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COLECALCIFEROL 20 000 IU CAPSULES

Active substance(s): COLECALCIFEROL

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Colecalciferol 20 000 IU Capsules

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Package leaflet: Information for the Patient

Colecalciferol 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 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

1. What Colecalciferol Capsules are
and what they are used for
Colecalciferol Capsules contain the active
ingredient Colecalciferol. Colecalciferol is a
form of vitamin D used in the prevention
and treatment of vitamin D deficiency
conditions.
Colecalciferol 20 000IU Capsules contain
the equivalent of 500 micrograms vitamin
D3 which is involved in bone formation.
The active ingredient, Colecalciferol,
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 Colecalciferol Capsules
Do not take Colecalciferol
± 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)
Warnings and precautions
Talk to your doctor or pharmacist before
taking Colecalciferol:
± 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.

Colonis Pharma Limited

Your doctor may want you to have regular
blood tests to check the amount of calcium
in your blood.
Children and adolescents
Colecalciferol 20 000 IU Capsules should
only be given to children and adolescents
aged 12 and over.
Other medicines and Colecalciferol
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
Colecalciferol should not affect your ability
to drive or operate machinery.

3. How to take
Colecalciferol 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.
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Colecalciferol 20 000 IU Capsules

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Colecalciferol 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.

5. How to store
Colecalciferol Capsules

Use in children and adolescents
Colecalciferol 20 000 IU Capsules should
only be given to children and adolescents
aged 12 and over.
If you take more Colecalciferol 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
Colecalciferol 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.

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 Colecalciferol Capsules contain
The active substance is Colecalciferol.
The other ingredients are triglycerides,
butylated hydroxytoluene (BHT), colloidal
silicon dioxide, titanium dioxide, yellow iron
oxide and gelatin.
What Colecalciferol 20 000 IU Capsules
look like and contents of the pack
Colecalciferol 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.

4. Possible side effects
Like all medicines, Colecalciferol can
cause side effects, although not everybody
gets them.
Side effects with Colecalciferol 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.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Colonis Pharma Limited
Hanover Place
8 Church Road
Royal Tunbridge Wells
Kent, TN1 1JP
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

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.
This leaflet was last revised in
You can also report side effects directly to
the relevant medicine authority (see details March 2016
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

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Colonis Pharma Limited

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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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