This combination is indicated for the treatment and prevention of osteoporosis in women (especially after menopause) and men. It increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

Ibandronic Acid is a group of medicine 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 fracture. Ibandronic Acid has an affinity for hydroxyapatite crystals in bone and acts as a hydroxyapatite agent. At the cellular level, Ibandronic Acid inhibits osteoclasts. The osteoclasts adhere normally to the bone surface but show evidence of reduced active resorption.

Osteoporosis: The human body constantly breaks down old bone and makes new bone tissue. If people have osteoporosis, their body breaks down more bone than it forms. So gradually bone loss occurs and bones become thinner and fragile. This is especially common in women after menopause. Many people with osteoporosis have no symptoms and may not even know that they have it. However, osteoporosis makes them more likely to have fractures, especially in the spine, hips and wrists.

One tablet of Ibandronic Acid 150 mg once monthly on the same date of each month is recommended. To maximize the clinical benefit of Ibandronic Acid, two tablets of Calcium Orotate per day are usually recommended in divided dosage.

To maximize absorption and clinical benefit, the Ibandronic Acid tablet of this Kit should be taken at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins.

To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, the Ibandronic Acid tablet should be swallowed whole with a full glass of plain water (250 ml) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking the Ibandronic Acid tablet.

The Ibandronic Acid 150 mg tablet of this Kit should be taken on the same date of each month (i.e., the patient's Ibandronic Acid day).

If the once monthly dose is missed, and the patient's next scheduled Ibandronic Acid day is more than 7 days away, the patient should be instructed to take one Ibandronic Acid 150 mg tablet in the morning following the date that it is remembered. The patient should then return to taking another Ibandronic Acid 150 mg tablet every month in the morning of their chosen day, according to their original schedule.

If the once monthly dose is missed, and the patient's next scheduled Ibandronic Acid day is only 1 to 7 days away, the patient must wait until the subsequent month's scheduled Ibandronic Acid day to take their tablet. The patient should then return to taking one Ibandronic Acid 150 mg tablet every month in the morning of their chosen day according to their original schedule.

The patient must not take two Ibandronic Acid 150 mg tablets within the same week.

Start taking Calcium Orotate tablets from the next day of Ibandronic Acid day (from day-2 and onwards).

Ibandronic Acid: Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron) are likely to interfere with the absorption of Ibandronic Acid. Ibandronic Acid should be taken at least 60 minutes before any oral medications. Aspirin, NSAIDs, and bisphosphonates are all associated with gastrointestinal irritation; caution should be exercised in the concomitant use of aspirin or NSAIDs with Ibandronic Acid.

Calcium Orotate: Calcium can decrease the absorption of other drugs such as bisphosphonates (e.g., alendronate/risedronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotics (e.g., doxycycline, levofloxacin).

Ibandronic Acid: Abnormalities of the esophagus, hypocalcemia, known hypersensitivity to Ibandronic Acid or any of its components.
Calcium Orotate: Incomplete bowel movements, kidney stones, kidney disease and lung disease.

Ibandronic Acid: Common side effects include hypertension, dyspepsia, nausea, diarrhea, abdominal pain, arthralgia, back pain, localized osteoarthritis, myalgia, muscle cramp, influenza, nasopharyngitis, bronchitis, urinary tract infection, upper respiratory tract infection, headache, dizziness, skin rash, insomnia, etc.

Calcium Orotate: Bloating and swelling in the abdomen are common side effects of Calcium Orotate. Loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, mood changes, bone/muscle pain, headache, increased thirst/urination, weakness, unusual tiredness, and formation of kidney stones may occur infrequently.

There are no adequate and well-controlled studies in pregnant women for this kit. This kit should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. It is not known whether this kit is excreted in human milk. Caution should be exercised when this kit is administered to a nursing woman.

Ibandronic Acid:

• Ibandronic Acid of this Kit may cause local irritation of the upper gastrointestinal mucosa.
• Adequate intake of calcium is important in all patients with hypocalcemia.
• Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Ibandronic Acid.
• Ibandronic Acid is not recommended for use in patients with severe renal impairment (creatinine clearance <30 ml/min).

Calcium Orotate: Before taking Calcium Orotate, precaution is needed if the patient is allergic to Calcium Orotate. Any calcium supplement taken without food may increase the risk of kidney stones. Therefore, it is advisable that Calcium Orotate be taken with food.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Renal and hepatic impaired patients: No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal to or greater than 30 ml/min. No dose adjustment is required for patients with hepatic impairment.

Minerals in bone formation, Specific mineral preparations

Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.