Gliclazide 80mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gliclazide 80mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Gliclazide, BP 80.00 mg
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Tablet
White, biscored, oblong tablet marked 'GLI 80' on one side
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of maturity onset diabetes in patients who cannot be controlled on diet alone.
4.2 Posology and method of administration
Adults: 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 (L2 - 1 tablet) and increasing until adequate control is achieved. A single dose should not exceed 160 mg (2 tablets) and when higher doses are required, a twice daily dosage is advised, which should be divided according to the main meals of the day.
In obese patients or those not showing adequate response to GLICLAZIDE alone, additional therapy may be added.
Elderly: Plasma clearance of gliclazide is not altered in the elderly. Steady state plasma levels can therefore be expected to be similar to those in adults under 65 year. Clinical experience in the elderly to date shows that GLICLAZIDE is effective and well tolerated. Care should be exercised when prescribing sulphonylureas in the elderly, due to a possible age-related increase tendency for hypoglycaemia.
Children: GLICLAZIDE, as with other sulphonylureas, is not indicated for the treatment of juvenile onset diabetes mellitus.
4.3 Contraindications
GLICLAZIDE should not be used in:
1. Juvenile onset diabetes
2. Diabetes complicated by ketosis and acidosis
3. Pregnancy
4. Diabetics undergoing surgery, after severe trauma or during infections
5. Patients known to have hypersensitivity to other sulphonylureas and related drugs
6. Diabetic precoma and coma
7. Severe renal or hepatic insufficiency
4.4 Special warnings and precautions for use
Care should be exercised in patients with hepatic and /or renal impairment and a small starting dose should be used with careful patient monitoring.
As with other sulphonylureas, hypoglycaemia will occur if the patients dietary intake is reduced or if they have received a larger dose of GLICLAZIDE than is required. Contributing factors are: age above 70 years, renal insufficiency and the possibility of medical interactions (see 4.5).
Hypoglycaemia: all sulphonylureas drugs are capable of producing moderate or severe hypoglycaemia, particularly in the following conditions:
- in patients controlled by diet alone;
- in cases of accidental overdose;
- when calorie or glucose intake is deficient;
- in patients with hepatic and/or renal impairment; however, in long-term clinical trials, patients with renal insufficiency have been treated satisfactorily, using gliclazide at reduced doses.
In order to reduce the risk of hypoglycaemia it is therefore recommended:
- to initiate treatment for non-insulin dependent diabetics by diet alone, if this is possible;
- to take into account the age of the patient: blood sugar levels not strictly controlled by diet alone might be acceptable in the elderly;
- to adjust the dose of gliclazide according to the blood glucose response and the 24 hours urinary glucose during the first days of treatment.
Dosage adjustments may be necessary:
- on the occurrence of mild symptoms of hypoglycaemia (sweating, pallor, hunger pangs, tachycardia, sensation of malaise). Such findings should be treated with oral glucose and adjustments made in drug dosage and/or meal patterns;
- on the occurrence of mild symptoms of hypoglycaemic reactions (for coma or neurological impairment, see overdose);
- If there is loss of control of blood glucose (hyperglycaemia). When a patient stabilised on any diabetic regimen is exposed to stress such as a fever, trauma, infection or surgery, a loss of control may occur. At such times, it may be necessary to progressively increase the dosage of Gliclazide and if this is insufficient, to discontinue the treatment with Gliclazide and to administer insulin.
4.5 Interaction with other medicinal products and other forms of interaction
Care should be taken when giving GLICLAZIDE with drugs which are known to alter the diabetic state or potentiate that drug’s action. Examples that may potentiate the hypoglycaemic effect are sulphonamides, silicates, phenylbutazone, ^-blocking agents, MAOI’s, coumarin derivatives, tetracyclines, chloramphenicol, clofibrate, disopyramide, oral miconazole and cimetidine.
The hypoglycaemic effect may be diminished by corticosteroids, oral contraceptives, thiazide diuretics, phenothiazine derivatives, thyroid hormones and laxative abuse.
4.6 Fertility, Pregnancy and lactation
Pregnancy is a contra-indication.
Nursing mothers: it has not yet been established whether GLICLAZIDE is transferred in human milk. However, other sulphonylureas have been found in milk and there is no evidence to suggest that GLICLAZIDE differs from the group in this respect.
4.7 Effects on ability to drive and use machines
Patients should be informed that their concentration may be affected if their diabetes is not satisfactorily controlled, especially at the beginning of treatment (see other warnings and precautions).
4.8 Undesirable effects
Hypoglycaemia (see other warnings and precautions).
GLICLAZIDE is generally well tolerated, but mild gastro-intestinal disturbances such as nausea, dyspepsia, vomiting, diarrhoea and constipation may occur with sulphonylureas. They are usually mild and dose-dependant, and can be avoided by taking GLICLAZIDE with a meal.
Abnormalities of hepatic function are not uncommon during gliclazide therapy. There are rare reports of hepatic failure, hepatitis and jaundice following treatment with gliclazide.
Skin reactions including pruritus, erythema, bullous eruption; blood dyscrasias including anaemia, leucopenia, thrombocytopenia and granulocytopenia have been observed during treatment with gliclazide but are not known to be directly attributed to the drug.
4.9 Overdose
The symptom to be expected of overdose would be hypoglycaemia. The treatment is gastric lavage and correction of hypoglycaemia by appropriate means with continued monitoring of patient’s blood sugar until the effect of the drug has ceased.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
GLICLAZIDE is a hypoglycaemic sulphonylurea, which stimulates secretion of insulin through functioning islet beta cells. However, the insulin secretion falls again the hypoglycaemic effect persists; this may be due to inhibition of hepatic glucose production and increased sensitivity to any available insulin.
GLICLAZIDE has been shown to reduce platelet adhesiveness and aggregation and increase fibrinolytic activity.
5.2 Pharmacokinetic properties
GLICLAZIDE is well absorbed from the gastro-intestinal tract. It is extensively bound to plasma proteins. It has a half-life of approximately 6 to 15 hours in man.
It is extensively metabolised in the liver to metabolites without significant hypoglycaemic activity.
Both unchanged drug (less than 5% of the dose) and metabolites are excreted in the urine.
5.3 Preclinical safety data
As a well established pharmacopoeial product with a wealth of human safety data, no preclinical safety studies have been performed on this product.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate Maize Starch Povidone K25 Talc
Magnesium stearate
6.2 Incompatibilities
None
6.3 Shelf life
24 months
6.4 Special precautions for storage
Do not store above 30°C.
6.5 Nature and contents of container
Cartons of 60 tablets, containing four PVC/aluminium blister strips of 15 tablets.
Cartons of 28 tablets, containing two PVC/aluminium blister strips of 14 tablets.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
EcoGen Europe Ltd
Old Police Station, Church Street,
Swadlincote, DE11 8LN United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44473/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31 March 2009
10 DATE OF REVISION OF THE TEXT
03/09/2015