Alendroninezuur Kwizda 70 mg één tablet per week, tabletten

Quốc gia: Hà Lan

Ngôn ngữ: Tiếng Hà Lan

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

Thành phần hoạt chất:

NATRIUMALENDRONAAT 3-WATER 91,37 mg/stuk SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR 70 mg/stuk

Sẵn có từ:

Kwizda Pharma GmbH Effingergasse 21 1160 WENEN (OOSTENRIJK)

INN (Tên quốc tế):

NATRIUMALENDRONAAT 3-WATER 91,37 mg/stuk SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR 70 mg/stuk

Dạng dược phẩm:

Tablet

Thành phần:

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)

Tuyến hành chính:

Oraal gebruik

Ngày ủy quyền:

1900-01-01

Tờ rơi thông tin

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALENDRONINEZUUR KWIZDA 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 symptoms 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 Kwizda 70 mg één tablet per week, tabletten, before
taking this medicine.
WHAT IS IN THIS LEAFLET
:
1.
What Alendroninezuur Kwizda 70 mg één tablet per week, tabletten is
and what it is used for
2.
What you need to know before you take Alendroninezuur Kwizda70 mg
één tablet per week, tabletten
3.
How to take Alendroninezuur Kwizda 70 mg één tablet per week,
tabletten
4.
Possible side effects
5
How to store Alendroninezuur Kwizda 70 mg één tablet per week,
tabletten
6.
Contents of the pack and other information
1.
WHAT ALENDRONINEZUUR KWIZDA 70 MG ÉÉN TABLET PER WEEK, TABLETTEN IS
AND WHAT IT IS
USED FOR
WHAT IS ALENDRONINEZUUR KWIZDA 70 MG ÉÉN TABLET PER WEEK, TABLETTEN?
Alendroninezuur Kwizda 70 mg één tablet per week, tabletten is a
tablet containing the active substance
alendronic acid (commonly called alendronate) and belongs to a group
of non-hormonal medicines called
bisphosphonates. Alendroninezuur Kwizda 70 mg één tablet per week,
tabletten 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 ALENDRONINEZUUR KWIZDA 70 MG ÉÉN TABLET PER WEEK, TABLETTEN
USED FOR?
Your doctor has prescribed Alendroninezuur Kwizda 70 mg �

Đặc tính sản phẩm

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alendroninezuur Kwizda 70 mg één tablet per week, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid (as alendronate sodium).
Excipients with known effect:
Each tablet contains 272.07 mg lactose anhydrous.
For a 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
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. 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 Kwizda 70 mg
één tablet per week, tabletten’ 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 GFR greater than
35 ml/min. Alendronic acid tablet
is not recommended for patients with renal impairment where GFR is
less than 35 ml/min, due to lack of
experience.
_Paediatric population_
:
Alendronate sodium is not recommended for use in children under the
age of 18 years due to insufficient
2
data on safety and efficacy in conditions associated with paediatric
osteoporosis (see also section 5.1).
Alendronic acid Once Weekly 70 mg has not been investigated in the
treatment of glucocorticoid-
induced osteoporosis.
Method of administration
Oral use.
_To permit adequate absorption of alendronic acid: _
Alendroninezuu