Patient leaflet - Desunin 1000 IU tablets
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.
Children
Desunin is not intended for use in children under 12 years due to lack of study data.
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, breast-feeding and fertility
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.
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.
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’.
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 (frou 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.
4. 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.
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 blister and carton after EXP. The expiry date refers to the last day of the month.
Do not store above 30°C. Store the tablets in the original package in order to protect from light and 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 to protect the environment.
6. Contents of the pack and further information
What Desunin contains
- The active substance is colecalciferol
25 microgram corresponding to
1000 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-alpha-tocopherol.
What Desunin looks like and contents of the pack
Desunin is a white to light yellow, bioconvex, tablet, 8 mm in diameter.
30 or 90 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Products Limited,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
Manufacturer
Vemedia Manufacturing B.V.
NL-1112 AX Diemen,
Netherlands