Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, Risedronate inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption.

Calcium suppresses parathyroid hormone (PTH) secretion and decreases bone turnover. Increased levels of PTH are known to contribute to age-related bone loss, especially at cortical sites, while increased bone turnover is an independent risk factor of fractures.

• To prevent and treat osteoporosis in postmenopausal women.
• To increase bone mass in men with osteoporosis.
• To prevent and treat osteoporosis in men and women that is caused by treatment with Steroid medicines such as prednisolone.
• To treat Paget’s disease of bone in men and women.

This is a co-package product containing 1 tablet of Risedronate Sodium 35 mg for once weekly dosing and 6 tablets of Calcium Carbonate 500 mg for daily dosing of the remaining 6 days of the week. Risedronate is in a group of medicines called bisphosphonates. It alters the cycle of bone formation and breakdown in the body. It slows bone loss while increasing bone mass, which may prevent bone fractures.

Administration

The following instructions are applicable to all patients taking this tablet:

• Take this tablet exactly as prescribed by your healthcare provider
• At first take this tablet in the morning before you eat or drink anything except plain water.
• Take this tablet while you are sitting up or standing.
• Take a this tablet with 1 glass of plain water. Do not take it with any other drink besides plain
• water.
• Swallow whole this tablet. Do not chew the tablet or keep it in your mouth to melt or dissolve.
• After taking this tablet you must wait at least 30 minutes before: lying down. You may sit, stand, or do normal activities. Eating or drinking anything except plain water. Taking vitamins, calcium, or antacids.
• Take vitamins, calcium, & antacids at a different time of the day from when you take this tablet.
• Keep taking this tablet for as long as your healthcare provider tells you.

SCHEDULE: One this tablet should be taken orally once a week (Day 1 of the 7-day treatment cycle). One calcium 500 mg tablet should be taken orally with food daily on each of the remaining six days (Days 2 through 7 of the 7-day treatment cycle).

Chest pain, difficulty or pain when swallowing, pain or burning under the ribs or in the back, new or worsening heartburn, severe joint, bone, or muscle pain, jaw pain, numbness, or swelling, mild heartburn or stomach upset, diarrhea, gas, or constipation, mild joint or back pain, headache.

Take special care with if you:

• Have low blood calcium (hypocalcemia).
• Cannot sit or stand up for 30 minutes.
• Have kidneys that work poorly.
• Have an allergy to Risedronate Sodium.
• Are pregnant or may become pregnant.
• Are breast-feeding or plan to breast-feed.
• Have kidney problems, Risedronate Sodium may not be right for you.

Use in Special Populations

FOR RENAL IMPAIRED PATIENTS: Risedronate Sodium is not recommended for use in patients with severe renal impairment (creatinine clearance <30 ml/min). No dosage adjustment is necessary in patients with a creatinine clearance >30 ml/min or in the elderly.

Pregnancy & Lactation

PREGNANCY: It should not be taken during pregnancy. If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.

LACTATION: Breast-feeding women should not take this medicine. If you take it by accident during breast-feeding, stop taking it straight away and talk to your doctor.