Thorens® Hard Capsules

Prescribing Information

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THORENS 25 000 IU capsules, hard: Please refer to the Summary of Product Characteristics (SPC) before prescribing.

Abbreviated Prescribing Information.

Presentation: Hard gelatin capsule filled with oily solution. Transparent body and white cap, with a green band. One capsule contains 625 micrograms colecalciferol equivalent to 25,000 IU.

Indications: Initial treatment of clinically relevant vitamin D deficiency in adults.

Dosage and administration: Dosage must be determined individually by the treating doctor depending on the extent of the necessary vitamin D supplementation. The dose should be adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), severity of the disease and patients response to treatment. Adults: One capsule (25 000 I.U.) weekly. After first month, lower doses may be considered. Following initial treatment, maintenance therapy may be required with a dose determined individually by the treating doctor. Alternatively, national dosage recommendations in treatment of vitamin D deficiency can be followed. Children and adolescents under 18 years: Not recommended. Pregnancy and breastfeeding: Not recommended. No dose adjustment is required in patients with hepatic impairment. THORENS must not be used in patients with severe renal impairment. The capsules should be swallowed whole preferably with a meal.

Contraindications: Hypersensitivity to the active ingredient or any of the excipients. 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. Particular caution is required in patients treated with benzothiadiazine derivatives and in immobilized patients (risk of hypercalcaemia and hypercalciuria); plasma and urinary calcium levels should be monitored in these patients. 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 D, foods enriched with vitamin D3, milk enriched with vitamin D 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. THORENS should not be taken if pseudohypoparathyroidism is present. In such cases, more manageable vitamin D derivatives are available.

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. Rifampicin may reduce the effectiveness of colecalciferol due to hepatic enzyme induction. Isoniazid may reduce the effectiveness of colecalciferol due to inhibition of the metabolic activation of colecalciferol.

Fertility, pregnancy and lactation: THORENS 25.000 IU capsules is not recommended in pregnancy and lactation. A low strength formulation should be used. There are no or limited amount of data from the use of colecalciferol in pregnant women. Studies in animals have shown reproductive toxicity. 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 SPC.

Legal category: POM

NHS Price: Pack of 3 capsules: £3.16; 12 capsules: £13.60.

MA Number: PL 27827/0044.

Full prescribing information available from the MA Holder: Galen Limited, Seagoe Industrial Estate, Craigavon, Northern Ireland, BT63 5UA, UK.

Date of Preparation: November 2020.