Posology : מינונים

4.2    Posology and method of administration
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, PROTELOS should be administered in-between meals. Given the slow absorption, PROTELOS 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.
Treatment should only be initiated by a physician with experience in the treatment of osteoporosis.

Elderly patients
The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of postmenopausal women with osteoporosis. No dose adjustment is required in relation to age.

Patients with renal impairment
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 section 4.4 and 5.2).

Patients with hepatic impairment
No dose adjustment is required in patients with hepatic impairment (see section 5.2).

Paediatric population
The safety and efficacy of PROTELOS in children aged below 18 years have not been established. No data are available.

Method of administration
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.