Composition
Each capsule contains:
The equivalent of 40 mg fluvastatin free acid.

Properties / Actions
Fluvastatin is a fully synthetic cholesterol-lowering agent. In patients with hypercholesterolaemia and mixed dyslipidaemia, Lescol reduces total cholesterol, LDL –cholesterol, apolipoprotein- B and triglycerides, and increases HDL cholesterol, as an adjunct to diet.

Indications
Lescol is indicated as an adjunct to diet in patients with primary hypercholesterolaemia and mixed dyslipidaemia. Lescol is also indicated to slow the progression of coronary atherosclerosis in patient with primary hypercholesterolaemia, including mild forms, and coronary heart disease.

Dosage and administration
Prior to initiating treatment with Lescol the patient should be placed on a standard cholesterol-lowering diet. Dietary therapy should be continued during treatment. The recommended starting dose is 40 mg once daily, may be taken in the evening or at bedtime without regard to meals, and swallowed whole with a glass of water. Starting doses should be individualized according to baseline LDL cholesterol levels; dosage may be increased to 40 mg twice daily to accomplish the recommended goal of therapy. Doses should be adjusted according to the patient’s response and dose adjustment made at intervals of 4 weeks or more. The therapeutic effect of Lescol is maintained with prolonged administration. Lescol is efficacious as monotherapy. Data exist to support the efficacy and safety of fluvastatin in combination with nicotinic acid, cholestyramine, or fibrates.

Contraindications
Known hypersensitivity to fluvastatin or any of the excipients. Active liver disease, or unexplained, persistent elevations in serum transaminases. Pregnancy and lactation, women of childbearing potential not taking adequate contraceptive precautions.

Precautions
Caution is required in patients with a history of liver disease or heavy alcohol ingestion. As there is no experience with the use of fluvastatin in individuals less than 18 year of age, its use cannot be recommended in such patients. Lescol therapy should be discontinued if markedly elevated Creatine Phosphokinase levels occur, or myopathy is diagnosed or suspected.

Adverse reaction
Lescol is generally well tolerated, adverse events are usually mild and transient: dyspepsia, insomnia, nausea, abdominal pain, headache and minor gastrointestinal symptoms. Rare cases of hypersensitivity reactions, mainly rash and urticaria. Myalgia, muscle tenderness/ weakness, myopathy. Elevation of transaminase and CPK levels.

Interactions
Bile acid sequestrants. Lescol should not be given for at least 4 hours after the resin (e.g. cholestramine) to avoid a significant interaction due to drug binding of the resin.
Rifampicin For patients undertaking long-term rifampicin therapy, appropriate adjustment of fluvastatin dosage may be warranted to ensure a satisfactory reduction in lipid levels (reduction of the bioavailability of Fluvastatin by about of 50%).
Warfarin It is recommended that prothrombin times are monitored when fluvastatin treatment is initiated, discontinued or the dosage changed in patients receiving warfarin
Phenytoin Routine monitoring of phenytoin plasma levels is sufficient during co-administration with fluvastatin.

Overdosage
No specific recommendations concerning the treatment of an overdosage can be made. Should an overdosage occur, it should be treated symptomatically and supporting measures should be undertaken as required.

Storage
Do not store above 25° C. Keep out of the reach of children.

Packing
21 capsules