Description
Vigantol is a medicinal product containing vitamin D (cholecalciferol), which supports normal development and maintenance of strong bones. The product is suitable for use from the first day of life.
Composition
Vigantol, 500 micrograms/ml (20,000 IU), oral drops, solution.
1 ml (40 drops) contains 500 µg of cholecalciferol (equivalent to 20,000 IU of vitamin D₃).
One drop contains 12.5 µg of cholecalciferol (equivalent to 500 IU of vitamin D₃).
Dosage
This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
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Newborns and infants (up to 12 months): 1 drop daily (equivalent to 500 IU of vitamin D). In preterm infants, newborns and infants, the product should be administered under medical supervision.
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Adults, adolescents, and elderly patients: 1 drop of Vigantol solution daily (equivalent to 500 IU of vitamin D).
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Adjunct treatment of osteoporosis in adults: 2 drops daily (equivalent to 1,000 IU of vitamin D).
Do not use the medicinal product long-term or in higher doses without medical supervision.
Pharmacological Action
Vitamin D₃ (cholecalciferol):
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Supports proper mineralisation of bones and teeth.
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Helps maintain normal blood levels of calcium and phosphorus.
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Supports normal muscle function.
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Strengthens the immune system.
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Contributes to normal functioning of the nervous system.
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Plays a role in cell division processes.
Indications
VIGANTOL 500 µg oral drops is indicated for:
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Prevention of rickets and osteomalacia in children and adults.
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Prevention of rickets in preterm infants.
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Prevention of conditions related to vitamin D deficiency risk in children and adults.
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Prevention of vitamin D deficiency in children and adults.
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Adjunct treatment of osteoporosis in adults.
Contraindications
Do not use this medicine:
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If you are allergic to the active substance or any of the excipients.
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In cases of hypercalcaemia or hypercalciuria.
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If you have renal calculi or severe renal impairment.
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In cases of pseudohypoparathyroidism.
Adverse Reactions
Like all medicines, this product may cause side effects, although not everybody gets them.
Possible side effects include:
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Gastrointestinal symptoms: constipation, flatulence, nausea, abdominal pain, diarrhoea.
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Hypersensitivity reactions: skin itching, rash, urticaria.
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Prolonged use of high doses: hypercalcaemia (elevated calcium levels in blood) and hypercalciuria (excessive urinary calcium excretion).
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Rarely, fatal outcomes have been reported.
Warnings and Precautions
Before using Vigantol, consult a doctor or pharmacist.
Vigantol should be used under medical supervision:
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If the patient is taking other medicinal products containing vitamin D, as additional supplementation should only occur under medical supervision.
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If the patient has sarcoidosis (an immune system disease that may increase vitamin D levels in the body).
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If the patient has impaired renal function.
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If the patient is being treated with cardiac glycosides or diuretics.
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In newborns, infants and young children.
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During long-term therapy, serum and urinary calcium levels, as well as renal function (creatinine levels), should be monitored.
Use with Other Medicinal Products
Inform your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
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Aluminium-containing antacids taken with Vigantol may increase aluminium blood levels, raising the risk of aluminium-induced bone toxicity.
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Magnesium-containing antacids taken with Vigantol may increase blood magnesium levels.
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Certain antiepileptic, sedative or hypnotic medicines (containing phenytoin or barbiturates) may reduce the effectiveness of Vigantol.
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Some thiazide diuretics may lead to hypercalcaemia due to reduced calcium excretion. Long-term treatment requires calcium monitoring in serum and urine.
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Glucocorticosteroids may reduce the effect of Vigantol.
Pregnancy and Breast-Feeding
If you are pregnant or breastfeeding, consult your doctor before using this medicine.
Vigantol may be taken during pregnancy only under medical supervision.
Excessive vitamin D intake during pregnancy may lead to physical and mental developmental impairment, heart defects, and retinal abnormalities in the child.
Use in Children and Adolescents
The product may be used from the first day of life.
Effects on Ability to Drive and Use Machines
Vigantol has no influence on the ability to drive or operate machinery.
