Protelos

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

strontium ranelate

Available from:

Les Laboratoires Servier

ATC code:

M05BX03

INN (International Name):

strontium ranelate

Therapeutic group:

Drugs for treatment of bone diseases

Therapeutic area:

Osteoporosis, Postmenopausal

Therapeutic indications:

Treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures. Treatment of severe osteoporosis in adult men at increased risk of fracture. The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks.,

Product summary:

Revision: 19

Authorization status:

Withdrawn

Authorization date:

2004-09-20

Patient Information leaflet

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROTELOS 2 G GRANULES FOR ORAL SUSPENSION
Strontium ranelate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What PROTELOS is and what it is used for
2.
What you need to know before you take PROTELOS
3.
How to take PROTELOS
4.
Possible side effects
5.
How to store PROTELOS
6.
Contents of the pack and other information
1.
WHAT PROTELOS IS AND WHAT IT IS USED FOR
PROTELOS is a medicine used to treat severe osteoporosis:
-
in postmenopausal women,
-
in adult men,
at high risk of fracture, for whom other alternative treatments are
not possible. In postmenopausal
women, strontium ranelate reduces the risk of fracture at the spine
and at the hip.
About osteoporosis
Your body is constantly breaking down old bone and making new bone
tissue. If you have
osteoporosis, your body breaks down more bone than it forms so that
gradually bone loss occurs and
your bones become thinner and fragile. This is especially common in
women after the menopause.
Many people with osteoporosis have no symptoms and you may not even
know that you have it.
However, osteoporosis makes you more likely to have fractures (break
bones), especially in your
spine, hips and wrists.
How PROTELOS works
PROTELOS, which contains the substance strontium ranelate, belongs to
a group of medicines used
to treat bone diseases.
PROTELOS works by reducing bone breakdown and stimulating rebuilding
of bone and therefore
reduces the risk of fracture. The newly formed bone is of no

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 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.
3
_Renal impairment _
Strontium ranelate is not recommended for patients with se