País: Malta
Idioma: anglès
Font: Medicines Authority
METFORMIN HYDROCHLORIDE
Lamda Laboratories SA 59, Ioannou Metaxa str, Karellas,Koropi, Attiki, Greece
A10BA02
METFORMIN HYDROCHLORIDE 1000 mg/5ml
ORAL SOLUTION
METFORMIN HYDROCHLORIDE 1000 mg/5ml
POM
DRUGS USED IN DIABETES
Withdrawn
2016-05-30
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER1000 MG/5 ML ORAL SOLUTION For use in adults and children from 10 years of age 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 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 doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Llegiu el document completis and what it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR contains metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides. Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce 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. helps to lower your blood glucose to as normal a level as possible. If you are an overweight adult, taking over a long period of time also helps to lower the risk of complications associated with diabetes. is associated with either a stable body weight or modest weight loss. is use
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Metformin Hydrochloride Lamda 1000 mg/5 ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 ml oral solution contain 1000 mg of metformin hydrochloride. Excipients with known effect: Sodium propyl parahydroxybenzoate (E 217) 0.55 mg/5 ml Ethanol (alcohol) 5 mg/5 ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Clear, colourless solution with characteristic peach odour 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. • In adults,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, Llegiu el document completmay 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 _ _ _ MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS The usual starting dose is 500 mg (2.5 ml) or 850 mg (4.25 ml) metformin hydrochloride 2 or 3 times daily given during or after meals. Page 2 of 13 After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 3 g (15 ml) daily, taken as 3 divided doses. If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated above. COMBINATION WITH INSULIN Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual st