Medication info
Bonseive 35 mg Tablet (Sodium Risedronate)

Bonseive 35 mg Tablet (Sodium Risedronate)

Prescription medicationTabletOral
Ingredient · strength
Anhydrous Risedronate Sodium›35mg / 1 tablet
Manufacturer / importer
Daehan Pharmaceutical Co., Ltd.
Appearance
Pale orange round film-coated tablet
Packaging
4 tablets/PTP
Approval status
Active

MFDS item code 200800281 · Notified 2008.01.08

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 dosage adjustment is necessary in elderly patients (over 60 years) because the bioavailability and pharmacodynamics of this drug are similar to those in younger people. No dosage adjustment is necessary in patients with a creatinine clearance of 30 mL/min or higher. This drug is contraindicated in patients with severe renal impairment and a creatinine clearance below 30 mL/min. Food interferes with the absorption of this drug. For adequate absorption, take it at least 30 minutes before breakfast or at least 2 hours before or after consuming food or beverages at any time of day. To help the drug 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 drug with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this drug 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, 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: Safety and efficacy have not been established.

Ingredients

Manufacturer
Daehan 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 in postmenopausal women and men. It helps maintain bone health and reduce the risk of fractures.

How to take

Adult dose

Adults: Administer 35 mg of risedronate sodium orally once weekly. No dosage adjustment is necessary in elderly patients (over 60 years) because the bioavailability and pharmacodynamics of this drug are similar to those in younger people. No dosage adjustment is necessary in patients with a creatinine clearance of 30 mL/min or higher. This drug is contraindicated in patients with severe renal impairment and a creatinine clearance below 30 mL/min. Food interferes with the absorption of this drug. For adequate absorption, take it at least 30 minutes before breakfast or at least 2 hours before or after consuming food or beverages at any time of day. To help the drug 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 drug with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this drug 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, 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: Safety and efficacy have not been established.

Precautions

This medication can irritate the mucosa of the stomach and esophagus, so patients with upper gastrointestinal diseases such as gastritis or esophageal disorders should be particularly careful. Take with a sufficient amount of water and do not lie down for a certain period after taking it to reduce esophageal irritation. If symptoms such as pain in the esophagus, difficulty swallowing, or heartburn occur, stop taking the medication immediately and consult a doctor. This medication should not be administered to certain patients, including those with esophageal strictures, hypocalcemia, pregnant or breastfeeding women, and those with severe kidney disorders. Additionally, patients with genetic issues such as lactose intolerance should avoid taking this medication. It is important to ensure adequate intake of calcium and vitamin D while taking this medication, and patients receiving long-term corticosteroid treatment should be particularly cautious. During treatment, it is advisable to avoid taking this medication with food or drugs containing divalent cations and to avoid eating for a certain period before and after taking the medication. This medication can rarely cause serious side effects such as osteonecrosis of the jaw, atypical femoral fractures, and severe bone, joint, and muscle pain, so if symptoms occur, immediate medical attention is required. Pregnant women or women who may become pregnant and nursing mothers should not take this medication, as it may also be secreted in breast milk. Safety and efficacy have not been established in children under 18, and it can be used in elderly patients without special differences. In cases of overdose, blood calcium and phosphorus levels may drop, and symptoms of hypocalcemia may occur, requiring immediate treatment. Keep this medication out of reach of children and do not transfer it to other containers for safety.

Side effects

  • esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • infection
  • back pain
  • accidental injury
  • pain
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  • abdominal pain
  • flu symptoms
  • headache
  • fatigue
  • throat pain
  • chest pain
  • allergic reaction
  • hypertension
  • constipation
  • diarrhea
  • dyspepsia
  • nausea
  • peripheral edema
  • arthralgia
  • arthritis
  • fracture
  • joint abnormality
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • cataract
  • urinary tract infection
  • loss of appetite
  • asthenia
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • eye pain
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Lyle syndrome
  • angioedema
  • blister
  • skin reaction
  • external auditory canal osteonecrosis
  • iritis
  • uveitis
  • jawbone necrosis
  • liver dysfunction
  • jaundice
  • vomiting
  • upper abdominal pain
  • fever
  • influenza-like symptoms
  • acute reaction
  • arrhythmia
  • benign prostatic hyperplasia
  • nephrolithiasis

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

Storage

Store this medication in a tightly closed container to prevent exposure to air or moisture. It is also important to keep it at a room temperature between 1°C and 30°C to maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pale orange round film-coated tablet

Package unit

4 tablets/PTP

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.