Alendroninezuur Heumann 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 91,4 mg/stuk SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR 70 mg/stuk

Sẵn có từ:

Heumann Pharma GmbH Südwestpark 50 D-90449 NÜRNBERG (DUITSLAND)

INN (Tên quốc tế):

NATRIUMALENDRONAAT 3-WATER 91,4 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

Alendroninezuur Heumann 70 mg één tablet per week, tabletten –
NL/H/4911/001/DC
NL (common) pl
NL/p/004/20/2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONINEZUUR HEUMANN 70 MG ÉÉN TABLET PER WEEK, TABLETTEN
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 Heumann, before taking this medicine.
WHAT IS IN THIS LEAFLET
1.
What Alendroninezuur Heumann is and what it is used for
2.
What you need to know before you take Alendroninezuur Heumann
3.
How to take Alendroninezuur Heumann
4.
Possible side effects
5.
How to store Alendroninezuur Heumann
6.
Contents of the pack and other information
1.
WHAT ALENDRONINEZUUR HEUMANN IS AND WHAT IT IS USED FOR
WHAT IS ALENDRONINEZUUR HEUMANN?
Alendroninezuur Heumann is a tablet containing the active substance
alendronic acid (commonly called
alendronate) and belongs to a group of non-hormonal medicines called
bisphosphonates. Alendroninezuur
Heumann 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 HEUMANN USED FOR?
Your doctor has prescribed Alendroninezuur Heumann to treat your
osteoporosis. Alendroninezuur
Heumann reduces the risk of spine and hip fractures.
ALENDRONINEZUUR HEUMANN 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,

Đặc tính sản phẩm

Alendroninezuur Heumann 70 mg één tablet per week, tabletten –
NL/H/4911/001/DC
NL (common) SmPC
NL/s/001/20/3
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ALENDRONINEZUUR HEUMANN 70 MG ÉÉN TABLET PER WEEK, TABLETTEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid (as alendronate sodium).
Excipient with known effect
Each tablet contains 272.07 mg lactose anhydrous.
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
Alendroninezuur Heumann is indicated in adults for the treatment of
postmenopausal osteoporosis. It
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
Alendroninezuur Heumann, 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 ‘Alendroninezuur Heumann’ on an individual patient basis,
particularly after 5 or more years of
use.
Elderly
Alendroninezuur Heumann 70 mg één tablet per week, tabletten –
NL/H/4911/001/DC
NL (common) SmPC
NL/s/001/20/3
2
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 is not recommended for patients with ren