Alendroninezuur betapharm 70 mg één tablet per week, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NATRIUMALENDRONAAT 3-WATER 91,4 mg/stuk SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR 70 mg/stuk

Beschikbaar vanaf:

Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)

INN (Algemene Internationale Benaming):

NATRIUMALENDRONAAT 3-WATER 91,4 mg/stuk SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR 70 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALENDRONINEZUUR BETAPHARM 70 MG ÉÉN TABLET PER WEEK, 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 before taking this
medicine.
WHAT IS IN THIS LEAFLET
1.
What [PRODUCT NAME] is and what it is used for
2.
What you need to know before you take [PRODUCT NAME]
3.
How to take [PRODUCT NAME]
4.
Possible side effects
5
How to store [PRODUCT NAME]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
WHAT IS [PRODUCT NAME]?
[PRODUCT NAME] is a tablet containing the active substance alendronic
acid (commonly called
alendronate) and belongs to a group of non-hormonal medicines called
bisphosphonates. [PRODUCT
NAME] 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 [PRODUCT NAME] USED FOR?
Your doctor has prescribed [PRODUCT NAME] to treat your osteoporosis.
[PRODUCT NAME]
reduces the risk of spine and hip fractures.
[PRODUCT NAME] IS A ONCE WEEKLY TREATMENT.
WHAT IS OSTEOPOROSIS?
Osteoporosis is a thinning and weakening of the bones. It is common in
women after the menopause. At
the menopause, the ovaries stop producing the female hormone,
oestrogen, which helps to keep a
woman’s skeleton healthy. As a result, bone loss occurs and bones
become weaker. The earlier a woman
reaches the menopause, the greater the risk of osteopo

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alendroninezuur betapharm 70 mg één tablet per week, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid (as sodium alendronate).
Excipients with known effect
Each tablet contains 272.07 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off white, oval, biconvex tablet, approximately 17.30 x 9.20
mm in dimensions, debossed with
“AHI” on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alendronic acid is indicated in adults for the treatment of
post-menopausal osteoporosis. Alendronic acid
reduces the risk of vertebral and hip fractures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is one 70 mg tablet once weekly.
Patients should be instructed that if they miss a dose of [PRODUCT
NAME] Once Weekly, 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.
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 [PRODUCT NAME] on an individual patient basis, particularly
after 5 or more years of use.
_Elderly _
In clinical studies there was no age-related difference in the
efficacy or safety profiles of alendronic
acid. Therefore no dosage adjustment is necessary for the elderly.
_Renal impairment _
No dosage adjustment is necessary for patients with creatinine
clearance greater than 35 ml/min.
Alendronic acid tablet is not recommended for patients with renal
impairment where creatinine clearance
is less than 35 ml/min, due to lack of experience.
_Paediatric population_
The safety and efficacy of [PRODUCT NAME] in children less than 18
years of age has not been
established. This medicina