Risedronate belongs to a group of medicines called bisphosphonates. It works by changing the cycle of bone formation and breakdown in the body. It slows down bone loss while increasing bone mass, which helps reduce the risk of bone fractures.

Risedronate is used in the following conditions:

• Prevention and treatment of osteoporosis in postmenopausal women.
• Increase of bone mass in men with osteoporosis.
• Prevention and treatment of steroid-induced osteoporosis in men and women taking medicines such as prednisone.
• Treatment of Paget’s disease of bone in both men and women.

The human body continuously breaks down old bone and forms new bone tissue. In osteoporosis, bone breakdown happens faster than bone formation, leading to gradual bone loss and making bones thin and fragile. This condition is common in postmenopausal women. Many patients have no symptoms and may not realize they have osteoporosis, but it significantly increases the risk of fractures, especially in the spine, hips, and wrists.

Risedronate has a strong affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, it inhibits the activity of osteoclasts, the cells responsible for bone resorption. Although osteoclasts still attach to the bone surface normally, their bone-resorbing activity is significantly reduced.

Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures: The recommended dose is Risedronate Sodium 5 mg once daily or Risedronate Sodium 35 mg once weekly on the same day each week or Risedronate Sodium 150 mg once monthly.

Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis: The recommended dose is Risedronate Sodium 5 mg once daily.

To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months) systemic corticosteroid treatment at doses 7.5 mg/day prednisone or equivalent: The recommended dose is Risedronate Sodium 5 mg once daily.

Treatment of osteoporosis in men at high risk of fractures: The recommended dose is Risedronate Sodium 35 mg once weekly. The tablet should be taken on the same day each week.

The absorption of Risedronate Sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate tablets at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.

In the particular instances that before breakfast dosing is not practical, Risedronate 5 mg tablet can be taken between meals or in the evening at the same time every day, with strict adherence to the following instructions, to ensure Risedronate Sodium tablet is taken on an empty stomach.

Risedronate Sodium tablet should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water).

Risedronate Sodium tablet should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day.

Risedronate 5 mg tablet: If an occasional dose is missed, Risedronate 5 mg tablet can be taken before breakfast, between meals, or in the evening according to the instructions above.

Risedronate 35 mg tablet: If a dose is missed, take one Risedronate 35 mg tablet on the morning after remembering. Then return to taking one tablet once a week on the usual day. Two tablets should not be taken on the same day.

Risedronate 150 mg tablet: If a dose is missed and the next month’s scheduled dose is more than 7 days away, take the missed tablet on the morning after remembering. Then return to taking one tablet once a month on the usual schedule.

The tablet must be swallowed whole and not sucked or chewed. To aid delivery to the stomach, the tablet should be taken in an upright position with a glass of plain water (120 ml or more). Patients should not lie down for 30 minutes after taking the tablet. Supplemental calcium and vitamin D should be considered if dietary intake is inadequate.

Inform your doctor if you are taking or have recently taken any other medicines, including over-the-counter drugs such as aspirin or other NSAIDs. Antacids, supplements, or medicines containing aluminum, calcium, magnesium, or other minerals may reduce the absorption of Risedronate Sodium. If such products are used, they should be taken at least 30 minutes after taking a Risedronate Sodium tablet.

Risedronate Sodium is contraindicated in patients with known hypersensitivity to the drug, in patients with hypocalcaemia, severe renal impairment (creatinine clearance <30 ml/min), and during pregnancy and lactation.

Serious side effects:

• Chest pain
• Difficulty or pain while swallowing
• Pain or burning sensation under the ribs or in the back
• New or worsening heartburn
• Severe joint, bone, or muscle pain
• Jaw pain, numbness, or swelling

Less serious side effects:

• Mild heartburn or stomach discomfort
• Diarrhea, gas, or constipation
• Mild joint or back pain
• Headache

Risedronate Sodium is intended only for postmenopausal women and should not be used during pregnancy. If accidentally taken during pregnancy, it should be stopped immediately and medical advice should be sought. Similarly, it is not intended for use during breastfeeding. If taken accidentally while breastfeeding, it should be discontinued and a doctor should be consulted immediately.

Take special care if you:

• Have low blood calcium (hypocalcemia)
• Cannot sit or stand upright for at least 30 minutes
• Have impaired kidney function
• Have known allergy to Risedronate Sodium

Consult your doctor before use if you:

• Are pregnant or planning pregnancy (effects on fetus are unknown)
• Are breastfeeding or planning to breastfeed (unknown if excreted in milk)
• Have kidney disease (may not be suitable)

Risedronate is not recommended for children.

If any allergic reaction occurs (such as facial, tongue or throat swelling, difficulty breathing or swallowing, or skin rash), stop the medicine immediately and seek medical help. Do not restart the medicine after a hypersensitivity reaction.

Pediatric Use: Safety and efficacy have not been established in children and adolescents.

Elderly: No dose adjustment is required. Pharmacokinetics are similar in elderly (≥60 years) and younger patients, including those aged ≥75 years.

Renal Impairment: No dose adjustment is needed in mild to moderate renal impairment. It is contraindicated in severe renal impairment (creatinine clearance <30 ml/min).

There is no specific treatment for Risedronate Sodium overdose. A significant overdose may lead to decreased serum calcium levels and symptoms of hypocalcaemia. Milk or antacids containing magnesium, calcium, or aluminum may be given to bind the drug and reduce absorption. Gastric lavage may be considered in severe cases to remove unabsorbed drug.

Bisphosphonate preparations

Store in a cool, dry place. Protect from light and moisture. Keep out of reach of children.