Vantavo (previously Alendronate sodium and colecalciferol, MSD)
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
20-02-2024
Charakterystyka produktu
(SPC)
20-02-2024
Sprawozdanie z oceny publicznego
(PAR)
20-08-2015
Składnik aktywny:
alendronic acid, colecalciferol
Dostępny od:
N.V. Organon
Kod ATC:
M05BB03
INN (International Nazwa):
alendronic acid, colecalciferol
Grupa terapeutyczna:
Drugs for treatment of bone diseases
Dziedzina terapeutyczna:
Osteoporosis, Postmenopausal
Wskazania:
Treatment of postmenopausal osteoporosis in patients at risk of vitamin-D insufficiency.Vantavo reduces the risk of vertebral and hip fractures.Treatment of postmenopausal osteoporosis in patients who are not receiving vitamin-D supplementation and are at risk of vitamin-D insufficiency.Vantavo reduces the risk of vertebral and hip fractures.
Podsumowanie produktu:
Revision: 18
Status autoryzacji:
Authorised
Data autoryzacji:
2009-10-16
Ulotka dla pacjenta
28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
VANTAVO 70 MG/2800 IU TABLETS
VANTAVO 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 VANTAVO is and what it is used for
2.
What you need to know before you take VANTAVO
3.
How to take VANTAVO
4.
Possible side effects
5
How to store VANTAVO
6.
Contents of the pack and other information
1.
WHAT VANTAVO IS AND WHAT IT IS USED FOR
WHAT IS VANTAVO?
VANTAVO 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 a
greater risk of f
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
VANTAVO 70 mg/2800 IU tablets
VANTAVO 70 mg/5,600 IU tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VANTAVO 70 mg/2,800 IU tablets
Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and
70 micrograms (2800 IU)
colecalciferol (vitamin D
3
).
_Excipients with known effect_
Each tablet contains 62 mg lactose (as lactose anhydrous) and 8 mg
sucrose.
VANTAVO 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
VANTAVO 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.
VANTAVO 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
VANTAVO 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 VANTAVO 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, VANTAVO 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
VANTAVO on an individual pat
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