Patient leaflet - Desunin 800 IU tablets

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.

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.
- Orlistat (for weight loss, reduces the amount of fat your body absorbs).

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 breast-feeding. 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 known effects on ability to drive or use machines.

Desunin contains sucrose and isomalt

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Desunin.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 accidentally 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.

Ref: 2005/080725/1/F

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(colecalciferol (vitamin D3)

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Patient Information Leaflet (continued)

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Desunin and seek immediate medicinal 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 urticaria.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Desunin

* Keep out of the sight and reach of children.

* Do not store above 30°C.

* Store in the original container in order to protect from light and moisture. * Do not use this medicine after the expiry date which is stated on the blister label and outer carton after EXP. The expiry date refers to the last day of that month.

* If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.

* If the tablet becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

* Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

What Desunin contains

Each tablet contains: 800 IU colecalciferol corresponding to 20 micrograms vitamin D3.

The other ingredients are pregelatinized maize starch, isomalt (E 953) (see section 2 'Desunin contains sucrose and isomalt'), magnesium stearate, sucrose, sodium ascorbate (see section 2 'Sodium content'), medium chain triglycerides, silica colloidal anhydrous, modified food (maize) starch and all-rac-alpha-tocopherol.

What Desunin looks like and contents of the pack

Desunin Tablets are white to light yellow, biconvex, 7 mm in diameter. Each carton contains 30 or 90 tablets.

Manufacturer and Licence Holder

Manufactured by Rottapharm Ltd., Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

Desunin is a registered trademark of MEDA Pharma GmbH & Co. KG.

PL 15184/2005 Desunin 800 IU Tablets

Leaflet revision date: 08/07/2025

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you

Ref: 2005/080725/1/B

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Desunin 800 IU Tablets