Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
ATORVASTATIN AS CALCIUM TRIHYDRATE; EZETIMIBE
ORGANON PHARMA ISRAEL LTD., ISRAEL
C10BA05
FILM COATED TABLETS
ATORVASTATIN AS CALCIUM TRIHYDRATE 10 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 Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument