Cholecalciferol Viatris 10.000 IE, zachte capsules

Страна: Нідерланди

мова: голландська

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

Активний інгредієнт:

CHOLECALCIFEROL 0,25 mg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 10000 IE/stuk

ІПН (Міжнародна Ім'я):

CHOLECALCIFEROL 0,25 mg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 10000 IE/stuk

Фармацевтична форма:

Capsule, zacht

Склад:

ALLURAROOD AC (E 129) ; BUTYLHYDROXYTOLUEEN (E 321) ; GELATINE, GEMODIFICEERD, GESUCCINYLEERD (MOLECUULGEWICHT ONBEKEND) ; GLYCEROL (E 422) ; OLIJFOLIE, GEZUIVERD ; TITAANDIOXIDE (E 171) ; WATER, GEZUIVERD, ALLURAROOD AC (E129) ; BUTYLHYDROXYTOLUEEN (E 321) ; GELATINE, GEMODIFICEERD, GESUCCINYLEERD (MOLECUULGEWICHT ONBEKEND) ; GLYCEROL (E 422) ; OLIJFOLIE, GEZUIVERD ; TITAANDIOXIDE (E 171) ; WATER, GEZUIVERD

Адміністрація маршрут:

Oraal gebruik

Дата Авторизація:

1900-01-01

інформаційний буклет

15
PACKAGE LEAFLET
16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CHOLECALCIFEROL VIATRIS 10.000 IE, ZACHTE CAPSULES
CHOLECALCIFEROL VIATRIS 25.000 IE, ZACHTE CAPSULES
Cholecalciferol (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 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 Cholecalciferol Viatris, zachte capsules is and what it is used
for
2.
What you need to know before you take Cholecalciferol Viatris, zachte
capsules
3.
How to take Cholecalciferol Viatris, zachte capsules
4.
Possible side effects
5.
How to store Cholecalciferol Viatris, zachte capsules
6.
Contents of the pack and other information
1.
WHAT CHOLECALCIFEROL VIATRIS, ZACHTE CAPSULES IS AND WHAT IT IS USED
FOR
Cholecalciferol Viatris, zachte capsules contains the active substance
Cholecalciferol, better known as
Vitamin D3.
Cholecalciferol Viatris, zachte capsules is indicated for:
-
Prevention and treatment of vitamin D deficiency in adults.
-
For prevention of vitamin D deficiency Cholecalciferol Viatris 25.000
IE, zachte capsulesis
used in adults only in the cases where therapeutic adherence is not
obtained with the daily
dosing of low dosages of cholecalciferol.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHOLECALCIFEROL VIATRIS, ZACHTE
CAPSULES
DO NOT TAKE CHOLECALCIFEROL VIATRIS, ZACHTE CAPSULES
-
If you are allergic to Cholecalciferol (vitamin D3) or any of the
other ingredients of this medicine
(listed in section 6).
-
if you have high levels of calcium in the blood (hypercalcaemia) or in
the urine (hypercalciuria)
-
if
you
suffer
from
kidney
stones
(neph

Характеристики продукта

2
SUMMARY OF PRODUCT CHARACTERISTICS
3
1.
NAME OF THE MEDICINAL PRODUCT
Cholecalciferol Viatris 10.000 IE, zachte capsules
Cholecalciferol Viatris 25.000 IE, zachte capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cholecalciferol Viatris 10.000 IE, zachte capsules
Each soft capsule contains: Cholecalciferol (vitamin
D
3
) 0.250 mg corresponding to 10,000 IU.
Cholecalciferol Viatris 25.000 IE, zachte capsules
Each soft capsule contains: Cholecalciferol (vitamin
D
3
) 0.625 mg corresponding to 25,000 IU.
Excipients with known effect: glycerol.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Cholecalciferol Viatris 10.000 IE, zachte capsules are bourgogne red,
size 2, oblong, soft capsules
containing a clear colourless or greenish-yellow transparent solution
Cholecalciferol Viatris 25.000 IE, zachte capsules are bourgogne red,
size 4, oblong, soft capsules
containing a clear colourless or greenish-yellow transparent solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D deficiency in adults.
Prevention of vitamin D deficiency for 25,000 UI only in adults with
an identified risk when
therapeutic
adherence
(or
compliance)
is
not
achieved
by
daily
administration
of
low
cholecalciferol doses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Dose should be established on an individual basis 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.
Cholecalciferol
Viatris
10.000
IE,
zachte
capsules
are
suitable
for
weekly
vitamin
D
supplementation. Cholecalciferol Viatris 25.000 IE, zachte capsules
are suitable for weekly
(treatment) and monthly (prevention) vitamin D supplementation.
Dosage should be established by a physician.
_ _
CHOLECALCIFEROL VIATRIS 10.000 IE, ZACHTE CAPSULES
_Adults _
_Prevention of vitamin D deficiency: _
1 capsule every 2 weeks. In a population