Ergocalciferol 50 000 Iu Capsules
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Ergocalciferol 50 000 IU Capsules Ergocalciferol
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. See section 4
What is in this leaflet
1. What Ergocalciferol Capsules are and what they are used for
2. What you need to know before you take Ergocalciferol Capsules
3. How to take Ergocalciferol Capsules
4. Possible side effects
5. How to store Ergocalciferol Capsules
6. Contents of the pack and other information
1. What Ergocalciferol Capsules are and what they are used for
Ergocalciferol is a form of vitamin D used in the treatment of vitamin D deficiency conditions and in the maintenance of vitamin D levels.
Ergocalciferol 50 000 IU Capsules is equivalent to 1.25 milligrams of vitamin D2 which is involved in bone formation.
The active ingredient Ergocalciferol is identical to the Ergocalciferol that is found as a plant-derived form of vitamin D named as vitamin D2.
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 require extra vitamin D, do not take it without medical supervision.
2. What you need to know before you take Ergocalciferol Capsules
Do not take Ergocalciferol Capsules:
• if you are allergic (hypersensitive) to ergocalciferol or any of the other ingredients in the capsules (listed in section 6, Contents of the pack and other information)
• have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria)
• if you are suffering from kidney failure
• if you suffer from kidney stones 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 Ergocalciferol Capsules:
• if you suffer from heart disease or narrowing of arteries
• if you suffer from kidney problems
• 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.
Your doctor may want you to have regular blood tests to check the amount of calcium in your blood.
Children and adolescents
Ergocalciferol 50 000 IU Capsules should not be given to children and adolescents under the age of 18.
Other medicines and Ergocalciferol Capsules
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 anticonvulsants (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
• glucocorticoidsteroids (steroid hormones such as hydrocortisone or prednisolone)
• sodium sulphate, by mouth, or are having magnesium sulphate injections 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 calcium or vitamin D, do not take this medicine without medical supervision because too much calcium or vitamin D may harm your baby.
Driving and using machines
Ergocalciferol should not affect your ability to drive or operate machinery.
3. How to take Ergocalciferol Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Recommended Dose and Dosage Schedules
- Treatment of vitamin D deficiency: 50 000 IU (1 capsule) once a week for 12 weeks, followed by maintenance therapy of 50 000 IU (1 capsule) every 4 weeks, as directed by your doctor.
- Maintenance of vitamin D levels: 50 000 IU (1 capsule) every 4 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.
Ergocalciferol 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
Ergocalciferol 50 000 IU Capsules should not be given to children and adolescents under the age of 18.
If you take more Ergocalciferol 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 Ergocalciferol 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 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, this medicine can cause side effects, although not everybody gets them.
Side effects with Ergocalciferol Capsules may include:
Rare side effects
(affecting less than 1 in 1000 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).
• 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 Ergocalciferol Capsules
Keep this medicine out of the sight and reach of children.
Store below 25°C. 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 Ergocalciferol Capsules contain
The active substance is ergocalciferol.
The other ingredients are medium-chain triglycerides, colloidal silicon dioxide, butylated hydroxytoluene (BHT), titanium dioxide, yellow iron oxide, red iron oxide and gelatin.
What Ergocalciferol Capsules look like and contents of the pack
Ergocalciferol 50 000 IU Capsule is an orange, unprinted hard capsule containing a clear, slightly oily, liquid.
Ergocalciferol 50 000 IU Capsules are available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 84 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder, Manufacturer and Distributor
Marketing Authorisation Holder
Colonis Pharma Limited
Hanover Place
8 Church Road
Royal Tunbridge Wells
Kent
TN1 2JP
United Kingdom
Manufacturer
MW Encap Limited Oakbank Park Way Building 1 Units 4, 5 & 6
Livingston West Lothian EH53 0TH United Kingdom
Marketed and Distributed by:
Quantum Pharmaceutical Quantum House 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 : Ergocalciferol 50 000 IU Capsules