Cholecalciferol Pharmacare 10,000 IU soft capsules

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Доступно од:

Pharmacare Srl Via Marghera, 29 20149, Milan, Italy

АТЦ код:

A11CC05

INN (Међународно име):

COLECALCIFEROL 10000 IU

Фармацеутски облик:

SOFT CAPSULE

Састав:

COLECALCIFEROL 10000 IU

Тип рецептора:

POM

Терапеутска област:

VITAMINS

Резиме производа:

Licence number in the source country: NOT APPLICAPABLE

Статус ауторизације:

Authorised

Датум одобрења:

2022-12-20

Информативни летак

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CHOLECALCIFEROL PHARMACARE 10,000 IU, SOFT CAPSULES
CHOLECALCIFEROL PHARMACARE 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 Pharmacare soft capsules is and what it is used
for
2.
What you need to know before you take Cholecalciferol Pharmacare soft
capsules
3.
How to take Cholecalciferol Pharmacare soft capsules
4.
Possible side effects
5.
How to store Cholecalciferol Pharmacare soft capsules
6.
Contents of the pack and other information
1. WHAT CHOLECALCIFEROL PHARMACARE SOFT CAPSULES IS AND WHAT IT IS
USED FOR
Cholecalciferol Pharmacare soft capsules contains the active substance
Cholecalciferol, better known
as Vitamin D3.
_ _
Cholecalciferol Pharmacare soft capsules is indicated for:
-
Prevention and treatment of vitamin D deficiency in adults.
For prevention of vitamin D deficiency Cholecalciferol Pharmacare soft
capsules 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 Pharmacare soft capsules 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 PHARMACARE
SOFT CAPSULES
DO NOT TAKE CHOLECALCIFEROL PHARMACARE SOFT CAPSULES
-
If you are allergic to Cholecalciferol (vitamin D3) or any of the
other ingredients of this
medicine (listed in section 6).

Карактеристике производа

PAGE 1 OF 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cholecalciferol Pharmacare 10,000 IU soft capsules
Cholecalciferol Pharmacare 25,000 IU soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Cholecalciferol Pharmacare 10,000 IU soft capsules _
Each soft capsule contains: Cholecalciferol (vitamin
D
3
) 0.250 mg corresponding to 10,000 IU.
_Cholecalciferol Pharmacare 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 Pharmacare 10,000 IU soft capsules are bourgogne red,
size 2, oblong, soft capsules
containing a clear colourless or greenish-yellow transparent solution
Cholecalciferol Pharmacare 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
PAGE 2 OF 9
vitamin D content of certain food types should be taken into
consideration. Cholecalciferol soft
capsules 10,000 IU are suitable for wee