מדינה: ארמניה
שפה: אנגלית
מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
metformin (metformin hydrochloride)
Denk Pharma GmbH & Co. KG
A10BA02
metformin (metformin hydrochloride)
500mg
tablets film-coated
(30/3x10/) blisters, (100/10x10/) blisters
Prescription
Registered
2015-03-25
_Metformin Denk 500_ Film-coated tablet – Oral use Oral anti-diabetic agent Active substance: Metformin Package leaflet: Information for the user READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CON- TAINS 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. – 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 doc- tor or pharmacist. This includes any pos- sible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. WHAT METFORMIN DENK 500 IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METFORMIN DENK 500 3. HOW TO TAKE METFORMIN DENK 500 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE METFORMIN DENK 500 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1 . What Metformin Denk 500 is and what it is used for Metformin Denk 500 contains metformin, a med- icine to treat diabetes. It belongs to a group of medicines called biguanides. Insulin is a hormone produced by the pancre- as that makes your body take in glucose (sugar) from the blood. Your body uses glucose to pro- duce energy or stores it for future use. If you have diabetes, your pancreas does not make enough insulin or your body is not able to use properly the insulin it produces. This leads to a high level of glucose in your blood. Metformin Denk 500 helps to lower your blood glucose to as normal levels as possible. If you are an overweight adult, taking Metform- in Denk 500 over a long period of time also helps to lower the risk of complications associated with diabetes. Metformin Denk 500 is associ- ated with either a stable body weight or mod- est weight loss. Metformin Denk 500 is used to treat patients with type 2 diabetes (also called ‚non-insulin dependent diabetes’) when diet and exercise alone have not been enough to control you קרא את המסמך השלם
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Metformin Denk 500 Metformin Denk 850 Metformin Denk 1000 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: metformin _Metformin Denk 500 _ Each film-coated tablet contains 500 mg metformin hydrochloride equivalent to 390 mg metformin. Excipient with known effect: Each film-coated tablet contains 7.04 mg of lactose monohydrate. _Metformin Denk 850 _ Each film-coated tablet contains 850 mg metformin hydrochloride equivalent to 662.8 mg metformin. _Metformin Denk 1000 _ Each film-coated tablet contains 1000 mg metformin hydrochloride equivalent to 780 mg metformin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet _Metformin Denk 500 _ White, round, biconvex film-coated tablets, without facet. _Metformin Denk 850 _ White, oblong film-coated tablets, with a deep snap-tab break mark on one side and break mark on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. _Metformin Denk 1000 _ White, oblong film-coated tablets with a deep snap-tab break mark on one side and break mark on the other side. The film-coated tablets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. 2 - In adults, metformin _ _ may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin. - In children from 10 years of age and adolescents, metformin may be used as monotherapy or in combination with insulin. A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults with normal renal function (GFR ≥ 90 mL/min) _ MONOTHERAPY AND COMBINATION WITH OTH קרא את המסמך השלם