Patient leaflet - Choli-D3 50 000 IU capsules, soft
1. What Choli-D3 Capsules are and what they are used for
The active substance of Choli-D3 Capsules is Colecalciferol (Vitamin D3). Vitamin D helps the body to absorb calcium and enhances bone formation. Vitamin D is found in the diet and is also produced in the skin after exposure to the sun. Often vitamin D is given in combination with calcium. Vitamin D is also essential for bone formation and normal bone metabolism.
Choli-D3 10,000 IU Capsules, soft are used for treatment and prevention of Vitamin D deficiency and as an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency in adults and elderly.
Choli-D3 50,000 IU Capsules, soft is used in the treatment of Vitamin D3 deficiency.
2. What you need to know before you take Choli-D3 Capsules
Do not take Choli-D3 Capsules:
- if you are allergic(hypersensitive) to colecalciferol 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.
- You have parathyroid hormone imbalance (pseudohypoparathyroidism) Warnings and precautions
Talk to your doctor or pharmacist before taking Choli-D3 Capsules if:
- You have high tendency to kidney stone formation.
- You have cancer or any other condition that may have affected your bones. 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
Choli-D3 Capsules is not suitable for children and adolescents (under 18 years of age). Other medicines and Choli-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:
Medicines that may reduce absorption of vitamin D:
- Laxatives such as paraffin oil.
- Cholesterol lowering drugs (ion exchange resins) such as cholestyramine, colestipol hydrochloride or orlistat.
Medicines that may reduce the effect of vitamin D:
- Medicines to treat epilepsy (antiepileptics) such as phenytoin.
- Medicines to treat sleep disorders (barbiturates) such as phenobarbitone.
- Steroid hormones (glucocorticoids) such as hydrocortisone or prednisolone.
- Medicine used to treat some forms of cancer (cytotoxics) such as actinomycin.
- Medicines used to treat fungal diseases (imidazole antifungals) such as clotrimazole and ketoconazole.
Medicines that may increase the risk of hypercalcaemia:
- Heart medicines (cardiac glycosides) such as digoxin. Your doctor may monitor your heart with an electrocardiogram (ECG) and measure the levels of calcium in your blood.
- Medicines used to treat high blood pressure (thiazide diuretics) may reduce the urinary excretion of calcium and can increase the risk of hypercalcaemia. Pregnancy and breast-feeding
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine
Do not take Choli-D3 Capsules during pregnancy unless advised to do so by your doctor. Breast-feeding
Colecalciferol may appear in breast milk. Do not take Choli-D3 Capsules if you are breast-feeding unless advised to do so by your doctor. Ask your doctor for advice if you are taking Colecalciferol while breast-feeding and vitamin D is also prescribed for your child. The dose given to the child may have to be adjusted to account for the amount of vitamin D that the child is getting from breast milk.
Driving and using machines
There is no known effect on your ability to drive or use machines.
Choli-D3 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. This medicine contains 5.28 mg sorbitol in each capsule.
3. How to take Choli-D3 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.
The dose prescribed for you will depend on your risk of developing vitamin D deficiency level of vitamin D in your blood and your response to treatment.
The usual recommended dose is:
Adults
Choli-D3 10,000 IU Capsules
Prevention of vitamin D deficiency: 1 capsule every 2 weeks or 1 capsule weekly for those at high risk of vitamin D deficiency (see below).
Treatment of vitamin D deficiency: 2 capsules weekly for up to 4-12 weeks Higher doses can be necessary depending on severity deficiency and the patient´s response to treatment.
Choli-D3 50,000 IU Capsules:
Your doctor will usually prescribe 1 capsule every week for 6-8 weeks, followed by a maintenance and prevention therapy of 1 capsule every 2 months.
Children and adolescents
Choli-D3 Capsules are not suitable for children and adolescents (under 18 years of age). Method of administration
You should swallow the capsules whole with water, do not chew the capsules. Choli-D3 Capsules with food and drink
Choli-D3 Capsules should be taken with the main meal of the day.
If you take more Choli-D3 Capsules than you should
The symptoms of vitamin D3 overdose are: nausea, vomiting, initially also diarrhoea, later constipation, loss of appetite, weariness, headache, muscle pain, joint pain, muscle weakness, persistent sleepiness, elevation of blood urea nitrogen (BUN) and serum creatinine levels, increase in thirst and frequent urination.
If you experience any of the above symptoms whilst taking Choli-D3, ask your doctor for advice as soon as possible.
If you take too many Choli-D3 capsules than was prescribed for you, 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 Choli-D3 Capsules
If you forget to take a dose of Choli-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.
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 Choli-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 Choli-D3 Capsules may include:
Common (may affect up to 1 in 10 people):
- nausea, constipation, passing wind (flatulence), stomach ache, diarrhoea. 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 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 Choli-D3 Capsules
Keep this medicine out of the sight and reach of children.
Store the capsules 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 Choli-D3 Capsules contain
The active substance is Colecalciferol.
Choli-D3 10,000 IU Capsules:
Each capsule contains 10,000 IU of Colecalciferol, equivalent to 250 micrograms Vitamin D3.
The other ingredients are:
Capsule fill: Medium chain triglycerides, all-rac-α-Tocopheryl acetate (Vitamin E acetate) Capsule shell 10,000 IU: Gelatin, Glycerol, Sorbitol liquid, partially dehydrated, Brilliant Blue FCF (Color FD & C Blue 1) (E133) and Purified water
Choli-D3 50,000 IU Capsules:
Each capsule contains 50,000 IU of Colecalciferol, equivalent to 1250 micrograms Vitamin D3.
Capsule fill: Medium chain triglycerides, all-rac-α-Tocopheryl acetate (Vitamin E acetate) Capsule shell: Gelatin, Glycerol, Sorbitol liquid, partially dehydrated and purified water What Choli-D3 Capsules look like and contents of the pack
Choli-D3 10,000 IU Capsules are light blue transparent, round shaped soft gelatin capsules containing clear transparent liquid.
Choli-D3 50,000 IU Capsules are natural transparent, oval soft gelatin capsule containing clear transparent liquid.
Choli-D3 10,000 IU Capsules: blister packs containing 4, 5, 7, 10, 14, 15, 20, 30, 50, 60, 90 and 100 capsules.
Choli-D3 50,000 IU Capsules: blister packs containing 3, 4, 6, 8, 10, 20 and 30 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
OSGEN PHARMACEUTICALS LIMITED
Unit 2 Cleveland Way, Hemel Hempstead Industrial Estate,
Hemel Hempstead, HP2 7DL
United Kingdom
Manufacturer
SANTA S.A.
Panselelor str. no.25, no.27 and no.29,
Brasov Municipality,
Brasov County, postal code 500419,
Romania
This leaflet was last revised in NOV 2022.