Ország: Örményország
Nyelv: angol
Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
glimepiride, metformin (metformin hydrochloride)
Handok Inc.
A10BD02
glimepiride, metformin (metformin hydrochloride)
2mg+ 500mg
tablets prolonged-release
(30/3x10/) in blister
Prescription
Registered
2018-05-30
_GLIMEPIRIDE / METFORMIN HYDROCHLORIDE_ Prolonged-release film-coated tablets 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. You should 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 AMARYL M SR is and what it is used for 2. What you need to know before you take AMARYL M SR 3. How to take AMARYL M SR 4.Possible side effects 5.How to store AMARYL M SR 6. Contents of the pack and other information 1.WHAT AMARYL M SR IS AND WHAT IT IS USED FOR PHARMACOTHERAPEUTIC GROUP AND THERAPEUTIC INDICATIONS AMARYL M SR is a medicine taken by mouth to help lower blood sugar. AMARYL M SR is used, with diet and physical exercise, to treat a certain form of diabetes (type 2 diabetes mellitus): - in case the use of glimepiride or metformin alone does not control your blood glucose level, - in place of taking the combination of glimepiride tablet with a metformin tablet. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMARYL M SR CONTRAINDICATIONS DO NOT TAKE AMARYL M SR: - if you have insulin-dependent diabetes (type 1 diabetes mellitus), - if you have diabetic ketoacidosis (a complication of diabetes when your acid level is raised in your body and you may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness), - if you are in a diabetic pre-coma, - if you are allergic (hypersensitive) to glimepiride or metformin hydrochloride, or any of the other ingredients of AMARYL M SR (listed in section 6 under “Contents of the pack and other information”), to sulfonamides (medicines for bacterial infection Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amaryl M SR 2mg/500mg prolonged-release film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH TABLET CONTAINS: Active ingredients: Glimepiride 2mg Metformin 500mg Excipients: lactose monohydrate, povidone K30, hypromellose, magnesium stearate, macrogol, titanium dioxide, sodium laurilsulfate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM prolonged-release film-coated tablets 4. CLINICAL PARTICULARS 4.1.THERAPEUTIC INDICATIONS _For Glimepiride and Metformin: _As an adjunct to diet and exercise in type 2 diabetes mellitus patients In case that the monotherapy with glimepiride or metformin does not result in adequate glycemic control Replacement of combination therapy of glimepiride or metformin 4.2.POSOLOGY AND METHOD OF ADMINISTRATION In principle, THE DOSAGE OF AMARYL M SR IS GOVERNED BY THE DESIRED BLOOD GLUCOSE LEVEL. THE DOSAGE OF AMARYL M SR MUST BE THE LOWEST WHICH IS SUFFICIENT TO ACTIVE THE DESIRED METABOLIC CONTROL. DURING TREATMENT WITH AMARYL M SR GLUCOSE LEVELS IN BLOOD AND URINE MUST MEASURED REGULARLY. Inaddition, it is recommended that regular determination of the proportion of glycated haemoglobin be carried out. MISTAKES, E.G. FORGETTING TO TAKE A DOSE, MUST NEVER BE CORRECTED BY SUBSEQUENTLY TAKING A LARGER DOSE. Measure for dealing with such mistakes (in particular forgetting a dose or skipping a meal) or situations where a dose cannot be taken at the prescribed time must be discussed and agreed between physician and patient beforehand. As an improvement in control of diabetes is, itself, associated with higher insulin sensitivity, GLIMEPIRIDE REQUIREMENTS MAY FALL AS TREATMENT PROCEEDS. TO AVOID HIPOGLYCAEMIA TIMELY DOSE REDUCTION OR CESSATION OF AMARYL M SR THERAPY MUST THEREFORE BE CONSIDERED. _If a country is registering the Immediate Release formulation: _ AMARYL M SR should be administered once or twice per day during meals. The maximum dose of metformin per administration Olvassa el a teljes dokumentumot