Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pharmathen S.A., 6, Dervenakion str., 153 51 Pallini, Attiki, Greece
Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures (see section 5.1).
Treatment of osteoporosis in men at high risk of fractures (see section 5.1).
The recommended dose in adults is one 35 mg tablet orally once a week. The tablet should be taken on the same day each week.
No dose adjustment is necessary since bioavailability, distribution and elimination were 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.
No dose 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 30 mL/min) (see sections 4.3 and 5.2).
Risedronate sodium is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy (see also section 5.1).
The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take risedronate sodium:
Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.
Patients should be instructed that if a dose is missed, one risedronate sodium 35 mg tablet should be taken on the day that the tablet is remembered. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day.
The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach risedronate sodium is to be taken while in an upright (standing or sitting) 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 risedronate on an individual patient basis, particularly after 5 or more years of use.
No specific information is available on the treatment of overdose with risedronate sodium.
Decreases in serum calcium following substantial overdose may be expected. Signs and symptoms of hypocalcaemia may also occur in some of these patients.
Milk or antacids containing magnesium, calcium or aluminium should be given to bind risedronate and reduce absorption of risedronate sodium. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed risedronate sodium.
Shelf life: 5 years.
This medicinal product does not require any special storage conditions.
Nature of container: Opaque PVC/PE/PVDC/Aluminium blister in a carton box.
Pack sizes: 1, 2, 4, 10, 12, 16, 24 film-coated tablets
Not all pack sizes may be marketed.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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