This combination is indicated for:

• 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 receiving medicines such as prednisolone.
• Treatment of Paget’s disease of bone in both men and women.

The human body continuously removes old bone and forms new bone tissue. In osteoporosis, bone breakdown occurs faster than bone formation, leading to gradual bone loss and making bones thin and fragile. This condition is especially common in postmenopausal women. Many patients remain asymptomatic and may not be aware of the disease, but it significantly increases the risk of fractures, particularly 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 osteoclast activity. Although osteoclasts continue to attach to the bone surface normally, their bone resorption activity is significantly reduced. Calcium suppresses parathyroid hormone (PTH) secretion and reduces bone turnover. Elevated PTH levels are associated with age-related bone loss, particularly in cortical bone, while increased bone turnover itself is an independent risk factor for fractures.

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.

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 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).

Inform your doctor if you are taking or have recently taken any other medicines, including non-prescription 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 medicines are used, they should not be taken within at least 30 minutes after taking a Risedronate Sodium tablet.

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, mild heartburn or stomach upset, diarrhea, gas, constipation, mild joint or back pain, and headache.

This medicine should not be used during pregnancy. If taken accidentally during pregnancy, it should be stopped immediately and medical advice should be taken. It is also not recommended during breastfeeding. If taken accidentally while breastfeeding, it should be discontinued immediately and a doctor should be consulted.

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
• Are pregnant or may become pregnant
• Are breastfeeding or planning to breastfeed

If you have kidney problems, Risedronate Sodium may not be suitable for you.

For patients with renal impairment: Risedronate Sodium is not recommended in severe renal impairment (creatinine clearance <30 ml/min). No dose adjustment is required in patients with creatinine clearance >30 ml/min or in elderly patients.

Bisphosphonate preparations

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