Dronel Tablet 35 mg (Sodium Risedronate Dihydrate)

Adult dose

1. Adults : Administer 35 mg of risedronate sodium orally once weekly. 2. Older adults : No dosage adjustment is necessary in older adults (over 60 years of age), as the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. 4. Patients with renal impairment : No dosage adjustment is necessary in 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 of less than 30 mL/min. ○ Food interferes with the absorption of this medicine. 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 this medicine 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. This medicine must not be chewed or sucked 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 this medicine on the scheduled dosing day, they should take it the next morning when they remember. The next dose should then be taken on the originally scheduled dosing 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.

This drug is an oral bisphosphonate used for treating osteoporosis of the bone. It may irritate the upper gastrointestinal mucosa, so patients with gastrointestinal diseases such as esophagitis, esophageal ulcers, or gastritis should be careful. Take this medication with a sufficient amount of water (about 170-230 mL), and do not lie down for at least 30 minutes after ingestion. It should be taken at least 2 hours apart from medications or beverages containing calcium, magnesium, iron, etc., as they may interfere with absorption. This medication is not to be administered to patients with esophageal stricture, hypocalcemia, severe renal impairment, pregnant or nursing women, and patients with certain genetic disorders. It should also be used with caution in patients with a history of esophageal disease or dysphagia, and if symptoms such as dysphagia, chest pain, or heartburn occur during use, discontinue the medication immediately and consult a physician. Though rare, serious gastrointestinal adverse reactions such as esophageal obstruction, perforation, gastric ulcers, and duodenal ulcers can occur, so be cautious if symptoms arise. Some patients may experience adverse reactions such as muscle pain, joint pain, bone pain, rash, headache, dizziness, etc. Rare side effects, such as osteonecrosis of the jaw, have been reported, so consult a physician before dental treatment. Long-term use may also pose a risk of atypical femoral fractures, so evaluation is necessary if leg pain persists. Pregnant or nursing women should avoid or discontinue this medication, and safety has not been established for children under 18 years of age. In case of overdose, hypocalcemia may occur, so visit a medical facility immediately for appropriate treatment. This medication should be kept out of reach of children, and care should be taken not to transfer it to other containers.

• esophagitis
• esophageal ulcer
• esophageal erosion
• esophageal obstruction
• esophageal perforation
• bleeding
• infection
• back pain
• accidental injury
• pain

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. This will help maintain the efficacy of the medication for a longer time.

Appearance

Light yellow oblong film-coated tablet

Package unit

4 tablets (4 tablets/PTP × 1)