Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Colecalciferol 3,200 IU capsules, soft
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Colecalciferol; cholecalciferol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What you need to know before you take it
e Colecalciferol capsules 3. How to take Colecalciferol capsules 4. Possible side effects 5. How to store Colecalciferol capsules 6. Contents of the pack and other information
Warnings and precautions Talk to your doctor or pharmacist before taking Colecalciferol capsules:
- if you have kidney damage or disease and long term treatment with this medicine. Your doctor may want to measure the levels of calcium in your blood or urine;
- if you are being treated for heart disease;
- you have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes);
- if you are already taking additional doses of calcium or vitamin D. Whilst you are taking Colecalciferol capsules your doctor will monitor your blood levels of calcium to make sure they are not too high. Children and adolescents Colecalciferol capsules is not suitable for children under 12 years. Other medicines and Colecalciferol capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular the following medicines may interact with Colecalciferol capsules:
- 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.
- Thiazide diuretics (used to treat high blood pressure) reduce the urinary excretion of calcium and can increase risk of hypercalcaemia.
- Medicines used to treat epilepsy (such as phenytoin) or medicines to make you sleep (barbiturates such as phenobarbitone) can decrease the effects of vitamin D.
- Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone) can decrease the effects of vitamin D.
- Laxatives (such as paraffin oil), or a cholesterol lowering drug (colestyramine, colestipol), orlistat may reduce the absorption of vitamin D.
- Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) may interfere with the metabolism of vitamin D. Colecalciferol capsules with food and drink You can take Colecalciferol capsules with or without food and drink. 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. If you require extra vitamin D, do not take it without the supervision of your doctor. Too much vitamin D may harm your baby.
Front Side
Dimension – 140 x 240 mm
Non Printing Colour Colecalciferol 3,200 IU capsules, soft Colecalciferol Pack Insert
SPUK
—-
140 x 240 mm 1048276 BLACK PC-TSG/2022/050 – Record Number: 333166 Front & Back side printing, To be supplied in a unfolded size. 60 GSM Paper. PRINTING CLARITY TO BE CLEAR AND SHARP.
1047517 1 3.0
How to take it
Colecalciferol 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 capsules should be swallowed whole with water and can be taken with or without food. The recommended dose is: In severe vitamin D deficiency (for adults and the elderly) Your doctor will usually prescribe you a dose of 1 capsule daily for up to 12 weeks. The amount will depend on how low your vitamin D levels are and how you respond to treatment. Use in children Colecalciferol capsules is not suitable for children under 12 years. If you take more Colecalciferol capsules than you should If you accidentally take one capsule too many, nothing is likely to happen. If you accidentally take several capsules too many, tell your doctor or get other medical advice immediately. If possible, take the capsules, the box and this leaflet with you to show the doctor. If you take too many capsules, you may feel or be sick, become constipated or have stomach pains, weak muscles, tiredness, lack of appetite, kidney problems and in severe cases irregular heartbeats. If you forget to take Colecalciferol capsules If you forget to take your capsules, take them as soon as you can. After that, take the next capsule in accordance with the instructions given to you by your doctor. 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.
very thirsty, have muscle weakness, drowsiness or confusion;
- too much calcium in your urine (hypercalciuria). Rare (may affect up to 1 in 1,000 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
Possible side effects
not listed in this leaflet. You can also report side effects directly via 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.
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Driving and using machines Colecalciferol capsules should not affect your ability to drive or operate machinery. Colecalciferol contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 3,200 IU, that is to say essentially 'sodium-free'.
Back Side
Non Printing Colour Colecalciferol 3,200 IU capsules, soft Colecalciferol Pack Insert
SPUK
—-
140 x 240 mm 1048276 BLACK PC-TSG/2022/050 – Record Number: 333166 Front & Back side printing, To be supplied in a unfolded size. 60 GSM Paper. PRINTING CLARITY TO BE CLEAR AND SHARP.
1047517 1 3.0
How to store it
Colecalciferol capsules Keep this medicine out of the sight and reach of children. This medicine does not require any special temperature storage conditions. Keep the blister in the outer carton in order to protect from light. Do not use this medicine after the expiry date which is stated on the carton 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 to protect the environment.
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Contents of the pack and other information
What Colecalciferol capsules contains
- The active ingredient is colecalciferol. Each capsule contains 3,200 IU colecalciferol (equivalent to 80 micrograms Vitamin D3).
- The other ingredients are: Capsule Content: maize oil, refined Capsule Shell: gelatin, glycerol (E 422), chlorophyllin copper complex sodium (E141) What Colecalciferol looks like and contents of the pack Colecalciferol 3,200 IU Capsule is a translucent green to greenish yellow coloured and has no markings. It is available in blister packs containing 7, 10, 14, 20, 28, 30, 56, 60, 84 or 90 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Strides Pharma UK Ltd. Unit 4, The Metro Centre Dwight Road, Watford, WD18 9SS United Kingdom This leaflet was last revised in 12/2022.
Dimension – 140 x 240 mm
1048276
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Colecalciferol and seek immediate medical help if you experience symptoms of serious allergic reactions, such as:
- swollen face, lips, tongue or throat
- difficulty to swallow
- hives and difficulty breathing. Side effects with Colecalciferol may include Uncommon (may affect up to 1 in 100 people)
- too much calcium in your blood (hypercalcaemia). You may feel or be sick, lose your appetite, have constipation, stomach ache, feel
Frequently asked questions about Colecalciferol 3,200 IU capsules, soft
How do I take Colecalciferol 3,200 IU capsules, soft?
Colecalciferol 3,200 IU capsules, soft comes as capsule containing 3.2iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Colecalciferol 3,200 IU capsules, soft?
The active substance in Colecalciferol 3,200 IU capsules, soft is colecalciferol; cholecalciferol.
Are there equivalent medicines to Colecalciferol 3,200 IU capsules, soft?
Medicines with the same active substance, strength and form include: Fultium-D3 3,200IU capsules. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Colecalciferol 3,200 IU capsules, soft, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Colecalciferol 3,200 IU capsules, soft without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: colecalciferol; cholecalciferol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the treatment of vitamin D deficiency (serum 25(OH)D <25 nmol/l). STRIVIT-D3 is indicated in adults and the elderly.
4.2. Posology and method of administration
Posology
Vitamin D deficiency in adults and the elderly (serum levels <25 nmol/l (<10 ng/ml)) 1 capsule (3,200 IU) daily for up to 12 weeks dependent upon the severity of the disease and the patient's response to treatment.
Not all given recommended doses can be achieved with this product.
Dosage in hepatic impairment
No dose adjustment is required.
Dosage in renal impairment
In patients with mild or moderate renal impairment, no specific adjustment is required. STRIVIT-D3 should not be used in patients with severe renal impairment (see section 4.3).
Paediatric population
Not recommended for use in children.
Method of administration
Oral
The capsules should be swallowed whole (not chewed) with water. The capsules should not be chewed in order to facilitate the swallowing of the capsule content. In order to enhance absorption, it is recommended to take vitamin D with a meal.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.Hypervitaminosis D
• Nephrolithiasis
• Nephrocalcinosis
• Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria
• Severe renal impairment
4.4. Special warnings and precautions for use
In the case of therapeutic treatment the dose should established on an individual basis for the patients by regular checking (initially weekly, then once every 2-4 weeks) of plasma calcium levels. During long-term treatment, serum calcium level, urinary calcium excretion and renal function should be monitored by measuring the serum creatinine level. In case of hypercalciuria (exceeding 300 mg (7.5 mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued.
Renal impairment
Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used (see section 4.3).
Sarcoidosis
STRIVIT-D3 should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine.
Use of additional supplements
Allowances should be made for vitamin D supplements from other sources.
The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision.
Medical supervision is required whilst on treatment to prevent hypercalcaemia.
Paediatric population
STRIVIT-D3 3,200 IU Capsules should not be given to children.
Sodium
This medicine contains less than 1 mmol sodium (23 mg) per 3,200 IU, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Thiazide diuretics reduce the urinary excretion of calcium. Due to the increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation.
Concomitant use of glucocorticoids can decrease the effect of vitamin D.
The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium.
Simultaneous treatment with bile-acid binding resins (i.e. cholestyramine, colestipol), orlistat or laxatives such as paraffin oil, may reduce the gastrointestinal absorption of vitamin D.
The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25- dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited data from the use of STRIVIT-D3 in pregnant women. Vitamin D deficiency is harmful for mother and child. High doses of vitamin D have been shown to have teratogenic effects in animal experiments (see section 5.3).
Overdose of vitamin D must be avoided during pregnancy, as prolonged hypercalcaemia may lead to physical and mental retardation, supravalvular aortic stenosis and retinopathy of the child.
Where there is a vitamin D deficiency the recommended dose is dependent on national guidelines, however, the maximum recommended dose during pregnancy is 4,000 I.U./day vitamin D3. For treatment during pregnancy at higher doses, STRIVIT-D3 is not recommended during pregnancy.
Breastfeeding
Vitamin D3 and its metabolites are excreted in breast milk. No adverse events have been observed in infants. STRIVIT-D3 can be used at recommended doses during lactation in case of a vitamin D deficiency. This should be considered when giving additional vitamin D to the child.
Fertility
There are no data on the effect of STRIVIT-D3 on fertility. However, normal endogenous levels of vitamin D are not expected to have any adverse effects on fertility.
4.7. Effects on ability to drive and use machines
STRIVIT-D3 has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000).
Immune system disorders:
Not known (cannot be estimated from the available data): Hypersensitivity reactions such as angio-oedema or laryngeal oedema.
Metabolism and nutrition disorders
Uncommon: Hypercalcaemia and hypercalciuria. Skin and subcutaneous disorders
Rare: Pruritus, rash and urticaria.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of vitamin D and rehydration.
💬 Ask about this leaflet
Ask anything about Colecalciferol 3,200 IU capsules, soft. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Colecalciferol; cholecalciferol
- Colecalciferol 1 000 IU Capsules
- Colecalciferol 1000 iu Oral capsule
- Colecalciferol 20,000 IU capsules, soft
- Colecalciferol 3000IU/ml Oral Solution
- Colecalciferol 800 IU Capsules, Soft
- Desunin 4000 IU Tablets
- Desunin 800 IU Tablets
- Fultium-D3 20,000IU capsules
- Fultium-D3 3,200IU capsules
- Fultium-D3 800IU capsules
- Stexerol-D3 1,000 IU Film-coated Tablets
- Stexerol-D3 25,000 IU Film-coated Tablets
- STRIVIT 1000 iu Oral capsule
- STRIVIT D3 800 IU Capsules, Soft (PL 13606/0226)