Desunin 4000 IU Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Beli sekarang

Download Risalah maklumat (PIL)
17-03-2021
Download Ciri produk (SPC)
17-03-2021

Bahan aktif:

Colecalciferol concentrate

Boleh didapati daripada:

Mylan IRE Healthcare Limited

Kod ATC:

A11C

INN (Nama Antarabangsa):

Colecalciferol concentrate

Dos:

4000 international unit(s)

Borang farmaseutikal:

Tablet

Kawasan terapeutik:

VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO

Tarikh kebenaran:

2015-12-11

Risalah maklumat

                                1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
DESUNIN 4000 IU TABLETS
Colecalciferol (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 Desunin is and what it is used for
2.
What you need to know before you take Desunin
3.
How to take Desunin
4.
Possible side effects
5.
How to store Desunin
6.
Contents of the pack and other information
1.
WHAT
DESUNIN IS AND WHAT IT IS USED FOR
Desunin contains vitamin D
3
which regulates the uptake and metabolism of calcium as well as
the incorporation of calcium in bone tissue.
Desunin is used to treat vitamin D
3
deficiency in adults and adolescents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESUNIN
_ _
DO NOT TAKE DESUNIN
-
if you are allergic to colecalciferol or any of the other ingredients
of this medicine
(listed in section 6).
-
if you have hypercalcaemia (increased levels of calcium in the blood)
or hypercalciuria
(increased levels of calcium in the urine).
-
if you have hypervitaminosis D (increased levels of vitamin D in the
blood).
-
if you have kidney stones.
If any of the above applies to you, talk to your doctor or pharmacist
before taking Desunin.
WARNINGS AND PRECAUTIONS
Talk to your doctor of pharmacist before using Desunin
-
if you suffer from sarcoidosis (a special type of connective tissue
disease that affects the
lungs, skin and joints).
-
when using other drugs containing vitamin D.
-
if you have kidney problems or have had kidney stones.
OTHER MEDICINES AND DESUNIN
Tell your doctor if you are taking, have recently taken or
                                
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                                Health Products Regulatory Authority
16 March 2021
CRN009KDD
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desunin 4000 IU Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains colecalciferol (vitamin D
3
) 4000 IU (equivalent to 100 microgram vitamin D
3
).
Excipients with known effect:
Each tablet contains isomalt 455.0 mg and sucrose 8.4 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to light yellow, oblong, 16 mm long, with a score line.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of vitamin D deficiency in adults and adolescents.
Vitamin D deficiency is defined as serum levels of
25-hydroxycolecalciferol (25(OH)D) < 25 nmol/l.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose: One tablet per day.
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 4000 IU (one tablet per day).
_Pediatric population_
The safety and efficacy of Desunin in children under 12 years have not
been established.
_Dosage in hepatic impairment_
No dose adjustment is required.
_Dosage in renal impairment_
Desunin should not be used in patients with severe renal impairment
(see section 4.3).
Method of administration
The tablets can be swallowed whole or crushed. The tablets can be
taken with food.
Health Products Regulatory Authority
16 March 2021
CRN009KDD
Page 2 of 5
4.3 CONTRAINDICATIONS
- Diseases and/or conditions resulting in hypercalcaemia or
hypercalciuria
- Nephrolithiasis
- Nephrocalcinosis
- Hypervitaminosis D
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Desunin should be prescribed with caution to patients suffering from
sarcoidosis due to risk of incre
                                
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