Patient leaflet - Vitamin D3 400 IU capsules, soft
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:
- if you are allergic to vitamin D or any of the other ingredients of this medicine (listed in section 6)
- if you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria)
- if you have severe kidney problems (severe renal impairment)
- if you have high levels of vitamin D in your blood (hypervitaminosis D)
- 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.
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:
- diuretics (water tablets). As your doctor will need to monitor your blood calcium levels regularly
- corticosteroids (‘steroids’ e.g. prednisolone, dexamethasone). As your dose of vitamin D may need to be increased
- colestyramine (a cholesterol lowering medicine) or laxatives (e.g. paraffin oil). As they reduce vitamin D absorption
- 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
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 Capsules contain:
Sorbitol: This medicine contains 16.5 mg sorbitol in each capsule. 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 allergic reactions.
3. HOW TO TAKE VITAMIN D3 CAPSULES
Always take this medicine exactly as described in this leaflet or as your 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.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you forget to take Vitamin D3 Capsules
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
- 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.
Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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.
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 (E422), sorbitol liquid partially dehydrated (E420), allura red (E129), brilliant blue (E133) and purified water.
What Vitamin D3 Capsules looks like and contents of the pack
Vitamin D3 Capsules are purple coloured, clear transparent round shaped gelatin capsules with a clear, colourless liquid fill.
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:
Copea Pharma Europe Limited,
Unit 2, Medici House,
Ashbourne Manufacturing Park,
Ashbourne, Co. Meath,
A84 KH58, Ireland
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Vitamin D3 400 IU Capsules, soft Ireland: Solferol 400 IU Soft Capsules