Medication info
Risnel Tablet 35 mg (Risedronate Sodium Hydrate)

Risnel Tablet 35 mg (Risedronate Sodium Hydrate)

Prescription medicationTabletOral
Ingredient · strength
Risedronate Sodium Monohydrate›37.07mg / 1 tablet
Manufacturer / importer
Yuhan Corporation
Appearance
Orange rectangular film-coated tablet
Packaging
4 tablets (4 tablets/PTP packaging x 1)
Approval status
Active

MFDS item code 200713108 · Notified 2007.12.07 · Insurance code 642103120

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women; treatment of osteoporosis in men
Who takes it
Adults · Children
Adult dose
1. Adults: Administer 35 mg of risedronate sodium orally once weekly. 2. Elderly patients: No dose adjustment is necessary in elderly patients (over 60 years of age), because the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. 4. Patients with renal impairment: No dose adjustment is necessary for patients with a creatinine clearance of 30 mL/min or higher. This medicine is contraindicated in patients with severe renal impairment and a creatinine clearance below 30 mL/min. Because food interferes with the absorption of this medicine, take it at least 30 minutes before breakfast to ensure adequate absorption, or at least 2 hours apart from food or beverages at any time of day. Take this medicine in an upright position with a sufficient amount of plain water (170 ∼ 230 mL) to facilitate passage into the stomach and reduce the possibility of esophageal irritation. Taking this medicine with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this medicine because of the possibility of oropharyngeal ulceration. Patients should not lie down for at least 30 minutes after taking it. If a patient forgets to take the medicine on the scheduled day, take it the next morning when remembered. Resume the usual dosing schedule on the next scheduled day. Do not take 2 tablets on the same day.
Child dose
Children under 18 years of age: Safety and efficacy have not been established.

Ingredients

Manufacturer
Yuhan Corporation

Efficacy & effects

Treatment and prevention of osteoporosis in postmenopausal women; treatment of osteoporosis in men

  • Osteoporosis
View approved original text

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

How to take

Adult dose

1. Adults: Administer 35 mg of risedronate sodium orally once weekly. 2. Elderly patients: No dose adjustment is necessary in elderly patients (over 60 years of age), because the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. 4. Patients with renal impairment: No dose adjustment is necessary for patients with a creatinine clearance of 30 mL/min or higher. This medicine is contraindicated in patients with severe renal impairment and a creatinine clearance below 30 mL/min. Because food interferes with the absorption of this medicine, take it at least 30 minutes before breakfast to ensure adequate absorption, or at least 2 hours apart from food or beverages at any time of day. Take this medicine in an upright position with a sufficient amount of plain water (170 ∼ 230 mL) to facilitate passage into the stomach and reduce the possibility of esophageal irritation. Taking this medicine with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this medicine because of the possibility of oropharyngeal ulceration. Patients should not lie down for at least 30 minutes after taking it. If a patient forgets to take the medicine on the scheduled day, take it the next morning when remembered. Resume the usual dosing schedule on the next scheduled day. Do not take 2 tablets on the same day.

Child dose

Children under 18 years of age: Safety and efficacy have not been established.

Precautions

This medication can irritate the gastric and esophageal mucosa; caution is advised for those with gastrointestinal diseases such as esophagitis or ulcers. If symptoms of esophageal abnormalities such as dysphagia, pain, or heartburn occur, stop taking the medication immediately and consult a physician. Take with a sufficient amount of water and do not lie down for at least 30 minutes after ingestion. It is crucial to adhere to the exact method of taking this medication to reduce the risk of serious side effects if the medication remains in the esophagus. This medication should not be administered to patients with certain diseases or conditions, such as esophageal stricture, hypocalcemia, severe renal impairment, pregnant women or those who may become pregnant, and individuals with lactose intolerance. Caution is advised for individuals with upper gastrointestinal disorders such as Barrett's esophagus, gastritis, or duodenitis. Various side effects like dyspepsia, abdominal pain, diarrhea, muscle pain, joint pain, headache, dizziness may occur, so consult a physician if unusual symptoms persist. The absorption of this medication may be hindered if taken with foods or medications containing calcium, magnesium, or iron, so it is best to maintain an interval of some time before and after taking this medication. Pregnant or breastfeeding women should avoid taking this medication or should make a decision after consulting a specialist. Safety has not been established for children; it is advisable not to use in individuals under 18 years of age. Overdose can lead to hypocalcemia, and treatment such as administering milk or calcium-containing antacids and gastric lavage may be necessary. Store this medication out of reach of children and do not transfer to another container for safety and quality reasons.

Side effects

  • esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • hemorrhage
  • infection
  • low back pain
  • accidental injury
  • pain
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  • abdominal pain
  • flu symptoms
  • headache
  • weakness
  • throat pain
  • chest pain
  • allergic reaction
  • hypertension
  • constipation
  • diarrhea
  • dyspepsia
  • nausea
  • peripheral edema
  • arthralgia
  • arthritis
  • fracture
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • cataract
  • urinary tract infection
  • vomiting
  • uveitis
  • scleritis
  • iritis
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • angioedema
  • blister
  • skin reaction
  • external ear bone necrosis
  • jaw bone necrosis
  • liver dysfunction
  • jaundice
  • loss of appetite
  • asthenia
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • eye pain

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 or moisture from entering. It is recommended to maintain a room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Orange rectangular film-coated tablet

Package unit

4 tablets (4 tablets/PTP packaging x 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.