Țară: Armenia
Limbă: engleză
Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
glimepiride, metformin (metformin hydrochloride)
Handok Inc.
A10BD02
glimepiride, metformin (metformin hydrochloride)
2mg+ 500mg
tablets film-coated
(30/3x10/) in blister
Prescription
Registered
2020-03-04
30/05/2015 11:18 - VISTAlink folder 1271966 - Page 2/4 _GLIMEPIRIDE / METFORMIN HYDROCHLORIDE_ 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 or 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 of 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 is and what it is used for 2. What you need to know before you take AMARYL M 3. How to take AMARYL M 4. Possible side effects 5. How to store AMARYL M 6. Contents of the pack and other information 1.WHAT AMARYL M IS AND WHAT IT IS USED FOR PHARMACOTHERAPEUTIC GROUP AND THERAPEUTIC INDICATIONS AMARYL M is a medicine taken by mouth to help lower blood sugar. AMARYL M 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 CONTRAINDICATIONS DO NOT TAKE AMARYL M: - 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 (listed in section 6 under “Contents of the pack and other information”), to sulphonamides (medicines for bacterial infec Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amaryl M Nonproprietary Name: Glimepiride + Metformin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 Description White, oval, film-coated tablets. 2.2 Composition One tablet contains: _Active substances:_ Glimepiride - 2 mg, Metformin hydrochloride - 500 mg; 3. PHARMACEUTICAL FORM Film-coated tablets 2 mg + 500 mg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct to diet and exercise in NIDDM (type 2) patients - In case that the monotherapy with glimepiride or metformin do not result in adequate glycemic control - Replacement of combination therapy of glimepiride and metformin 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This drug should be administered once or twice per day immediately before or with the meals. The dosage may be individualized based on the patient’s current treatment regimen, efficacy and tolerability; adequate monitoring of blood glucose levels should be performed for this. Generally, it should be recommended to initiate the lowest effective dose and increase the dose depending on the patient’s current medication and blood glucose levels. The initial daily dose of this drug in a clinical study was glimepiride / metformin hydrochloride 2mg/500mg which was gradually increased up to glimepiride/ metformin hydrochloride 8mg/2000mg as per the blood glucose monitoring results. Although glimepiride monotherapy generally had little additional effects when dosed at 4mg or more a day, some patients showed improved metabolic control when the dose was increased up to 6mg (or 8 mg). When switching from combination therapy, this drug should be administered based on the dosage and administration method of glimepiride and metformin hydrochloride that are being currently administered in combination. Although the previous dose was omitted, do not overdose this drug for the next dose. 4.3 CONTRAINDICATIONS 1) Patients with Insulin-dependent (type I) diabetes mellitus (e.g., diabetic patients with a history of ketonemia), diabeti Citiți documentul complet