FULTIUM-D3

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

COLECALCIFEROL

Available from:

Internis Pharmaceuticals Limited

ATC code:

A11CC05

INN (International Name):

COLECALCIFEROL

Dosage:

3200 International Unit

Pharmaceutical form:

Capsule

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

colecalciferol

Authorization status:

Authorised

Authorization date:

2017-11-24

Patient Information leaflet

11009
11009
MHRA HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
Leaflet
30's
20230201
210 x 297mm
5
16.01.2018
Fultium-D3 3,200 IU Capsules Ireland
Rockwell
Helvetica
9.8pt
9pt
11pt
9pt
Process Black
Keyline (Non-Printing)
POINT SIZES USED
MIN MAX
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.
Q Keep this leaflet. You may need to read it again.
Q If you have any further questions, ask your doctor or
pharmacist.
Q 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.
Q 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
Q if you are allergic to vitamin D or any of the other
ingredients of this medicine (listed in section 6)
Q if you have high levels of vitamin D in your blood
(hypervitaminosis D)
Q if you have high blood levels of calcium
(hypercalcaemia) or high urine levels of calcium
(hypercalciuria)
Q if you have kidney stones or serious kidney
problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Fultium-D
3
Q if you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fultium-D
3
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
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