Medication info
Ricalbon Tablet 35 Milligrams (Risedronate Sodium)

Ricalbon Tablet 35 Milligrams (Risedronate Sodium)

Prescription medicationTabletOral
Ingredient · strength
Risedronate Sodium›35mg / 1 tablet
Manufacturer / importer
McNulty Pharmaceutical Co., Ltd.
Appearance
Light orange oval film-coated tablet
Packaging
4 tablets/box [4 tablets/PTPX1]
Approval status
Active

MFDS item code 202000412 · Approved 2020.01.28 · Insurance code 641502860

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women; treatment of osteoporosis in men
Who takes it
Adults · Children
Adult dose
Adults: Administer 35 mg of risedronate sodium orally once weekly. No dose adjustment is necessary in older adults (over 60 years), as the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. No dose adjustment is necessary in patients with creatinine clearance of 30 mL/min or more. This medicine is contraindicated in patients with severe renal impairment with creatinine clearance below 30 mL/min. Food interferes with the absorption of this medicine. For adequate absorption, take it at least 30 minutes before breakfast, or at any time of day at least 2 hours before or after consuming food or beverages. To allow this medicine to reach the stomach easily and reduce the possibility of esophageal irritation, take it in an upright position with a sufficient amount of plain water (170 ∼ 230 mL). 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 a dose on the scheduled day, they should take it the next morning when they remember. The next dose should then be taken on the originally scheduled day. Do not take 2 tablets on the same day.
Child dose
The safety and efficacy of this medicine in children under 18 years of age have not been established.

Ingredients

Manufacturer
McNulty Pharmaceutical Co., Ltd.

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 occurring in postmenopausal women and men.

How to take

Adult dose

Adults: Administer 35 mg of risedronate sodium orally once weekly. No dose adjustment is necessary in older adults (over 60 years), as the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. No dose adjustment is necessary in patients with creatinine clearance of 30 mL/min or more. This medicine is contraindicated in patients with severe renal impairment with creatinine clearance below 30 mL/min. Food interferes with the absorption of this medicine. For adequate absorption, take it at least 30 minutes before breakfast, or at any time of day at least 2 hours before or after consuming food or beverages. To allow this medicine to reach the stomach easily and reduce the possibility of esophageal irritation, take it in an upright position with a sufficient amount of plain water (170 ∼ 230 mL). 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 a dose on the scheduled day, they should take it the next morning when they remember. The next dose should then be taken on the originally scheduled day. Do not take 2 tablets on the same day.

Child dose

The safety and efficacy of this medicine in children under 18 years of age have not been established.

Precautions

This medication can irritate the gastric or esophageal mucosa, so patients with esophageal diseases, gastritis, duodenitis, or ulcers should take it with caution. If symptoms such as difficulty swallowing, chest pain, or heartburn occur during treatment, stop taking the medication immediately and consult a doctor. When taking the medication, it is essential to take it with a sufficient amount of water and to avoid lying down for at least 30 minutes afterwards to reduce the risk of esophageal irritation. Patients with esophageal motility disorders, hypocalcemia, pregnant or nursing women, and patients with severe renal impairment should not take this medication. Patients with lactose intolerance are advised not to take this medication. As a bisphosphonate, serious side effects such as esophagitis, esophageal ulcers, esophageal obstruction, and perforation may rarely occur, so caution is advised. Additionally, rare side effects have been reported, including osteonecrosis of the jaw, atypical femoral fractures, and external auditory canal osteonecrosis, so regular check-ups and management are required for long-term use. It is important to ensure adequate intake of calcium and vitamin D while taking this medication, and medications or foods containing calcium, magnesium, iron, etc. should be taken at least 2 hours apart, as they may interfere with absorption. Pregnant or nursing women should avoid taking this medication as it may affect the fetus or newborn. Safety in children under 18 years has not been established, and it can be used in the elderly without special dosage adjustment. In cases of overdose, serum calcium levels may drop, so consult healthcare professionals immediately and receive necessary treatment. This medication should be kept out of reach of children and should not be transferred to another container.

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
  • joint pain
  • arthritis
  • fracture
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • cataract
  • urinary tract infection
  • decreased serum calcium
  • decreased serum phosphorus
  • liver dysfunction
  • mucous membrane syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • angioedema
  • blisters
  • skin reactions
  • external auditory canal osteonecrosis
  • iritis
  • uveitis
  • jaw necrosis
  • jaundice
  • loss of appetite
  • asthenia
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • ocular pain

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

Storage

This medication should be stored in a well-closed container to prevent exposure to air and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

Light orange oval film-coated tablet

Package unit

4 tablets/box [4 tablets/PTPX1]

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.