Forthcoming Submission: cholcalciferol (invita D3)

Indication: For the prevention and treatment of vitamin D deficiency.

Drug Details

Drug Name:	cholcalciferol (invita D3)
Drug Manufacturer:	Consilient Health Ltd
BNF Category:	9. Nutrition and blood
Sub Category:	9.6 Vitamins
Submission type:	Abbreviated Submission
SMC Meeting Date:	4/11/2014
Advice Due:	8/12/2014

PACKAGE LEAFLET: INFORMATION FOR THE USER

25,000 IU oral solution
Cholecalciferol

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, or nurse.
• This medicine has been prescribed for you only. Do not pass it onto 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 or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What InVita D3 is and what it is used for
2. What you need to know before you use InVita D3
3. How to use InVita D3
4. Possible side effects
5. How to store InVita D3
6. Contents of the pack and other information

1. WHAT INVITA D3 IS AND WHAT IT IS USED FOR
InVita D3 is a vitamin product containing cholecalciferol (equivalent to vitamin D3). Vitamin D can
be found in some foods and also produced by the body when skin is exposed to sunlight. Vitamin
D helps the kidneys and intestine absorb calcium and it helps build bones.
InVita D3 25,000 IU is used:
for the prevention of vitamin D deficiency when there is a significant risk of deficiency or an
increased demand for vitamin D
• with other medicines to treat certain bone conditions, such as thinning of the bone
(osteoporosis)
• to treat vitamin D deficiency that has been confirmed by laboratory tests.
•

2. WHAT YOU NEED TO KNOW BEFORE YOU USE INVITA D3
Do not use InVita D3
• if you are allergic to vitamin D or any of the other ingredients of InVita D3 (listed in section 6)
• if you have hypercalcaemia (high levels of calcium in the blood)
• if you have hypercalciuria (high levels of calcium in the urine)
• if you have pseudohypoparathyroidism (disturbed parathyroid hormone metabolism)
• if you have renal calculi (kidney stones)
• if you have hypervitaminosis D (high levels of vitamin D in the blood).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using InVita D3 if you:
• are undergoing treatment with certain medicines used to treat heart disorders (e.g. cardiac
glycosides, such as digoxin)
• 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 sunshine whilst using InVita D3
• take additional supplements containing calcium. Your doctor will monitor your blood levels of
calcium to make sure they are not too high whilst you are using InVita D3
• have kidney damage or disease. Your doctor may want to measure the levels of calcium in
your blood or urine.

Other medicines and InVita D3
Tell your doctor or pharmacist if you are using, have recently used or might use 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
• medicines containing vitamin D or eating food rich in vitamin D, such as, some types of
vitamin D-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 process vitamin D
• the following medicines because they can interfere with the effect or the absorption of
vitamin D:
– antiepileptic medicines (anticonvulsants), barbiturates
– glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These can
decrease the effect of vitamin D
– medicines that lower the level of cholesterol in the blood (such as cholestyramine, or
colestipol)
– certain medicines for weight loss that reduce the amount of fat your body absorbs (e.g.
orlistat)
– certain laxatives (such as liquid paraffin).
InVita D3 with food, drink and alcohol
You should take this medicine preferably together with a large meal to help your body absorb the
vitamin D. You can also mix the solution with cold or lukewarm food, to help you take this
medicine. For detailed information see section 3 “How to use InVita D3”.
Pregnancy and breast-feeding
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 breastfeeding 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 to operate machinery.

3. How to use InVita D3
Always take InVita D3 exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
You should take InVita D3 preferably together with a large meal.
This medicine has a delicate taste of olive oil. The contents of the ampoule is to be emptied
directly into the mouth and swallowed orally as per the diagram below.

To help you take this medicine, the full contents of the ampoule may be emptied onto a spoon and
taken orally. You may also mix the contents of the ampoule with a small amount of cold or
lukewarm food immediately before use. Make sure the entire dose is taken.

Use in children and adolescents
The recommended dose for:
• Prevention of vitamin D deficiency in 0-1 years:
1 ampoule of InVita D3 25,000 IU every 8 weeks
Prevention of vitamin D deficiency in 1-18 years:
1 ampoule of InVita D3 25,000 IU every 6 weeks

•

Treatment of vitamin D deficiency in 0-18 years:
1 ampoule of InVita D3 25,000 IU once every 2 weeks for 6 weeks (followed by maintenance
therapy of 400-1000 IU/day).
•

In children, InVita D3 can be mixed with a small amount of children’s foods, yogurt, milk, cheese
or other dairy products. Do not mix this medicine into a bottle of milk or container of soft food, in
case your child does not consume the whole portion, and does not receive the full dose. You
should make sure that the entire dose is taken. For children who are no longer breast-feeding you
should give the prescribed dose with a substantial meal.
Do not store any product or food mixture that contains InVita D3 for use at a later time or a next
meal.

Use in pregnancy and breast-feeding
This high strength formulation is not recommended.
Use in adults
The recommended dose for:
• Prevention of vitamin D deficiency:
1 ampoule of InVita D3 25,000 IU once monthly. Higher doses may be required based on the
advice of your doctor.
Addition to specific therapy for osteoporosis:
1 ampoule of InVita D3 25,000 IU once monthly.

•

Treatment of vitamin D deficiency:
2 ampoules of InVita D3 25,000 IU once weekly for 6-8 weeks, followed by maintenance
therapy (1400-2000 IU once daily may be required), based on the advice of your doctor.
•

If you take more InVita D3 than you should
If you or your child takes more medicine than prescribed, stop using this medicine and contact
your doctor. If it is not possible to talk to a doctor, go to the nearest hospital emergency
department and take the medicine package with you.
The most common symptoms of overdose are: nausea, vomiting, excessive thirst, the production
of large amounts of urine over 24 hours, constipation and dehydration, high levels of calcium in
the blood (hypercalcaemia and hypercalciuria) shown by lab test.
If you forget to take InVita D3
If you forget to take a dose of InVita D3, 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects may include:
Uncommon (affects less than 1 in 100 people)
• Too much calcium in your blood (hypercalcaemia)
• Too much calcium in your urine (hypercalciuria)
Rare (affects 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 effect 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 InVita D3
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after “Exp”.
The expiry date refers to the last day of that month.
Do not store above 30°C. Store InVita D3 in the original carton to protect the contents from light.
Do not freeze or refrigerate.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What InVita D3 contains
• The active substance is cholecalciferol (vitamin D3).
• The other ingredients are tocopherol acetate, polyglyceryl oleate (E475), olive oil, refined, sweet
orange peel oil.
What InVita D3 looks like and contents of the pack
InVita D3 is a clear, slightly yellow, oily liquid. It is supplied in transparent PVC/PVDC/PE ampoules.
InVita D3 is available in packs of 3 PVC/PVDC/PE ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Consilient Health Limited,
5th Floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland.
Manufacturer
SMB Technology S.A.
39, rue du Parc Industriel, 6900 Marche en Famenne, Belgium.
This leaflet was last revised in October 2013.