Land: Israel
Språk: engelsk
Kilde: Ministry of Health
ATORVASTATIN AS CALCIUM TRIHYDRATE; EZETIMIBE
K.S.KIM INTERNATIONAL LTD
C10BA05
FILM COATED TABLETS
EZETIMIBE 10 MG; ATORVASTATIN AS CALCIUM TRIHYDRATE 80 MG
PER OS
Required
ELPEN PHARMACEUTICAL CO. INC., GREECE
ATORVASTATIN AND EZETIMIBE
- Prevention of Cardiovascular EventsEzator S.K. 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.- HypercholesterolaemiaEzator S.K. 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)Ezator S.K. 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).
2022-11-21
Patient leaflet IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicinal product is dispensed with a doctor’s prescription only EZATOR S.K. 10 MG/10 MG EZATOR S.K. 10 MG/20 MG EZATOR S.K. 10 MG/40 MG EZATOR S.K. 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, please see Section 6, “Further information”. See also Section 2.8, “Important information about some of the ingredients of EZATOR S.K..” READ ALL OF THE LEAFLET CAREFULLY BEFORE USING THE MEDICINAL PRODUCT. • This leaflet contains concise information about EZATOR S.K.. If you have more questions, ask your doctor or pharmacist. • This medicinal product has been prescribed for your treatment. Do not pass it on to others. It may harm them even if it seems that their medical condition is similar to yours. • EZATOR S.K. is intended for the treatment of adults over the age of 18 years. 1. WHAT Ezator S.K. is and what it is used for EZATOR S.K. is used, in combination with diet, • for the treatment of primary heterozygous familial and non-familial] hypercholesterolemia or to reduce high levels of blood lipids (combined hyperlipidemia) in adults patients who are: • not balanced using statin only; or • already treated using statin and ezetimibe • for the treatment of adult patients with hereditary disease (homozygous familial hypercholesterolemia). The treatment may be administered in combination with other treatments. • in the event of heart disease, to reduce the risk of cardiovascular events (such as heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain). THERAPEUTIC GROUP: Ezetimibe belongs to a group of medicines called _CAIs_ (cholesterol absorption inhibitors), which delay the absorption of cholesterol in the intestines. Atorvastatin belongs to a group of medicines called statins, which are inhibitors of the enzyme HMG- Les hele dokumentet