Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gliclazide
Lupin Healthcare (UK) Ltd
A10BB09
Gliclazide
30mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201; GTIN: 8901107021597 8901107023126
PACKAGE LEAFLET: INFORMATION FOR THE USER ZICLASEG 30MG PROLONGED RELEASE TABLET GLICLAZIDE 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. 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 Ziclaseg Tablets are and what they are used for 2. What you need to know before you take Ziclaseg Tablets 3. How to take _ _ Ziclaseg Tablets 4. Possible side effects 5. How to store Ziclaseg Tablets 6. Contents of the pack and other information 1. WHAT ZICLASEG TABLETS ARE AND WHAT THEY ARE USED FOR Gliclazide-Lupin 30mg prolonged-release tablet. Each tablet contains 30 mg Gliclazide. Pharmacotherapeutic group: Sulfonamides, urea derivatives, ATC code: A10BB09 Ziclaseg is a medicine which REDUCES BLOOD SUGAR LEVELS (oral antidiabetic medicine belonging to the sulphonylurea group). Ziclaseg 30mg prolonged release tablets are used to keep blood sugar at the correct level in adults with DIABETES (type 2 diabetes mellitus) when it is not controlled by dietary measures, physical exercise and weight loss alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZICLASEG TABLETS DO NOT TAKE ZICLASEG 30MG PROLONGED RELEASE TABLETS: if you are ALLERGIC (hypersensitive) TO GLICLAZIDE or any of the other ingredients in this medicine (see section 6,“Further Information”) or to any other medicines of the same group (sulphonylureas or sulphonamides). if you have insulin-dependent (Type 1) DIABETES; if you have ketone bodies and sugar in your urine (this may mean you have DIABETIC KETO-ACIDOSIS ), diabetic pre-coma or coma if you have SEVERE KIDNEY OR LIVER DISEASE; Preberite celoten dokument
OBJECT 1 ZICLASEG 30MG PROLONGED-RELEASE TABLETS. Summary of Product Characteristics Updated 17-Aug-2016 | Lupin Healthcare (UK) Ltd 1. Name of the medicinal product Ziclaseg 30mg prolonged-release tablet. 2. Qualitative and quantitative composition Each tablet contains 30mg gliclazide. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged-release tablet. White to off-white capsule shaped, biconvex tablet debossed with 30 on one side, and plain on the other side. 4. Clinical particulars 4.1 Therapeutic indications Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. 4.2 Posology and method of administration Posology Adults: The daily dose may vary from 1 to 4 tablets per day i.e 30 120mg taken orally in a single intake at breakfast time. It is recommended that the tablet(s) are swallowed whole without chewing. If a dose is forgotten, there must be no increase in the dose taken the next day. As with any hypoglycaemic agent, the dose should be adjusted according to the individual patients metabolic response (blood glucose, HbAlc). Initial Dose: The recommended starting dose is 30mg daily. If blood glucose is effectively controlled, this dose may be used for maintenance treatment. If blood glucose is not adequately controlled, the dose may be increase to 60, 90 or 120mg daily, in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment. The maximum recommended daily dose is 120mg. _Switching from Gliclazide 80mg tablets to Ziclaseg 30mg prolonged release tablets:_ 1 tablet of Gliclazide 80mg is comparable to 1 tablet of Ziclaseg 30mg prolonged release tablets. Consequently the switch can be performed provided a careful blood monitoring. _Switching from another oral antidiabetic agent t Preberite celoten dokument