Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Aristo Pharma GmbH, Wallenroder Straße 8–10, 13435 Berlin, Germany
Treatment of Paget’s disease of the bone.
The recommended daily dose in adults is one 30 mg tablet orally for 2 months. If re-treatment is considered necessary (at least two months post-treatment), a new treatment with the same dose and duration of therapy could be given. 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.
In the particular instance that before breakfast dosing is not practical, Risedronate sodium can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Risedronate sodium is taken on an empty stomach:
Between meals: Risedronate sodium should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water).
In the evening: Risedronate sodium should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. Risedronate sodium should be taken at least 30 minutes before going to bed.
If an occasional dose is missed, Risedronate sodium can be taken before breakfast, between meals, or in the evening according to the instructions above.
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 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).
Physicians should consider the administration of supplemental calcium and vitamin D if dietary intake is inadequate, especially as bone turnover is significantly elevated in Paget’s disease.
No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects.
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 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 its efficacy and safety (see also section 5.1).
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.
4 years.
No special storage conditions.
Nature of container: Clear PVC/PE/PVDC/aluminium foil blisters in a cardboard carton.
Blister pack of 14 tablets in a cardboard carton, tablet count 28 (2 × 14) and 14 (1 × 14)
Sample pack – 3 tablets in cardboard carton, tablet count 3 (1 × 3).
Not all pack sizes may be marketed.
No special requirements for disposal.
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