Alendroninezuur/Cholecalciferol 1A Pharma 70mg/2800 IE, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CHOLECALCIFEROL CONCENTRAAT, POEDERVORM 28 mg/stuk SAMENSTELLING overeenkomend met ; CHOLECALCIFEROL 70 µg/stuk ; NATRIUMALENDRONAAT 3-WATER 91,4 mg/stuk SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR 70 mg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 2800 IE/stuk

INN (Algemene Internationale Benaming):

CHOLECALCIFEROL CONCENTRAAT, POEDERVORM 28 mg/stuk SAMENSTELLING overeenkomend met ; CHOLECALCIFEROL 70 µg/stuk ; NATRIUMALENDRONAAT 3-WATER 91,4 mg/stuk SAMENSTELLING overeenkomend met ; ALENDRONINEZUUR 70 mg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 2800 IE/stuk

farmaceutische vorm:

Tablet

Samenstelling:

ALUMINIUMMAGNESIUMSILICAAT ; BUTYLHYDROXYTOLUEEN (E 321) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; SACCHAROSE ; ZONNEBLOEMOLIE, GEZUIVERD, ALUMINIUMMAGNESIUMSILICAAT ; BUTYLHYDROXYTOLUEEN (E 321) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; SACCHAROSE ; ZONNEBLOEMOLIE, GEZUIVERD

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

1 A Pharma
Page 1/9
Alendroninezuur/Cholecalciferol 1A Pharma 70
mg/2800 IE, 70mg/5600 IE, tabletten
RVG 128749-50
1313-v1
1.3.1.3 Bijsluiter
Februari 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALENDRONINEZUUR/CHOLECALCIFEROL 1A PHARMA 70 MG/2800 IE, TABLETTEN
ALENDRONINEZUUR/CHOLECALCIFEROL 1A PHARMA 70 MG/5600 IE, TABLETTEN
alendroninezuur/cholecalciferol
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
WHAT IS [NATIONALLY COMPLETED NAME]?
[Nationally completed name] 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

Productkenmerken

1 A Pharma
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Alendroninezuur/Cholecalciferol 1A Pharma 70
mg/2800 IE, 70mg/5600 IE, tabletten
RVG 128749-50
1311-v1
1.3.1.1 1 Samenvatting van de Productkenmerken
Februari 2023
1.
NAME OF THE MEDICINAL PRODUCT
Alendroninezuur/Cholecalciferol 1A Pharma 70 mg/2800 IE, tabletten
Alendroninezuur/Cholecalciferol 1A Pharma 70 mg/5600 IE, tabletten
alendroninezuur/cholecalciferol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Nationally completed name] <70 mg/2 800 IU>
Each tablet contains 70 mg of alendronic acid (as sodium trihydrate)
and 70 microgram (2 800
IU) colecalciferol (vitamin D
3
).
[Nationally completed name] <70 mg/5 600 IU>
Each tablet contains 70 mg of alendronic acid (as sodium trihydrate)
and 140 microgram (5 600 IU)
colecalciferol (vitamin D
3
).
Excipients with known effect:
[Nationally completed name] <70 mg/2 800 IU>
Each tablet contains 87.1 mg lactose and 13.75 mg sucrose.
[Nationally completed name] <70 mg/5 600 IU>
Each tablet contains 59.1 mg lactose and 27.5 mg sucrose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
[Nationally completed name] <70 mg/2 800 IU>
Oblong-shaped, white to off-white, biconvex tablet, mottled, engraved
with ‘2800’ on one side,
12.3 mm in length and 6.5 mm in width.
1 A Pharma
Page 2/16
Alendroninezuur/Cholecalciferol 1A Pharma 70
mg/2800 IE, 70mg/5600 IE, tabletten
RVG 128749-50
1311-v1
1.3.1.1 1 Samenvatting van de Productkenmerken
Februari 2023
[Nationally completed name] <70 mg/5 600 IU>
Modified rectangle-shaped, white to off-white tablet, mottled,
engraved with ‘5600’ on one side,
11.4 mm in length and 7.2 mm in width.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] 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.
Patien