800 IU tablet 
cholecalciferol ( vitamin D 3 )

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Divisun is and what it is used for 
2. What you need to know before you use Divisun 
3. How to use Divisun 
4. Possible side effects 
5. How to store Divisun 
6. Contents of the packaging 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 storage of calcium in the skeleton.

Divisun is used to prevent and treat vitamin D deficiency in adults and adolescents.

Your doctor may prescribe Divisun as an adjunct to specific therapy for osteoporosis ( osteoporosis ).

2. What you need to know before using Divisun

Do not use Divisun

  • if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6).
  • if you have hypercalcemia (increased amount of calcium in the blood) or hypercalciuria (increased amount of calcium in the urine).
  • if you have hypervitaminosis D (an excess of vitamin D in your blood).
  • if you have kidney stones.

If any of the above apply to you, talk to your doctor or pharmacist before using Divisun.

Warnings and cautions

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, among other things).
  • if you are taking other medicines that contain vitamin D.
  • if you have impaired kidney function or have had kidney stones.

Other medicines and Divisun

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

  • Cholestyramine (treatment of high cholesterol ).
  • Phenytoin or barbiturate is (treatment of epilepsy ).
  • Laxatives containing paraffin oil.
  • Thiazide – diuretics (for high blood pressure ).
  • Glucocorticoid is (treatment of inflammation ).
  • Cardiac glycosides, e.g. digoxin (for irregular heartbeat).

Divisun with food and drink

Divisun can be taken with a meal.

Pregnancy and breastfeeding

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 of vitamin D.

Divisun should only be used during pregnancy if you have been told by your doctor that you have a vitamin D deficiency.

Divisun can be used during breast-feeding. Vitamin D 3 passes into breast milk. This should be taken into account when giving another vitamin D supplement to breastfed children.

Driving and using machines

Divisun has no known effects on the ability to drive and use machines.

Divisun contains sucrose, isomalt, and sodium

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

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

3. How to use Divisun

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is 1 tablet daily.

The daily dose should not exceed 4000 IU (5 tablets).

The tablets can be swallowed whole or crushed.

Use for children

Divisun should not be used in children under 12 years of age as there is no evidence from clinical trials.

If you take more Divisun then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Divisun

Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, 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 Divisun and contact a doctor immediately if you get any of the following symptoms ( angioedema ):

  • swelling of the face, lips, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing

Uncommon (affects less than 1 user in 100): Hypercalcaemia (increased amount of calcium in the blood) and hypercalciuria (increased amount of calcium in the urine).

Rare (affects less than 1 user in 1,000): Itching, rash, and urticaria ( hives ).

5. How to store Divisun

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 blister or can after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store in the original package. Sensitive to light.

Close the package tightly. Moisture sensitive.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is cholecalciferol 20 micrograms, equivalent to 800 IU vitamin D 3.
  • The other ingredients are pregelatinized maize starch, magnesium stearate, sucrose, sodium ascorbate, isomalt (E953) (see section 2 “Divisun contains sucrose, isomalt, and sodium”), medium-chain triglycerides, anhydrous colloidal silica-modified too feral halophilic- tocolphalic-halophilic-to-corn.

What the medicine looks like and the contents of the pack

Divisun is white to slightly yellowish, biconvex tablets, 7 mm in diameter.

30, 60, or 90 tablets in blisters.

250 tablets in a plastic jar.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

Tel: 08 – 630 19 00

Manufacturer
Rottapharm LtdDamastown Industrial ParkMulhuddartDublin 15Ireland Vemedia Manufacturing BVVerrijn Stuartweg 60NL-1112 AX Diemen Netherlands

Muhammad Nadeem

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