País: Israel
Idioma: anglès
Font: Ministry of Health
ATORVASTATIN AS CALCIUM
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
C10AA05
FILM COATED TABLETS
ATORVASTATIN AS CALCIUM 20 MG
PER OS
Required
PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY
ATORVASTATIN
ATORVASTATIN
Lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol LDL- cholesterol apolipoprotein B and triglycerides and to increase HDL Cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types IIa and IIb of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Lipitor is also indicated to reduce total-C and LDL -C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. LDL apheresis) or if such treatments are unavailable. Pediatric patients (10-17 years of age) : Atorvastatin is indicated as an adjunct to diet to reduce total -C LDL-C and apo B levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. LDL-C rema
2012-02-28
Lipitor PIL CC 100123 USPI 2022 - 12 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only LIPITOR ® 10 MG LIPITOR ® 20 MG LIPITOR ® 40 MG LIPITOR ® 80 MG FILM-COATED TABLETS ATORVASTATIN (AS CALCIUM) 10 MG, 20 MG, 40 MG, 80 MG For a list of inactive ingredients and allergens in this preparation: see section 2 "Important information about some of this medicine’s ingredients" and section 6 "Further information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? • To reduce blood lipid levels (cholesterol and triglycerides) and to increase HDL. • To prevent cardiovascular diseases (such as myocardial infarction or stroke) in patients at high risk for a primary event. • In patients with a coronary heart disease, Lipitor reduces the risk of myocardial infarction, stroke, hospitalization due to heart failure, angina pectoris and/or need for catheterization. THERAPEUTIC GROUP: Statins – HMG-CoA reductase enzyme inhibitors. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • you have liver problems (acute liver failure or decompensated cirrhosis) • you are sensitive (allergic) to the active ingredient or to any of the other ingredients contain the medicine (listed in section 6). Stop using the medicine and get medical help right away have signs of a serious allergic reaction including: o swelling of your face, lips, tongue or throat o difficulty breathing or swallowing o fainting or dizziness o very rapid heartbeat o severe skin rash or itching • o flu-like symptoms including fever, sore throat, cough, tiredness, and joint pain SPECIAL WARNINGS REGARDING US Llegiu el document complet
Lipitor LPD CC 100123 USPI 12-2022 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipitor 10 mg Lipitor 20 mg Lipitor 40 mg Lipitor 80 mg 2 THERAPEUTIC INDICATION HYPERCHOLESTEROLAEMIA LIPITOR is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides and to increase HDL-cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. LIPITOR is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. _ _ _ _ _Pediatric Patients (10-17 years of age) _ _ _ LIPITOR is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: a. LDL-C remains ≥ 190 mg/dL or b. LDL-C remains ≥ 160 mg/dL and: • there is a positive family history of premature cardiovascular disease or • two or more other CVD risk factors are present in the pediatric patient PREVENTION OF CARDIOVASCULAR DISEASE Prevention of cardiovascular and/or cerebrovascular events such as MI or stroke: as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. In patients with clinically evident coronary heart disease, LIPITOR is indicated to: Reduce the risk of non-fatal myocardial infarction Reduce the risk of fatal and non-fatal stroke Reduce the risk for revascularization procedures Reduce the risk of hospitalization for CHF Reduce the risk of angina 3 DOSAGE AND ADMIN Llegiu el document complet