Fultium-D3 3200 IU Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colecalciferol

Available from:

Stada Arzneimittel AG

ATC code:

A11CC; A11CC05

INN (International Name):

Colecalciferol

Dosage:

3200 international unit(s)

Pharmaceutical form:

Capsule

Therapeutic area:

Vitamin D and analogues; colecalciferol

Authorization date:

2017-11-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FULTIUM-D
3 3200 IU CAPSULES
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 additional d

Summary of Product characteristics

Health Products Regulatory Authority
29 January 2021
CRN00C49H
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fultium-D3 3200 IU Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
3 200 IU Cholecalciferol (equivalent to 80 micrograms vitamin D
3
)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft
Green coloured translucent soft gelatin capsule, 10.6 mm x 6.2 mm
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 capsule per day.
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.
The capsule should be swallowed whole with water, preferably with the
main meal of the day.
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
Severe renal impairment
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
29 January 2021
CRN00C49H
Page 2 of 5
Vitamin D should be used with caution in patients with impairment of
renal function and the effect on calcium and phosphate
levels should be monitored. The risk of soft tissue calcification
should be taken into account. In patients with severe renal
insufficiency, vitamin D in the f