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

Dosage & Administration - One tablet of Ibandronic Acid 150 mg once monthly of 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, 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, 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 Ibandronic Acid tablet. Ibandronic Acid 150 mg tablet of this Kit should be taken on the same date of each month (i.e., the patients Ibandronic Acid day) If the once monthly dose is missed, and the patients 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 one 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 patients 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).

Side Effects - Ibandronic Acid: Common side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bonchitis, 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, formation of kidney stones may occur infrequently.

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

Others - Pregnancy & Lactation 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.