Fosavance
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
20-02-2024
Produktets egenskaber
(SPC)
20-02-2024
Offentlige vurderingsrapport
(PAR)
07-07-2015
Aktiv bestanddel:
alendronic acid, colecalciferol
Tilgængelig fra:
N.V. Organon
ATC-kode:
M05BB03
INN (International Name):
alendronic acid, colecalciferol
Terapeutisk gruppe:
Drugs for treatment of bone diseases
Terapeutisk område:
Osteoporosis, Postmenopausal
Terapeutiske indikationer:
Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency.Fosavance reduces the risk of vertebral and hip fractures.
Produkt oversigt:
Revision: 27
Autorisation status:
Authorised
Autorisation dato:
2005-08-24
Indlægsseddel
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSAVANCE 70 MG/2,800 IU TABLETS
FOSAVANCE 70 MG/5,600 IU TABLETS
alendronic acid/colecalciferol
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 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.
-
It is particularly important to understand the information in section
3 before taking this
medicine.
WHAT IS IN THIS LEAFLET
1.
What FOSAVANCE is and what it is used for
2.
What you need to know before you take FOSAVANCE
3.
How to take FOSAVANCE
4.
Possible side effects
5
How to store FOSAVANCE
6.
Contents of the pack and other information
1.
WHAT FOSAVANCE IS AND WHAT IT IS USED FOR
WHAT IS FOSAVANCE?
FOSAVANCE is a tablet containing the two active substances, alendronic
acid (commonly called
alendronate) and colecalciferol known as vitamin D
3
.
WHAT IS ALENDRONATE?
Alendronate belongs to a group of non-hormonal medicines called
bisphosphonates. Alendronate
prevents the loss of bone that occurs in women after they have been
through the menopause, and helps
to rebuild bone. It reduces the risk of spine and hip fractures.
WHAT IS VITAMIN D?
Vitamin D is an essential nutrient, required for calcium absorption
and healthy bones. The body can
only absorb calcium properly from our food if it has enough vitamin D.
Very few foods contain
vitamin D. The main source is through exposure to summer sunlight,
which makes vitamin D in our
skin. As we get older our skin makes less vitamin D. Too little
vitamin D may lead to bone loss and
osteoporosis. Severe vitamin D deficiency may cause muscle weakness
which can lead to falls and
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
FOSAVANCE 70 mg/2,800 IU tablets
FOSAVANCE 70 mg/5,600 IU tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FOSAVANCE 70 mg/2,800 IU tablets
Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and
70 micrograms (2,800 IU)
colecalciferol (vitamin D
3
).
_Excipients with known effect _
Each tablet contains 62 mg lactose (as lactose anhydrous) and 8 mg
sucrose.
FOSAVANCE 70 mg/5,600 IU tablets
Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and
140 micrograms (5,600 IU)
colecalciferol (vitamin D
3
).
_Excipients with known effect _
Each tablet contains 63 mg lactose (as lactose anhydrous) and 16 mg
sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
FOSAVANCE 70 mg/2,800 IU tablets
Modified capsule-shaped, white to off-white tablets, marked with an
outline of a bone image on one
side, and '710' on the other.
FOSAVANCE 70 mg/5,600 IU tablets
Modified rectangle-shaped, white to off-white tablets, marked with an
outline of a bone image on one
side, and '270' on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FOSAVANCE is indicated for the treatment of postmenopausal
osteoporosis in women at risk of
vitamin D insufficiency. It reduces the risk of vertebral and hip
fractures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
The recommended dose is one tablet once weekly.
Patients should be instructed that if they miss a dose of FOSAVANCE
they should take one tablet on
the morning after they remember. They should not take two tablets on
the same day but should return
to taking one tablet once a week, as originally scheduled on their
chosen day.
Due to the nature of the disease process in osteoporosis, FOSAVANCE is
intended for long-term use.
3
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need
for continued treatment should be re-evaluated periodically based on
the benefits and potential risks of
FOSAVAN
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