Země: Malta
Jazyk: angličtina
Zdroj: Malta Medicines Authority
Auxilto Healthcare s.r.o. Bucharova 2657/12, Stodulky 158 00 Praha 5 , Czech Republic
A10BD07
METFORMIN HYDROCHLORIDE 850 mg SITAGLIPTIN 50 mg
FILM-COATED TABLET
METFORMIN HYDROCHLORIDE 850 mg SITAGLIPTIN 50 mg
POM
DRUGS USED IN DIABETES
Licence number in the source country: NOT APPLICAPABLE
Authorised
2023-05-18
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN/METFORMIN AUXILTO 50 MG/850 MG FILM-COATED TABLETS SITAGLIPTIN/METFORMIN AUXILTO 50 MG/1000 MG FILM-COATED TABLETS sitagliptin/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 Sitagliptin/Metformin Auxilto is and what it is used for 2. What you need to know before you take Sitagliptin/Metformin Auxilto 3. How to take Sitagliptin/Metformin Auxilto 4. Possible side effects 5. How to store Sitagliptin/Metformin Auxilto 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN/METFORMIN AUXILTO IS AND WHAT IT IS USED FOR Sitagliptin/Metformin Auxilto contains two different medicines called sitagliptin and metformin. • sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) • metformin belongs to a class of medicines called biguanides. They work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus’. This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body. Along with diet and exercise, this medicine helps lower your blood sugar. This medicine can be used alone or with certain other medicines for diabetes (insulin, sulphonylureas, or glitazones). What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as w Přečtěte si celý dokument
Page 1 of 21 1. NAME OF THE MEDICINAL PRODUCT Sitagliptin/Metformin Auxilto 50 mg/850 mg film-coated tablets Sitagliptin/Metformin Auxilto 50mg/1000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sitagliptin/Metformin Auxilto 50 mg/850 mg film-coated tablets Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride. Sitagliptin/Metformin Auxilto 50mg/1000 mg film-coated tablets Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Sitagliptin/Metformin Auxilto 50 mg/850 mg film-coated tablets Pink, oblong oval-shaped film-coated tablets with a score line on one side and ‘SA’ on the other side. Tablet diameter: 19.5 ± 0.5mm Sitagliptin/Metformin Auxilto 50mg/1000 mg film-coated tablets Red to brown, oblong oval-shaped film-coated tablets with a scoreline in between ‘S’ and ‘B’ on one side and with a scoreline on the other side. Tablet diameter: 21.3 ± 0.5mm The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin Auxilto is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Sitagliptin/Metformin Auxilto is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Sitagliptin/Metformin Auxilto is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR ) agonist (i.e., a thiazolidinedione) as an adjunct to Page 2 of Přečtěte si celý dokument