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COLECALCIFEROL INTERNIS 800 IU SOFT CAPSULES

Active substance(s): CHOLECALCIFEROL / COLECALCIFEROL / CHOLECALCIFEROL / COLECALCIFEROL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Colecalciferol Internis 800 IU Soft Capsules
(Colecalciferol)
Read all of this leaflet carefully before you start taking this medicine.

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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.

1.

What Colecalciferol Internis is and what it is taken for
Before you take Colecalciferol Internis
How to take Colecalciferol Internis
Possible side effects
How to store Colecalciferol Internis
Further information

WHAT COLECALCIFEROL INTERNIS IS AND WHAT IT IS
TAKEN FOR

Colecalciferol Internis are soft capsules. They contain the active ingredient:
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Vitamin D3 (800 IU colecalciferol equivalent to 20 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. Colecalciferol Internis is
recommended for use when you have a normal intake of dietary calcium.
Colecalciferol Internis 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). Colecalciferol Internis 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 COLECALCIFEROL INTERNIS

Do not take Colecalciferol Internis if you
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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 Colecalciferol Internis if
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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 Colecalciferol Internis 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 Colecalciferol Internis:
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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 Colecalciferol Internis with food and drink
You can take Colecalciferol Internis 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 Colecalciferol Internis. Colecalciferol
Internis should be used during pregnancy and breast-feeding only if recommended by
your doctor.
Driving and using machines
Colecalciferol Internis should not affect your ability to drive or operate machinery.

3.

HOW TO TAKE COLECALCIFEROL INTERNIS

Always take Colecalciferol Internis 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 1-4 capsules daily for up to12 weeks.
The amount will depend on how low your vitamin D levels are and how you respond
to treatment. Your doctor will then tell you to take 1-2 capsules daily to maintain your
vitamin D levels.
In moderate vitamin D deficiency (for adults and the elderly) or to prevent
vitamin D deficiency
Your doctor will usually prescribe you 1-2 capsules daily.
In vitamin D deficiency in children over 12 years
Your doctor will usually prescribe you 1 capsule daily.
In osteoporosis (you will also be taking other medicines for this)
Your doctor will usually prescribe you 1 capsule daily
Use in pregnancy and breast-feeding
To treat vitamin D deficiency: Your doctor will usually prescribe 1 – 5 capsules
daily for up to 12 weeks, followed by a long term maintenance dose.

Long term maintenance and to prevent vitamin D deficiency: Your doctor will
usually prescribe 1 – 2 capsules daily.
You should check with your doctor or pharmacist if you are unsure.
The capsules should be swallowed whole (not chewed) with water.
Colecalciferol Internis is not suitable for children under 12 years.
If you take more Colecalciferol Internis 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 Colecalciferol Internis
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, Colecalciferol Internis can cause side effects, although not everybody
gets them.
Side effects with Colecalciferol Internis may include:
Uncommon side effects (affecting less than 1 in 100 people)
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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)
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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 COLECALCIFEROL INTERNIS

Keep 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 Colecalciferol Internis 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 Colecalciferol Internis contains
The active ingredient (which makes the medicine work) is colecalciferol. Each
capsule contains 800 IU colecalciferol (equivalent to 20 micrograms Vitamin D3).
The other ingredients are:
Capsule content
Maize oil, refined

Butylated hydroxytoluene (BHT) (E321)
Capsule Shell
Gelatin
Glycerol
Brilliant Blue WS (E133)
Purified Water
What Colecalciferol Internis looks like and contents of the pack
Colecalciferol Internis 800 IU Soft Capsule is a blue coloured translucent soft
gelatin capsule.
It is available in blister packs containing 28, 30, 56, 60 or 90 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 medicinal product is authorised in the Member States of the EEA under the
following names:
United Kingdom:

Colecalciferol Internis 800 IU Soft Capsules

This leaflet was last revised in April 2017.

Expand Transcript

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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