The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: colecalciferol; cholecalciferolOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Colecalciferol 3000IU/ml Oral Solution

⚠ 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.

Active substance: Colecalciferol; cholecalciferol

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for 2. What you need to know before you take Colecalciferol Oral Solution 3. How to take Colecalciferol Oral Solution 4. Possible side effects 5. How to store Colecalciferol Oral Solution 6. Contents of the pack and other information

1. What Colecalciferol Oral Solution is and what it is used for Colecalciferol Oral Solution is an oily solution which contains the active substance called colecalciferol (Vitamin D3). 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 D3 is also essential for bone formation and normal bone metabolism. Colecalciferol Oral Solution is used for prevention and treatment of Vitamin D deficiency in adults, elderly and children over 12 years of age.

What you need to know before you take it

e Colecalciferol Oral Solution Do not take Colecalciferol

► If you are allergic (hypersensitive) to colecalciferol or any of the other ingredients of this medicine (listed in section 6). PIL/UK/MFG005/06/SMD/v2

► If you have high levels of Vitamin D in your blood (hypervitaminosis D).

Driving and using machines Colecalciferol should not affect your ability to drive or operate machinery.

Warnings and precautions Talk to your doctor or pharmacist before taking Colecalciferol if you: ► Have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine.

► Are being treated for heart disease. ► Have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes). ► Are using other drugs containing calcium or vitamin D. Whilst you are taking Colecalciferol your doctor will monitor your blood levels of calcium to make sure they are not too high. ► Have increase parathyroid hormone in your blood or rickets (problems in bone). Other medicines and Colecalciferol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Colecalciferol may affect or be affected by other medicines, such as:

► Thiazide diuretics (to treat high blood pressure); ► Phenytoin (to treat epilepsy) and barbiturates (to make you sleep); ► Glucocorticoid (to treat inflammation); ► Cardiac glycosides (to treat heart conditions); ► Laxatives which contain paraffin oil; ► Cholestyramine used for treating high cholesterol; ► Actinomycin (used to treat some forms of cancer) and imidazole antifungals (used to treat fungal diseases). Colecalciferol with food, drink and alcohol Colecalciferol can be taken with or without food and drink. Pregnancy, breastfeeding and fertility Pregnancy Your doctor may prescribe Colecalciferol during pregnancy if you suffer from Vitamin D deficiency.

Colecalciferol Oral Solution contains: Almond oil (nut oil): Not suitable for someone with nut allergy.

How to take it

Colecalciferol Oral Solution Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Doses Dosages used in the treatment of vitamin D deficiency should be based on the severity of deficiency and the patient's response to treatment. Adults and Elderly: ► Treatment dose: 4000 IU daily (1.33ml) for 10 weeks (280,000 IU in total). ► Maintenance dose: 800-2000 IU daily (0.27ml-0.67ml) (occasionally up to 4000 IU daily may be required). Adolescents (children >12 years): For treatment and maintenance ► 500-2000 IU/day (equivalent to 0.17 ml-0.67 ml per day). Children: Do not give this medicine to children below 12 years. Dose in pregnancy and lactation: ► 400 IU (0.13ml). However, your physician may prescribe higher dose which suits you better. Method of administration Use the measuring syringe provided in the pack to deliver the required dose. Instructions for the use of syringe: a) Open the bottle: press the cap and turn it anticlockwise (figure 1) b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

Breast-feeding Vitamin D passes into breast milk. Your doctor may need to adjust the dose for additional Vitamin D supplementation in your child.

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The name of your medicine is Colecalciferol 3000IU/ml Oral Solution but it will be referred to as Colecalciferol Oral Solution or Colecalciferol throughout this leaflet.

► If you have kidney stones or serious kidney problems.

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.

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► Keep this leaflet. You may need to read it again. ► If you have any further questions, ask your doctor or pharmacist. ► This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. ► If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

► If you have high blood levels of calcium (hypercalcaemia) or high urine levels of calcium (hypercalciuria).

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C, this pictogram represents an example for measuring a dose of 0.17ml).

Empty the contents of the syringe into the patient's mouth by pushing the piston to the bottom of the syringe (figure 7). Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).

If you take more Colecalciferol than you should Contact your nearest hospital casualty department or tell your doctor immediately. Taking more than the recommended dose may lead to abnormally high levels of calcium in the blood which can eventually damage the soft tissues and kidney. Symptoms of overdose may include: lack of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, increased urination, bone pain and in severe cases may result in coma and death. If you forget to take Colecalciferol

0.1 0.2

0.17 ml

0.3 An example for measuring a dose of 0.17ml

The total volume delivered from the syringe is 1ml with each numbered increment of 0.1ml, which is equivalent to 300 IU colecalciferol. Each of the 0.1ml increment is further divided into ten divisions and each of these divisions represent 0.01ml, equivalent to 30 IU colecalciferol (see figure below).

If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Colecalciferol Keep taking this medicine until your doctor tells you to stop. Do not stop taking Colecalciferol just because you feel better. 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.

Dose measurement – The maximum dose of colecalciferol is 1.33ml. Divide your dose into two (1ml & 0.33ml). Take one full syringe with solution up to 1ml mark. Then take 0.33ml by measuring the solution to 0.3ml and 3 further small divisions (as shown in the figure above using arrow). Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

Uncommon (may affect up to 1 in 100 people):

 Too much calcium in your blood (hypercalcaemia). Symptoms may include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, increased urination, muscle weakness, drowsiness and confusion;  Too much calcium in urine (hypercalciuria). If you are on long-term treatment, your doctor may wish to check the level of calcium in your blood and urine as well as your kidney functions. Rare (may affect up to 1 in 1,000 people):  Itching  Rash  Urticaria.

PIL/UK/MFG005/06/SMD/v2

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 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.

How to store it

Colecalciferol Oral Solution  Keep this medicine out of the sight and reach of children.  Do not use this medicine after the expiry date which is stated on the carton and bottle label after 'EXP:'. The expiry date refers to the last day of that month.  Do not store above 25°C.  Store in the original package. Keep the bottle in the outer carton in order to protect from light.  Discard 60 days after first opening.  Do not use this medicine if you notice that the solution becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.  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.

Contents of the pack and other information

What Colecalciferol Oral Solution contains The active substance is colecalciferol. Each ml contains 3000IU colecalciferol. The other ingredients are refined almond oil and refined sunflower oil. What Colecalciferol Oral Solution looks like and contents of the pack Colecalciferol Oral Solution is a clear, yellow coloured solution supplied in amber glass bottles with a tamperevident child-resistant plastic screw cap. Colecalciferol Oral Solution is supplied in bottles containing 100ml solution along with a 1ml oral syringe with 0.01ml graduations and LDPE adaptor. Marketing Authorisation Holder and Manufacturer: SyriMed, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. POM This leaflet was last revised in 07/2021.

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Frequently asked questions about Colecalciferol 3000IU/ml Oral Solution

How do I take Colecalciferol 3000IU/ml Oral Solution?

Colecalciferol 3000IU/ml Oral Solution comes as oral solution containing 3000iu/ml. 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 3000IU/ml Oral Solution?

The active substance in Colecalciferol 3000IU/ml Oral Solution is colecalciferol; cholecalciferol.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Colecalciferol 3000IU/ml Oral Solution, 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 3000IU/ml Oral Solution 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 →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Colecalciferol; cholecalciferol (34 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Colecalciferol is indicated for treatment and prevention of vitamin D deficiency in adults, elderly and children over 12 years of age.

4.2. Posology and method of administration

Posology

The dosage regimen based on the 'National Osteoporosis Society Guideline 2013' proposed for Colecalciferol 3000IU/ml Oral Solution in the treatment and prevention of vitamin D deficiency is as follows:

Adults and Elderly:

• Treatment dose: 4000 IU daily (1.33ml) for 10 weeks (280,000 IU in total).

• Maintenance dose: 800-2000 IU daily (0.27ml-0.67ml) (occasionally up to 4000 IU daily may be required).

Adolescents (children >12 years)

For treatment and maintenance

• 500-2000 IU/day (equivalent to 0.17 ml-0.67 ml per day).

Children < 12 years

No data are available.

Dose in hepatic impairment:

No dose adjustment is required.

Dose in renal impairment:

Colecalciferol should not be used in patients with severe renal impairment (typically defined as a patient with eGFR of <30 ml/min/1.73m2, where the normal eGFR is typically >90 ml/min/1.73m2).

Dose in pregnancy and lactation:

The recommended daily intake for pregnant and breast-feeding women is 400 IU (0.13ml), however, in women who are considered to be vitamin D deficient a higher dose may be required as recommended by the doctor.

Method of administration

For oral administration only.

The measuring syringe provided in the pack should be used to deliver the required dose.

For instructions on use of the syringe for administration, see section 6.6.

4.3. Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

• Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria

• Nephrolithiasis

• Nephrocalcinosis

• Hypervitaminosis D

• Severe renal impairment

4.4. Special warnings and precautions for use

During long-term treatment, serum and urinary calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued.

Patients with mild to moderate impairment of renal function should be supervised carefully 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).

In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria.

Colecalciferol should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine.

Colecalciferol should be used with caution in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

Colecalciferol should be used with caution in other patients with increased risk of hypercalcaemia e.g. those suffering from malignancies.

Patients with primary hyperparathyroidism and vitamin deficiency should have their serum calcium measured.

The content of vitamin D in Colecalciferol oral solution should be considered when prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.

For patients with elevated levels of parathyroid hormone (PTH) or clinical evidence of rickets, calcium should be supplemented along with vitamin D. This is because vitamin D replacement and a normalisation of PTH levels can precipitate hypocalcaemia by suppressing bone resorption and from increased bone mineralisation, also referred to as the "hungry bone" syndrome.

Patients being treated specifically for vitamin D deficiency require a repeat 25(OH)D measurement approximately three to four months after initiating therapy as necessary.

Patients with obesity, malabsorption syndromes or taking concomitant medications may not respond to this treatment or may require higher doses due to the impact on vitamin D absorption. In such cases, vitamin D levels in the patient should be monitored and the dose should be followed as per the advice of their medical practitioner.

Patients who remain deficient or insufficient on the proposed doses will need to be treated with alternative therapies.

Excipient(s) Warnings

Almond oil (nut oil): Not suitable for someone with nut allergy.

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 use of phenytoin or barbiturates may reduce the effect of vitamin D since the metabolism increases.

Excessive dosing of vitamin D can induce hypercalcaemia, which may increase the risk of digitalis toxicity and serious arrhythimias due to the additive inotropic effects. The electrocardiogram (ECG) and serum calcium levels of patients should be closely monitored.

Glucocorticoid steroids may increase vitamin D metabolism and elimination. During concomitant use, it may be necessary to increase the dose of colecalciferol.

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-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.

4.6. Fertility, pregnancy and lactation

Pregnancy

Colecalciferol should be given during pregnancy in cases of vitamin D3 deficiency. The recommended daily intake for pregnant and breast-feeding women is 400 IU, however, in women who are considered to be vitamin D deficient a higher dose may be required in line with the recommended treatment regimen for vitamin insufficiency in adults and the elderly. During pregnancy and breast-feeding women should follow the advice of their medical practitioner as their individual requirements may vary depending on the severity of their disease and their response to treatment. It is recommended that levels of 25[OH]D are routinely monitored in these treatment groups.

There are no human data available indicating that colecalciferol at therapeutic doses is teratogenic in humans.

Breast-feeding

Colecalciferol can be used during breast-feeding. Vitamin D passes into breast milk. This should be considered when giving additional vitamin D to the child.

Fertility

There are no data on the effect of colecalciferol 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

There are no data on the effect of this product on the ability to driver or use machines, however an effect is unlikely.

4.8. Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (≥1/1,000 to <1/100) or rare (≥1/10,000 to <1/1,000).

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Skin and subcutaneous tissue 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

Overdose can lead to hyper-vitaminosis D. An excess of colecalciferol causes abnormally high levels of calcium in the blood, which can eventually severely damage the soft tissues, and kidneys.

Symptoms:

Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification.

Management of hypercalcaemia:

The treatment with colecalciferol must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, and cardiac glycosides must also be discontinued. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Not the same combination. This medicine contains Colecalciferol; cholecalciferol. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

VITAMIN D3 KRKA 7000 UI prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth
VITAMIN D3 KRKA 30000 UI prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth
BONFAL 20000 UI prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth
VIGANTOLETTEN 1000 prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth
BONFAL 10000 UI prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth
VIGANTOLETTEN 500 prescription partial — not the same combinationCOLECALCIFEROLUM · 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. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

Vigantol partial — not the same combinationCholecalciferolum · taken by mouth
Vigantoletten 1000 partial — not the same combinationCholecalciferolum · taken by mouth
Vigantoletten 500 partial — not the same combinationCholecalciferolum · taken by mouth
Juvit D3 partial — not the same combinationCholecalciferolum · taken by mouth
Orocal D3 partial — not the same combinationCalcium + Cholecalciferolum · taken by mouth
Orocal D3 Lemon partial — not the same combinationCalcium + Cholecalciferolum · taken by mouth

💬 Ask about this leaflet

Ask anything about Colecalciferol 3000IU/ml Oral Solution. 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.

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