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COLECALCIFEROL 1000 IU CAPSULES

Active substance(s): CHOLECALCIFEROL / COLECALCIFEROL

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Package leaflet: Information for the Patient

Aviticol 1 000 IU Capsules
Colecalciferol
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.

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

Other medicines and Aviticol 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.
What is in this leaflet
1. What Aviticol Capsules are and what they You must tell your doctor or pharmacist if
you are taking any of the following
are used for
medicines:
2. What you need to know before you take
Aviticol Capsules
■ medicines for epilepsy such as
barbiturates or other anti-convulsants
3. How to take Aviticol Capsules
(e.g. carbamazepine, phenobarbital,
4. Possible side effects
phenytoin, primidone)
5. How to store Aviticol Capsules
■ other vitamin D containing medicines
6. Contents of the pack and other
including multi-vitamins
information
■ medicines to control the rate of your
heart beat (e.g. digoxin, digitoxin)
1. What Aviticol Capsules are and
■ diuretics (water tablets) such as
what they are used for
bendroflumethiazide
Aviticol Capsules contain the active
■ calcium supplements
ingredient colecalciferol. Colecalciferol is a
■ medicines to treat tuberculosis
form of vitamin D used in the prevention
e.g. rifampicin, isoniazid
and treatment of vitamin D deficiency


medicines leading to fat malabsorption
conditions. It may also be prescribed for
e.g. orlistat, cholestyramine, liquid paraffin
certain bone conditions, such as thinning of
the bone (osteoporosis) when it will be given ■ medicines to treat fungal infections i.e.
ketoconazole, itraconazole
to you with other medicines.
■ a
 ctinomycin (a medicine used to treat
Aviticol 1 000 IU is the equivalent of
some forms of cancer) as it may interfere
25 micrograms vitamin D3, which is involved
with the metabolism of vitamin D
in bone formation.
■ glucocorticosteroids (steroid hormones
The active ingredient colecalciferol is
such as hydrocortisone or prednisolone).
identical to the Colecalciferol that is found
in the human body. It is found in the diet
Pregnancy and breast-feeding
and is also produced in the skin after
If you are pregnant or breast-feeding, think
exposure to the sun.
you may be pregnant or are planning to have
Deficiency of vitamin D may occur when your a baby, ask your doctor or pharmacist for
diet or lifestyle does not provide you with
advice before taking this medicine. If you
enough vitamin D or when your body
require extra vitamin D do not take it
requires more vitamin D (for instance when
without medical supervision because too
you are pregnant).
much vitamin D may harm your baby.
If you are planning to get pregnant or you
are pregnant and you require extra vitamin Driving and using machines
Aviticol Capsules should not affect your
D do not take it without medical
ability to drive or operate machinery.
supervision.

2. What you need to know before
you take Aviticol Capsules
Do not take Aviticol Capsules
■ 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 Aviticol 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

Colonis Aviticol PIL 1 000 IU v1.12.indd 1

Aviticol Capsules contain azorubine,
carmoisine
Azorubine, carmoisine may cause allergic
reaction.

3. How to take Aviticol 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 Doses
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.

12/10/2017 12:50

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.
Aviticol Capsules with food and drink
The capsules should be swallowed whole
with a glass of water, preferably with the
main meal of the day.
Use in children and adolescents
Aviticol Capsules should only be given to
children and adolescents aged 12 and over.
If you take more Aviticol Capsules than
you should
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 Aviticol 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, Aviticol Capsules can
cause side effects, although not everybody
gets them.
Side effects with Aviticol Capsules 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)
■ s
 kin rash
■ itching
■ raised itchy rash (hives)
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.yellowcard.mhra.gov.uk
Malta:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
Gżira GŻR-1368, Malta,
Website:
www.medicinesauthority.gov.mt
e-mail:
postlicensing.medicinesauthority@gov.mt

Colonis Aviticol PIL 1 000 IU v1.12.indd 2

5. How to store Aviticol Capsules
Keep this medicine out of the sight and
reach of children.
Store below 25°C.
Store in the original package to protect from
light and moisture.
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 Aviticol Capsules contain
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.
What Aviticol Capsules look like and
contents of the pack
Aviticol Capsules is an unprinted, hard
gelatin red capsule containing clear, slightly
yellow oily liquid.
Capsule length: 21.7mm
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
Quantum House
Hobson Industrial Estate
Burnopfield
County Durham
NE16 6EA
United Kingdom
E-mail: medinfo@colonis.co.uk
Manufacturer
Labialfarma
Laborório de Produtos Farmacêuticos e
Nutracêuticos, S.A.
Felgueira
Sobral Mortágua
3450-336
Portugal
This medicinal product is authorised in
other Member States of the EEA under the
following names:
Malta: Aviticol 1 000 IU Capsules
UK: Aviticol 1 000 IU Capsules
This leaflet was last revised in 10/2017

K0068

12/10/2017 12:50

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Further information

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