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.
Colextra-D3 25,000 IU Tablets
⚠ 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 may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Colextra-D3 Tablets contain the ac�ve substance Vitamin D3, also known as Colecalciferol. Vitamin D is found in the diet and is also produced in the skin a�er exposure to the sun. O�en vitamin D is given in combina�on with calcium. Colextra-D3 tablets are recommended for use when you have a normal intake of dietary calcium. Colextra-D3 Tablets may be prescribed by your doctor to treat or prevent vitamin D deficiency. Deficiency of vitamin D may occur when your diet or lifestyle does not provide you enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant). Colextra-D3 tablets may also be prescribed for certain bone condi�ons, such as thinning of the bone (osteoporosis) when it will be given to you with other medicines.
What you need to know before you take it
e Colextra-D3 Tablets
● Laxa�ves (such as paraffin oil) or a cholesterol lowering drug called colestyramine may reduce the absorp�on of vitamin D
Do not take Colextra-D3 Tablets: ● If you are allergic (hypersensi�ve) to vitamin D or any of the other ingredients in the tablets (listed in Sec�on 6) ● If you have high levels of vitamin D in your blood (hypervitaminosis D) ● If you have high levels of calcium (hypercalcaemia) or high urine levels of calcium (hypercalciuria) ● If you have kidney stones or serious kidney problems
● Ac�nomycin (a medicine used to treat some forms of cancer) and imidazole an�fungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) as they may interfere with the metabolism of vitamin D.
Warnings and precau�ons Check with your doctor before taking Colextra-D3 Tablets: ● If you have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine ● If you are being treated for heart disease ● If you have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes) ● If you are already taking addi�onal doses of calcium or vitamin D. Whilst you are taking Vitamin D3 your doctor will monitor your blood levels of calcium to make sure they are not too high Children and adolescents Do not give this medicine to children and adolescents under 12 years of age. Other medicines and Colextra-D3 Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescrip�on. In par�cular, the following medicines may interact with Colextra-D3 Tablets: ● 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 diure�cs (used to treat high blood pressure) reduce the urinary excre�on of calcium and can increase the risk of hypercalcaemia ● Medicines to treat epilepsy (such as phenytoin) or medicines to make you sleep (barbiturates such as phenobarbitone) as these medicines can decrease the effect of vitamin D ● Glucocor�coids (steroid hormones such as hydrocor�sone or prednisolone). These can decrease the effect of vitamin D
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. Colextra-D3 Tablets should be used during pregnancy and breast-feeding only if recommended by your doctor. Driving and using machines Colextra-D3 Tablets should not affect your ability to drive or operate machinery. Colextra-D3 Tablets contains sucrose Colextra-D3 25,000 IU Tablets contain 43.75 mg of sucrose in each tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take it
Colextra-D3 Tablets Always take Colextra-D3 Tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Recommended Dose in Adults Preven�on of vitamin D deficiency
Colextra-D3 25,000 IU Tablets 1 tablet every 4-6 weeks as directed by your doctor
In osteoporosis (you will also be taking other medicines for this)
Colextra-D3 25,000 IU Tablets 1 tablet every 4-6 weeks as directed by your doctor
Treatment of vitamin D deficiency:
Colextra-D3 25,000 IU Tablets 1 tablet every 4 weeks as directed by your doctor
The dose may be adjusted depending on the severity of the disease and your response to the treatment. Recommended Dose in Adolescents 12-18 years of age Your doctor will decide the dose. The dose will be dependent on the severity of the disease and your response to the treatment. Use in Children under 12 years of Age Colextra-D3 Tablets should not be given to children under 12 years of age. If you have problems absorbing Colextra-D3 or have other condi�ons such as liver disease, the dose of Colextra-D3 may be different. This will be directed by your doctor. During long term treatment, the calcium levels in blood and urine and the func�on of the kidney will be monitored regularly by your doctor to ensure you are taking correct dose. Method of administra�on The tablets should be swallowed whole (not chewed) with water. If you take more Colextra-D3 Tablets than you should If you accidentally take one tablet too many, nothing is likely to happen. If you accidentally take several tablets too many tell your doctor or get other medical advice immediately. If possible, take the tablets, the box and this leaflet with you to show the doctor. If you take too many tablets you may feel or be sick, become cons�pated or have stomach pains, weak muscles, �redness, lack of appe�te, kidney problems and in severe cases irregular heartbeats. If you forget to take Colextra-D3 Tablets If you forget to take your tablets, take them as soon as you can. Do not take a double dose to make up for a forgo�en dose. A�er that, take the next tablets as scheduled If you have any further ques�ons on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
6. Contents of the pack and other informa�on
Like all medicines, this medicine can cause side effects, although not everybody gets them.
What Colextra-D3 Tablets contain
Possible side effects
with Colextra-D3 Tablets may include:
Colextra-D3 25,000 IU Tablets: Each tablet contains 25,000 IU Colecalciferol (equivalent to 625 micrograms vitamin D3)
Uncommon side effects (may affect up to 1 in 100 people) ● Too much calcium in your blood (hypercalcaemia). You may feel or be sick, lose your appe�te, have cons�pa�on, stomach ache, feel very thirsty, have muscle weakness, drowsiness or confusion. ● Too much calcium in your urine (hypercalciuria). Rare side effects (may affect up to 1 in 1,000 people) ● Skin rash ● Itching ● Hives Repor�ng 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 at: www.mhra.gov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store. By repor�ng side effects, you can help provide more informa�on on the safety of this medicine.
How to store it
Colextra-D3 Tablets Keep this medicine out of the sight and reach of children. Store below 25°C. Keep the blister in the outer carton in order to protect from light. For Colextra-D3 25,000 IU tablets packaged in a container, store in the original package in order to protect from light. Do not use Colextra-D3 Tablets a�er the expiry date which is stated on the carton and container/blister as "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 required. These measures will help to protect the environment.
The ac�ve substance is Colecalciferol (Vitamin D3).
The other ingredients are: modified food starch medium chain triglycerides dl-alpha-tocopherol sodium ascorbate sucrose silicon dioxide microcrystalline cellulose hydroxypropyl cellulose low-subs�tuted silica colloidal anhydrous What Colextra-D3 Tablets look like and contents of the pack Colextra-D3 25,000 IU Tablets: Colextra-D3 25,000 IU Tablet is a white, or almost white, oval, biconvex tablet, plain on both sides with dimensions 17 mm x 8 mm. It is available in blister packs containing 4, 6 and 12 tablets. Not all pack sizes may be marketed. Manufacturer Meditop Pharmaceu�cal Ltd. Ady Endre street 1 2097 Pilisborosjenő Hungary Marke�ng Authorisa�on Holder Synergy Biologics Limited Unit 1, The Stamp Factory Wednesbury Road Walsall, West Midlands WS1 3QY United Kingdom This leaflet was last revised in July 2023.
Frequently asked questions about Colextra-D3 25,000 IU Tablets
How do I take Colextra-D3 25,000 IU Tablets?
Colextra-D3 25,000 IU Tablets comes as tablet containing 25iu. 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 Colextra-D3 25,000 IU Tablets?
The active substance in Colextra-D3 25,000 IU Tablets is colecalciferol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Colextra-D3 25,000 IU Tablets, 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 Colextra-D3 25,000 IU Tablets 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
- 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
Prevention and treatment of vitamin D deficiency in adults and adolescents with an identified risk.
As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.
4.2. Posology and method of administration
Posology
The dosage of vitamin D depends on severity of the disease, as well as patient's response to treatment. Based on patient's needs, capabilities and preferences daily, weekly or monthly dosing regimens can be offered. Lower dosage forms (e.g. 400 IU, 500 IU, 800 IU and 1,000 IU) are suitable for daily vitamin D supplementation, while higher dosage forms like 20,000 IU contain amounts equal to the weekly and monthly vitamin D doses respectively, which should be taken into consideration. The dosage and the frequency of administration has to be established individually by a physician.
The following may apply as dosage recommendation
Adults
Prevention of vitamin D deficiency and as an adjunct to specific therapy for osteoporosis: Recommended dose range is 600 IU- 800 IU per day.
Treatment of vitamin D deficiency:
800 IU per day. Higher doses should be adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient´s response to treatment.
The daily dose should not exceed 4,000 IU.
Adolescents:
The dose should be adjusted dependent upon desirable serum levels of 25 hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient´s response to treatment.
The daily dose should not exceed 4,000 IU per day.
Alternatively, national posology recommendations in prevention and treatment of vitamin D deficiency can be followed.
Paediatric population:
Colextra-D3 25,000 IU tablets should not be given to children under 12 years of age due to the risk of choking. Instead, it is advisable to use drops or dissolvable tablets.
• Special Populations
o Dosage in hepatic impairment
No dose adjustment is required.
o Dosage in renal impairment
Patients with mild or moderate renal impairment: no specific adjustment is required
Colecalciferol must not be used in patients with severe renal impairment.
o Dosage in pregnancy
The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be Vitamin D deficient a higher dose may be required (up to 2,000 IU/day).
o Other conditions: such as obese patients, patients with malabsorption syndromes, and patients on medications affecting Vitamin D metabolism, higher doses are required for the treatment and prevention of Vitamin D deficiency.
Method of administration
Oral.
The tablet should be swallowed whole (not chewed) with water.
4.3. Contraindications
Hypersensitivity to vitamin D or any of the excipients in the product.
Hypervitaminosis D.
Nephrolithiasis.
Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria.
Severe renal impairment.
4.4. Special warnings and precautions for use
Colextra-D3 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, Contraindications).
Caution is required in patients receiving treatment for cardiovascular disease (see section 4.5 – cardiac glycosides including digitalis).
Colextra-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.
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.
During long-term treatment with a daily dose exceeding 1,000 IU vitamin D, calcium values must be monitored.
Colextra-D3 25000 IU Tablets should not be given to children under 12 years.
This medicine contains 43.75 mg of sucrose in each tablet. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
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 ion exchange resins such as cholestyramine 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-dihydroxyvtiamin D by the kidney enzyme, 25-hydroxyvtiamin D-1- hydroxylase.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of colecalciferol in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be vitamin D deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment.
Breast-feeding
Vitamin D and its metabolites are excreted in breastmilk. Overdose in infants induced by nursing mothers has not been observed, however, when prescribing additional vitamin D to a breast-fed child the practitioner should consider the dose of any additional vitamin D given to the mother.
Fertility
There are no data available on the effect of colecalciferol on fertility.
4.7. Effects on ability to drive and use machines
Colextra-D3 25000 IU Tablets have no 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).
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 risk/benefit balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: 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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- VITAMIN D3 KRKA 7000 UI prescriptionCOLECALCIFEROLUM · taken by mouth
- VITAMIN D3 KRKA 30000 UI prescriptionCOLECALCIFEROLUM · taken by mouth
- BONFAL 20000 UI prescriptionCOLECALCIFEROLUM · taken by mouth
- VIGANTOLETTEN 1000 prescriptionCOLECALCIFEROLUM · taken by mouth
- BONFAL 10000 UI prescriptionCOLECALCIFEROLUM · taken by mouth
- VIGANTOLETTEN 500 prescriptionCOLECALCIFEROLUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Colecalciferol. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Vitaminum A + D3 Medana partial — not the same combinationColecalciferolum + Retinolum · taken by mouth
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Colextra-D3 25,000 IU Tablets. 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.