Thorens® (colecalciferol) - ROI

Prescribing Information

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THORENS 10 000 I.U./ml oral drops, solution and THORENS 25 000 I.U./2.5ml oral solution: Please refer to the Summaries of Product Characteristics (SPCs) before prescribing.

Abbreviated Prescribing Information. Presentation: Both presentations of THORENS consist of a clear and colourless to greenish-yellow oily solution without visible solid particles and/or precipitate. THORENS 10 000 I.U./ml oral drops, solution: 10ml oral drops solution per bottle (corresponding to 500 drops, with one drop containing 200 I.U. [equivalent to 0.005mg] colecalciferol); each pack contains 1 bottle and 1 dropper applicator cap. THORENS 25 000 I.U./2.5ml oral solution: 2.5ml oral solution per single-dose bottle containing 25 000 I.U. colecalciferol (equivalent to 0.625mg). 1ml solution of both presentations is equivalent to 0.25mg colecalciferol. Indications: THORENS 10 000 I.U./ml oral drops, solution: Prevention and treatment of vitamin D deficiency in adults, adolescents and children 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. THORENS 25 000 I.U. oral solution: Initial treatment of clinically relevant vitamin D deficiency in adults. Dosage and administration: THORENS 10 000 I.U./ml oral drops, solution: Prevention of deficiency: Adults and adolescents (12-18 years): 3-4 drops (600-800 I.U.)/day. Children aged 0-11 years: 2 drops (400 I.U.)/day. Treatment of deficiency: Adults: 4 drops (800 I.U.)/day. Children and adolescents: Daily dose should not exceed 5 drops (1 000 I.U.)/day for infants <1 year, 10 drops (2 000 I.U.)/day for children 1-10 years and 20 drops (4 000 I.U.)/day for adolescents >11 years. 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 in adults should not exceed 20 drops (4 000 I.U.)/day. As an adjunct to specific therapy for osteoporosis: Adults: 3-4 drops (600-800 I.U.)/day. Pregnancy and breastfeeding: 2 drops (400 I.U.)/day is recommended, although doses of up to 10 drops (2 000 I.U.)/day may be required in women who are considered to be vitamin D3 deficient. Higher doses are required for the treatment and prevention of vitamin D3 deficiency in obese patients, patients with malabsorption syndromes, and patients on medications affecting vitamin D3 metabolism. National dosage recommendations in prevention and treatment of vitamin D deficiency can be followed as an alternative to the doses listed above. THORENS 25 000 I.U. oral solution: Treatment of deficiency: Adults: 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 patien's response to treatment. Alternatively, national dosage recommendations in treatment of vitamin D deficiency can be followed. Children and adolescents under 18 years: Not recommended. Pregnancy and breastfeeding: the 25 000 I.U. formulation is not recommended. No dose adjustment is required for either presentation in patients with hepatic impairment or mild to moderate renal impairment. Colecalciferol should not be used in patients with severe renal impairment. Patients should be advised to take THORENS preferably with a meal. Refer to the SPCs for full details on method of administration for both products and the instructions for use for the THORENS 10 000 I.U./ml oral drops, solution. Contraindications: Hypersensitivity to the active ingredient or any of the excipients contained in THORENS. Hypercalcaemia, hypercalciuria, hypervitaminosis D, kidney stones (nephrolithiasis, nephrocalcinosis) in patients with current, chronic hypercalcaemia, and severe renal impairment. Warnings and Precautions: THORENS should be used with caution in patients with renal function impairment 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. Caution is also required in patients with sarcoidosis due to a possible increase in the metabolism of vitamin D3 in its active form (serum and urinary calcium levels should be monitored). Allowances should be made for the total dose of vitamin D3 with use of treatments already containing vitamin D3, foods enriched with vitamin D3, milk enriched with vitamin D3 and the patient’s level of sun exposure. Renal stones are a plausible risk, despite no clear evidence for causation, especially in the context of concomitant calcium supplementation; the need for calcium supplementation should be considered for individual patients and given under close medical supervision. Serum calcium values must be monitored during long-term treatment with a daily dose exceeding 1 000 I.U. Interactions: Effect of vitamin D3 may be reduced by metabolic inactivation by concomitant use of anticonvulsants (such as phenytoin), barbiturates and possibly other drugs that induce hepatic enzymes. Monitoring of serum calcium is recommended in cases of treatment with thiazide diuretics, which decrease urinary elimination of calcium. Concomitant use of glucocorticoids can decrease the effect of vitamin D3. Strict medical supervision is needed, with serum calcium and electrocardiographic monitoring if necessary, in cases of treatment with drugs containing digitalis and other cardiac glycosides, as the vitamin D3 may increase the risk of digitalis toxicity (arrhythmia). Gastrointestinal absorption of vitamin D3 may be reduced by ion exchange resin such as cholestyramine, colestipol hydrochloride, orlistat or laxative such as paraffin oil. Actinomycin and imidazole antifungal agents interfere with vitamin D3 activity by inhibiting conversion of 25-hydroxyvitamin D3 to 1,25-dihydroxyvitamin D3 by the kidney enzyme, 25-hydroxyvitamin D-1 hydroxylase. Fertility, pregnancy and lactation: THORENS 25 000 I.U. oral solution is not recommended in pregnancy and lactation. There are no or limited amount of data from the use of colecalciferol in pregnant women. Studies in animals have shown reproductive toxicity. Refer to dosage and administration section for recommended dose. During pregnancy women should follow the advice of their medical practitioner as requirements may vary. Vitamin D overdose must be avoided during pregnancy as prolonged hypercalcaemia may lead to retardation of physical and mental development, supravalvular aortic stenosis and retinopathy in the child. Vitamin D3 and its metabolites are excreted in breast milk. Vitamin D3 can be prescribed while the patient is breastfeeding, if necessary. This supplementation does not replace the administration of vitamin D3 in the neonate; however, when prescribing vitamin D3 to a breast-fed child, the practitioner should consider the dose of vitamin D3 given to the mother. 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. 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 is unlikely. Undesirable effects: Uncommon (>1/1,000 and <1/100): hypercalcaemia and hypercalciuria; rare (>1/10,000 and <1/1,000): pruritus, rash and urticaria. Overdose: Refer to SPCs. Legal Category: These products are subject to medical prescription. MIMS Ireland Price: THORENS 10 000 I.U./ml oral drops, solution: €6.63 per bottle. THORENS 25 000 I.U. oral solution: €7.97 per 4-pack. MA Number: THORENS 10 000 I.U./ml oral drops, solution: PA 22680/5/1. THORENS 25 000 I.U. oral solution: PA 22680/5/2. Full prescribing information available from the MA Holder: Galen Pharma Ireland Limited, Finnabair Industrial Estate, Dundalk, Co Louth, Ireland. Date of Preparation: February 2023.

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