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GLICLAZIDE KRKA is a brand name for Gliclazide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The daily dose of Gliclazide Krka 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 Gliclazide Krka 60 mg modified-release tablet corresponds to two Gliclazide Krka 30 mg modified-release tablets. Switching from gliclazide (80 mg) tablets (immediate release formulation) to Gliclazide Krka 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 Gliclazide Krka 60 mg: Gliclazide Krka modified-release tablets can be used to replace another oral antidiabetic medicinal product.
The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Gliclazide Krka 60 mg modified release tablets. A transitional period is not generally necessary. A starting dose of 30 mg 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. e. a starting dose of 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response.
Combination with other antidiabetic medicines Gliclazide Krka modified-release tablets can be given in combination with biguanides, alpha-glucosidase inhibitors or insulin. In patients not adequately controlled with Gliclazide Krka 60 mg modified-release tablets, concomitant insulin therapy can be initiated under close medical supervision.
Based on the experience with gliclazide the following undesirable effects have been reported. Frequencies are defined as follows: - Very common (≥1/10) - Common (≥1/100 to <1/10) - Uncommon (≥1/1,000 to <1/100) - Rare (≥1/10,000 to <1/1,000) - Very rare (<1/10,000) - Not known (cannot be estimated from the available data) Description of selected adverse reactions Hypoglycaemia The most frequent adverse reaction with gliclazide is hypoglycaemia.
As with other sulfonylureas, treatment with Gliclazide Krka modified-release tablets can commonly cause hypoglycaemia if meals are taken irregularly, and, in particular, if they are skipped. Possible symptoms of hypoglycaemia are: headache, intense hunger, nausea, vomiting, lassitude, sleep disorders, agitation, aggression, poor concentration, reduced awareness and slowed reactions, depression, confusion, visual and speech disorders, aphasia, tremor, paresis, sensory disorders, dizziness, feeling of powerlessness, loss of self-control, delirium, convulsions, shallow respiration, bradycardia, drowsiness and loss of consciousness, possibly resulting in coma and lethal outcome.
In addition, signs of adrenergic counter-regulation may be observed: sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris and cardiac arrhythmia. Usually, symptoms disappear after the intake of carbohydrates (sugar).
However, artificial sweeteners have no effect. Experience with other sulfonylureas shows that hypoglycaemia can recur even when measures prove effective initially. If a hypoglycaemic episode is severe or prolonged, and even if it is temporarily controlled by intake of sugar, immediate medical treatment or even hospitalisation are required.
Other undesirable effects Gastrointestinal disorders Gastrointestinal disturbances, including abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation are uncommon; if these should occur, they can be avoided or minimised if gliclazide is taken with breakfast.
Hypoglycaemia This treatment should be prescribed only if the patient is likely to have a regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk of hypoglycaemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate.
Hypoglycaemia is more likely to occur during low caloric diets, following prolonged or strenuous exercise, alcohol intake or if a combination of hypoglycaemic agents is being used. 8). Some cases may be severe and prolonged. Hospitalisation may be necessary and glucose administration may need to be continued for several days.
Careful selection of patients, of the dose used, and clear patient directions are necessary to reduce the risk of hypoglycaemic episodes. 5) Renal and hepatic insufficiency The pharmacokinetics and/or pharmacodynamics of gliclazide may be altered in patients with hepatic insufficiency or severe renal failure.
A hypoglycaemic episode occurring in these patients may be prolonged; so appropriate management should be initiated. 8), treatment and conditions that predispose to its development, should be explained to the patient and to family members.
The patient should be informed of the importance of following dietary advice, of taking regular exercise and of regular monitoring of blood glucose levels. 5), fever, trauma, infection or surgical intervention. In some cases it may be necessary to administer insulin.
The hypoglycaemic efficacy of any oral antidiabetic agent, including gliclazide, is attenuated over time in many patients: this may be due to progression in the severity of the diabetes, or to a reduced response to treatment. This phenomenon is known as secondary failure which is distinct from primary failure, when an active substance is ineffective as first-line treatment.
Adequate dose adjustment and dietary compliance should be considered before classifying the patient as secondary failure. Dysglycaemia Disturbances in blood glucose, including hypoglycaemia and hyperglycaemia have been reported, in diabetic patients receiving concomitant treatment with fluoroquinolones, especially in elderly patients.
6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Special populations Elderly Gliclazide Krka modified-release tablets should be prescribed using the same dosing regimen recommended for patients under 65 years of age. Renal impairment In patients with mild to moderate renal impairment the same dosing regimen can be used as in patients with normal renal function with careful patient monitoring.
These data have been confirmed in clinical trials. Patients at risk of hypoglycaemia - undernourishment or malnourishment, - severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency), - withdrawal of a prolonged and/or high-dose corticoid therapy, - severe vascular disease (serious coronary heart disease, severe carotid impairment, diffuse vascular disease).
It is recommended that the minimum daily dose of 30 mg is used. Paediatric population The safety and efficacy of Gliclazide Krka in children and adolescents have not been established. No data are available in children. Method of administration Gliclazide Krka is to be taken as a single dose at breakfast time.
It is recommended that the tablet(s) is swallowed whole.
The following undesirable effects have been more rarely reported:
Skin and subcutaneous tissue disorders Rash, pruritus, urticaria, angioedema, erythema, maculopapular rashes, bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis and autoimmune bullous disorders) and exceptionally, drug rash with eosinophilia and systemic symptoms (DRESS).
Blood and lymphatic system disorders Changes in haematology are rare. They may include anaemia, leucopenia, thrombocytopenia and granulocytopenia. These are generally reversible upon discontinuation of the medication. Hepatobiliary disorders Raised hepatic enzyme levels (AST, ALT, alkaline phosphatase), hepatitis (isolated reports); Discontinuation of therapy if cholestatic jaundice appears.
These undesirable effects normally disappear after discontinuation of treatment. Eye disorders Transient visual disturbances may occur, especially on initiation of treatment, due to changes in blood glucose levels. g. with cholestasis and jaundice) and hepatitis which regressed after withdrawal of the sulfoonylurea or led to life-threatening liver failure in isolated cases.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Indeed, careful monitoring of blood glucose is recommended in all patients receiving at the same time gliclazide and a fluoroquinolone. Laboratory tests Measurement of glycated haemoglobin levels (or fasting venous plasma glucose) is recommended in assessing blood glucose control.
Blood-glucose self-monitoring may also be useful. Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia. Since gliclazide belongs to the chemical class of sulfonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.
Porphyric patients Cases of acute porphyria have been described with some other sulfonylurea drugs, in patients who have porphyria. Lactose Gliclazide Krka modified release tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not this medicine.