Posology : מינונים

4.2 Posology and method of Administration
RIBONE 150 tablets should be taken orally once a month. The tablet should be taken on the same date each month.

The absorption of risedronate sodium is affected by food and polyvalent cations (see section 4.6), thus to ensure adequate absorption patients should take RIBONE 150 before breakfast: at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. Plain water is the only drink that should be taken with RIBONE 150 tablet. Please note that some mineral water may have a higher concentration of calcium and therefore should not be used (see section 5.2).

Patients who miss a dose of RIBONE 150 should be instructed to take one RIBONE 150 tablet the morning after the day it is remembered, unless the time to the next month’s scheduled doses is within 7 days.
If the next month’s scheduled doses of RIBONE 150 are within 7 days, patients should wait until their next month’s scheduled doses and then continue taking RIBONE 150 as originally scheduled.

The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach RIBONE 150 is to be taken while in an upright position with a glass of plain water (>120 ml). Patients should not lie down for 30 minutes after taking the tablet (see section 4.4).

Supplemental calcium and vitamin D should be considered if the 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 RIBONE 150 on an individual patient basis, particularly after 5 or more years of use.

Elderly: No dosage adjustment is necessary since bioavailability, distribution and elimination was similar in elderly (>60 years of age) compared to younger subjects.
This has also been shown in the very elderly, 75 years old and above, postmenopausal population.

Renal Impairment: No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of risedronate sodium is contraindicated in patients with severe renal impairment (creatinine clearance lower than 30ml/min) (see sections 4.3 and 5.2).

Children: Safety and efficacy of RIBONE 150 have not been established in children and adolescents.