Actonel 35 mg Tablets (Risedronate Sodium)

Adult dose

1. Adults : Administer 35 mg of risedronate sodium orally once weekly. 2. Elderly patients : 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. 4. Patients with renal impairment : 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

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

This medication may irritate the mucosa of the stomach and esophagus, so individuals with esophageal diseases or upper gastrointestinal disorders such as gastritis, duodenitis, or ulcers should take special care. Symptoms like esophagitis, esophageal ulcers, dysphagia, pain behind the sternum, or heartburn may occur after taking this medication; if these symptoms appear, discontinue use immediately and consult a doctor. When taking this medication, it must be consumed with a sufficient amount of water, and one should not lie down for at least 30 minutes after taking it. The timing of food intake before and after taking the medication must also be adhered to. Individuals with conditions that delay esophageal emptying such as esophageal stricture or achalasia, hypocalcemia, severe renal impairment, pregnant or breastfeeding women, and patients with lactose intolerance should not take this medication. Patients with esophageal diseases such as Barrett's esophagus or dysphagia or those allergic to dyes included in this medication should use it with caution. This medication is used for the treatment of osteoporosis, and it is important to take calcium and vitamin D supplements concurrently. During treatment, side effects such as joint pain, muscle pain, dyspepsia, diarrhea, headache, dizziness may occur, and rare serious reactions such as severe skin reactions, osteonecrosis of the jaw, or eye inflammation have been reported. Long-term use may also result in rare side effects such as atypical femoral fractures or osteonecrosis of the external auditory canal, so discuss unusual symptoms with healthcare providers. This medication may interfere with the absorption of antacids or supplements that contain calcium, magnesium, or iron, so maintain an appropriate interval between dosages. If pregnant or breastfeeding, avoid taking this medication or consult healthcare providers thoroughly, and safety in children under 18 has not been established. In cases of overdose, symptoms of hypocalcemia may occur; in such cases, calcium supplementation and appropriate treatment are necessary. Finally, this medication must be kept out of reach of children, and it should not be transferred to a different container.

• esophagitis
• esophageal ulcer
• esophageal erosion
• esophageal obstruction
• esophageal perforation
• hemorrhage
• gastric ulcer
• duodenal ulcer
• infection
• lumbago

This medication should be stored in a tightly sealed container to prevent air exposure and is safe when stored at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a long time.

Appearance

Pale orange oval film-coated tablet

Package unit

4 tablets/PTP