Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
ATORVASTATIN AS CALCIUM TRIHYDRATE; EZETIMIBE
ORGANON PHARMA ISRAEL LTD., ISRAEL
C10BA05
FILM COATED TABLETS
ATORVASTATIN AS CALCIUM TRIHYDRATE 20 MG; EZETIMIBE 10 MG
PER OS
Required
ORGANON LLC, USA
ATORVASTATIN AND EZETIMIBE
- Prevention of Cardiovascular EventsAtozet is indicated to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), either previously treated with a statin or not.- HypercholesterolaemiaAtozet is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate• patients not appropriately controlled with a statin alone• patients already treated with a statin and ezetimibe- Homozygous Familial Hypercholesterolaemia (HoFH)Atozet is indicated as adjunctive therapy to diet for use in adults with HoFH. Patients may also receive adjunctive treatments (e.g., low-density lipoprotein [LDL] apheresis).
2021-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is marketed upon doctor's prescription only ATOZET ® 10 MG/10 MG ATOZET ® 10 MG/20 MG ATOZET ® 10 MG/40 MG ATOZET ® 10 MG/80 MG FILM-COATED TABLETS Each film-coated tablet contains: Ezetimibe 10 mg and atorvastatin (as calcium trihydrate) 10 mg, 20 mg, 40 mg or 80 mg. For a list of inactive ingredients see section 6 "Further information". See also section 2.8, “Important information about some of the ingredients of ATOZET”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • This leaflet contains concise information about ATOZET. If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. • ATOZET is intended for treatment of adults above 18 years of age. 1. WHAT ATOZET IS INTENDED FOR? ATOZET is used in combination with a diet, • for the treatment of primary hypercholesterolaemia [heterozygous familial and non-familial] or to decrease elevated fat levels in the blood (mixed hyperlipidaemia) in adult patients: • that are not well controlled with a statin alone; or • are already treated with statin and ezetimibe • for the treatment of adult patients with a hereditary illness (homozygous familial hypercholesterolaemia). The treatment may be given in combination with other treatments. • If you have heart disease, to reduce the risk of cardiovascular events (as heart attack, stroke, surgery to increase heart blood flow, or hospitalisation for chest pain). THERAPEUTIC GROUP: Ezetimibe belongs to a group of medicines called _CAI_ (Cholesterol absorption Inhibitors), which inhibits the intestinal absorption of cholesterol. Atorvastatin belongs to a group of medicines called statins, which are HMG-CoA reductase enzyme inhibitors. ATOZET works to reduce your cholesterol in two ways. It reduces cholesterol absorption in yo Lestu allt skjalið
1. NAME OF THE MEDICINAL PRODUCT ATOZET® 10 mg/10 mg ATOZET® 10 mg/20 mg ATOZET® 10 mg/40 mg ATOZET® 10 mg/80 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of ezetimibe and 10, 20, 40 or 80 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipient(s) with known effect Each 10 mg/10 mg film-coated tablet contains 153 mg of lactose. Each 10 mg/20 mg film-coated tablet contains 179 mg of lactose. Each 10 mg/40 mg film-coated tablet contains 230 mg of lactose. Each 10 mg/80 mg film-coated tablet contains 334 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 10 mg/10 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated, size 12.74 mm x 5.10 mm, “257” debossed on one side 10 mg/20 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated, size 14.48 mm x 5.79 mm, “333” debossed on one side 10 mg/40 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated, size 16.38 mm x 6.27 mm, “337” debossed on one side 10 mg/80 mg tablet: Capsule-shaped, biconvex, white to off-white, film-coated, size 19.05 mm x 7.94 mm, “357” debossed on one side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Prevention of Cardiovascular Events _ ATOZET is indicated to reduce the risk of cardiovascular events (see section 5.1) in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), either previously treated with a statin or not. _Hypercholesterolaemia _ ATOZET is indicated as adjunctive therapy to diet for use in adults with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate. • patients not appropriately controlled with a statin alone • patients already treated with a statin and ezetimibe _Homozygous Familial Hypercholesterolaemia (HoFH) _ 2 ATOZET is indicated as adjunctive therapy to diet for use in adults with HoFH. Patients may also receive Lestu allt skjalið