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.
THORENS 25 000 I.U. /2.5 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.
What it is and what it is used for
for
THORENS oral solution contains the active ingredient colecalciferol (vitamin D3). Vitamin D3, can be found in some foods and is also produced by the body when skin is exposed to sunlight. Vitamin D3 helps the kidneys and intestine absorb calcium and it helps build bones. Vitamin D3 deficiency is the predominant cause of rickets (defective mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults). THORENS oral solution is used for initial treatment of clinically relevant vitamin D deficiency in adults.
2.
What you need to know before you take it
e THORENS
Do not use THORENS: if you are allergic to vitamin D3 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 kidney stones (renal calculi) or severe renal impairment; if you have high levels of vitamin D3 in your blood (hypervitaminosis D). Warnings and precautions Talk to your doctor, pharmacist or nurse before using THORENS if you:
are undergoing treatment with certain medicines used to treat heart disorders (eg, cardiac glycosides, such as digoxin); have sarcoidosis (an immune system disorder which may cause increased levels of vitamin D3 in the body);
1.3.1 Package Leaflet
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are taking medicines containing vitamin D3, or eating foods or milk enriched with vitamin D3; are likely to be exposed to a lot of sunshine whilst using THORENS; take additional supplements containing calcium. Your doctor will monitor your blood levels of calcium to make sure they are not too high whilst you are using THORENS; have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine; take a daily dose of vitamin D3 exceeding 1 000 I.U. over a long period of time, your doctor should monitor the level of calcium in your blood by lab test.
Children and adolescents The use is not recommended in children and adolescents under 18 years of age. Other medicines and THORENS Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is especially important if you are taking: medicines that act on the heart or kidneys, such as cardiac glycosides (eg, digoxin) or diuretics (eg, bendroflumethiazide). When used at the same time as vitamin D3 these medicines may cause a large increase in the level of calcium in the blood and urine; medicines containing vitamin D3 or eating food rich in vitamin D3, such as, some types of vitamin D3-enriched milk; actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (eg, clotrimazole and ketoconazole, medicines used to treat fungal disease). These medicines may interfere with the way your body processes vitamin D3; the following medicines because they can interfere with the effect or the absorption of vitamin D3:
- antiepileptic medicines (anticonvulsants), barbiturates;
- glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These can decrease the effect of vitamin D3;
- medicines that lower the level of cholesterol in the blood (such as cholestyramine, or colestipol);
- certain medicines for weight loss that reduce the amount of fat your body absorbs (eg, orlistat);
- certain laxatives (such as liquid paraffin). THORENS with food, drink and alcohol You should take this medicine preferably together with a large meal to help your body absorb the vitamin D3. You can also mix the solution with cold or lukewarm food, to help you take this medicine. For detailed information see section 3 "How to use THORENS". Pregnancy, breast-feeding and fertility 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. This high strength formulation is not recommended for use in pregnant and breast-feeding women. Driving and using machines There is limited information on the possible effects of this medicine on your ability to drive. However, it is not expected that it would affect your ability to drive or to operate machinery.
1.3.1 Package Leaflet
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3.
How to take it
THORENS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Shake before use. You should take THORENS preferably together with a meal. This medicine has a taste of olive oil. It can be taken on its own from the bottle or to help you take the medicine you can also mix the solution with a small amount of cold or lukewarm food immediately before use. Make sure the entire dose is taken. Use in adults The recommended dose is 1 bottle per week during the first month, your doctor will adjust the dose for you. Paediatric population THORENS 25 000 I.U. is not recommended in children and adolescents under 18 years of age. Pregnancy and breast-feeding THORENS 25 000 I.U. is not recommended. If you take more THORENS than you should If you take more medicine than prescribed, stop using this medicine and contact your doctor. If it is not possible to talk to a doctor go to the nearest hospital emergency department and take the medicine package with you. The most common symptoms of overdose are: nausea, vomiting, excessive thirst, the production of large amounts of urine over 24 hours, constipation and dehydration, high levels of calcium in the blood and in urine (hypercalcaemia and hypercalciuria) shown by lab test. If you forget to take THORENS If you forget to take a dose of THORENS, 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.
Possible side effects
may include: Uncommon (affects less than 1 in 100 people)
- Too much calcium in your blood (hypercalcaemia)
- Too much calcium in your urine (hypercalciuria) Rare (affects less than 1 in 1000 people)
- Skin rash
- Itching
- Hives
1.3.1 Package Leaflet
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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 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.
5.
How to store it
THORENS
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 after "Exp". The expiry date refers to the last day of that month. Do not store above 30° C. Keep the bottle in the outer carton in order to protect from light. Do not freeze or refrigerate. Do not use this medicine if you notice the solution is cloudy. 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.
6.
Contents of the pack and other information
What THORENS contains –
–
The active substance is colecalciferol (vitamin D3). A single-dose bottle of 2.5 ml oral solution contains: 25 000 I.U. colecalciferol (vitamin D3) equivalent to 0.625 mg 1 ml oral solution contains 10 000 I.U. colecalciferol (vitamin D3), equivalent to 0.25 mg The other ingredient is refined olive oil.
What THORENS looks like and contents of pack THORENS 25 000 I.U. /2.5 ml oral solution, is a clear and colourless to greenish-yellow oily solution without visible solid particles and/or precipitate. It is supplied in an amber glass bottle sealed with a plastic cap. Each pack contains 1 or 4 single dose bottles containing 2.5 ml solution. Not all pack sizes may be marketed. Marketing authorisation holder Galen Limited Seagoe Industrial Estate Craigavon BT63 5UA UK
1.3.1 Package Leaflet
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Manufacturer Abiogen Pharma S.p.A. Via Meucci, 36 – Pisa (Italy) [email protected] This medicinal product is authorised in the Member States of the EEA under the following names: United Kingdom: THORENS 25 000 I.U. /2.5 ml oral solution Ireland: THORENS 25 000 I.U. /2.5 ml oral solution Belgium: THORENS 25 000 UI/2,5 ml solution buvable This leaflet was last revised in 03/2020
1.3.1 Package Leaflet
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Frequently asked questions about THORENS 25 000 I.U. /2.5 ml oral solution
How do I take THORENS 25 000 I.U. /2.5 ml oral solution?
THORENS 25 000 I.U. /2.5 ml oral solution comes as oral solution containing 2.5ml. 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 THORENS 25 000 I.U. /2.5 ml oral solution?
The active substance in THORENS 25 000 I.U. /2.5 ml oral solution is colecalciferol; cholecalciferol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for THORENS 25 000 I.U. /2.5 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 THORENS 25 000 I.U. /2.5 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 →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Initial treatment of clinically relevant vitamin D deficiency in adults.
4.2. Posology and method of administration
Posology
Recommended dose: One bottle (25 000 I.U.) weekly.
After first month, lower doses may be considered, dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient´s response to treatment.
Alternatively, national posology recommendations in treatment of vitamin D deficiency can be followed.
Special population
Dosage in hepatic impairment
No dose adjustment is required.
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.
Paediatric population
THORENS 25 000 I.U. /2.5 ml is not recommended in children and adolescents under 18 years of age.
Pregnancy and breastfeeding
THORENS 25 000 I.U. /2.5 ml is not recommended
Method of administration
Patients should be advised to take THORENS preferably with meal (see section 5.2 Pharmacokinetic properties - “Absorption”).
The product should be shaken before use.
THORENS has a taste of olive oil. THORENS can be taken as is from the bottle or to facilitate intake it can also mixed with a small amount of cold or lukewarm food immediately prior to use. The patient should be sure to take the entire dose.
See also section 6.6 Special precautions for handling and disposal.
4.3. Contraindications
Hypersensitivity to the active ingredient, colecalciferol (vitamin D3), or to any of the excipients listed in section 6.1.
Hypercalcaemia, hypercalciuria
Hypervitaminosis D
Kidney stones (nephrolithiasis, nephrocalcinosis) in patients with current chronic hypercalcaemia
Severe renal impairment
4.4. Special warnings and precautions for use
Vitamin 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 have to be used.
Caution is required in patients receiving treatment for cardiovascular disease (see section 4.5 Interaction with other medicinal products and other forms of interaction - cardiac glycosides including digitalis).
THORENS should be prescribed with caution in patients with sarcoidosis, due to a possible increase in the metabolism of vitamin D3 in its active form. In these patients the serum and urinary calcium levels should be monitored.
Allowances should be made for the total dose of vitamin D3 in cases associated with treatments already containing vitamin D, foods enriched with vitamin D3, cases using milk enriched with vitamin D, and the patient's level of sun exposure.
There is no clear evidence for causation between vitamin D3 supplementation and renal stones, but the risk is plausible, especially in the context of concomitant calcium supplementation. The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision.
During long-term treatment with a daily dose exceeding 1 000 I.U. vitamin D3 the serum calcium values must be monitored.
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant use of anticonvulsants (such as phenytoin) or barbiturates (and possibly other drugs that induce hepatic enzymes) may reduce the effect of vitamin D3 by metabolic inactivation.
In cases of treatment with thiazide diuretics, which decrease urinary elimination of calcium, monitoring of serum calcium concentration is recommended.
Concomitant use of glucocorticoids can decrease the effect of vitamin D3.
In cases of treatment with drugs containing digitalis and other cardiac glycosides, the administration of vitamin D3 may increases the risk of digitalis toxicity (arrhythmia). Strict medical supervision is needed, together with serum calcium concentration and electrocardiographic monitoring if necessary.
Simultaneous treatment with ion exchange resin such as cholestyramine, colestipol hydrochloride, orlistat or laxative such as paraffin oil may reduce the gastrointestinal absorption of vitamin D3.
The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D3 activity by inhibiting the conversion of 25-hydroxyvitamin D3 to 1,25-dihydroxyvitamin D3 by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.
4.6. Fertility, pregnancy and lactation
THORENS 25 000 I.U. /2.5ml oral solution is not recommended in pregnancy and lactation. A low strength formulation should be used.
Pregnancy
There are no or limited amount of data from the use of colecalciferol (vitamin D3) in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3 Preclinical safety data). The recommended daily intake for pregnant women is 400 I.U., however, in women who are considered to be vitamin D3 deficient a higher dose may be required (up to 2 000 I.U. /day - 10 drops with the oral drops presentation). 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 D3 and its metabolites are excreted in breast milk. Vitamin D3 can be prescribed while the patient is breast-feeding if necessary. This supplementation does not replace the administration of vitamin D3 in the neonate.
Overdose in infants induced by nursing mothers has not been observed, however, when prescribing additional vitamin D3 to a breast-fed child the practitioner should consider the dose of any additional vitamin D3 given to the mother.
Fertility
There are no data on the effect of THORENS 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 effects of THORENS on the ability to drive. However, an effect on this ability 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, <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 benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the 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
Discontinue THORENS when calcaemia exceeds 10.6 mg/dl (2.65 mmol/l) or if the calciuria exceeds 300 mg/24 hours in adults or 4-6 mg/kg/day in children. An overdose manifests as hypercalcaemia and hypercalciuria, the symptoms of which include the following: nausea, vomiting, thirst, constipation, polyuria, polydipsia and dehydration.
Chronic overdosage may lead to vascular and organ calcification, as a result of hypercalcaemia.
Treatment in cases of overdose
Discontinue administration of THORENS and initiate rehydration.
🇷🇴 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
⚠ 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.
- 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
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 THORENS 25 000 I.U. /2.5 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.
Medicines containing Colecalciferol; cholecalciferol
- Colecalciferol 1 000 IU Capsules
- Colecalciferol 1000 iu Oral capsule
- Colecalciferol 20,000 IU capsules, soft
- Colecalciferol 3,200 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