Osteo Update

PROTELOS® 2g granules for oral suspension
Strontium ranelate
Refer to the Summary of Product Characteristics (SPC) before prescribing.

Presentation:Sachets containing 2g strontium ranelate, yellow granules for oral suspension. Indication: Treatment of osteoporosis in postmenopausal women to reduce the risk of vertebral and hip fractures. Dosage and Administration: One 2g sachet once daily by oral administration. The granules must be taken as a suspension in a glass of water. The bioavailability of strontium ranelate is reduced by food, dairy and calcium containing products and therefore Protelos® should be taken preferably at bedtime at least two hours after eating. Elderly and patients with hepatic impairment and/or mild to moderate renal impairment: No dosing modification required. Severe renal impairment (ClCR < 30ml/min): Not recommended. Children and adolescents: Not recommended. Contraindications: Hypersensitivity to strontium ranelate or excipients. Precautions: Monitor renal function in chronic renal impairment. Use with caution in patients at risk of venous thromboembolism (a small but significant increase was observed in clinical trials). Contains a source of phenylalanine, which may be harmful for people with phenylketonuria. Discontinue in case of serious allergic reaction. Discontinue immediately and permanently in cases of severe hypersensitivity syndromes: including drug rash with eosinophilia and systemic syndromes (DRESS). Pregnancy and lactation: Only for use in postmenopausal women. Interactions: Strontium may reduce the absorption of oral tetracycline or quinolone antibiotics, discontinue Protelos® during treatment. It is preferable to take antacids at least two hours after Protelos® as concomitant intake, though acceptable, may cause a slight decrease in the absorption of strontium. Side effects: Adverse reactions were usually mild and transient. Common: nausea, diarrhoea, loose stools, headache, disturbances in consciousness, memory loss, dermatitis and eczema, venous thromboembolism, blood creatinine kinase increased. Uncommon: seizures. Frequency unknown: hypersensitivity skin reactions (rash, pruritus, urticaria, angioedema), Stevens-Johnson syndrome, severe hypersensitivity syndromes including drug rash with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis. Consult SPC for full list of side effects. NHS price: 28 pack - £ 25.60; Legal Category: POM Product Licence Number: EU/1/04/288/003 Further information: Servier Laboratories Ltd, Gallions, Wexham Springs, Slough SL3 6RJ Tel (01753) 666409. Date of Revision: October 2009

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Servier Laboratories Ltd. Tel (01753) 666409