Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Aristo Pharma GmbH, Wallenroder Straße 8-10, 13435, Berlin, Germany
Treatment of severe osteoporosis:
at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance. In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section 5.1).
The decision to prescribe strontium ranelate should be based on an assessment of the individual patient’s overall risks (see sections 4.3 and 4.4).
Treatment should only be initiated by a physician with experience in the treatment of osteoporosis.
The recommended dose is one 2 g sachet once daily by oral administration.
Due to the nature of the treated disease, strontium ranelate is intended for long-term use.
The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, Strontium ranelate Aristo should be administered in-between meals. Given the slow absorption, Strontium ranelate Aristo should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2).
Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate.
The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of adult men and postmenopausal women with osteoporosis. No dose adjustment is required in relation to age.
Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2). No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see sections 4.4 and 5.2).
No dose adjustment is required in patients with hepatic impairment (see section 5.2).
The safety and efficacy of Strontium ranelate Aristo in children aged below 18 years have not been established. No data are available.
For oral use.
The granules in the sachets must be taken as a suspension in a glass containing a minimum of 30 ml (approximately one third of a standard glass) of water.
Although in-use studies have demonstrated that strontium ranelate is stable in suspension for 24 hours after preparation, the suspension should be drunk immediately after being prepared.
Good tolerance was shown in a clinical study investigating the repeated administration of 4 g strontium ranelate per day over 25 days in healthy postmenopausal women. Single administration of doses up to 11 g in healthy young male volunteers did not cause any particular symptoms.
Following episodes of overdoses during clinical trials (up to 4 g/day for a maximal duration of 147 days), no clinically relevant events were observed.
Administration of milk or antacids may be helpful to reduce the absorption of the active substance. In the event of substantial overdose, vomiting may be considered to remove unabsorbed active substance.
4 years.
Once reconstituted in water, the suspension is stable for 24 hours. However, it is recommended to drink the suspension immediately after preparation (see section 4.2).
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Polyethylene/aluminium/paper sachets.
Pack sizes: boxes containing 14, 28 or 84 sachets.
Not all pack sizes may be marketed.
No special requirements.
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