Indicated for the treatment of type 2 diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose.
Sulphonylurea; Antidiabetic
Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca+2 transport across the β-cell membranes and decreases hepatic glucose output.
The usual initial dose of Gliclazide is 40 to 80 mg daily, gradually increased, if necessary up to 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg. When higher doses are required it should be taken twice daily, according to the main meals of the day. For extended release tablet the initial recommended dose is 30 mg daily, even in elderly patients (>65 years); the daily dose may vary from 30 to 120 mg taken orally, once daily. Gliclazide should be taken with food because there is increased risk of hypoglycemia if a meal is taken late. It is recommended that the medication b taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased. Dose titration should be carried out in steps of 30 mg, according to the fasting blood glucose response. Each step should last for at least two weeks. Gliclazide is an extended release tablet & therefore, should be neither broken nor chewed. Gliclazide 30, can replace Gliclazide 80 mg tablets, tablet for tablet, for doses of 1 to 4 tablets per day. Elderly: Plasma clearance of Gliclazide is not altered in the elderly & steady state plasma levels are similar to those in adults under 65 years. Clinical experience in the elderly shows that it is effective & well tolerated.
Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
antibiotics (sulphonamides, clarithromycin)
medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
medicines to treat fungal infections (miconazole, fluconazole)
medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
medicines to treat depression (monoamine oxidase inhibitors)
painkiller or antirheumatics (phenylbutazone, ibuprofen)
medicines containing alcohol
The blood-glucose-lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:
medicines to treat disorders of the central nervous system (chlorpromazine)
medicines reducing inflammation (corticosteroids)
medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
St John's Wort- Hypericum perforatum- preparations
Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as gliclazide especially in elderly patients.
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
have frequent episodes of low blood sugar (hypoglycaemia)
have few or no warning signals of low blood sugar (hypoglycaemia)
Gliclazide contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Gliclazide should not be used in juvenile onset diabetes, diabetes complicated by ketosis & acidosis, diabetes undergoing surgery, after severe trauma or during infections, patients known to have hypersensitivity to other sulfonylureas & related drugs, diabetic pre-coma & coma, severe renal or hepatic insufficiency, combination with miconazole tablets. Care should be exercised with patients having hepatic & or renal impairment & a small starting dose should be used with careful patient monitoring. In long term clinical trials, patients with renal insufficiency have been treated satisfactorily using Gliclazide at reduced doses.
Hypoglycemia may occur in concurrent conditions such as hepatic & renal diseases, alcohol intoxication & adrenal & pituitary insufficiency. Mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhea, & constipation have been reported but these types of adverse reactions can be avoided if Gliclazide is taken during a meal. Allergic dermatological reactions including rash, pruritus, erythema, bullous eruption have been reported during treatment with the drug but are not known to be directly attributable to it.
Pregnancy: Gliclazide should not be used in pregnancy. Nursing mothers: No study has reported its presence in human breast milk. However, other sulfonylureas have been found in milk & there is no evidence to suggest that gliclazide differs from the group in this respect.
Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
.png&w=384&q=75)