Aprogen Risedronate Sodium Tablets 35 mg (Risedronate Sodium 2.5 Hydrate)

Adult dose

As Risedronate Sodium, 35 mg should be taken orally once a week. Since food can interfere with the absorption of this medication, it should be taken at least 30 minutes before breakfast or at least 2 hours before and after consuming any food or drink during the day. It should be taken upright with a sufficient amount of pure water (170-230 mL) and not chewed or sucked; patients should not lie down for at least 30 minutes after taking it.

Child dose

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

This medication is an oral bisphosphonate and is mainly used for the treatment of osteoporosis. It may irritate the upper gastrointestinal mucosa; therefore, caution is required in patients with esophageal disease, gastritis, duodenitis, or ulcers. Severe esophageal adverse reactions such as esophagitis, esophageal ulcers, and esophageal erosion may occur rarely, so if symptoms like difficulty swallowing, pain behind the sternum, or heartburn occur, the medication should be stopped immediately and a doctor should be consulted. This medication must be taken with sufficient water (170-230 mL), and patients should not lie down for at least 30 minutes afterward. Also, food should not be consumed for a period of time before and after taking the medication. Failing to adhere to the administration instructions may greatly increase the risk of esophageal irritation. Furthermore, it's important to take this medication in conjunction with calcium and vitamin D, and patients with metabolic disorders like hypocalcemia, parathyroid dysfunction, or vitamin D deficiency should ensure treatment before use. Women who are pregnant or potentially pregnant, nursing mothers, patients with severe renal impairment, and those with esophageal motility disorders should not use this medication. Bisphosphonate medications have rarely been reported to cause serious side effects such as osteonecrosis of the jaw, atypical femoral fractures, and necrosis of the external auditory canal; if any of these symptoms are suspected, the doctor should be informed immediately. This medication should not be taken with antacids or supplements that contain divalent cations such as calcium, magnesium, iron, or aluminum at the same time, as they can interfere with absorption. Adverse reactions such as fever, myalgia, arthralgia, dyspepsia, diarrhea, and headache may occur during treatment, and if these symptoms are severe or persistent, a consultation with a doctor is necessary. Finally, the safety and efficacy of this medication in children have not been established, and it can be used in the elderly without dose adjustment.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress associated with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, numbness, and urinary issues.

Mild side effects

• Back pain
• accidental injury
• pain
• abdominal pain
• flu-like symptoms
• headache
• weakness
• neck pain
• allergic reactions
• hypertension

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow, elongated film-coated tablet

Package unit

4 tablets/PTP (4 tablets/PTP × 1)