1. Name Of The Medicinal Product
Glimil 80mg Tablets / Gliclazide 80mg Tablets
2. Qualitative And Quantitative Composition
Each tablet contains 80mg Gliclazide
3. Pharmaceutical Form
Glimil (Gliclazide) 80mg Tablets are presented as white round tablets with 'G 80' on one side and score line on other side.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of maturity onset diabetes mellitus.
4.2 Posology And Method Of Administration
Adults: The total daily dose may vary from 40 to 320mg taken orally. The dose should be adjusted according to the individual patient's response, commencing with 40 - 80mg daily (½ to 1 tablets) and increasing until adequate control is achieved. A single dose should not exceed 160mg (2 tablets). When higher dose is required, Gliclazide 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 alone, additional therapy may be required.
Elderly: Plasma clearance of gliclazide is not altered in the elderly and steady state plasma levels can therefore be expected to be similar to those in adults under 65 years. Clinical experience in the elderly to date shows that gliclazide is effective and well tolerated. Care should be exercised, however, when prescribing sulphonylureas in the elderly due to possible age-related increased risk of hypoglycaemia.
Children: Gliclazide, as with other sulphonylureas, is not indicated for the treatment of juvenile onset diabetes mellitus.
4.3 Contraindications
Gliclazide is contra indicated in:
- Juvenile onset diabetes
- Diabetes complicated by ketosis and acidosis
- Pregnancy
- Diabetes undergoing surgery, after severe trauma or during infections
- Patients known to have hypersensitivity to other sulphonylureas and related drugs
- Diabetes pre-coma and coma
- Severe renal or hepatic insufficiency
4.4 Special Warnings And Precautions For Use
Care should be exercised in patients with hepatic impairment and a small starting dose should be used with careful patient monitoring.
All sulphonylurea drugs are capable of producing moderate or severe hypoglycaemia. As with other sulphonylureas, hypoglycaemia will occur if the patient's dietary intake is reduced or if they are receiving a larger dose of Gliclazide than required, 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 to the 24 hour urinary glucose during the first days of treatment.
Dosage adjustments may be necessary;
- On the occurrence of mild symptoms of hypoglycaemia (seating, 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 severe hypoglyceemic reactions (coma or neurological impairment, see overdose)
- Loss of control of blood glucose (hyperglycaemia). When a patient stabilised on any diabetic regimen is exposed to stress such as 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 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 the drug's action. The hypoglycaemic effect of Gliclazide may be potentiated by phenylbutazone, salicylates, sulphonamides, coumarin derivatives, MAOIs, beta adrenergic blocking agents, tetracycline compounds, chloramphenicol, clofibrate, disopyramide, miconazole (oral forms) and cimetidine.
It may be diminished by corticosteroids, oral contraceptives, thiazide diuretics, phenothiazine derivatives, thyroid hormones and abuse of laxatives.
4.6 Pregnancy And Lactation
Pregnancy: 'See Contra-indications'
Nursing mothers: It has not yet been established whether gliclazide is transferred to 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 special warnings and precautions).
4.8 Undesirable Effects
Hypoglycaemia (see special warnings and precautions).
Abnormalities of hepatic functions are not uncommon during gliclazide therapy. There are rare reports of hepatic failure, hepatitis and jaundice following treatment with gliclazide.
Mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhoea and constipation have been reported, but this type of adverse reaction can be avoided, if Gliclazide is taken during the meal.
Skin reactions including rash, pruritis, erythmea, bullous eruption, blood dyscarsia including anaemia, leucopenia, thrombocytopenia and granulocytopenia have been during treatment with gliclazide but are not known to be directly attributable to the drug.
4.9 Overdose
The symptoms to be expected with an overdose would be hypoglycaemia. The treatment is gastric lavage and correction of the hypoglycaemia by appropriate means with continued monitoring of the patient's blood sugar until the effect of the drug has ceased.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Gliclazide is a hypoglycaemic sulphonylurea differing from other related compounds by the addition of an azabicyclo octane ring. Oral sulphonylureas act by stimulating the release of insulin from beta cells, but they may also have long term extrapancreatic effects that reduce hepatic glucose production and increase the number of peripheral insulin receptors. Sulphonylureas are effective only in individuals with functional beta cells.
In man, apart from having a similar hypoglycaemic effect to the other sulphonylureas, gliclazide has been shown to reduce platelet adhesiveness and aggregation and increase fibrinolytic activity. These factors are thought to be implicated in the pathogenesis of long-term complications of diabetes mellitus.
5.2 Pharmacokinetic Properties
The drug is well absorbed and its half-life in man is approximately 10 - 12 hours. Gliclazide is metabolised in the liver to inactive metabolites; less than 5% of the dose is excreted unchanged in the urine. Although there is a dose-dependent relationship between gliclazide and plasma concentrations, no clear correlation with hypoglycaemic activity exists.
5.3 Preclinical Safety Data
No further relevant information.
6. Pharmaceutical Particulars
6.1 List Of Excipients
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6.2 Incompatibilities
None known.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
The tablets are packaged into polyvinyl chloride (PVC)/aluminium foil blister packs. Boxes of 28 tablets or 60 tablets are available.
Boxes of 28 tablets contain 2 blister packs each of 14 tablets. Boxes of 60 tablets contain 6 blister packs each of 10 tablets or 3 blister packs each of 20 tablets or 4 blister packs each of 15 tablets.
6.6 Special Precautions For Disposal And Other Handling
No special instructions. Tablets to be taken as directed by a physician.
7. Marketing Authorisation Holder
Milpharm Limited,
Ares,
Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom
8. Marketing Authorisation Number(S)
PL 16363/0006
9. Date Of First Authorisation/Renewal Of The Authorisation
10 June 1999
10. Date Of Revision Of The Text
28/05/2007
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