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VITAMIN D3 400 IU CAPSULES SOFT

Active substance(s): COLECALCIFEROL / COLECALCIFEROL

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Package leaflet: Information for the user
Vitamin D3 400 IU Capsules, soft
Colecalciferol
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor
or pharmacist has told you.
− Keep this leaflet. You may need to read it again.

Other medicines and Vitamin D3 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:

− Ask your pharmacist if you need more information or advice.

• diuretics (water tablets). As your doctor will need to monitor your blood
calcium levels regularly

− 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.

• corticosteroids (‘steroids’ e.g. prednisolone, dexamethasone). As your dose
of vitamin D may need to be increased

− You must talk to a doctor if you do not feel better or if you feel worse.

• colestyramine (a cholesterol lowering medicine) or laxatives (e.g. paraffin
oil). As they reduce vitamin D absorption

What is in this leaflet
1. What Vitamin D3 Capsules are and what they are used for
2. What you need to know before you take Vitamin D3 Capsules
3. How to take Vitamin D3 Capsules
4. Possible side effects
5. How to store Vitamin D3 Capsules
6. Contents of the pack and other information

1. WHAT VITAMIN D3 CAPSULES ARE
AND WHAT THEY ARE USED FOR
The active substance of Vitamin D3 Capsules is vitamin D3. Vitamin D helps the
body to absorb calcium and enhances bone formation.
This medicine is recommended in the following cases:
• To prevent vitamin D deficiency in pregnant and breastfeeding women when
there is a risk of deficiency.
Vitamin D3 Capsules are used in adults and adolescents.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE VITAMIN D3 CAPSULES
Do not take Vitamin D3 Capsules:

• heart medicines (cardiac glycosides). As you should be monitored by a
physician and possibly an ECG and your calcium levels monitored
• anticonvulsants (for the treatment of epilepsy), sleeping medicines
(e.g. hydantoin barbiturates) or primidone. As these reduce the effect of
vitamin D
• calcitonin, etidronate, gallium nitrate, pamidronate or plicamycin. As these
decrease blood calcium levels
• calcium containing products in high doses. As these increase the risk of
high blood calcium levels
• magnesium containing products (e.g. antacids). As these should not
be used during treatment with vitamin D because of the risk of high
magnesium levels
• phosphorus containing products in large doses. As these in large doses
increase the risk of high phosphate blood levels.
Vitamin D3 Capsules with food and drink
You can take Vitamin D3 Capsules with or without food.
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.
Driving and using machines

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

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.

• if you have high levels of calcium in your blood (hypercalcaemia) or urine
(hypercalciuria)

Vitamin D3 Capsules contain:

• if you have severe kidney problems (severe renal impairment)
• if you have high levels of vitamin D in your blood (hypervitaminosis D)

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.
Allura red: May cause an allergic reaction.

• if you have kidney stones or calcium deposits in your kidneys.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vitamin D3 Capsules if:
• You have high tendency to kidney stone formation.
• You have cancer or any other condition that may have affected your bones.
• You have parathyroid hormone imbalance (pseudohypoparathyroidism).
If you have any of the following conditions, your doctor will monitor the
levels of calcium or phosphate in your blood, or the level of calcium in
your urine:
• if you are on long term treatment with this medicine
• if you have kidney problems
• if you suffer from ‘sarcoidosis’; an immune system disorder which may
affect your liver, lungs, skin or lymph nodes.
Children
Vitamin D3 Capsules are not indicated for use in children under 12 years.

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3. HOW TO TAKE VITAMIN D3 CAPSULES
Always take this medicine exactly as described in this leaflet or as you doctor
or pharmacist has told you. Check with your doctor or pharmacist if you are
not sure.
Adults and adolescents
400 IU Vitamin D3 Capsules:
The recommended dose is 1 capsule (400 IU) daily.
Use in children
Vitamin D3 Capsules are not suitable for children under 12 years.

5. HOW TO STORE VITAMIN D3 CAPSULES
Keep this medicine out of the sight and reach of children.
Store below 30°C.
HDPE Containers and Amber Glass Bottles: Once opened use within 105 days.
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.

Method of administration
You should swallow the capsules whole with water, do not chew the capsules.
If you take more Vitamin D3 Capsules than you should
You may develop the following symptoms: loss of appetite, thirst, nausea,
vomiting, constipation, abdominal pain, muscle weakness, tiredness,
confusion, having to pass urine more than usual, bone pain, kidney problems
and in severe cases, irregular heartbeat, coma or even death.
If you take too many capsules, contact your doctor immediately or go to
the emergency department of the nearest hospital. Take the packet and any
remaining capsules with you.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Vitamin D3 Capsules contain
− The active substance is colecalciferol. Each capsule contains 400 IU of
colecalciferol, equivalent to 10 micrograms Vitamin D3.
− The other ingredients are:
Capsule: medium chain triglycerides and vitamin E acetate (α-tocopheryl
acetate)
Capsule shell: Gelatin, glycerol, sorbitol liquid partially dehydrated, allura
red, brilliant blue and purified water.

If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

What Vitamin D3 Capsules looks like and contents of the pack

If you forget to take Vitamin D3 Capsules

Vitamin D3 Capsules are purple coloured, clear transparent round shaped
gelatin capsules with a clear, colourless liquid fill.

If you forgot to take a dose of Vitamin D3 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.
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking Vitamin D3 Capsules and seek immediate medical help if you
experience symptoms of serious allergic reactions, such as:
• swollen face, lips, tongue or throat
• difficult to swallow
• hives and difficulty breathing.
Side effects with Vitamin D3 Capsules may include:
Uncommon (may affect up to 1 in 100 people):
• too much calcium in your blood (hypercalcaemia). Symptoms include
nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain,
extreme thirst, a need to pass more water than usual, muscle weakness,
drowsiness and confusion

Vitamin D3 Capsules are 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
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Alissa Healthcare Research Limited,
Unit 5 Fulcrum 1,
Solent Way,
Whiteley,
Fareham,
Hampshire,
United Kingdom, PO15 7FE
Manufacturer:
Geryon Pharma Limited,
18 Owen Drive,
Liverpool,
L24 1YL,
United Kingdom
This medicinal product is authorised in the Member States of the EEA
under the following names:
Ireland & United Kingdom: Vitamin D3 400 IU Capsules, soft
This leaflet was last revised in 08/2017

• too much calcium in your urine (hypercalciuria).
Rare (may affect up to 1 in 1,000 people):
• skin rash (pruritus, urticaria)
• itching.
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 or search
for MHRA Yellow Card in the Google Play or Apple App Store.
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.

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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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