Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
sitagliptin hydrochloride monohydrate, metformin hydrochloride
Mylan Ireland Limited
A10BD07
sitagliptin hydrochloride monohydrate, metformin hydrochloride
Drugs used in diabetes
Diabetes Mellitus, Type 2
For adult patients with type 2 diabetes mellitus:Sitagliptin/Metformin hydrochloride Mylan 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 hydrochloride Mylan 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 hydrochloride Mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARg agonist.Sitagliptin/Metformin hydrochloride Mylan is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Revision: 2
Authorised
2022-02-16
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SITAGLIPTIN/METFORMIN HYDROCHLORIDE MYLAN 50 MG/850 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 hydrochloride Mylan is and what it is used for 2. What you need to know before you take Sitagliptin/Metformin hydrochloride Mylan 3. How to take Sitagliptin/Metformin hydrochloride Mylan 4. Possible side effects 5. How to store Sitagliptin/Metformin hydrochloride Mylan 6. Contents of the pack and other information 1. WHAT SITAGLIPTIN/METFORMIN HYDROCHLORIDE MYLAN IS AND WHAT IT IS USED FOR Sitagliptin/Metformin hydrochloride Mylan 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 Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sitagliptin/Metformin hydrochloride Mylan 50 mg/850 mg film-coated tablets Sitagliptin/Metformin hydrochloride Mylan 50 mg/1,000 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sitagliptin/Metformin hydrochloride Mylan 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 hydrochloride Mylan 50 mg/1,000 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 hydrochloride Mylan 50 mg/850 mg film-coated tablets A pink, capsule shaped, biconvex, bevelled edge tablet, debossed with ‘M’ on one side of the tablet and ‘SM5’ on the other side. Dimension: approximately 20 mm X 10 mm. Sitagliptin/Metformin hydrochloride Mylan 50 mg/1,000 mg film-coated tablets A peach to brown, capsule shaped, biconvex, bevelled edge tablet, debossed with ‘M’ on one side of the tablet and ‘SM7’ on the other side. Dimension: approximately 21 mm X 10 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin hydrochloride Mylan 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 hydrochloride Mylan 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 hydrochloride Mylan is indicated as triple combination ther Lugege kogu dokumenti