Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Metformin hydrochloride
Colonis Pharma Ltd
A10BA02
Metformin hydrochloride
170mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5060380960399
Package leaflet: Information for the user Metformin hydrochloride Metformin Colonis 850mg/5ml Oral Solution 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 Metformin Oral Solution is and what it is used for 2. What you need to know before you take Metformin Oral Solution 3. How to take Metformin Oral Solution 4. Possible side effects 5. How to store Metformin Oral Solution 6. Contents of the pack and other information 1. What Metformin Oral Solution is and what it is used for ■ Metformin Colonis 850mg/5ml Oral Solution (referred to as Metformin Oral Solution in this leaflet) contains metformin hydrochloride, a medicine to treat diabetes. It belongs to a group of medicines called biguanides. ■ After you have eaten, your body converts the carbohydrates and sugar in your food into glucose, which travels in your blood to where it is needed. Insulin is a hormone produced in your pancreas which moves the glucose from your blood into your body’s cells where it is used as energy (fuel) ■ If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use properly the insulin it produces, (known as insulin resistance). This leads to high levels of glucose in your blood. Metformin Oral Solution helps to lower your blood glucose to as normal a level as possible. ■ This medicine 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 your blood glucose Lue koko asiakirja
OBJECT 1 METFORMIN COLONIS 850 MG/5ML ORAL SOLUTION Summary of Product Characteristics Updated 08-Dec-2017 | Colonis Pharma Ltd 1. Name of the medicinal product Metformin Colonis 850 mg/5ml Oral Solution 2. Qualitative and quantitative composition Each 5ml oral solution contains 850 mg of metformin hydrochloride. _Excipients with known effect_: Sodium propyl parahydroxybenzoate (E217) 0.55 mg/5ml 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, Metformin Colonis Oral Solution 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 Colonis Oral Solution 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 Note: Metformin Colonis Oral Solution 850mg/5ml is intended for the administration of doses of 850mg or multiples of 850mg. 500mg/5ml and 1000mg/5ml presentations are also available. Posology _Adults_ MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS The usual starting dose is 500mg or 850 mg (5ml) metformin hydrochloride 2 or 3 times daily given during or after meals. 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 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 indic Lue koko asiakirja