Strontium Ranelate

VERBATIM UK SPC §4.2 (Strontium ranelate Aristo 2 g granules for oral suspension): 'Treatment should only be initiated by a physician with experience in the treatment of osteoporosis. Posology 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.' §2: 'Each sachet contains 2 g of strontium ranelate' (and 20 mg of aspartame). §4.1 (licensed use): 'Treatment of severe osteoporosis - in postmenopausal women; - in adult men 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.' '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).' Method of administration (§4.2, verbatim): '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.' Elderly: 'No dose adjustment is required in relation to age.' Hepatic impairment: 'No dose adjustment is required in patients with hepatic impairment.' Paediatric: 'The safety and efficacy of Strontium ranelate Aristo in children aged below 18 years have not been established. No data are available.' The SPC prints no maximum dose, so none is given. Contraindications limit use (see the contraindications list): any established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, current or previous VTE, immobilisation, or uncontrolled hypertension. Some sections of the product information we used were incomplete — check the full SPC.