Fultium-D3 67 IU/drop Oral Drops, solution

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Colecalciferol

Dostopno od:

Stada Arzneimittel AG

Koda artikla:

A11CC; A11CC05

INN (mednarodno ime):

Colecalciferol

Odmerek:

67 international unit(s)

Farmacevtska oblika:

Oral drops, solution

Terapevtsko območje:

Vitamin D and analogues; colecalciferol

Datum dovoljenje:

2017-11-24

Navodilo za uporabo

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

Lastnosti izdelka

Health Products Regulatory Authority
29 January 2021
CRN00C49H
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fultium-D3 67 IU/drop Oral Drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains: 2 740 IU Cholecalciferol (equivalent to
68.5 micrograms/ml vitamin D
3
)
1 drop contains 67 IU Cholecalciferol (equivalent to 1.67 micrograms
vitamin D
3
)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution.
Clear, colourless to slightly yellow oil.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of vitamin D deficiency in adults,
adolescents and children with an identified risk.
In addition to specific therapy for osteoporosis in patients with
vitamin D deficiency, preferably in combination with calcium.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
_Prevention of vitamin D deficiency and osteoporosis:_
Recommended dose is 6-12 drops (400 IU – 800 IU) per day.
_Treatment of vitamin D deficiency:_
12 drops (800IU) 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 (60 drops).
Paediatric population
_Prevention:_
Children (0 up to 11 years old) with an identified risk: 6 drops (400
IU) per day.
Adolescents (12 years to 18 years) with an identified risk: 6-12 drops
(400 IU – 800 IU) per day.
_Treatment:_
In vitamin D deficiency, 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 prevention and
treatment of vitamin D deficiency can be followed.
Where higher doses are required,