• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

1. What Colecalciferol Capsules are and what they are used for
2. What you need to know before you take Colecalciferol Capsules
3. How to take Colecalciferol Capsules
4. Possible side effects
5. How to store Colecalciferol Capsules
6. Contents of the pack and other information

• If you are allergic (hypersensitive) to Colecalciferol or any of the other ingredients in the capsules (these are listed in section 6. Contents of the pack and other information)
• if you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria)
• if you are suffering from kidney failure, have kidney stones (renal calculi) or have a tendency to form kidney stones
• if you have high levels of vitamin D in your blood (hypervitaminosis D).

Talk to your doctor or pharmacist before taking Colecalciferol Capsules:

• if you suffer from heart disease or narrowing of the arteries
• if you suffer from sarcoidosis (a multisystem chronic inflammatory condition which can affect your lungs, heart and kidneys), then there is a risk of increased conversion of vitamin D into its active form
• if you are taking medicines containing vitamin D, or eating foods or drinking milk enriched with vitamin D.

Your doctor may want you to have regular blood tests to check the amount of calcium in your blood.

Colecalciferol Capsules should only be given to children and adolescents aged 12 and over.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines which you have bought without a prescription.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines for epilepsy such as barbiturates or other anti-convulsants (e.g. carbamazepine, phenobarbital, phenytoin, primidone)
• other vitamin D containing medicines including multi-vitamins
• medicines to control the rate of your heart beat (e.g. digoxin, digitoxin)
• diuretics (water tablets) such as bendroflumethiazide
• calcium supplements
• medicines to treat tuberculosis e.g rifampicin, isoniazid
• medicines leading to fat malabsorption e.g orlistat, cholestyramine, liquid paraffin
• medicines to treat fungal infections i.e. ketoconazole, itraconazole
• actinomycin (a medicine used to treat some forms of cancer) as it may interfere with the metabolism of vitamin D
• glucocorticosteroids (steroid hormones such as hydrocortisone or prednisolone).

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. If you require extra vitamin D do not take it without medical supervision because too much vitamin D may harm your baby.

Colecalciferol Capsules should not affect your ability to drive or operate machinery.

Azorubine, carmoisine may cause allergic reaction.

Adults

• Treatment of vitamin D deficiency: 1-4 capsules (1 000 - 4 000 IU) daily for 10 weeks, followed by maintenance therapy of 1-2 capsules (1 000 - 2 000 IU) daily, as directed by your doctor.
• Prevention of vitamin D deficiency: 1-2 capsules (1 000 - 2 000 IU) daily, as directed by your doctor. Higher doses may be required in certain populations.
• In osteoporosis (you will also be taking other medicines for this): 1 capsule (1 000 IU) daily, as directed by your doctor.

Children and adolescents (12- 18 years)

• Treatment or prevention of vitamin D deficiency: 1 capsule (1 000 IU) daily, as directed by your doctor.

If you have problems absorbing vitamin D or have other conditions such as liver disease the dose may be different and will depend on your medical condition.

It is important not to exceed the prescribed dose.

The capsules should be swallowed whole with a glass of water, preferably with the main meal of the day.

Colecalciferol Capsules should only be given to children and adolescents aged 12 and over.

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 forget to take your capsules, take them as soon as possible. Then take the next dose at the correct time, in accordance with the instructions given to you by your doctor. However, if it is almost time to take the next dose, do not take the dose you have missed; just take the next dose as normal.

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

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 to the relevant medicine authority (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom:

or search for MHRA Yellow Card in the Google Play or Apple App Store

The active substance is Colecalciferol. Each capsule contains:1 000 IU colecalciferol (equivalent to 25 micrograms vitamin D₃).

The other ingredients are medium-chain triglycerides, butylated hydroxytoluene (BHT), colloidal anhydrous silica, purified water, polysorbate 80, red iron oxide, yellow iron oxide, titanium dioxide, azorubine carmoisine and gelatin.

Colecalciferol Capsules is an unprinted, hard gelatin red capsule containing clear, slightly yellow oily liquid.

Capsule length: 21.7 mm.

It is available in blister packs containing 10, 14, 20, 28, 30, 56, 60, 84, 100 capsules.

Not all pack sizes may be marketed.

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Manufacturer