Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom
Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis (see section 5.1).
To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses ≥7.5mg/day prednisone or equivalent.
The recommended daily dose in adults is one 5 mg tablet orally. 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 tablets 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).
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 sodium on an individual patient basis, particularly after 5 or more years of use.
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 and adolescents below age 18 due to insufficient data on safety and efficacy (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.
This medicinal product does not require any special storage conditions.
Transparent PVC / PE / PVdC / Aluminium blisters in a cardboard box, Packs 14, 20, 28, 84, 98 or 140 tablets.
Not all pack sizes may be marketed.
No special requirements.
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