Cholecalciferol Acure 25.000 IE zachte capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CHOLECALCIFEROL 625 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 25000 IE/stuk

INN (Algemene Internationale Benaming):

CHOLECALCIFEROL 625 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 25000 IE/stuk

farmaceutische vorm:

Capsule, zacht

Samenstelling:

GELATINE (E 441) ; GLYCEROL (E 422) ; TITAANDIOXIDE (E 171) ; TOCOFEROL, DL-ALFA ACETAAT ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-12-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CHOLECALCIFEROL ACURE 20.000 IE ZACHTE CAPSULES
CHOLECALCIFEROL ACURE 25.000 IE ZACHTE CAPSULES
cholecalciferol (vitamin D
3
)
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.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains cholecalciferol (vitamin D). Vitamin D helps
the body to absorb calcium
and enhances bone formation.
This medicine is recommended for the starting treatment of clinically
relevant vitamin D deficiency in
adults.
is indicated in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
-
if you are allergic to cholecalciferol or any of the other ingredients
of this medicine (listed in
section 6)
-
if you have high levels of calcium in your blood (hypercalcaemia) or
urine (hypercalciuria)
-
if you have severe kidney problems (severe renal impairment)
-
if you have high levels of vitamin D in your blood (hypervitaminosis
D)
if you have calcium kidney stones (calcium nephrolithiasis) or calcium
deposits in your kidneys
(nephrocalcinosis)
WARNINGS AND PRECAUTIONS
Do not take more than your doctor has prescribed,
since overdosage may occur. Do
not at the same time take other vitamin D containing products (e.g.,
medicinal products,

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Cholecalciferol Acure 20.000 IE zachte capsules
Cholecalciferol Acure 25.000 IE zachte capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 micrograms of cholecalciferol (vitamin D
3
, equivalent to 20 000 IU).
Each capsule contains 625 micrograms of cholecalciferol (vitamin D
3
, equivalent to 25 000 IU).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
20 000 IU capsule, soft
Transparent, blue, round with 7.2 mm of diameter, soft capsules with a
seam in the middle, filled with
light yellow viscous liquid.
25 000 IU capsule, soft
White to almost white, oval with 12 mm of length and 6.7 mm of
thickness, soft capsules with a seam
in the middle, filled with light yellow viscous liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Initial treatment of clinically relevant vitamin D deficiency (serum
levels < 25 nmol/l or < 10 ng/ml)
in adults.
20 000 IU and 25 000 IU soft capsules are indicated in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dose should be established on an individual basis depending on the
extent of the necessary vitamin D
supplementation. The dosage must be determined individually by the
treating doctor depending on the
extent of the necessary vitamin D supplementation.
The patient’s dietary habits should be carefully evaluated and
artificially added vitamin D content of
certain food types should be taken into consideration.
_ _
_Initial treatment of clinically relevant vitamin D deficiency (serum
levels < 25 nmol/l or < 10 ng/ml) _
_in adults: _
1 capsule of 20 000 IU /week for up to 4-5 weeks
1 capsule of 25 000 IU /week for up to 4 weeks
After first month, a lower maintenance dose should be considered,
dependent upon desirable serum
levels of 25- hydroxycolecalciferol (25(OH)D), the severity of the
disease and the patient´s response to
treatment.
Alternatively, national posology recommendations in treatment of
vitamin D deficiency can be
2
fo