Reefcal Kit

• Treatment and prevention of osteoporosis
• Increases Bone Mineral Density (BMD)
• Reduces incidence of vertebral fractures

Dosing Schedule (Oral):

• Day 1: Take one Ibandronic Acid tablet on empty stomach (1 hour before breakfast with plain water); do not lie down for 60 minutes; do not chew or suck the tablet
• Day 2-31: Take one Calcium & Vitamin D3 tablet morning and evening after meal

Adult Dose: Ibandronic Acid 150 mg once monthly on same date each month; Calcium 500 mg & Vitamin D3 200 IU (2 tablets daily in divided doses)

Child Dose: Safety and efficacy in pediatric patients have not been established

Ibandronic Acid: Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bronchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin rash, Insomnia

Calcium & Vitamin D3: Flatulence, diarrhea, constipation, upper GI discomfort; hypercalciuria and hypercalcemia (rare with prolonged use)

Use in Pregnancy: Category C; no adequate and well-controlled studies in pregnant women; use only if potential benefit justifies potential risk to mother and fetus.

Precautions:

• Ibandronic Acid: Caution in active upper GI problems (Barrett's esophagus, dysphagia, gastritis, duodenitis, ulcers)
• Treat hypocalcemia and other bone/mineral disturbances before starting therapy
• Severe bone, joint and muscle pain reported
• Osteonecrosis of the jaw reported
• Calcium & Vitamin D3: Reduce dose in mild hypercalciuria; monitor plasma and serum calcium in mild to moderate renal impairment; increase fluid intake if history of kidney stones

Overdose: Oral overdose of Ibandronic acid may result in hypocalcemia, hypophosphatemia and upper gastrointestinal adverse events; milk or antacids should be given.