Prescribing information

PRESCRIBING INFORMATION

DESUNIN® PRESCRIBING INFORMATION

Presentation: Each Desunin tablet contains colecalciferol (vitamin D3) 800 IU (equivalent to 20 microgram vitamin D3). Each tablet also contains isomalt 91.0 mg and sucrose 1.68 mg.

Indications: Prevention and treatment of vitamin D deficiency in adults and adolescents. 

Dosage and administration: Recommended dose is one tablet per day. Higher doses can be necessary to achieve desirable serum levels of 25-hydroxycolecalciferol (25(OH)D). The daily dose should not exceed 5 tablets. The tablets can be swallowed whole or crushed. The tablets can be taken with food.

Contra-indications: Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria, nephrolithiasis, nephrocalcinosis, hypervitaminosis D and hypersensitivity to the active substance or to any of the excipients. 

Precautions: Prescribe with caution to patients suffering from sarcoidosis due to 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. During long-term treatment, serum 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 and in patients with a high tendency to calculus formation. In case of hypercalciuria (exceeding 300 mg [7.5 mmol]/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued. Use 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 also 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. The content of vitamin D in Desunin should be considered when prescribing other medicinal products containing vitamin D. Additional doses of 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. 
Contains sucrose and isomalt. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 

Interactions: Thiazide diuretics reduce the urinary excretion of calcium, excessive dosing of vitamin D can induce hypercalcaemia, glucocorticoid steroids may increase vitamin D metabolism and elimination, concomitant use of phenytoin or barbiturates may reduce the effect of vitamin D since metabolism can increase, simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.

Pregnancy and lactation: Use during pregnancy only in cases of vitamin D deficiency. Vitamin D passes into breast milk.

Undesirable effects: Serious (frequency not known): hypersensitivity reactions such as angio-oedema or laryngeal oedema, Rare: pruritus, rash and urticarial, Uncommon: hypercalcaemia and hypercalciuria. For complete information, consult the Summary of Product Characteristics.

Special precautions for storage: Do not store above 30oC, store the tablets in the original container, in order to protect from light. Keep the container tightly closed, in order to protect from moisture. 

Basic price (UK): 30 tablet pack £3.60, 90 tablet pack £10.17

Product licence number: 15142/0248

Legal category: POM

Marketing Authorisation Holder: Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU

Date of preparation of prescribing information: Aug 2015

UK/DES/13/0003(1)
 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Meda's Medical Information line on 01748 828810.

DESUNIN® 4,000IU (COLECALCIFEROL) PRESCRIBING INFORMATION

Presentation: Each Desunin 4,000IU tablet contains colecalciferol (vitamin D3) 4,000IU (equivalent to 100 microgram vitamin D3). Each tablet also contains isomalt 455.0 mg and sucrose 8.4 mg.

Indications: Treatment of vitamin D deficiency in adults and adolescents. 

Dosage and administration: Recommended dose is one tablet per day. The dose 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 should not exceed 4000IU (one tablet per day). The tablets can be swallowed whole or crushed. The tablets can be taken with food.

Contra-indications: Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria, nephrolithiasis, nephrocalcinosis, hypervitaminosis D and hypersensitivity to the active substance or to any of the excipients.

Precautions: Prescribe with caution to patients suffering from sarcoidosis due to 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. During long-term treatment, serum 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 and in patients with a high tendency to calculus formation. In case of hypercalciuria (exceeding 300 mg (7.5 mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued. Use with caution in patients with impairment of renal function and the effect of calcium and phosphate levels should be monitored. The risk of soft tissue calcification should also 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. The content of vitamin D in Desunin 4,000IU should be considered when prescribing other medicinal products containing vitamin D. Additional doses of 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. Contains sucrose and isomalt. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Interactions: Thiazide diuretics reduce the urinary excretion of calcium, excessive dosing of vitamin D can induce hypercalcaemia, glucocorticoids may increase vitamin D metabolism and elimination, concomitant use of phenytoin or barbiturates may reduce the effect of vitamin D since metabolism can increase, simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.

Pregnancy and lactation: Use during pregnancy only in cases of Vitamin D deficiency. Vitamin D passes into breast milk.

Undesirable effects: Serious (frequency not known): Hypersensitivity reactions such as angio-oedema or laryngeal oedema, Rare: Pruritus, rash and urticaria, Uncommon: Hypercalcaemia and hypercalciuria. For complete information, consult the Summary of Product Characteristics.

Special precautions for storage: Do not store above 30°C. Store the tablets in the original package in order to protect from light and moisture.

Basic price (UK): 70 tablet pack £15.90

Product licence number: 15142/0272

Legal category: POM

Marketing Authorisation Holder: Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU

Date of preparation of prescribing information: March 2016
UK/DES/16/0012


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Meda’s Medical Information line on 01748 828810