Posology: The recommended dose is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month.
Ibandronic acid should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day or any other oral medicinal products or supplementation (including calcium).
In case a dose is missed, patients should be instructed to take one ibandronic acid 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date.
If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled.
Patients should not take two tablets within the same week.
Patients should receive supplemental calcium and/or vitamin D if dietary intake is inadequate.
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of ibandronic acid on an individual patient basis, particularly after 5 or more years of use.
Special Populations: Patients with renal impairment: No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/min.
Ibandronic acid is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience.
Patients with hepatic impairment: No dose adjustment is required.
Elderly Population: No dose adjustment is required.
Paediatric Population: There is no relevant indication of use of ibandronic acid in children, and ibandronic acid was not studied in the paediatric population.
Method of Administration: For oral use.
Tablets should be swallowed whole with a glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position. Patients should not lie down for 1 hour after taking ibandronic acid.
Plain water is the only drink that should be taken with ibandronic acid. Note that some mineral waters may have a higher concentration of calcium and therefore, should not be used.
Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration.