Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLICLAZIDE
PAHANG PHARMACY SDN. BHD.
GLICLAZIDE
90 Tablets
KRKA, d.d., Novo mesto
GLICLADA MODIFIED RELEASE TABLETS Gliclazide 60 mg _Consumer Medication Information Leaflet (RiMUP)_ _ _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What _Gliclada _is used for 2. How _Gliclada_ works 3. Before you use _Gliclada_ 4. How to use _Gliclada_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Gliclada_ Product Description 8. Manufacturer and Product Registration Holder 9. Date of revision WHAT _GLICLADA_ IS USED FOR _Gliclada_ is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level. HOW _GLICLADA_ WORKS _Gliclada_ is a medicine that reduces blood sugar levels (antidiabetic medicine taken orally) by stimulating insulin secretion. BEFORE YOU USE _GLICLADA _ - _When you must not use it _ Do not take _Gliclada:_ if you are allergic (hypersensitive) to gliclazide, to other sulphonylureas, to sulphonamides or to any of the other ingredients of this medicine, if you have insulin-dependent (type 1) diabetes, if you have ketone bodies and sugar in the urine (this may mean you have diabetic keto-acidosis), diabetic pre-coma or coma, if you have severe kidney or liver disease, if you are taking medicines to treat fungal infections (miconazole), if you are breast feeding _ _ _Pregnancy and lactation _ Do not take _Gliclada_ if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking _Gliclada_ stop taking it immediately and contact your doctor so he may prescribe you a more suitable treatment for you. Do not take _Gliclada_ if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. _ _ _ _ - _Before you start use it _ This medicine should be used only if you are likely to have a regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk of low blood sugar level (hypoglycaemia) if a meal is delayed or Perskaitykite visą dokumentą
1.3.1 Gliclazide SPC, Labeling and Package Leaflet MY SmPCPIL043814_4 04.11.2013 – Updated: 13.10.2021 Page 1 of 8 GLICLADA _Gliclazide_ NAME OF THE MEDICINAL PRODUCT Gliclada 60 mg modified-release tablets COMPOSITION Each modified-release tablet contains 60 mg gliclazide. PRODUCT DESCRIPTION White to almost white, oval, biconvex tablets. THERAPEUTIC INDICATIONS Non-insulin dependent Diabetes mellitus (Type II) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. POSOLOGY AND METHOD OF ADMINISTRATION Posology The daily dose of Gliclada may vary from 30 to 120 mg taken orally in a single intake at breakfast time. If a dose is forgotten, there must be no increase in the dose taken next day. As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbAlc). _Initial dose_ The recommended initial dose is 30 mg 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 increased to 60, 90 or 120 mg 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 120 mg. One Gliclada 60 mg modified-release tablet corresponds to two Gliclada 30 mg modified-release tablets. _Switching from gliclazide (80 mg) tablets (immediate release formulation) to Gliclada 60 mg tablets _ _with modified release_ One tablet of gliclazide (80 mg) is comparable to one modified-release tablet 30 mg. Consequently, the switch can be performed with careful blood monitoring. _Switchover from another oral antidiabetic medicinal product to Gliclada 60 mg:_ Gliclada modified-release tablets can be used to replace another oral antidiabetic medicinal product. 1.3.1 Glicl Perskaitykite visą dokumentą