Ginotinel Tablet 150 mg (Risedronate Sodium Hydrate)

Adult dose

1. Adults : Administer 150 mg of risedronate sodium orally once a month. 2. Older adults : No dose adjustment is necessary in older adults (over 60 years of age), because the bioavailability and pharmacodynamics of this medicine 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 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 the first food or beverage other than water of the day. To facilitate passage of this medicine to the stomach and reduce the possibility of esophageal irritation, take it in an upright position with an adequate amount of plain water (170 ∼ 230 mL). Taking it 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 this medicine on the scheduled day, follow the instructions below. - If 7 days or more remain until the next scheduled dose, take 1 tablet the next morning after remembering. Take the next dose again on the originally scheduled day. Do not take more than 1 tablet of this medicine within 7 days. - If fewer than 7 days remain until the next scheduled dose, wait until the originally scheduled dose date and take 1 tablet.

Child dose

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

This drug may irritate the gastrointestinal mucosa, so patients with diseases of the esophagus or stomach should be particularly cautious. Take this medication with sufficient water, and do not lie down for at least 30 minutes after taking it. If symptoms such as pain in the esophagus or difficulty swallowing occur, discontinue use immediately and consult a doctor. Patients with esophageal motility disorders, hypocalcemia, pregnant or breastfeeding women, and patients with severe renal impairment should not take this medicine. This drug contains lactose, so patients with lactose intolerance should not use it. Taking this drug with other medications containing divalent cations like calcium or magnesium may interfere with absorption, so it should be taken at intervals. Prior to taking this medication, conditions like hypocalcemia and vitamin D deficiency causing bone and mineral metabolism disorders must be treated, and adequate intake of calcium and vitamin D is essential. Rare but serious side effects such as osteonecrosis of the jaw, atypical fractures, and external auditory canal osteonecrosis may occur; report any abnormal symptoms to a healthcare provider immediately. During long-term use, regular evaluations by a doctor should be conducted, and discontinuation may be necessary if required. Safety and efficacy in children or adolescents under 18 years of age have not been established, and the elderly should follow the general dosage instructions. In case of overdose, symptoms of hypocalcemia may appear, requiring appropriate treatment and calcium supplementation. Store this medication out of reach of children and avoid transferring it to another container.

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

Store this medication in a sealed container to prevent air from entering, preferably at a temperature between 1 degree and 30 degrees Celsius. Maintaining this storage condition will help preserve the effectiveness of the medication and prevent deterioration.

Appearance

Bright blue rectangular film-coated tablet

Package unit

1 tablet (1 tablet x 1 PTP)