Fultium-D3 800 IU Capsules

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Colecalciferol

थमां उपलब्ध:

Stada Arzneimittel AG

ए.टी.सी कोड:

A11CC; A11CC05

INN (इंटरनेशनल नाम):

Colecalciferol

डोज़:

800 international unit(s)

फार्मास्यूटिकल फॉर्म:

Capsule

चिकित्सीय क्षेत्र:

Vitamin D and analogues; colecalciferol

प्राधिकरण की तारीख:

2017-11-24

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FULTIUM-D
3 800 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 to prevent and treat vitamin D
3
deficiency in adults and adolescents 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 disease
-
if you have s

उत्पाद विशेषताएं

Health Products Regulatory Authority
29 January 2021
CRN00C49H
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fultium-D3 800 IU Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
800 IU Cholecalciferol (equivalent to 20 micrograms vitamin D
3
)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft
Blue coloured translucent soft gelatin capsule, 10.6 mm x 6.2 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and prevention of vitamin D deficiency in adults and
adolescents 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
Recommended dose: One capsule per day.
Higher doses can be necessary in treatment of vitamin D deficiency,
where 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 4,000 IU (5 capsules per day).
_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 under 12 years of age
Method of administration
This medicine is taken orally.
The capsule should be swallowed whole with water, preferably with
food.
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 PRECAUTIONS FOR USE
Vitamin D should be used with caution in patients with impairment of
renal function and the effect on calcium and phosphate
levels should be monitor