el-GRen-US

 

Name of the medicinal product: IPRAMID

Content: Each tablet contains 40 mg of Simvastatin

Pharmaceutical Form: Film-coated tablets

Pharmacotherapeutic group: HMG-CoA reductase inhibitor

Packaging Description: Carton containing 30 film-coated tablets placed in PVC / Aluminium blisters.

IPRAMID reduces levels of cholesterol and triglycerides in your blood. It belongs to the class of medicines called hydroxymethylglutaryl - coenzyme A reductase (HMG - CoA) inhibitors.
Cholesterol may cause heart disease, occluding the blood vessels that carry oxygen and nutrients to the heart. This clogging or hardening of the arteries is called atherosclerosis. Atherosclerosis can result in chest pain (angina) and heart attack.
If you have heart disease, your doctor has prescribed IPRAMID to slow the progression of atherosclerosis, reduce the incidence of cardiovascular events and to reduce the risk of heart attack.
Hypercholesterolemia: Treatment of primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet when the response to diet and other pharmacological agents (e.g. exercise, weight reduction) is inadequate. Treatment of homozygous familial hypercholesterolemia as an adjunct to diet and other treatments, lowering lipids (eg LDL-apheresis) or if such treatments are not appropriate.

Cardiovascular prevention: Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy.
  • Hypersensitivity to simvastatin or any of the excipients
  • Active liver disease or unexplained persistent elevations of serum transaminases
  • Pregnancy and lactation
  • If you receive one of the following medicines:
    • antifungals itraconazole or ketoconazole
    • antibiotics erythromycin, clarithromycin or telithromycin
    • HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and saquinavir)
    • the antidepressant nefazodone
  • Hypercholesterolemia: Before starting with IPRAMID treatment you should undergo dietary treatment for lowering cholesterol and if the response to diet and other nonpharmacological means prove ineffective, then continue with this diet and receive parallel treatment with IPRAMID, as your doctor recommends. Doses are individualized by your doctor depending on the initial levels of LDL cholesterol and the desired treatment goal and your response to the drug. The usual starting dose is 10-20mg once daily in the evening. Patients who require a large reduction in LDL levels (greater than 45%) may start treatment with 20-40mg / day, administered as a single dose in the evening. The maximum dose is 80mg / daily . The dose of 80mg is only recommended in patients with severe hypercholesterolaemia and high risk for cardiovascular complications. The dosage range is 5 - 80 mg daily. The dose adjustment should be made at intervals of not less than 4 weeks to a maximum dose of 80mg / day given as a single dose in the evening.
  • Homozygous familial hypercholesterolaemia: Based on the results of a controlled clinical study, the recommended dosage for patients with homozygous familial hypercholesterolemia is 40 mg / day in the evening or 80 mg / day divided into three doses, both of 20 mg during the day and a dose of 40 mg in the evening. The IPRAMID be used in these patients as an adjunct to other lipid-lowering treatments (eg LDL apheresis) or if such treatments are unavailable
  • Cardiovascular prevention: The usual dose of IPRAMID is 20 to 40 mg / day given as a single dose in the evening in patients at high risk for coronary heart disease (CHD, with or without hyperlipidaemia). The drug treatment can begin simultaneously with diet and exercise. Adjustments of dosage, if required, should be made as specified above.
    Combined therapy: IPRAMID is effective alone or when used in combination with binding resins of bile acids. Administration should be either two hours before or four hours after administration of a bile acid sequestrant.
    In patients receiving, concomitant with IPRAMID, cyclosporine, danazol, gemfibrozil, or other fibrates (except fenofibrate) or niacin doses, lowering lipids (1g / day), the dosage of IPRAMID should not exceed 10mg / day.
    In patients treated with amiodarone or verapamil simultaneously with the dosage of IPRAMID, IPRAMID should not exceed 20mg / day.
    In patients taking amiodarone or verapamil concomitantly with IPRAMID, the dosage of IPRAMID should not exceed 20mg daily.