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DESUNIN 800 IU TABLETS

Active substance(s): COLECALCIFEROL

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Package leaflet: Information for the user

Desunin 800 IU tablets
colecalciferol (vitamin D3)

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 D3 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 D3 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 stones.
Other medicines and Desunin
Tell your doctor if you are taking, have
recently taken or might take any other
medicines.
- Cholestyramine
(used to treat high cholesterol).
- Phenytoin or barbiturates
(used to treat epilepsy).
- Laxatives which contain paraffin oil.
- Thiazide diuretics
(to treat high blood pressure).
- Glucocorticoids
(to treat inflammation).
- Cardiac glycosides
(to treat heart conditions), e.g. digoxin
Desunin with food and drink
Desunin can be taken with food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.
During pregnancy the daily intake should
not exceed 600 IU vitamin D.
Desunin should only be used during
pregnancy if vitamin D deficiency has
been clinically established.
Desunin can be used during breastfeeding, Vitamin D3 passes over into
breast milk. This should be considered
when giving additional vitamin D to the
breast-fed child.
Driving and using machines
Desunin has no know effects on ability
to drive or use machines.
Desunin contains sucrose and isomalt
If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before taking
Desunin.
3. HOW TO TAKE DESUNIN
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are not
sure.
The recommended dose is 1 tablet every
day.

The daily dose shall not exceed 4000 IU
(five tablets).
The tablets can be swallowed whole or
crushed.
Use in children
Desunin is not intended for use in children
under 12 years due to lack of study data.
If you take more Desunin than you
should
If you have taken more of this medicine
than directed, or if a child accidently has
taken this medicine, please contact your
doctor or emergency unit for judgement
of the risk and advice.
If you forget to take Desunin
Do not take a double dose to make up for
a forgotten dose.
If you stop taking Desunin
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can
cause side effects, although not everybody gets them.
Stop taking Desunin and seek immediate
medical help if you experience symptoms
of serious allergic reactions, such as:
• Swollen face, lips, tongue or throat
• Difficult to swallow
• Hives and difficulty breathing
Uncommon (occurs in less than 1 out of
100 patients): Hypercalcaemia
(increased levels of serum calcium) and
hypercalciuria (increased levels of urine
calcium).
Rare (occurs in less than 1 out of 1 000
patients): Pruritus, rash and urticarial.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly (see details below). By reporting
side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

5. HOW TO STORE DESUNIN
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton and the
blister or the bottle after EXP. The expiry
date refers to the last day of the month.
Do not store above 30ºC. Store the tablets
in the original container, in order to
protect from light. Keep the container
tightly closed in order to protect from
moisture.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Desunin contains
- The active substance is colecalciferol
20 microgram corresponding to
800 IU Vitamin D3.
- The other ingredients are pregelatinized
maize starch, isomalt (E 953), magnesium stearate sucrose, sodium
ascorbate, medium chain triglycerides,
silica colloidal anhydrous, modified
food (maize) starch and all-rac-alphatocopherol.
What Desunin looks like and contents
of the pack
Desunin is a white to light yellow,
biconvex, tablet, 7 mm in diameter.
30, 60 or 90 tablets in blisters.
250 tablets in plastic bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd, Skyway
House, Parsonage Road, Takeley, Bishop’s
Stortford, CM22 6PU, United Kingdom.
Meda Health Sales Ireland Limited,
Unit 34/35, Block A, Dunboyne Business
Park, Bunboyne, Co.Meath, Ireland
Manufacturer
Vemedia Manufacturing B.V.
NL-1112 AX Diemen
Netherlands
This medicinal product is authorised in
the Member States of the EEA under
the following names:
Desunin: Ireland and United Kingdom
Divisun: Austria, Denmark, Finland, the
Netherlands, Norway, Spain and Sweden
This leaflet was last approved in June 2016
731542 07/16

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