Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
vildagliptin, metformin hydrochloride
Novartis Europharm Limited
A10BD08
vildagliptin, metformin
Drugs used in diabetes
Diabetes Mellitus, Type 2
Zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone.in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets.in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate.
Revision: 23
Authorised
2008-11-30
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOMARIST 50 MG/850 MG FILM-COATED TABLETS ZOMARIST 50 MG/1000 MG FILM-COATED TABLETS vildagliptin/metformin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET 1. What Zomarist is and what it is used for 2. What you need to know before you take Zomarist 3. How to take Zomarist 4. Possible side effects 5. How to store Zomarist 6. Contents of the pack and other information 1. WHAT ZOMARIST IS AND WHAT IT IS USED FOR The active substances of Zomarist, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”. Zomarist is used to treat adult patients with type 2 diabetes. This type of diabetes is also known as non-insulin-dependent diabetes mellitus. Zomarist is used when diabetes cannot be controlled by diet and exercise alone and/or with other medicines used to treat diabetes (insulin or sulphonylureas). Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should. It can also develop if the body produces too much glucagon. Both insulin and glucagon are made in the pancreas. Insulin helps to lower the level of sugar in the blood, especially after meals. Glucagon triggers the liver to make sugar, causing the blood sugar level to rise. HOW ZOMARIST WORKS Both active substances, vildagliptin and metformin, help to control the level of sugar in the blood. The substance vildagliptin works by making the pancreas p Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zomarist 50 mg/850 mg film-coated tablets Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin). Zomarist 50 mg/1000 mg film-coated tablets Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Zomarist 50 mg/850 mg film-coated tablets Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “SEH” on the other side. Zomarist 50 mg/1000 mg film-coated tablets Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: • in patients who are inadequately controlled with metformin hydrochloride alone. • in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. • in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults with normal renal function (_ GFR ≥ 90 ml/min _) _ The dose of antihyperglycaemic therapy with Zomarist should be individualised on the basis of the patient’s current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin. Zomarist may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet Przeczytaj cały dokument