Cholecalciferol 20 000 Iu Capsules
Package leaflet: Information for the Patient
Cholecalciferol 20 000 IU Capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ 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.
What is in this leaflet?
1. What Cholecalciferol Capsules are and what they are used for
2. What you need to know before you take Cholecalciferol Capsules
3. How to take Cholecalciferol Capsules
4. Possible side effects
5. How to store Cholecalciferol Capsules
6. Contents of the pack and other information
1. What Cholecalciferol Capsules are and what they are used for
Cholecalciferol Capsules contain the active ingredient Cholecalciferol. Cholecalciferol is a form of vitamin D used in the prevention and treatment of vitamin D deficiency conditions.
Cholecalciferol 20 000IU Capsules contain the equivalent of 500 micrograms vitamin D3 which is involved in bone formation.
The active ingredient, Cholecalciferol, is identical to the vitamin D3 that is found in the human body.
Deficiency of vitamin D may occur when your diet or lifestyle does not provide you with enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant).
If you are planning to get pregnant or you are pregnant and you require extra vitamin D do not take it without medical supervision.
2. What you need to know before you take Cholecalciferol Capsules Do not take Cholecalciferol
■ if you are allergic (hypersensitive) to Cholecalciferol 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)
Warnings and precautions
Talk to your doctor or pharmacist before taking Cholecalciferol:
■ if you suffer from heart disease or narrowing of 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.
Children and adolescents
Cholecalciferol 20 000 IU Capsules should only be given to children and adolescents aged 12 and over.
Other medicines and Cholecalciferol
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, phenobarbitol, 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).
Pregnancy and breast-feeding
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.
Driving and using machines
Cholecalciferol should not affect your ability to drive or operate machinery.
3. How to take Cholecalciferol Capsules
Always take this medicine exactly as your doctor or pharmacist has told you and as written on the label. Check with your doctor or pharmacist if you are not sure.
Recommended Dose and Dosage Schedules
Adults
■ Treatment of vitamin D deficiency:
40 000 IU/week (2 capsules) for 7 weeks, followed by maintenance therapy (equivalent to 1400-2000 IU/day) such as 2-3 capsules every 4 weeks, as directed by your doctor.
■ Prevention of vitamin D deficiency:
20 000 IU every 4 weeks (1 capsule), higher doses may be required in certain situations as directed by your doctor.
Children (12 - 18 years)
■ Treatment of vitamin D deficiency:
20 000 IU (1 capsule) once every 2 weeks for 6 weeks.
■ Prevention of vitamin D deficiency:
20 000 IU (1 capsule) every 6 weeks.
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.
Cholecalciferol Capsules with food and drink
The capsules should be swallowed whole with a glass of water, preferably with the main meal of the day.
It is important not to exceed the prescribed dose.
Use in children and adolescents
Cholecalciferol 20 000 IU Capsules should only be given to children and adolescents aged 12 and over.
If you take more Cholecalciferol Capsules than you should
If you accidentally take more capsules than you have been prescribed, contact your doctor or get medical advice immediately.
If possible, take the capsules, the box and this leaflet with you to show the doctor.
If you forget to take Cholecalciferol Capsules
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Cholecalciferol can cause side effects, although not everybody gets them.
Side effects with Cholecalciferol 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
■ raised itchy rash (hives)
Tell your doctor or pharmacist if any of the side effects become serious or if you notice any side effects not listed.
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 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:
The Yellow Card Scheme Medicines and Healthcare Products Regulatory Agency 151 Buckingham Palace Road Victoria
London, SW1W 9SZ United Kingdom
Website: www.mhra.gov.uk/yellowcard Malta:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3
Rue D’Argens
GZR-1368 Gzira
Malta
Website: www.medicinesauthority.gov.mt e-mail:
postlicensing.medicinesauthority@gov.mt
5. How to store Cholecalciferol Capsules
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions. Store blister foil in the original container in order to protect from light.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
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 protect the environment.
6. Contents of the pack and other information
What Cholecalciferol Capsules contain
The active substance is Cholecalciferol.
The other ingredients are triglycerides, butylated hydroxytoluene (BHT), colloidal silicon dioxide, titanium dioxide, yellow iron oxide and gelatin.
What Cholecalciferol 20 000 IU Capsules look like and contents of the pack
Cholecalciferol 20 000 IU Capsule is an ivory unprinted hard gelatin capsule containing a clear, slightly oily liquid.
It is available in blister packs containing 10, 14, 20, 28, 30, 56, 60, 84, 100 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Colonis Pharma Limited
Hanover Place
8 Church Road
Royal Tunbridge Wells
Kent, TN11JP
United Kingdom
E-mail: medinfo@colonis.co.uk
Manufacturer
MW Encap Limited
Oakbank Park
Building 1
Units 4, 5 & 6
Livingston
West Lothian, EH53 0TH United Kingdom
Marketed and Distributed by
Quantum Pharmaceutical Hobson Industrial Estate Burnopfield
County Durham, NE16 6EA United Kingdom
This medicinal product is authorised in other Member States of the EEA under the following names:
Malta: Cholecalciferol 20 000 IU Capsules
This leaflet was last revised in August 2015
K0044
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Artwork for: |
Colonis Pharma Limited |
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Product name: |
Cholecalciferol 20 000 IU Capsules |
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PL/PA no: | |
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Type: |
Leaflet |
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Artwork dimensions: |
320mm x 148mm |
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Profile supplied: |
No |
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Artwork code: |
K0044 |
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Date of first artwork: 7 May 2014 | |
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Reason for request: |
Name change from Colecalciferol |
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Version no: |
2.2 |
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Date of revision: |
17 August 2015 |
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Colours: |
As swatch(es) |
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Font(s): |
Titles and headings: Congress Text 9pt Kohinoor |
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Artwork software: |
InDesign CS6 |
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BAC ref: |
S824 (formerly R627) |
