Colecalciferol 1A Pharma 3200 IE, zachte capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CHOLECALCIFEROL 80 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 3200 IE/stuk

INN (Algemene Internationale Benaming):

CHOLECALCIFEROL 80 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 3200 IE/stuk

farmaceutische vorm:

Capsule, zacht

Samenstelling:

BUTYLHYDROXYTOLUEEN (E 321) ; GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE GEEL (E 172) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

Sandoz B.V.
Page 1/7
Colecalciferol 1A Pharma 800 IE/ 3200 IE, zachte
capsules
RVG 128772-3
1313-v1
1.3.1.3 Bijsluiter
September 2022
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
Colecalciferol 1A Pharma 800 IE, zachte capsules
Colecalciferol 1A Pharma 3200 IE, zachte capsules
colecalciferol (Vitamin D3)
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.
-
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.
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
{[Nationally completed name]} contains colecalciferol (vitamin D).
Vitamin D helps the body to
absorb calcium and enhances bone formation.
This medicine is recommended in the following cases:
800 IU soft capsules
•
Treatment of vitamin D deficiency (serum level < 25 nmol/L (<10
ng/mL)) in adults and
adolescents.
•
Prevention of vitamin D deficiency (serum level < 25 nmol/L (<10
ng/mL)) in adults with an
identified risk.
3,200 IU soft capsules
Treatment of vitamin D deficiency (serum level < 25 nmol/L (<10
ng/mL)) in adults and
adolescents.
Sandoz B.V.
Page 2/7
Colecalciferol 1A Pharma 800 IE/ 3200 IE, zachte
capsules
RVG 128772-3
1313-v1
1.3.1.3 Bijsluiter
September 2022
2 .
WHAT YOU NEED TO KNOW BEFORE YOU TAKE {[NATIONALLY COMPLETED NAME]}
DO NOT TAKE {[NATIONALLY COMPLETED NAME]}:
-
if you are allergic t

Productkenmerken

Sandoz B.V.
Page 1/10
Colecalciferol 1A Pharma 800 IE, 3200 IE, zachte
capsules
RVG 128772-3
1311-v1b
1.3.1.1 Samenvatting van de Productkenmerken
Oktober 2022
1.
NAAM VAN HET GENEESMIDDEL
Colecalciferol 1A Pharma 800 IE, zachte capsules
Colecalciferol 1A Pharma 3200 IE, zachte capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 20 micrograms colecalciferol (Vitamin D3),
equivalent to 800 IU.
Each soft capsule contains 80 micrograms colecalciferol (Vitamin D3),
equivalent to 3,200 IU.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Soft capsule.
{[Nationally completed name] 800 IU soft capsules} are light yellow
opaque, size 2, oval soft
capsules. Capsule length is approximately 9.5 mm and width is
approximately 5.9 mm.
{[Nationally completed name] 3,200 IU soft capsules} are yellow
opaque, size 6, oval soft capsules.
Capsule length is approximately 13.6 mm and width is approximately 8.4
mm.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
800IU soft capsules
•
Treatment of vitamin D deficiency (serum level < 25 nmol/L (<10
ng/mL)) in adults and
adolescents.
•
Prevention of vitamin D deficiency (serum level < 25 nmol/L (<10
ng/mL)) in adults with an
identified risk.
3,200IU soft capsules
•
Treatment of vitamin D deficiency (serum level < 25 nmol/L (<10
ng/mL)) in adults and
adolescents.
{[Nationally completed name]} 800IU, 1,000IU and 3,200IU soft capsules
are indicated in
adolescents and adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sandoz B.V.
Page 2/10
Colecalciferol 1A Pharma 800 IE, 3200 IE, zachte
capsules
RVG 128772-3
1311-v1b
1.3.1.1 Samenvatting van de Productkenmerken
Oktober 2022
Posology
The dosage must be determined individually by the treating doctor
depending on the extent of the
necessary vitamin D supplementation. The dose should be adjusted
dependent upon desirable serum
levels of 25-hydroxycolecalciferol (25(OH)D), severity of the disease
and patients response to
treatment.
The patient’s dietary habits should be careful