** Atoreza® 10/20 (Atorvastatin 20 mg … Ezetimibe 10 mg) 21 Film-Coated tablets.

** Composition: Each film-coated contains: Atorvastatin calcium 21.7 mg (Eq. to Atorvastatin 20 mg) Ezetimibe 10 mg

** Indications and Usage:

# In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or family history of early coronary heart disease, Atoreza is indicated to: – Reduce the risk of myocardial infarction. – Reduce the risk of stroke. – Reduce the risk of revascularization procedures and angina.

# In patients with clinically evident coronary heart disease, Atoreza is indicated to: – Reduce the risk of non-fatal myocardial infarction. – Reduce the risk of fatal and non-fatal stroke. – Reduce the risk of revascularization procedures. – Reduce the risk of hospitalization for CHF. – Reduce the risk of angina.

# Hypercholesterolemia: Atoreza is indicated: 1. as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson Types IIa and IIb); 2. as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV); 3. for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

** Contraindications: – Patients with known hypersensitivity to Atorvastatin and/or Ezetimibe. – Evidence of acute liver disease or unexplained persistent elevations of serum transaminase.

** Dosage and Administration: The Fixed Dose Combination (FDC) is recommended for oral administration as once daily therapy or as directed by the physician. The patient should be placed on standard cholesterol lowering diet before receiving Atoreza and should be continued on this diet during treatment. Atoreza can be administered as a single dose at any time of the day with or without food. Therapy should be individualized according to goal of the therapy and response. After initiation of the therapy, lipid levels should be analyzed within 2-4 weeks and dose adjusted accordingly.

** Store at temperature not exceeding 25 degrees C, in a dry place. Keep out of reach of children.

** Manufactured by: Marcyrl Pharmaceutical Industries, El Obour City – Egypt