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FULTIUM-D3 20 000 IU CAPSULES

Active substance(s): COLECALCIFEROL

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Package Leaflet: Information for the user
Fultium-D3 20,000 IU Capsules
(Colecalciferol)

Read all of this leaflet carefully before you
start taking this medicine.
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.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Fultium-D3 is and what it is taken for
Before you take Fultium-D3
How to take Fultium-D3
Possible side effects
How to store Fultium-D3
Further information

1. What Fultium-D3 is and what it is
taken for
Fultium-D3 are capsules. They contain the active
ingredient:
Vitamin D3 (20,000 IU colecalciferol equivalent to
500 micrograms 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. Fultium-D3 is
recommended for use when you have a normal intake
of dietary calcium.
Fultium-D3 may be prescribed by your doctor to treat
or prevent vitamin D deficiency. Deficiency of vitamin
D may occur when your diet or lifestyle does not
provide you enough vitamin D or when your body
requires more vitamin D (for instance when you are
pregnant). Fultium-D3 may also be prescribed for
certain bone conditions, such as thinning of the bone
(osteoporosis) when it will be given to you with other
medicines.

2. Before you take Fultium-D3
Do not take Fultium-D3 if you
are allergic (hypersensitive) to vitamin D or any of
the other ingredients in the capsules (these are
listed in section 6, Further information)
have high levels of vitamin D in your blood
(hypervitaminosis D)
have high blood levels of calcium
(hypercalcaemia) or high urine levels of calcium
(hypercalciuria)
have kidney stones or serious kidney problems.

Check with your doctor before taking
Fultium-D3 if
you have kidney damage or disease. Your doctor
will need to measure the levels of calcium in your
blood or urine
you are being treated for heart disease
you have sarcoidosis (an immune system disorder
which may affect your liver, lungs, skin or lymph
nodes)
you are already taking additional doses of
calcium or vitamin D. Whilst you are taking
Fultium-D3 your doctor will monitor your blood
levels of calcium to make sure they are not too
high.

Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
In particular the following medicines may interact
with Fultium-D3:
Heart medicines (cardiac glycosides such as
digoxin). Your doctor may monitor your heart with
an electrocardiogram (ECG) and measure the
levels of calcium in your blood.
Medicines to treat epilepsy (such as phenytoin) or
medicines to make you sleep (barbiturates such
as phenobarbitone) as these medicines can
decrease the effect of vitamin D.
Glucocorticoids (steroid hormones such as
hydrocortisone or prednisolone). These can
decrease the effect of vitamin D.

Laxatives (such as paraffin oil) or a cholesterol
lowering drug called colestyramine may reduce
the absorption of vitamin D.
Actinomycin (a medicine used to treat some forms
of cancer) and imidazole antifungals (medicines
such as clotrimazole and ketoconazole used to treat
fungal diseases) as they may interfere with the
metabolism of vitamin D.

Taking Fultium-D3 with food and drink
You can take Fultium-D3 with or without food and
drink.

Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant or
you are breast-feeding you should talk to your doctor
or pharmacist before you take Fultium-D3.
Due to their high strength, Fultium-D3 20,000 IU
capsules are not recommended during pregnancy
and breast-feeding.

Driving and using machines
Fultium-D3 should not affect your ability to drive or
operate machinery.

3. How to take Fultium-D3
Always take Fultium-D3 exactly as your doctor has
told you.

Dose
Use in children and adolescents
The recommended dose for:
Prevention of vitamin D deficiency 12-18 years:
20,000 IU (1 capsule) every 6 weeks
Treatment of vitamin D deficiency 12-18 years:
20,000 IU (1 capsule) once every 2 weeks for 6
weeks
Fultium-D3 20,000 IU Capsules are not suitable for
children under 12 years.
Use in pregnancy and breast feeding
Fultium-D3 20,000 IU capsules are not recommended.
Use in adults
The recommended dose for:
Prevention of vitamin D deficiency:
20,000 IU/month (1 capsule), higher doses may be
required in certain situations
(continued overleaf)

Treatment of vitamin D deficiency:
40,000 IU/week (2 capsules) for 7 weeks,
followed by maintenance therapy, (equivalent
to 1,400-2,000 IU/day, such as 2-3 capsules per
month), based on the advice of your doctor.
You should check with your doctor or pharmacist if
you are unsure.
The capsule should be swallowed whole with water,
preferably with the main meal of the day.

If you take more Fultium-D3 than you should
If you accidentally take too many capsules 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 take too many
capsules you may feel or be sick, become
constipated or have stomach pains, weak muscles,
tiredness, lack of appetite, kidney problems and in
severe cases irregular heartbeats.

If you forget to take Fultium-D3
If you forget to take your capsules, take them as soon
as you can. Do not take a double dose to make up
for a forgotten dose. After that, take the next capsule
in accordance with the instructions given to you by
your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Fultium-D3 can cause side effects,
although not everybody gets them.
Side effects with Fultium-D3 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

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Fultium-D3
Keep out of the sight and reach of children.
Do not store above 30°C. Store blister foil in the
original container in order to protect from light.
Do not use Fultium-D3 after the expiry date which is
stated on the carton as "EXP". The expiry date refers
to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6. Further information
What Fultium-D3 contains
The active ingredient (which makes the medicine
work) is colecalciferol. Each capsule contains 20,000
IU colecalciferol (equivalent to 500 micrograms
Vitamin D3).
The other ingredients are:
Capsule Content
Maize oil, refined
Butylated hydroxytoluene (BHT) (E321)
Capsule Shell
Gelatin
Glycerol
Quinoline Yellow (E104)
Purified Water.

What Fultium-D3 looks like and contents of
the pack
Fultium-D3 20,000 IU Capsule is a yellow coloured
translucent soft gelatin capsule.

It is available in blister packs containing 7, 10, 14, 15,
20, 28, or 30 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder is:
Internis Pharmaceuticals Ltd.
Linthwaite Laboratories
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
The Manufacturer is:
Thornton and Ross Limited
Linthwaite Laboratories
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
This leaflet was last revised in 05/2015

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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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