Minalip Plus 10/40 mg - 7 Tablet

Combination therapy consisting of two antilipidemic agents; ezetimibe and the HMG-CoA Reductase Inhibitor; simvastatin used in the treatment of hypercholesterolemia.

-Administered without regard to meals. -Administer in the evening for maximal efficacy. -Ezetimibe/simvastatin should be taken ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

Side effects due to Simvastatin: -Increased serum transaminases and hepatotoxicity, myalgia, myopathy and rhabdomyolysis. -Atrial fibrillation, edema, eczema, abdominal pain, constipation, gastritis, nausea, cystitis, increased serum transaminases, headache, vertigo, increased creatine phosphokinase in blood specimen, bronchitis, upper respiratory infection, skin rash, increased gamma-glutamyl transferase, diarrhea, dyspepsia, flatulence, increased serum alkaline phosphatase and asthenia. Side effects due to Ezetimibe: -Increased serum transaminases and hepatotoxicity, myalgia, myopathy and rhabdomyolysis. -Arthralgia, sinusitis, upper respiratory tract infection and increase in gamma-glutamyl transferase.

-Should not be given to patients suffering from hypersensitivity to ezetimibe or simvastatin. -May cause an increase in HbA1c and fasting blood glucose. -Use with caution in patients who consume large amounts of ethanol and/or have a history of liver disease. -May rarely worsen or precipitate myasthenia gravis. -Use with caution in patients with severe renal impairment. -Use with caution in patients ≥65 years of age; these patients are predisposed to myopathy. -ezetimibe/simvastatin has not been studied in patients <10 years of age or in premenarchal girls. -Coadministration of ezetimibe/simvastatin with niacin ≥1 g/day is not recommended in Chinese patients; it is not known if this also applies to other Asian patients; because, there is an increased risk of myopathy. -In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

Store at room temperature.

Interactions due to Simvastatin: -Amiodarone: May increase serum concentrations of the active metabolite(s) of Simvastatin. -Amlodipine: May increase the serum concentration of Simvastatin. -Azithromycin: May enhance the myopathic (rhabdomyolysis) effect of Simvastatin. -Ciprofloxacin: May enhance the myopathic (rhabdomyolysis) effect of Simvastatin. -Colchicine: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). -Dabigatran Etexilate: Simvastatin may enhance the anticoagulant effect of Dabigatran Etexilate. -Digoxin: Simvastatin may increase the serum concentration of Digoxin. -Diltiazem: Simvastatin may decrease the serum concentration of Diltiazem. -Erythromycin: May increase serum concentrations of the active metabolite(s) of Simvastatin. -Fenofibrate and Derivatives: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors. -Fosphenytoin-Phenytoin: May decrease the serum concentration of HMG-CoA Reductase Inhibitors. -Grapefruit Juice: May increase the serum concentration of Simvastatin. -Niacin: May enhance the myopathic (rhabdomyolysis) effect of Simvastatin. -Red Yeast Rice: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors. -Rifampin: May decrease the serum concentration of Simvastatin. -St John's Wort: May decrease serum concentrations of the active metabolite(s) of HMG-CoA Reductase Inhibitors. -Ticagrelor: May increase the serum concentration of Simvastatin. -Verapamil: May increase serum concentrations of the active metabolite(s) of Simvastatin. -Vitamin K Antagonists (eg, warfarin): HMG-CoA Reductase Inhibitors (Statins) may enhance the anticoagulant effect of Vitamin K Antagonists. Interactions due to Ezetimibe: -Bile Acid Sequestrants: May decrease the absorption of Ezetimibe. -Cyclosporine: Ezetimibe may increase the serum concentration of Cyclosporine. -Fenofibrate and Derivatives: May enhance the adverse/toxic effect of Ezetimibe.

-Use is contraindicated in pregnant women. -It is not known if ezetimibe or simvastatin are present in breast milk. Use is contraindicated in breastfeeding women. -Ask your physician before taking any medication during pregnancy or lactation.

ALFACURE PHARMACEUTICALS