Alendroninezuur BASICS 10 mg tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

NATRIUMALENDRONAAT 3-WATER SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR

Beschikbaar vanaf:

Basics GmbH Hemmelrather Weg 201 51377 LEVERKUSEN (DUITSLAND)

INN (Algemene Internationale Benaming):

Alendronate sodium 3-WATER COMPOSITION corresponding to ; alendronic acid

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2021-02-05

Bijsluiter

PACKAGE LEAFLET. INFORMATION FOR THE USER
ALENDRONINEZUUR BASICS 10 MG, TABLETTEN
alendroninezuur
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 How to take
Alendroninezuur BASICS, before taking this medicine.
WHAT IS IN THIS LEAFLET:
1.
What Alendroninezuur BASICS 10mg Tablets are and what they are used
for
2.
What you need to know before you take Alendroninezuur BASICS 10mg
Tablets
3.
How to take Alendroninezuur BASICS 10mg Tablets
4.
Possible side effects
5.
How to store Alendroninezuur BASICS 10mg Tablets
6.
Contents of the pack and other information
1.
WHAT ALENDRONINEZUUR BASICS 10MG TABLETS ARE AND WHAT THEY ARE USED
FOR
WHAT IS ALENDRONINEZUUR BASICS
Alendronic Acid is a tablet containing the active substance alendronic
acid (commonly called
alendronate) and belongs to a group of medicines called
bisphosphonates. Alendronic Acid
prevents the loss of bone that occurs in women after they have been
through the menopause.
It can also prevent loss of bone in men or people taking steroids,
such as prednisolone and
methylprednisolone. It also has been shown to help rebuild bone and
makes bone and reduce
the risk of spine and hip fractures (broken bones) in women (after
their menopause) and in men
who have thinning of their bones (osteoporosis).
WHAT IS ALENDRONINEZUUR BASICS USED FOR
Your doctor has prescribed alendronic acid because you either have
osteoporosis or you are
at risk of developing this disease.
WHAT IS OSTEOPOROSIS?
Osteoporosis i

Productkenmerken

S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
_ _
Alendroninezuur BASICS 10 mg tabletten
_ _
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each tablet contains 10mg alendronic acid (as sodium alendronate).
Excipients with known effect: Each tablet contains 38.867mg lactose
anhydrous.
For the full list of excipients see section 6.1.
3.
P
HARMACEUTICAL
F
ORM
Tablet
White to off white, oval, biconvex tablet, approximately 9.00 x 4.50
mm in dimensions, debossed with
“10” on one side and plain on other side.
4.
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of postmenopausal osteoporosis. Alendroninezuur BASICS
reduces the risk of
vertebral and hip fractures.
•
Treatment of osteoporosis in men at increased risk of fracture. A
reduction in the
incidence of vertebral, but not of non-vertebral fractures has been
demonstrated.
•
Behandlung und Präventionlaxis of glucocorticoid-induced
osteoporosis.
Risk factors often associated with the development of osteoporosis
include thin body build, family
history of osteoporosis, early menopause, moderately low bone mass and
long-term glucocorticoid
therapy, especially with high doses (15 mg/day).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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
Alendroninezuur BASICS on an individual patient basis, particularly
after 5 or more years of use.
_Treatment of post-menopausal osteoporosis:_
_ _
The recommended dosage is 10 mg once daily.
_Treatment of osteoporosis in men:_
_ _
The recommended dosage is 10 mg once daily.
_Treatment and Prevention of glucocorticoid-induced osteoporosis:_
_ _
For post-menopausal women who are not receiving oestrogen treatment
the recommended dose is
one 10 mg tablet daily. For other populations, see summary of product
characteristics for
preparations that contain 5 mg alendronate
_Elderly_
In clin