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INVITA D3 800 IU SOFT CAPSULES

Active substance(s): CHOLECALCIFEROL / COLECALCIFEROL

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PACKAGE LEAFLET INFORMATION FOR THE USER

InVita D3 800 IU
soft capsules



COLECALCIFEROL (VITAMIN D3)

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 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 take InVita D3
3. How to take 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 contains vitamin D3 which regulates the uptake
and metabolism of calcium as well as the incorporation of
calcium in bone tissue.
InVita D3 is used to prevent and treat vitamin D3
deficiency in adults and adolescents.
Your doctor may prescribe InVita D3 as an adjunct to
specific bone loss medication.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
InVita D3

Do not take InVita D3:
• if you are allergic to colecalciferol or any of the other
ingredients of this medicine (listed in section 6).
• if you have hypercalcaemia (increased levels of calcium
in the blood) or hypercalciuria (increased levels of
calcium in the urine).
• if you have hypervitaminosis D (increased levels of
vitamin D in the blood).
• if you have kidney stones.

If any of the above applies to you, talk to your doctor or
pharmacist before taking InVita D3.
Warnings and precautions
Talk to your doctor or pharmacist before taking InVita D3:
• if you suffer from sarcoidosis (a special type of
connective tissue disease that affects the lungs, skin
and joints).
• when using other drugs containing vitamin D.
• if you have kidney problems or have had kidney stones.
Children
This medicine is not recommended for use in children
under 12 years of age.
Other medicines and InVita D3
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, in
particular any of the following:
• Cholestyramine (used to treat high cholesterol).
• Phenytoin or barbiturates (used to treat epilepsy).
• Laxatives which contain paraffin oil.
• Thiazide diuretics (to treat high blood pressure).
• Glucocorticoids (to treat inflammation).
• Cardiac glycosides (to treat heart conditions), e.g.
digoxin.
• Actinomycin (chemotherapy)
• Imidazole (antifungal)
• Orlistat (weight loss aid)
InVita D3 with food and drink
See section 3 “How to take InVita D3”.
Pregnancy, breast-feeding and fertility
During pregnancy the daily intake should not exceed 600
IU vitamin D.
InVita D3 should only be used during pregnancy, if vitamin
D deficiency has been clinically established.
InVita D3 can be used during breastfeeding. Vitamin D3
passes over into breast milk. This should be considered
when giving additional vitamin D to the breast-fed child.
Ask your doctor or pharmacist for advice before taking
InVita D3 during pregnancy, if you are breast feeding or if
you are planning to have a baby.

Driving and using machines
InVita D3 has no known effects on ability to drive or use
machines.
InVita D3 contains Allura Red AC (E129)
InVita D3 800 IU soft capsules contain Allura Red AC
(E129) which may cause allergic reactions.
If you are allergic to the above colouring agent, consult
your doctor or pharmacist.
3. HOW TO TAKE InVita D3

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
The capsules should be swallowed whole with water.
InVita D3 can be taken with or without food.
The recommended dose is: 1 capsule every day.
The daily dose shall not exceed 5 capsules.
Use in children
InVita D3 800 IU capsules are not intended for use in
children under 12 years of age. Other forms of this
medicine maybe more suitable for children; ask your
doctor or pharmacist.
If you take more InVita D3 than you should
If you have taken more of this medicine than directed,
or if a child accidentally has taken this medicine, please
contact your doctor or emergency unit for judgement of
the risk and advice.
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
Do not take a double dose to make up for a forgotten
dose.
If you stop taking InVita D3
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.
Stop taking InVita D3 and seek immediate medical help
if you experience symptoms of serious allergic reactions,
such as:
• swollen face, lips, tongue or throat
• difficulty swallowing
• hives and difficulty breathing
Uncommon (may affect up to 1 in 100 people):
Hypercalcaemia (increased levels of serum calcium) and
hypercalciuria (increased levels of urine calcium).

Rare (may affect up to 1 in 1,000 people): Itching, rash
(Pruritus/urticaria).
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, website:
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 blister after Exp. The expiry date
refers to the last day of the month.
Do not store above 25°C. Keep the blister(s) in the outer
carton to protect from light.
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 to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION

What InVita D3 contains
• The active substance is colecalciferol (vitamin D3).
Each soft capsule contains 0.02 mg colecalciferol
corresponding to 800 IU vitamin D3.
• The other ingredients are: all-rac-α-tocopherol
(E307), medium chain triglycerides, glycerol, gelatine,
Opacode® White imprinting ink (consisting of: shellac
(E904), titanium dioxide (E171) and simethicone), Allura
Red AC (E129).
What InVita D3 looks like and contents of the pack
InVita D3 800 IU is a pink, oval-shaped, soft capsule.
It contains a slightly yellow oily liquid. Each capsule
has “0.8” printed in white ink. Capsule dimensions are
10.5mm x 7mm.
Each carton contains 28 capsules packed in blister strips.
Marketing Authorisation Holder
Consilient Health Limited.
5th Floor, Beaux Lane House, Mercer Street Lower,
Dublin 2, Ireland
Manufacturer
McGregor Cory Limited,
Middleton Close, Banbury, Oxfordshire,
OX16 4RS, United Kingdom
This leaflet was last revised in February 2016.
P0335

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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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