Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
Prevention and treatment of vitamin D deficiency in adults and adolescents. Vitamin D deficiency is defined as serum levels of 25-hydroxycolecalciferol (25(OH)D) <25 nmol/l.
In addition to specific osteoporosis treatment of patients who are at risk of vitamin D deficiency, preferably in combination with calcium.
Recommended dose: One tablet per day.
Higher dosed can be necessary in treatment of vitamin D deficiency, where 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 4000 IU (five tablets per day).
The safety and efficacy of Desunin in children under 12 years have not been established.
No dose adjustment is required.
Desunin should not be used in patients with severe renal impairment (see section 4.3).
The tablets can be swallowed whole or crushed. The tablets can be taken with food.
Overdose can lead to hyper-vitaminosis D. An excess of vitamin D causes abnormally high levels of calcium in the blood, which can eventually severely damage the soft tissues, and kidneys. Tolerable Upper Intake Level for vitamin D3 (colecalciferol) is set at 4000 IU (100 µg) per day. Vitamin D3 should not be confused with its active metabolites.
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.
Treatment of hypercalcaemia: The treatment with vitamin D 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. In severe cases, ECG and CVP should be followed.
3 years.
Do not store above 30°C.
Store the tablets in the original container, in order to protect from light. Keep the container tightly closed in order to protect from moisture.
30, 60, 90 in white opaque PVC/PVDC/aluminium blister in outer paper carton.
250 tablets in plastic containers of HDPE with LDPE snap on cap.
Not all pack sizes may be marketed.
No special requirements.
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