Vitamin D3 Internis 25 000 IU Oral Solution

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Colecalciferol

Dostupno od:

Stada Arzneimittel AG

ATC koda:

A11CC; A11CC05

INN (International ime):

Colecalciferol

Doziranje:

25000 international unit(s)

Farmaceutski oblik:

Oral solution

Područje terapije:

Vitamin D and analogues; colecalciferol

Datum autorizacije:

2017-11-24

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FULTIUM-D
3 25000 IU ORAL SOLUTION
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 Fultium-D
3
is and what it is used for
2.
What you need to know before you take Fultium-D
3
3.
How to take Fultium-D
3
4.
Possible side effects
5.
How to store Fultium-D
3
6.
Contents of the pack and other information
1.
WHAT FULTIUM-D
3 IS AND WHAT IT IS USED FOR
Fultium-D
3
contains the active ingredient cholecalciferol (vitamin D
3
):
Vitamin D
3
regulates the uptake and metabolism of calcium as well as the
incorporation of calcium in
bone tissue.
Fultium-D
3
is used for initial treatment of symptomatic vitamin D deficiency in
adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FULTIUM-D
3
DO NOT TAKE FULTIUM-D
3
-
if you are allergic to vitamin D or any of the other ingredients of
this medicine (listed in section
6)
-
if you have high levels of vitamin D in your blood (hypervitaminosis
D)
-
if you have high blood levels of calcium (hypercalcaemia) or high
urine levels of calcium
(hypercalciuria)
-
if you have kidney stones or serious kidney problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Fultium-D
3
-
if you have kidney damage or disease. Your doctor will need to measure
the levels of calcium in
your blood or urine
-
if you are being treated for heart disease
-
if you have sarcoidosis (an immune system disorder which may affect
your liver, lungs, skin or
lymph nodes)
-
if you are already taking additio

Svojstava lijeka

Health Products Regulatory Authority
29 January 2021
CRN00C49H
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitamin D3 Internis 25 000 IU Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
A 2.5 ml single-dose bottle containing 25 000 IU Cholecalciferol
(equivalent to 625 micrograms vitamin D
3
)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution, in single-dose container.
Pale yellow transparent, odourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Initial treatment of symptomatic vitamin D deficiency in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose: One bottle (25 000 IU) weekly.
After first month, lower doses may 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 followed.
_Dosage in hepatic impairment_
No dose adjustment is required.
_Dosage in renal impairment_
Fultium-D
3
should not be used in patients with severe renal impairment (see
section 4.3).
_Paediatric population_
Fultium-D
3
is not recommended in children and adolescents under 18 years of age
Method of administration
This medicine is taken orally.
Patients should be advised to take Fultium-D
3
25 000 IU Oral Solution preferably with a meal (see section 5.2).
The product should be shaken before use.
Fultium-D
3
Oral Solution can be dispensed onto a spoon or mixed with a small
amount of cold or lukewarm food or drink
immediately prior to use. The whole portion should be consumed.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Hypervitaminosis D
Nephrolithiasis
Diseases or conditions resulting in hypercalcaemia and/or
hypercalciuria
Health Products Regulatory Authority
29 January 2021
CRN00C49H
Page 2 of 5
Severe renal impairment
4.4 SPECIAL WARNINGS AND PRECAUTION