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COLECALCIFEROL 3000IU/ML ORAL SOLUTION

Active substance(s): CHOLECALCIFEROL CONCENTRATE (OILY FORM) / COLECALCIFEROL

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Package leaflet: Information for the user

Colecalciferol 3000IU/ml Oral Solution
(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 or pharmacist.
► 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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is
Colecalciferol 3000IU/ml Oral Solution
but it will be referred to as Colecalciferol
Oral Solution or Colecalciferol throughout
this leaflet.
What is in this leaflet

1. What Colecalciferol Oral Solution
is and what it is used for

2. What you need to know before
3.
4.
5.
6.

you take Colecalciferol Oral
Solution
How to take Colecalciferol Oral
Solution
Possible side effects
How to store Colecalciferol Oral
Solution
Contents of the pack and other
information

1. What Colecalciferol
Oral Solution is and
what it is used for
Colecalciferol Oral Solution is an oily
solution which contains the active
substance called colecalciferol (Vitamin
D3).
Vitamin D is found in the diet and is also
produced in the skin after exposure to the
sun. Often vitamin D is given in
combination with calcium. Vitamin D3 is
also essential for bone formation and
normal bone metabolism.
Colecalciferol Oral Solution is used for
prevention and treatment of Vitamin D
deficiency in adults, elderly and children
over 12 years of age.

2. What you need to know
before you take
Colecalciferol Oral
Solution
Do not take Colecalciferol:
► If you are allergic (hypersensitive) to
colecalciferol or any of the other
ingredients of this medicine (listed in
section 6). If you have an allergy to
PIL/UK/MFG005/01/v1

peanuts or soya, since this product
contains arachis oil (peanut oil).
► If you have high blood levels of
calcium (hypercalcaemia) or high
urine levels of calcium
(hypercalciuria).

► If you have kidney stones or serious
kidney problems.
► 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:
► Have kidney damage or disease. Your
doctor may want to measure the
levels of calcium in your blood or
urine.

► Are being treated for heart disease.
► Have sarcoidosis (an immune system
disorder which may affect your liver,
lungs, skin or lymph nodes).
► Are using other drugs containing
calcium or vitamin D. Whilst you are
taking Colecalciferol your doctor will
monitor your blood levels of calcium
to make sure they are not too high.
► Have increase parathyroid hormone in
your blood or rickets (problems in
bone)

Other medicines and
Colecalciferol
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. This includes
medicines obtained without a
prescription and herbal medicines.
Colecalciferol may affect or be affected
by other medicines, such as:

► Thiazide diuretics (to treat high blood
pressure);
► Phenytoin (to treat epilepsy) and
barbiturates (to make you sleep);
► Glucocorticoid (to treat
inflammation);
► Cardiac glycosides (to treat heart
conditions);
► Laxatives which contain paraffin oil.
► Cholestyramine used for treating high
cholesterol;
► Actinomycin (used to treat some
forms of cancer) and imidazole
antifungals (used to treat fungal
diseases).

Colecalciferol with food, drink
and alcohol
Colecalciferol can be taken with or
without food and drink.

Pregnancy and
breast-feeding
Pregnancy
Your doctor may prescribe Colecalciferol
during pregnancy if you suffer from
Vitamin D deficiency.

additional Vitamin D supplementation in
your child.
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.

Driving and using machines

Colecalciferol should not affect your
ability to drive or operate machinery.

Colecalciferol Oral
Solution contains:
Arachis oil (peanut oil): Not suitable
for someone with peanut or soya
allergies.
Almond oil (nut oil): Not suitable for
someone with nut allergy.

3. How to take Colecalciferol
Oral Solution
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are not
sure.

Doses
Dosages used in the treatment of vitamin
D deficiency should be based on the
severity of deficiency and the patient’s
response to treatment.
Adults and Elderly:
► Treatment dose: 4000 IU daily
(1.33ml) for 10 weeks (280,000 IU
in total).
► Maintenance dose: 800-2000 IU
daily (0.27ml-0.67ml) (occasionally
up to 4000 IU daily may be
required).
Adolescents (children >12 years):
For treatment and maintenance
► 500 - 2000 IU/day (equivalent to
0.17 ml – 0.67 ml per day).
Dose in pregnancy and lactation:
► 400 IU (0.13ml). However, your
physician may prescribe higher dose
which suits you better.

Method of administration:

Use the measuring syringe provided in
the pack to deliver the required dose.
Instructions for the use of syringe:
a) Open the bottle: press the cap and
turn it anticlockwise (figure 1)
b) Separate the adaptor from the
syringe (figure 2). Insert the adaptor
into the bottle neck (figure 3). Ensure
it is properly fixed. Take the syringe
and put it in the adaptor opening
(figure 4).

Breast-feeding
Vitamin D passes into breast milk. Your
doctor may need to adjust the dose for

TURN OVER

e)

c)

Turn the bottle upside down. Fill
the syringe with a small amount
of solution by pulling the piston
down (figure 5A), then push the
piston upwards in order to
remove any possible bubble
(figure 5B). Pull the piston down
to the graduation mark
corresponding to the quantity in
millilitres (ml) prescribed by your
doctor (figure 5C, this pictogram
represents an example for
measuring a dose of 0.17ml).

Empty the contents of the
syringe into the patient’s mouth
by pushing the piston to the
bottom of the syringe (figure 7).
Close the bottle with the plastic
screw cap. Wash the syringe with
water (figure 8).

0.2

Contact your nearest hospital casualty
department or tell your doctor
immediately.

Taking more than the recommended
dose may lead to abnormally high levels
of calcium in the blood which can
eventually damage the soft tissues and
kidney.

If you forget to take
Colecalciferol
0.17 ml

0.3
An example for
measuring a dose of
0.17ml

The total volume delivered from
the syringe is 1ml with each
numbered increment of 0.1ml,
which is equivalent to 300 IU
colecalciferol. Each of the 0.1ml
increment is further divided into
ten divisions and each of these
divisions represent 0.01ml,
equivalent to 30 IU Colecalciferol
(see figure below).

If you forget a dose, take it as soon as
you remember. However, if it is nearly
time for the next dose, skip the missed
dose.
Do not take a double dose to make up
for a forgotten dose.

d)

Keep taking this medicine until your
doctor tells you to stop. Do not stop
taking Colecalciferol just because you
feel better.

If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4. Possible side effects

Uncommon (may affect up to 1
in 100 people):
 Too much calcium in your blood



(hypercalcaemia). Symptoms may
include nausea, vomiting, lack of
appetite, constipation, stomach ache,
bone pain, extreme thirst, increased
urination, muscle weakness,
drowsiness and confusion;
Too much calcium in urine
(hypercalciuria).

If you are on long-term treatment, your
doctor may wish to check the level of
calcium in your blood and urine as well
as your kidney functions.

Rare (may affect up to 1 in
10,000 people):




PIL/UK/MFG005/01/v1

5. How to store
Colecalciferol Oral
Solution





Keep out of the sight and reach of
children.
Do not use after the expiry date,
which is printed on the carton and
bottle label after ‘Exp’. The expiry
date refers to the last day of that
month.
Do not store above 25ºC.



Store in the original package. Keep
bottle in the original carton in order
to protect from light.



Discard 60 days after first opening.
Do not use this medicine if you notice
that the solution becomes discoloured
or shows any signs of deterioration.
Seek the advice of your pharmacist.





Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to dispose of
medicines you no longer use. These
measures will help protect the
environment.

If you stop taking Colecalciferol

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
Dose measurement - The
maximum dose of colecalciferol is
1.33ml. Divide your dose into
two (1ml & 0.33ml). Take one
full syringe with solution up to
1ml mark. Then take 0.33ml by
measuring the solution to 0.3ml
and 3 further small divisions (as
shown in the figure above using
arrow).
Turn the bottle the right way up
(figure 6A). Remove the syringe
from the adaptor (figure 6B).

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 via the yellow card system at
www.mhra.gov.uk/yellowcard.
By Reporting side effects you can
help provide more information on
the safety of this medicine.

If you take more Colecalciferol
than you should

Symptoms of overdose may include: lack
of appetite, thirst, nausea, vomiting,
constipation, abdominal pain, muscle
weakness, fatigue, mental disturbances,
increased urination, bone pain and in
severe cases may result in coma and
death.

0.1

Reporting of side effects

Itching
Rash
Urticaria

6. Contents of the pack and
other information
What Colecalciferol Oral Solution
contains
The active substance is colecalciferol.
Each ml contains 3000IU colecalciferol.

Also contains arachis oil (peanut oil). The
other ingredients are refined almond oil
and refined sunflower oil.

What Colecalciferol Oral Solution
looks like and contents of the
pack
Colecalciferol Oral Solution is a clear,
yellow coloured solution supplied in
amber glass bottles with a tamperevident child-resistant plastic screw cap.
Colecalciferol Oral Solution is supplied in
bottles containing 100ml solution along
with a 1ml oral syringe with 0.01ml
graduations and LDPE adaptor.

Marketing Authorisation Holder
and Manufacturer:
Syri Limited, t/a Thame Laboratories,
Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Tel: +44 208 515 3700
POM

This leaflet was last revised in 12/2014.

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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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