Actonel 35 mg (Risedronate Sodium Monohydrate)

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), as the bioavailability and pharmacodynamics of this medication are similar to those in younger people. 4. Patients with renal impairment: No dose adjustment is necessary in patients with creatinine clearance of 30 mL/min or greater. This medication is contraindicated in patients with severe renal impairment and creatinine clearance below 30 mL/min. ○ Food interferes with the absorption of this medication. 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 medication 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 it with other beverages, including mineral water, may reduce the absorption of this medication. Do not chew or suck this medication 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 medication on the scheduled day, take it the next morning when remembered. Resume taking it on the regularly scheduled day thereafter. Do not take 2 tablets on the same day.

Child dose

3. Children: The safety and efficacy of this medication have not been established in children under 18 years of age.

This medication can irritate the gastrointestinal mucosa, and patients with esophageal or gastric problems should take special care. It should not be used in patients with abnormalities such as esophageal stricture or achalasia, those with hypocalcemia, pregnant or breastfeeding women, and patients with severe renal impairment. It should be taken with a sufficient amount of water, and the patient must remain upright for at least 30 minutes after taking it to prevent esophageal irritation. Additionally, it is important to appropriately supplement calcium and vitamin D if they are lacking. Medications or foods containing calcium, magnesium, iron, etc., may interfere with absorption, so a time interval between taking them is necessary. Rarely, gastrointestinal issues such as esophagitis, esophageal ulcer, gastric ulcer, as well as osteonecrosis of the jaw, musculoskeletal pain, and eye inflammation may occur, and if symptoms arise, the patient should consult a doctor immediately. Long-term use may carry the risk of atypical femoral fractures; thus, evaluation is necessary if there are abnormal symptoms like leg pain. It is safer for women who are pregnant or may become pregnant to avoid this medication, and breastfeeding women should also discontinue breastfeeding or stop use. The safety and efficacy for children have not been established, while elderly patients can generally use it safely. In case of overdose, there may be a reduction in blood calcium and phosphorus levels, requiring appropriate treatment. This drug should be kept out of the reach of children and should not be transferred to other containers.

• esophagitis
• esophageal ulcer
• esophageal erosion
• esophageal obstruction
• esophageal perforation
• hemorrhage
• gastric ulcer
• duodenal ulcer
• dyspepsia
• diarrhea

This medication should be stored in a tightly sealed container to prevent air or moisture from entering and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance

Light orange rectangular film-coated tablet

Package unit

4 tablets/PTP