Indications
Ezetimibe is indicated as adjunctive therapy to diet in patients: Primary hypercholesterolaemia (heterozygous familial and non-familial)
Monotherapy: in patients in whom a statin is considered inappropriate or is not tolerated.
Co-administered with an HMG-CoA reductase inhibitor (statin): in patients who are not appropriately controlled with a statin alone.
Homozygous familial hypercholesterolaemia: Co-administered with a statin. Homozygous familial sitosterolaemia.
Contraindications
Known hypersensitive to any of the active substance or excipients of the product.
Therapy with a statin is contraindicated during pregnancy and lactation, in active liver disease or unexplained persistent elevations in serum transaminases.
Compositon/Ingredients
Ezetimibe 10mg
Dosage and administration
The recommended dose is one tablet daily.
Ezetimibe is not recommended for use in children below age 10.
An appropriate lipid-lowering diet should continue during treatment.
Precaution
When ezetimibe is co-administered with a statin, liver function test should be performed at initiation of therapy and according to the recommendation of the statin.
If myopathy is suspected, drugs should be immediately discontinued.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ezetimibe should be given to pregnant women only if clearly necessary.
Ezetimibe should not be used during lactation.
Patients should be aware of how they react to drug before driving or operating machinery.
Storage
Store at temperature below 30°C, protect from light.
