Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gliclazide
Alliance Healthcare (Distribution) Ltd
A10BB09
Gliclazide
40mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201
1. WHAT GLICLAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR Gliclazide tablets contain the active substance gliclazide, one of a group of medicines called sulfonylureas. It is an oral hypoglycaemic medicine (blood sugar lowering drug). Gliclazide tablets are used to keep blood sugar at the correct level in adults with non-insulin dependent diabetes when it is not controlled by diet, physical exercise and weight loss alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLICLAZIDE TABLETS DO NOT TAKE GLICLAZIDE TABLETS: • If you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), to other medicines of the same group (sulfonylureas), to other related medicines (hypoglycaemic sulfonamides), • If you have insulin-dependent diabetes (type 1), • If you have ketone bodies and sugar in your urine (this may mean you have keto-acidosis), a diabetic pre-coma or coma, • If you have severe kidney or liver disease, • If you are taking miconazole (a treatment for fungal infections) (see OTHER MEDICINES AND GLICLAZIDE TABLETS), • If you are breast-feeding (see PREGNANCY AND BREAST-FEEDING). CHILDREN AND ADOLESCENTS Gliclazide tablets are not recommended for use in children. WARNINGS AND PRECAUTIONS Talk to your doctor before taking Gliclazide tablets. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, you observe the dietary regimen, have physical exercise and, where necessary, reduce weight. During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment the risk of having reduced blood sugar levels (hypo- glyceamia) may be increased. So particularly close medical monitoring is necessary. Low blood sugar (Hypoglycaemia) may occur: • if you take meals irregularly or skip meals altogether, if you are fasting, • if you are malnourished, • if you change your d Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gliclazide 40mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg of Gliclazide. Excipient with known effect: Also Contains Lactose Monohydrate Ph. Eur 55 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white, circular, flat, bevelled edged, uncoated tablets with “40” on one side, plain on reverse. 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 INITIAL DOSE: The total daily dose may vary from 40 to 320 mg taken orally. The dose should be adjusted according to the individual patient’s response, commencing with 40-80 mg daily (1 – 2 tablets) and increasing until adequate control is achieved. A single dose should not exceed 160 mg (4 tablets). When higher doses are required, Gliclazide Tablets should be taken twice daily and according to the main meals of the day. In obese patients or those not showing adequate response to Gliclazide Tablets alone, additional therapy may be required. SWITCHING FROM ANOTHER ORAL ANTIDIABETIC AGENT TO GLICLAZIDE 40 MG: Gliclazide 40 mg can be used to replace other oral antidiabetic agents. The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Gliclazide 40 mg. A transitional period is not generally necessary. A starting dose of 40-80 mg (1 to 2 tablets) should be used and this should be adjusted to suit the patient's blood glucose response, as described above. When switching from a hypoglycaemic sulfonylurea with a prolonged half- life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which might cause hypoglycaemia. COMBINATION TREATMENT WITH OTHER ANTIDIABETIC AGENTS: Gliclazide 40 mg can be given in combination wit Perskaitykite visą dokumentą