Divisun 4000 IE Tablett

País: Suécia

Língua: sueco

Origem: Läkemedelsverket (Medical Products Agency)

Ingredientes ativos:

kolekalciferol

Disponível em:

Viatris AB

Código ATC:

A11CC05

DCI (Denominação Comum Internacional):

cholecalciferol

Dosagem:

4000 IE

Forma farmacêutica:

Tablett

Composição:

sackaros Hjälpämne; kolekalciferol 100 mikrog Aktiv substans; isomalt Hjälpämne

Tipo de prescrição:

Receptbelagt

Resumo do produto:

Förpacknings: Blister, 30 tabletter; Blister, 70 tabletter; Blister, 90 tabletter

Status de autorização:

Godkänd

Data de autorização:

2015-12-04

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIVISUN 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 Divisun is and what it is used for
2.
What you need to know before you take Divisun
3.
How to take Divisun
4.
Possible side effects
5.
How to store Divisun
6.
Contents of the pack and other information
1.
WHAT DIVISUN IS AND WHAT IT IS USED FOR
Divisun contains vitamin D
3
which regulates the uptake and metabolism of calcium as well as the
incorporation of calcium in bone tissue.
Divisun is used to treat vitamin D
3
deficiency in adults and adolescents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIVISUN
DO NOT TAKE DIVISUN
-
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 Divisun.
WARNINGS AND PRECAUTIONS
Talk to your doctor of pharmacist before using Divisun
-
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 DIVISUN
Tell your doctor if you are taking, have recently taken or might t

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Divisun 4000 IU tablet
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
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
P
HARMACEUTICAL
F
ORM
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
C
LINICAL
P
ARTICULARS
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 Divisun in children under 12 years have not
been established.
_Dosage in hepatic impairment_
No dose adjustment is required.
_Dosage in renal impairment_
Divisun should be used with caution in patients with renal impairment
(see section 4.4).
Method of administration
The tablets can be swallowed whole or crushed. The tablets can be
taken with food.
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
Divisun should be prescribed with caution to patients suffering from
sarcoidosis due to risk of
increased metabolism of vitamin D into its active form. These patients
should be monitored with
regard to the calcium content in s