DivaD^® are capsules. They contain the active ingredient: Vitamin D3 (5000, 10000, 50000 IU colecalciferol). Vitamin D is found in the diet and is also produced in the skin after exposure to the sun. Often vitamin D is given in combination with calcium. DivaD^® is recommended for use when you have a normal intake of dietary calcium. DivaD^® may be prescribed by your doctor to treat or prevent vitamin D deficiency. Deficiency of vitamin D may occur when your diet or lifestyle does not provide you enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant). DivaD^® may also be prescribed for certain bone conditions, such as thinning of the bone (osteoporosis) when it will be given to you with other medicines. 

Do not take DivaD^® if you

·         are allergic (hypersensitive) to vitamin D or any of the other ingredients in the capsules.

·         have high levels of vitamin D in your blood (hypervitaminosis D)

·         have high blood levels of calcium (hypercalcaemia) or high urine levels of calcium (hypercalciuria)

·         have kidney stones or serious kidney problems.

Take special care with DivaD^®

Check with your doctor before taking DivaD^® if

·         you have kidney damage or disease. Your doctor will need to measure the levels of calcium in your blood or urine.

·         you are being treated for heart disease

·         you have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes)

·         you are already taking additional doses of calcium or vitamin D. Whilst you are taking DivaD^® your doctor will monitor your blood levels of calcium to make sure they are not too high.  

Taking other medicines, herbal or dietary supplements

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular the following medicines may interact with DivaD^®:

·         Heart medicines (cardiac glycosides such as digoxin). Your doctor may monitor your heart with an electrocardiogram (ECG) and measure the levels of calcium in your blood.

·         Medicines to treat epilepsy (such as phenytoin) or medicines to make you sleep (barbiturates such as phenobarbitone) as these medicines can decrease the effect of vitamin D.

·         Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These can decrease the effect of vitamin D.

·         Laxatives (such as paraffin oil) or a cholesterol lowering drug called colestyramine may reduce the absorption of vitamin D.

·         Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) as they may interfere with the metabolism of vitamin D.  

Taking DivaD^® with food and drink

You can take DivaD^® with or without food and drink.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant or you are breast-feeding you should talk to your doctor or pharmacist before you take DivaD^®. Due to their high strength, DivaD^® 50000 IU capsules are not recommended during pregnancy and breast-feeding.

Driving and using machines

DivaD^® should not affect your ability to drive or operate machinery.

Always take DivaD^® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Severe vitamin D deficiency: Loading doses 50,000 I.U. once weekly for 2 months. Maintenance dose: 800 to 2000 I.U. Once daily.

Vitamin D deficiency: 2000-5000 I.U. once daily or 10000 I.U. every other day for 2 months.

Vitamin D insufficiency: 2000-5000 I.U. once daily or 10000 I.U. every other day for 2 months.

Supplementation: 1000-2000 I.U. once daily.

Follow-up measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved.

DivaD^® capsules are not suitable for children under 12 years.

If you take more DivaD^® than you should

If you accidentally take too many capsules tell your doctor or get other medical advice immediately. If possible, take the capsules, the box and this leaflet with you to show the doctor. If you take too many capsules you may feel or be sick, become constipated or have stomach pains, weak muscles, tiredness, lack of appetite, kidney problems and in severe cases irregular heartbeats.

If you forget to take DivaD^®

If you forget to take your capsules, take them as soon as you can. Do not take a double dose to make up for a forgotten dose. After that, take the next capsule in accordance with the instructions given to you by your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.  

Like all medicines, DivaD^® can cause side effects, although not everybody gets them. Side effects with DivaD^® may include:

Uncommon side effects (affecting less than 1 in 100 people)

·         too much calcium in your blood (hypercalcaemia). You may feel or be sick, lose your appetite, have constipation, stomach ache, feel very thirsty, have muscle weakness, drowsiness or confusion.

·         too much calcium in your urine (hypercalciuria).

Rare side effects (affecting less than 1 in 1000 people)

·         skin rash

·         itching

·         hives

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Store in a dry place below 30°C.

Do not use DivaD^® after the expiry date stated on the carton and label.

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.