Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Ezetimibe 10mg; Simvastatin 20mg;
Viatris Limited
Ezetimibe 10 mg
10mg/20mg
Tablet
Active: Ezetimibe 10mg Simvastatin 20mg Excipient: Ascorbic acid Butylated hydroxyanisole Citric acid monohydrate Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate
Prescription
Mylan Laboratories Limited
Primary Hypercholesterolaemia Zimybe is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia in patients not adequately treated on a statin alone. Homozygous Familial Hypercholesterolaemia (HoFH) Zimybe is indicated for the reduction of elevated total-C and LDL-C levels in adult and adolescent (10 to 17 years of age) patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).
Package - Contents - Shelf Life: Blister pack, PVC/Aclar/Al - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C
2013-01-07
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION ZIMYBE ® 10/10, 10/20, 10/40 & 10/80 _EZETIMIBE/SIMVASTATIN TABLETS_ _10MG/10MG, 10MG/20MG, 10MG/40MG & 10MG/80MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Zimybe. This leaflet answers some common questions about Zimybe. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Zimybe against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZIMYBE IS USED FOR Zimybe helps to lower cholesterol and triglyceride levels. It is used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. Zimybe contains the active ingredients ezetimibe and simvastatin._ _ It works by reducing elevated total cholesterol, LDL cholesterol and triglycerides, and increasing HDL cholesterol. Zimybe works by decreasing the absorption of cholesterol in the small intestine and by reducing the amount of cholesterol made in the liver. Zimybe does not help you to lose weight. Your doctor may have prescribed it for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. This medicine is not addictive. ZIMYBE IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER 10 YEARS OF AGE. _CHOLESTEROL_ Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol. LDL cholesterol is often called ‘bad’ cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build- up can lead to narrowing of the arteries. This narrowing can slow Przeczytaj cały dokument
Page 1 of 42 NEW ZEALAND DATA SHEET ZIMYBE ® 10/10; ZIMYBE ® 10/20; ZIMYBE ® 10/40 AND ZIMYBE ® 10/80 1. PRODUCT NAME Zimybe 10/10, Zimybe 10/20, Zimybe 10/40 or Zimybe 10/80, tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg ezetimibe and 10, 20, 40 or 80 mg of simvastatin. Excipient(s) with known effect: lactose. Allergen declaration: sugars as lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Zimybe 10/10: A white to off-white, oval, biconvex tablet debossed with M on one side of the tablet and ES1 on the other side, containing 10 mg ezetimibe and 10 mg simvastatin. Zimybe 10/20: A white to off-white, oval, biconvex tablet debossed with M on one side of the tablet and ES2 on the other side, containing 10 mg ezetimibe and 20 mg simvastatin. Zimybe 10/40: A white to off-white, oval, biconvex tablet debossed with M on one side of the tablet and ES3 on the other side, containing 10 mg ezetimibe and 40 mg simvastatin. Zimybe 10/80: A white to off-white, oval, biconvex tablet debossed with M on one side of the tablet and ES4 on the other side, containing 10 mg ezetimibe and 80 mg simvastatin. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ PRIMARY HYPERCHOLESTEROLAEMIA Zimybe is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia in patients not adequately treated on a statin alone. HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH) Zimybe is indicated for the reduction of elevated total-C and LDL-C levels in adult and adolescent (10 to 17 years of age) patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheres Przeczytaj cały dokument