Protelos 2g granules sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Strontium ranelate

Available from:

Servier Laboratories Ltd

ATC code:

M05BX03

INN (International Name):

Strontium ranelate

Dosage:

2gram

Pharmaceutical form:

Granules

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200; GTIN: 5017476141002

Summary of Product characteristics

OBJECT 1
PROTELOS
Summary of Product Characteristics Updated 21-Oct-2016 | Servier
Laboratories Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
PROTELOS 2 g granules for oral suspension
2. Qualitative and quantitative composition
Each sachet contains 2 g of strontium ranelate.
Excipient with known effect:
Each sachet also contains 20 mg of aspartame (E951).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Granules for oral suspension
Yellow granules
4. Clinical particulars
4.1 Therapeutic indications
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. 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).
4.2 Posology and method of administration
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,
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.
_Elderly _
The effi