DESUNIN

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

COLECALCIFEROL

Dostupné z:

Meda Health Sales Ireland Limited

ATC kód:

A11C

INN (Medzinárodný Name):

COLECALCIFEROL

Dávkovanie:

1000 International Unit

Forma lieku:

Tablets

Spôsob podávania:

oral use

Počet v balení:

30, 90 tablets

Typ predpisu:

Product subject to prescription which may be renewed (B)

Výrobca:

Vemedia Manufacturing B.V.

Terapeutické skupiny:

Vitamin supplements

Terapeutické oblasti:

VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO

Terapeutické indikácie:

Prevention and 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. In addition to specific osteoporosis treatment of patients who are at risk of vitamin D deficiency, preferably in combination with calcium

Stav Autorizácia:

Not Marketed

Dátum Autorizácia:

2015-12-11

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
DESUNIN 1000 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 prevent and treat vitamin D
3
deficiency in adults and adolescents.
Your doctor may prescribe Desunin as an adjunct to specific bone loss
medication.
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 or 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 s

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desunin 1000 IU Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains colecalciferol (vitamin D
3
) 1000 IU (equivalent to 25 microgram vitamin D
3
).
Excipients with known effect:
Each tablet contains isomalt 113.8 mg and sucrose 2.1 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to light yellow, biconvex, 8 mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and 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.
In addition to specific osteoporosis treatment of patients who are at
risk of vitamin D deficiency, preferably in
combination with calcium.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose: One tablet 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 4000 IU (four tablets 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.
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