Vitamin D3 Internis 250 IU/drop Oral Drops, solution

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Colecalciferol

Disponible depuis:

Stada Arzneimittel AG

Code ATC:

A11CC; A11CC05

DCI (Dénomination commune internationale):

Colecalciferol

Dosage:

250 international unit(s)

forme pharmaceutique:

Oral drops, solution

Domaine thérapeutique:

Vitamin D and analogues; colecalciferol

Date de l'autorisation:

2017-11-24

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FULTIUM-D
3 250 IU/DROP ORAL DROPS, 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 to prevent and treat vitamin D
3
deficiency in adults, adolescents and children with
an identified risk of vitamin D
3
deficiency.
Fultium-D
3
can also be used
as an adjunct to specific bone loss medication
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 disea

Résumé des caractéristiques du produit

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 250 IU/drop Oral Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains: 10 000 IU Cholecalciferol (equivalent to
250 micrograms/ml vitamin D
3
)
1 drop contains 250 IU Cholecalciferol (equivalent to 6.25 micrograms
vitamin D
3
)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution
Pale yellow transparent, odourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D deficiency in adults,
adolescents and children with an identified risk.
As an adjunct to specific therapy for osteoporosis in patients with
vitamin D deficiency or at risk of vitamin D insufficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
_Preventionof vitamin D deficiency and osteoporosis_:
Recommended dose is 2-3 drops (500 IU- 750 IU) per day.
_Treatment of vitamin D deficiency_:
3 drops (750 IU) per day. Higher doses should be adjusted dependent
upon desirable serum levels of 25-hydroxycolecalciferol
(25(OH)D), the severity of the disease and the patient´s response to
treatment.
The daily dose should not exceed 4,000 IU (16 drops per day).
Paediatric population
_Prevention_:
For prevention in adolescents (12 years to 18 years old) with an
identified risk, the recommended dose is 2-3 drops (500 IU-
750 IU) per day. For children below 12 years, recommended doses may
not be feasible to administer with this drop strength.
_Treatment of deficiency in children and adolescents_:
The dose should be adjusted dependent upon desirable serum levels of
25-hydroxycolecalciferol (25(OH)D), the severity of the
disease and the patient´s response to treatment.
The daily dose should not exceed 1000 IU per day for infants <1 years,
2000 IU per day for children 1-10 years and 4000 IU per
day for adolescents >11 years.
Alternatively, national posology recommendations in p