Cholecalciferol Teva 20.000 IE, zachte capsules

Land: Nederland

Språk: nederlandsk

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

Aktiv ingrediens:

CHOLECALCIFEROL 0,5 mg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 20000 IE/stuk

INN (International Name):

CHOLECALCIFEROL 0,5 mg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 20000 IE/stuk

Legemiddelform:

Capsule, zacht

Sammensetning:

GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; TITAANDIOXIDE (E 171) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

Administreringsrute:

Oraal gebruik

Autorisasjon dato:

2023-09-29

Informasjon til brukeren

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CHOLECALCIFEROL TEVA 20.000 IE, ZACHTE CAPSULES
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.
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 vitamin D
3
which regulates the uptake and metabolism of calcium as well as
the incorporation of calcium in bone tissue.
is used for initial treatment of clinically relevant
vitamin D
3
deficiency 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 hypercalcaemia (increased levels of calcium in the blood)
or hypercalciuria (increased
levels of calcium in the urine).
•
if you have hypervitaminosis D (increased levels of vitamin D in the
blood).
•
if you have calcium deposits in your kidneys (nephrocalcinosis).
•
if you have kidney stones or serious kidney problems.
•
if you are allergic to peanut or soya.
If any of the above applies to you, talk to your doctor or pharmacist
before taking .
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking :
•
if you suffer from sar

Preparatomtale

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1.
NAAM VAN HET GENEESMIDDEL
Cholecalciferol Teva 20.000 IE, zachte capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.500 mg cholecalciferol, equivalent to 20 000
IU vitamin D
3
.
Excipient with known effect
The capsules may contain trace amounts of soya lecithin (may contain
soya oil).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
soft capsules.
Orange, opaque, oval-shaped, soft capsule filled with clear, slightly
yellow, oily liquid.
Dimension: Length: approx. 8-9 mm, Width: approx. 6-7 mm
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 and calcium content of certain food types
should be taken into
consideration.
_ _
_Adults _
Recommended dose: One capsule (20 000 IU) per week for up to 4-5
weeks.
After the first month, a lower maintenance dose should be considered
according to the desirable serum
levels of 25-hydroxycholecalciferol (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
followed.
_Dosage in hepatic impairment _
No dose adjustment is required.
_Dosage in renal impairment _
must not be used in patients with severe renal
impairment (see section 4.3).
_ _
_Paediatric population _
should not be used in children and adolescents. The
strength of 20 000 IU soft
capsules is not suitable for the use in paediatric population because
studies on the safe use of high
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doses in paediatric population are too limited. However, products