during use, and if symptoms are severe, consultation with medical personnel is necessary. Pregnant women or those who may become pregnant should not take it, and breastfeeding mothers should either discontinue the medication or breastfeeding. Safety and efficacy in pediatric patients under 18 years of age have not been established. In case of overdose, hypocalcemia may occur, and immediate medical attention should be sought if symptoms arise, and calcium supplementation therapy may be required. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, high fever with severe rash, blisters, skin peeling, pain in mouth/eyes mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, jaundice of the skin or eyes, severe lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache

Mild side effects

  • Headache
  • fatigue
  • neck pain
  • chest pain
  • hypertension
  • constipation
  • diarrhea
  • dyspepsia
  • nausea
  • peripheral edema
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  • joint pain
  • arthritis
  • bone trauma (fracture)
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased coughing
  • rash
  • cataracts
  • urinary tract infection
  • uveitis
  • scleritis
  • iritis
  • hematuria
  • increased sweating
  • flushing
  • burning sensation
  • kidney stones
  • belching
  • fever
  • indigestion

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

Storage

This medication should be stored in an airtight container and kept at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication over time.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

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.