• 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.

1. What STRIVIT-D3 is and what it is used for
2. What you need to know before take STRIVIT-D3
3. How to take STRIVIT-D3
4. Possible side effects
5. How to store STRIVIT-D3
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to vitamin D or any of the other ingredients in the capsules (these are listed in section 6, Further information)
• if you have high levels of vitamin D in your blood (hypervitaminosis D)
• if you have high blood levels of calcium (hypercalcaemia) or high urine levels of calcium (hypercalciuria)
• if you have kidney stones or serious kidney problems.

If any of the above applies to you, tell your doctor or pharmacist before taking STRIVIT-D3.

Talk to your doctor before taking STRIVIT-D3

• if you have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine.
• if you are being treated for heart disease
• you have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes)
• if you are already taking additional doses of calcium or vitamin D. Whilst you are taking STRIVIT-D3 your doctor will monitor your blood levels of calcium to make sure they are not too high.

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

In particular the following medicines may interact with STRIVIT-D3:

• 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.
• Thiazide diuretics (used to treat high blood pressure) reduce the urinary excretion of calcium and can increase risk of hypercalcaemia.
• Medicines used to treat epilepsy (such as phenytoin) or medicines to make you sleep (barbiturates such as phenobarbitone) can decrease the effects of vitamin D.
• Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone) can decrease the effects 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) may interfere with the metabolism of vitamin D.

You can take STRIVIT-D3 with or without food and drink.

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.

STRIVIT-D3 should not affect your ability to drive or operate machinery.

In severe vitamin D deficiency (for adults and the elderly)

Your doctor will usually prescribe you a dose of 1-4 capsules daily for up to 12 weeks. The amount will depend on how low your vitamin D levels are and how you respond to treatment. Your doctor will then tell you to take 1-2 capsules daily to maintain your vitamin D levels.

In moderate vitamin D deficiency (for adults and the elderly) or to prevent vitamin D deficiency

Your doctor will usually prescribe 1-2 capsules daily.

In vitamin D deficiency in children over 12 years

Your doctor will usually prescribe you 1 capsule daily.

In osteoporosis (you will also be taking other medicines for this)

Your doctor will usually prescribe 1 capsule daily. You should check with your doctor or pharmacist if you are unsure.

The capsules should be swallowed whole (not chewed) with water.

STRIVIT-D3 is not suitable for children under 12 years.

If you accidentally take one capsule too many, nothing is likely to happen. If you accidentally take several capsules too many, 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 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 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. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient (which makes the medicine work) is Colecalciferol.

Each capsule contains 800 IU Colecalciferol (equivalent to 20 micrograms Vitamin D3).

The other ingredients are:

Capsule Content

Maize oil, refined

Capsule Shell

Gelatin

Glycerol (E 422)

Brilliant Blue Supra containing Brilliant blue for coloring of food (E133), sodium chloride and sodium sulphate

Purified Water

STRIVIT-D3 800 IU Capsule is a translucent blue capsule (size 2) and has no markings.

It is available in blister packs containing 28, 30, 56, 60 or 90 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer: