Cholecalciferol Zentiva 25,000 IU soft capsules

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic

ATC code:

A11CC05

INN (International Name):

COLECALCIFEROL 25000 IU

Pharmaceutical form:

SOFT CAPSULE

Composition:

COLECALCIFEROL 25000 IU

Prescription type:

POM

Therapeutic area:

VITAMINS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-12-20

Patient Information leaflet

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CHOLECALCIFEROL ZENTIVA 10,000 IU, SOFT CAPSULES CHOLECALCIFEROL ZENTIVA 25,000 IU, SOFT 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 Zentiva is and what it is used for
2.
What you need to know before you take Cholecalciferol Zentiva
3.
How to take Cholecalciferol Zentiva
4.
Possible side effects
5.
How to store Cholecalciferol Zentiva
6.
Contents of the pack and other information
1.
WHAT CHOLECALCIFEROL ZENTIVA IS AND WHAT IT IS USED FOR
Cholecalciferol Zentiva contains the active substance Cholecalciferol,
better known as Vitamin D3.
_ _
Cholecalciferol Zentiva is indicated for:
-
Prevention and treatment of vitamin D deficiency in adults.
For prevention of vitamin D deficiency Cholecalciferol Zentiva 25,000
IU is used in adults only in
the cases where therapeutic adherence is not obtained with the daily
dosing of low dosages of
cholecalciferol.
Cholecalciferol Zentiva is indicated in adults.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHOLECALCIFEROL ZENTIVA
DO NOT TAKE CHOLECALCIFEROL ZENTIVA
-
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 (nephrolithiasis) or calcium deposits
in the kidneys
(nep

Summary of Product characteristics

PAGE 1 OF 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cholecalciferol Zentiva 10,000 IU soft capsules
Cholecalciferol Zentiva 25,000 IU soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Cholecalciferol Zentiva 10,000 IU soft capsules _
Each soft capsule contains: Cholecalciferol (vitamin
D
3
) 0.250 mg corresponding to 10,000 IU.
_Cholecalciferol Zentiva 25,000 IU soft 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 Zentiva 10,000 IU soft capsules are bourgogne red,
size 2, oblong, soft capsules
containing a clear colourless or greenish-yellow transparent solution
Cholecalciferol Zentiva 25,000 IU soft 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 IU 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
_ _
Recommended dose:
10,000 IU or 25,000 every week.
After first month, lower doses may be considered.
Following this initial treatment, maintenance therapy may be required
with a dose determined
individually by the treating doctor.
Alternatively, national posology recommendations in treatment of
vitamin D deficiency can be
followed.
_ _
_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 soft
PAGE 2 OF 8
capsules 10,000 IU are suitable for weekly vitamin D supp