Gliclazide Tablets 80mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gliclazide Tablets 80mg
2. Qualitative and Quantitative Composition
Each tablet contains 80mg Gliclazide
3. Pharmaceutical Form
Tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Gliclazide is used for the treatment of (non-insulin dependant) Type II diabetes mellitus.
4.2. Posology and Method of Administration
For Oral Use.
Adults: The normal daily dose is 40mg to 320mg. Starting doses are 40-80mg daily and should be adjusted according to the patient’s response, increasing until adequate control is achieved.
Dosages should be once daily up to 160mg. If higher doses are required the tablets should be taken twice daily with the main meals of the day.
In patients not showing an adequate response to gliclazide alone or in obese patients, additional therapy may be required.
Elderly: dosages should not require adjustment as it is reported that plasma clearance is unchanged in elderly patients. However, care is required as with all sulphonylureas because of the increased potential for age-related hypoglycaemia.
Children: Gliclazide is not indicated for juvenile onset diabetes mellitus.
4.3. Contra-indications
Gliclazide is contra-indicated in:-
• Juvenile onset diabetes mellitus
• Diabetes complicated with ketosis and acidosis.
• Pregnancy.
• Diabetic patients undergoing surgery, after severe trauma or during infections.
• Patients with a known hypersensitivity to sulphonylureas and related medicinal products.
• Diabetic pre-coma and coma.
• Patients with severe renal or hepatic insufficiency.
4.4. Special Warnings and Precautions for Use
As with all sulphonylurea drugs, hypoglycaemia may occur if a patient’s dietary intake is reduced or if too large a dose is being taken.
Because of the risk of hypoglycaemia particular care should be taken in patients who are usually controlled by diet alone, those whose calorie or glucose intake may be deficient and in patients with renal and/or hepatic impairment. However, in patients with renal insufficiency it is reported that patients have been treated successfully with reduced dosages.
Hypoglycaemia may also occur in cases of accidental overdose.
In order to minimise the risk of hypoglycaemia certain precautionary measures are recommended:
♦ If it is possible, treat patients with non-insulin diabetes by diet modifications alone. If the patient is elderly diet alone may be acceptable even if the blood sugar levels are not completely controlled.
♦ The gliclazide dose should be adjusted to take account of the response to blood glucose monitoring and 24 hour urine glucose at the start of treatment (during the first few days).
♦ At the first sign of hypoglycaemia (ie mild symptoms such as hunger pains, sweating, pallor, tachycardia, malaise) treatment should include dosage adjustments, changes in meal patterns or treatment with glucose to reduce these effects.
♦ For treatment of severe hypoglycaemia see overdose section.
4.4. Special Warnings and Precautions for Use continued
♦ If control of blood glucose is lost (ie hyperglycaemia) it may be necessary to progressively increase doses of gliclazide. If this is not enough to maintain control, the treatment with gliclazide should be discontinued and insulin given. Hyperglycaemia may result due to stress ie fever, trauma, infection or surgery.
4.5. Interactions with other Medicaments and other forms of Interaction
Drugs which may increase the hypoglycaemic effect of gliclazide include: phenylbutazone, salicylates, suphonamides, coumarin derivatives, clofibrate, MAOIs, beta adrenergic blocking drugs, cimetidine, disopyramide, miconazole, tetracycline compounds and chloramphenicol.
Drugs which may reduce the effectiveness of gliclazide include corticosteroids, oral contraceptives, thiazide diuretics, thyroid hormones, phenothiazine derivatives and abuse of laxatives.
Care should be taken with any other drugs which may affect the diabetic condition.
4.6. Pregnancy and Lactation
Gliclazide should not be taken during pregnancy.
It is reported that other sulphonylureas have been transferred to breast milk. Although there is no data with respect to gliclazide, there is no evidence to suggest that it will differ from other drugs in this group.
4.7. Effects on Ability to Drive and Use Machines
Patients should be informed that their concentration may be affected if their diabetes is inadequately controlled. This is more likely to occur at the start of treatment. See Special Warnings and Precautions.
4.8. Undesirable Effects
Hypoglycaemia is the most likely effect of gliclazide treatment (see special warnings and precautions for further details).
Other effects which have been reported include abnormalities of hepatic function, which are not uncommon, with rare reports of hepatic failure, hepatitis and jaundice.
There are reports of mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhoea and constipation. These can be minimised if the drug is taken with meals.
Dermatological reactions have been reported and include rash, pruritus, erythema and bullous eruption. Blood dyscrasia, including anaemia, granulocytopenia, leucopenia and thrombocytopenia have been observed, but it is not known if these are directly attributable to the gliclazide treatment.
4.9. Overdose
Hypoglycaemia is the most likely effect of overdose. It should be treated with gastric lavage and appropriate treatment to correct the hypoglycaemia. Monitoring of blood sugar levels should be carried out.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The ATC Classification for gliclazide is A10B B09. Gliclazide is a sulphonylurea hypoglycaemic agent which reduces blood glucose levels in non-insulin dependent diabetes mellitus by increasing the release of insulin from pancreatic P- cells. It primarily enhances the first phase of insulin secretion, but also to a degree its second phase. Both phases are diminished in (non-insulin dependant) Type II diabetes mellitus.
5.2. Pharmacokinetic Properties
Gliclazide is well absorbed following oral administration and it is reported to be extensively protein bound (85 to 97%). The plasma half life is reported to be 10 to 12 hours with maximum concentrations occurring between 2 and 8 hours. Metabolisation occurs in the liver with only a small amount of unchanged gliclazide being excreted.
5.3.
Preclinical Safety Data
No additional data provided. The pre-clinical safety of gliclazide is already well documented.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Lactose, povidone, magnesium stearate, microcrystalline cellulose, croscarmellose sodium and purified talc.
6.2. Incompatibilities
None known.
6.3. Shelf-Life
3 years.
6.4. Special Precautions for Storage
Do not store above 25°C. Store in the original package.
6.5. Nature and Contents of Container
LDPE lined Aluminium strip packaging containing 28, 30, 56, 60, 84 & 90* tablets packed in an outer carton.
* only marketed pack sizes will be included
6.6 Special precautions for disposal
Not applicable.
MARKETING AUTHORISATION HOLDER
7.
Sandoz Ltd
Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 04416/0321
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/03/2009
10 DATE OF REVISION OF THE TEXT
20/04/2011