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FULTIUM-D3 3 200 IU CAPSULES

Active substance(s): COLECALCIFEROL

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Package Leaflet: Information for the user
Fultium-D3 3,200 IU Capsules

Do not take Fultium-D3 if you

(Colecalciferol)

11009

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:
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 (3,200 IU colecalciferol equivalent to
80 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
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).

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
may want 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. Fultium-D3
should be used during pregnancy and breast-feeding
only if recommended by your doctor.

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
In severe vitamin D deficiency (for adults and the
elderly)
Your doctor will usually prescribe you a dose of 1
capsule daily for up to12 weeks. The amount will
depend on how low your vitamin D levels are and how
you respond to treatment.
Use in pregnancy and breast-feeding
To treat vitamin D deficiency: Your doctor will
usually prescribe 1 capsule daily for up to 12 weeks.
You should check with your doctor or pharmacist if
you are unsure.
The capsules should be swallowed whole (not
chewed) with water.
(continued overleaf)
25450701

MHRA Header Box
Product
Title

Fultium D3 3,200 IU Capsules

Component

Leaflet

Pack Size

30's/90's

IG Code

25450701

Dimensions

210 x 297mm

Proof No.

1

Date

22.10.2015

Colours Used

Fonts Used

Process Black + 60%

Helvetica

Keyline (Does not print)

Rockwell

11009

Read all of this leaflet carefully before you
start taking this medicine.

1.
2.
3.
4.
5.
6.

2. Before you take Fultium-D3

Fultium-D3 is not suitable for children.

If you take more Fultium-D3 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 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 30ÂșC.
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
3,200 IU colecalciferol (equivalent to 80 micrograms
Vitamin D3).
The other ingredients are:
Capsule Content
Maize oil, refined
Butylated hydroxytoluene (BHT) (E321)
Capsule Shell
Gelatin
Glycerol
Chlorophyllin copper complex sodium (E141)
Purified Water.

What Fultium-D3 looks like and contents of
the pack

Fultium-D3 3,200 IU Capsule is a green coloured
translucent soft gelatin capsule.
It is available in blister packs containing 7, 10, 14, 20,
28, 30, 56, 60, 84 or 90 capsules.
Not all pack sizes may be marketed.

MHRA Header Box
Product
Title

Fultium D3 3,200 IU Capsules

Component

Leaflet

Pack Size

30's/90's

IG Code

25450701

Dimensions

210 x 297mm

Proof No.

1

Date

22.10.2015

Colours Used

Fonts Used

Process Black + 60%

Helvetica

Keyline (Does not print)

Rockwell

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 medicinal product is authorised in the
Member States of the EEA under the following
names:
United Kingdom:
Fultium-D3 3,200 IU
Capsules
This leaflet was last revised in 10/2015
25450701

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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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