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ERGOCALCIFEROL 50 000 IU CAPSULES

Active substance(s): ERGOCALCIFEROL

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Package leaflet: Information for the Patient
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
GŻR-1368 Gżira
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 25ºC. 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
E-mail: medinfo@colonis.co.uk
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
This leaflet was last revised in October 2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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