Skip to Content

VITAMIN D3 20 000 IU CAPSULES SOFT

Active substance(s): CHOLECALCIFEROL / COLECALCIFEROL

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Vitamin D3 20,000 IU Capsules, soft
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.
What is in this leaflet:
1. What Vitamin D3 20,000 IU Capsules are and what they are used for
2. What you need to know before you take Vitamin D3 20,000 IU Capsules
3. How to take Vitamin D3 20,000 IU Capsules
4. Possible side effects
5. How to store Vitamin D3 20,000 IU Capsules
6. Contents of the pack and other information

1. WHAT VITAMIN D3 20,000 IU CAPSULES
ARE AND WHAT THEY ARE USED FOR

Children
Vitamin D3 20,000 IU Capsules are not indicated for use in children.
Other medicines and Vitamin D3 20,000 IU Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
This is especially important if you are taking:
• medicines that act on the heart or kidneys, such as cardiac glycosides
(e.g.digoxin) or diuretics (e.g. bendroflumethazide). When used at the same
time as vitamin D these medicines may cause a large increase in the level
of calcium in the blood and urine. Your doctor may monitor your heart with
an electrocardiogram (ECG) and measure the levels of calcium in your blood
• medicines containing vitamin D or eating food rich in vitamin D, such as,
some types of vitamin-enriched milk
• actinomycin (a medicine used to treat some forms of cancer) and imidazole
antifungals (e.g. clotrimazole and ketoconazole, medicines used to treat
fungal disease). These medicines may interfere with the way your body
processes vitamin D
• the following medicines because they can interfere with the effect or the
absorption of vitamin D:


− antiepileptic medicines (anticonvulsants such as phenytoin)

Vitamin D3 20,000 IU Capsules contains colcalciferol (vitamin D).



Vitamin D is found in some foods and is also produced in the body when
skin is exposed to sunlight. Vitamin D helps the kidneys and intestine absorb
calcium and it helps build bones.

− medicines that alter your nervous system (sedatives such
as barbiturates)



− glucocorticoids (steroid hormones such as hydrocortisine or
prednisolone). These can decrease the effect of vitamin D

Vitamin D3 20,000 IU Capsules are used:



• To prevent vitamin D deficiency when there is a significant risk of deficiency
or an increased demand for vitamin D.

− medicines that lower the level of cholesterol in the blood
(such as cholestyramine or colestipol)



• With other medicine to treat certain bone conditions, such as thinning of the
bone (osteoporosis).

− certain medicines for weight loss that reduce the amount of
fat your body absorbs (e.g. orlistat)



− certain laxatives (such as liquid paraffin)

• To treat vitamin D deficiency that has been confirmed by laboratory tests.



− antibiotics used to treat the bacterial infection called
tuberculosis (TB) (e.g. rifampicin and isoniazid) as they may
reduce the effectiveness of vitamin D.


2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE VITAMIN D3 20,000 IU CAPSULES

Vitamin D3 20,000 IU Capsules with food and drink

Do not take Vitamin D3 20,000 IU Capsules:

You should take Vitamin D3 20,000 IU Capsules with a large meal to help your
body absorb the vitamin D.

• if you are allergic to colecalciferol or any of the other ingredients of this
medicine (listed in section 6)

Pregnancy and breast-feeding

• if you have high levels of calcium in your blood (hypercalcaemia) or urine
(hypercalciuria)
• if you have a condition which means that your body is resistant to
parathyroid hormone (pseudhohypoparathyroidism)
• if you have high levels of vitamin D in your blood (hypervitaminosis D)
• if you have kidney stones or serious kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vitamin D3 20,000 IU Capsules
if you:
• are undergoing treatment with certain medicines used to treat heart
disorders (e.g. diuretics, cardiac glyosides such as digoxin)

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.
This high strength formulation is not recommended for use in pregnant and
breast-feeding women.
Driving and using machines
There is limited information on the possible effects of this medicine on your
ability to drive. However, it is not expected that it would affect your ability to
drive or operate machinery.
Vitamin D3 20,000 IU Capsules contains Sorbitol
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

• have sarcoidosis (an immune system disorder which may cause increased
levels of vitamin D in the body)
• are taking medicines containing vitamin D, or eating foods or milk enriched
with vitamin D
• are likely to be exposed to a lot of sunlight whilst using Vitamin D3 20,000 IU
Capsules
• take additional supplements which contain calcium or you take medicines
or have a condition that can alter your calcium or phosphate levels. Your
doctor will monitor your blood levels of calcium to make sure they are not
too high whilst you are using Vitamin D3 20,000 IU Capsules.
• have kidney damage or disease. Your doctor may want to measure the
levels of calcium in your blood or urine

Continued overleaf...

3. HOW TO TAKE VITAMIN D3 20,000 IU CAPSULES
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Adults
Prevention of vitamin D deficiency: 20 000 IU every 4 weeks (1 capsule),
higher doses may be required in certain situations, as directed by your doctor.
Addition to specific therapy for osteoporosis: 20,000IU (1 capsule) once a
month.
Treatment of vitamin D deficiency: 40 000 IU/week (2 capsules) for 7 weeks,
followed by maintenance therapy of 2-3 capsules (equivalent to 1400-2000 IU/
day) every 4 weeks as directed by your doctor.
Use in pregnancy and breast-feeding
This high strength formulation is not recommended.
Use in children
Vitamin D3 20,000 IU Capsules are not suitable for children.
Method of administration
You should swallow the capsules whole with water, do not chew the capsules.
If you take more Vitamin D3 20,000 IU Capsules than you should
If you take more medicine than prescribed, stop taking this medicine and
contact your doctor. If it is not possible to talk to your doctor go to the nearest
hospital emergency department and take the medicine package with you.
The most common symptoms of overdose are: feel or be sick (nausea &
vomiting), excessive thirst, production of large amounts of urine over 24 hours,
constipation and dehydration, high levels of calcium in the blood and urine
(hypercalcaemia and hypercalciurua) shown by lab tests.

5. HOW TO STORE VITAMIN D3 20,000 IU CAPSULES
Keep this medicine out of the sight and reach of children.
Store below 25°C. Store in the original container in order to protect from light.
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 Vitamin D3 20,000 IU Capsules contains
− The active substance is colecalciferol. Each capsule contains 20,000 IU of
colecalciferol (equivalent to 500 micrograms Vitamin D).
− The other ingredients are:
Capsule: medium chain triglycerides and vitamin E acetate (α-tocopheryl
acetate)
Capsule shell: gelatin, glycerol, sorbitol liquid partially dehydrated and
purified water.
What Vitamin D3 20,000 IU Capsules looks like and contents of the pack
Vitamin D3 20,000 IU Capsules are light yellow coloured, clear transparent
round shaped gelatin capsules with a clear, colourless liquid fill.
It is available in glass amber bottles, HDPE bottles and blister strips containing
20, 30, 50, 60 or 90 capsules.
Not all pack sizes may be marketed.

If you forget to take Vitamin D3 20,000 IU Capsules

Marketing Authorisation Holder and Manufacturer

If you forgot to take a dose of Vitamin D3 20,000 IU Capsules, take the
forgotten dose as soon as possible. Then take the next dose at the correct
time. 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.

Marketing Authorisation Holder: Alissa Healthcare Research Limited, Unit 5
Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, United Kingdom PO15
7FE

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
medicine, ask your doctor or pharmacist.

This medicinal product is authorised in the Member States of the EEA
under the following names:
Ireland & United Kingdom: Vitamin D3 20,000 IU Capsules, soft


4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Side effects with Vitamin D3 20,000 IU Capsules may include:
Uncommon (may affect up to 1 in 100 people):
• too much calcium in your blood (hypercalcaemia)
• too much calcium in your urine (hypercalciuria).
Rare (may affect up to 1 in 1,000 people):
• skin rash
• itching
• hives.
Not known (we do not know how often these happen):
• altered bowel movements
• wind
• feeling sick (nausea)
• stomach pain.
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 national reporting system.
UK: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971, Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety
of this medicine.


Manufacturer: NOVOCAT FARMA, S.A. Avda. de la Flores, 29. Local 7, Rubí,
Barcelona, Spain 08191

This leaflet was last revised in 05/2016

Expand view ⇕

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.

Hide