Divisun 1000 IE Tablett

देश: स्वीडन

भाषा: स्वीडिश

स्रोत: Läkemedelsverket (Medical Products Agency)

सक्रिय संघटक:

kolekalciferol

थमां उपलब्ध:

Viatris AB

ए.टी.सी कोड:

A11CC05

INN (इंटरनेशनल नाम):

cholecalciferol

डोज़:

1000 IE

फार्मास्यूटिकल फॉर्म:

Tablett

रचना:

isomalt Hjälpämne; sackaros Hjälpämne; kolekalciferol 25 mikrog Aktiv substans

प्रिस्क्रिप्शन प्रकार:

Receptbelagt

उत्पाद समीक्षा:

Förpacknings: Blister, 30 tabletter; Blister, 90 tabletter

प्राधिकरण का दर्जा:

Godkänd

प्राधिकरण की तारीख:

2015-12-04

सूचना पत्रक

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

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Divisun 1000 IU tablet
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
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
P
HARMACEUTICAL
F
ORM
Tablet
White to light yellow, biconvex, 8 mm in diameter.
4
C
LINICAL
P
ARTICULARS
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 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 metabo