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 20,000 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 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 capsules contain the active substance colecalciferol, also known as vitamin D. 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. Colextra-D3 capsules are recommended for use when you have a normal intake of dietary calcium. Colextra-D3 capsules may be prescribed by your doctor to treat or prevent vitamin D deficiency.
Warnings and precautions Check with your doctor before taking Colextra-D3 capsules: @ If you have kidney damage or disease. Your doctor may want to measure the level of calcium in your blood or urine e If you are being treated for heart disease e If you have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes) e Ifyou are already taking additional doses of calcium or vitamin D. Whilst you are taking Colextra-D3 capsules 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 capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
CM oT
1 capsule every 4 weeks as
directed by your doctor
in osteoporosis (you will also be taking other medicines for this)
directed by your doctor
1 capsule every 4 weeks as
(RM
ac)
directed by your doctor
The dose would be adjusted depending on the severity of the disease and the patient's response to the treatment. Recommended Dose in Adolescents 12- 18 years of Age
Back
|f you are allergic (hypersensitive) to vitamin D or any of the other ingredients in the capsules (listed in Section 6) @ |f you have high level of vitamin D in your blood (hypervitaminosis D) @ If you have high levels of calcium (hypercalcaemia) or high urine levels of calcium (hypercalciuria) e If you have kidney stones or serious kidney problems
2 to 3 capsules monthly as
Prevention of vitamin D deficiency
Prevention of vitamin D
©
2 capsules weekly for 7 weeks as directed by your doctor
Recommended Dose in Adults
Dose
Do not take Colextra-D3 capsules:
If you forget to take Colextra-D3 capsules If you forgot to take a dose of Colextra-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.
synergy biologics
Initial Treatment | Dose of vitamin D deficiency | Maintenance
What you need to know before you take it
e Colextracapsules
deficiency
1 capsule every 6 weeks as directed by your doctor
Treatment of vitamin D deficiency:
1 capsule every 2 weeks for 6 weeks as directed by your doctor
Use in Children under 12 years of Age Colextra-D3 capsules 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. Method of administration The capsules should be swallowed whole (not chewed) with water, preferably with the main meal of the day. If you take more Colextra-D3 capsules than you should If you accidentally take too many capsules 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.
In particular, the following medicines may interact with Colextra-D3 capsules: e@ Heart medicines (cardiac glycosides such as digoxin). Your doctor may monitor your heart with an electrocardiogram (ECG) and measure the level of calcium in your blood Thiazide diuretics (used to treat high blood pressure) reduce the urinary excretion 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 @ Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These can decrease the effect of vitamin D @ Laxatives (such as paraffin oil) or a cholesterol lowering drug called colestyramine 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) as they may interfere with the metabolism 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. Driving and using machines Colextra-D3 capsules should not affect your ability to drive or operate machinery. Colextra-D3 Capsules contains Sorbitol This medicine contains 5.28 mg sorbitol in each capsule.
How to take it
Colextra-D3 capsules Always take Colextra-D3 capsules exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure,
(continued overleaf)
Possible side effects
, you can help provide more information on the safety of this medicine.
Manufacturer . Cubic Pharmaceuticals Limited Unit 3, Sextant Park, Neptune Close,
ME2 4LU, United Kingdom Marketing Authorisation Holder
What Colextra-D3 capsules look like and contents of the pack
Synergy Biologics Limited
Colextra-D3 20,0001U Capsuleisa
Wednesbury
light yellow coloured transparent, round-shaped soft gelatin capsule containing a clear colourless liquid. Available in blister packs containing
West Midlands WS1 3QY
:
10, 30 and 100 capsules.
Not all pack sizes may be marketed.
"
Unit 1, The Stamp
ee
Factory
Road
United Kingdom This leaflet was last revised in April 2022
PL.00024-01
synergy biologics
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 capsules may also be prescribed for certain bone conditions, such as thinning of the bone (osteoporosis) when it will be given to you with other medicines.
How to store it
Colextra-D3 capsules Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use Colextra-D3 capsules after the expiry date which is stated on the carton and blister as "EXP". The expiry date refers to the last day of that month. Medicines should not be disposed of 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. CPT
eKe ele Cale
meldmi lacie)
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- What Colextra-D3 capsules contain
Side effects with Colextra-D3 capsules may include:
The active substance is colecalciferol. Each capsule contains 20,000 IU colecalciferol (equivalent to 500
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 appetite, have constipation, stomach ache, feel very thirsty, have muscle weakness, drowsiness or confusion.
micrograms Vitamin D3) The other ingredients are: : Capsule content: triglycerides, medium chain all-rac-a-Tocopheryl acetate
®
Capsule shell:
Medway City Estate,
gelatin, glycerol, sorbitol (E420), purified Water
Rochester,
Too much calcium in your urine (hypercalciuria).
Rare side effects (may affect up to 1 in 1,000 people) @ Skin rash @ Itching e@ Hives 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 at: www.mhra.gov.uk/yellowcard or by searching for MHRA Yellow Card in the Google Play or Apple App Store. By reporting
Frequently asked questions about Colextra-D3 20,000 IU Capsules, Soft
How do I take Colextra-D3 20,000 IU Capsules, Soft?
Colextra-D3 20,000 IU Capsules, Soft comes as capsule containing 20iu. 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 20,000 IU Capsules, Soft?
The active substance in Colextra-D3 20,000 IU Capsules, Soft is colecalciferol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Colextra-D3 20,000 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 Colextra-D3 20,000 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
- 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
The 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.
Colextra-D3 Capsules are indicated in adults, the elderly and adolescents.
4.2. Posology and method of administration
Posology
The dosage of vitamin D depends on severity of the disease, as well as patients response to treatment. Based on patients 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 is 20,000 IU/month (1 capsule), higher doses may be required in certain situations
Treatment of vitamin D deficiency:
Recommended dose is 40,000 IU/week (2 capsules) for 7 weeks, followed by maintenance therapy (equivalent to 1,400-2,000 IU/day, such as 2-3 capsules per month, may be required.
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
Adolescents:
Prevention of vitamin D deficiency 12-18 years:
20,000 IU (1 capsule) every 6 weeks
Treatment of vitamin D deficiency 12-18 years:
20,000 IU (1 capsule) once every 2 weeks for 6 weeks
Paediatric population:
Colextra-D3 capsules 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 D3 deficient a higher dose may be required (up to 2,000 IU/day)
o Other conditions (see above): such as obese patients, patients with malabsorption syndromes, and patients on medications affecting vitamin D3 metabolism, higher doses are required for the treatment and prevention of vitamin D3 deficiency
Method of administration
Oral
The capsules should be swallowed whole (not chewed) with water, preferably with the main meal of the day
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
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, Contraindications).
Caution is required in patients receiving treatment for cardiovascular disease (see section 4.5 – cardiac glycosides including digitalis).
Colextra-D3 capsules 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.
During long-term treatment with an equivalent daily dose exceeding 1,000 IU vitamin D, the serum calcium values must be monitored. Renal function should also be checked by measuring serum creatinine. It is recommended to reduce the dose or interrupt treatment if the calcium content in the urine exceeds 7.5 mmol/24 hours (300 mg/24 hours).
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. Colextra-D3 capsules should not be given to children under 12 years.
This medicine contains 5.28mg sorbitol in each capsule.
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
Studies have shown safe use of doses up to 4,000 IU during pregnancy, although studies in animals have shown reproductive toxicity (see section 5.3). The recommended daily intake for pregnant women in the United Kingdom 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 Capsules 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 20,000 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.