Gerard Laboratories

Diaclide 80 mg Tablets

Each tablet contains Gliclazide 80 mg

Excipients: Each tablet contains 40mg Lactose Monohydrate.

For a full list of excipients, see section 6.1

Tablets.

White, round, flat, bevel edged, scored tablets, marked “GZ80” on one side with a “G” on the other.

The scoreline allows the tablets to be divided into equal halves

Diaclide is used for the treatment of maturity onset diabetes mellitus, where therapy with insulin is not required and dietary modifications have failed to control hyperglycaemia.

Diaclide is for oral administration.

Adults

The total dose may vary from 40-320 mg daily. A single dose should not exceed 160 mg (2 tablets) and when higher doses are required a twice daily split dosage is advised and should be divided according to the main meals of the day. The final dosing regimen will be decided by the doctor and will be dependent upon individual patient requirements. The tablet is to be taken with food and in conjunction with a calorie and carbohydrate restricted diet. Diaclide may be used in combination with biguanide hypoglycaemic drugs if necessary.

Elderly

As for adults.

Children

Diaclide is contraindicated in children.

Diaclide should not be used in pregnant women or women who are breastfeeding, children, patients with known hypersensitivity to gliclazide or other sulphonylureas, diabetes complicated by ketoacidosis, severe renal, hepatic, adrenal or thyroid dysfunction or in patients with unstable or brittle diabetes.

The dosage of Diaclide may require adjustment in patients suffering from infection, trauma or shock or during anaesthesia.

Patients with such condition may require insulin to maintain control. Close observation and careful initiation is mandatory who are elderly, debilitate, malnourished. Severe hypoglycaemia may occur in such patients requiring corrective therapy over a period to several days. Alcoholism , insulinoma, adrenal, thyroid and pituitary insufficiency increase the sensitivity to sulphonylureas and may dispose towards hypoglycaemia.

In order to reduce the risk of hypoglcaemia it is therefore recommended:

To initiate treatment for non-insulin diabetics by diet alone if this is possible.

To take into account the age of the patients: blood sugar levels not strictly controlled by diet alone may be acceptable in the elderly.

Particular care must be taken during the initial period of stabilization with the dose of Diaclide adjusted according to the blood glucose response and the 24 hour urinary glucose.

In patients suffering from hepatic or renal dysfunction, reduction of the dosage may be necessary.

Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia. Since Diaclide belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD-deficiency and a non-sulfonylurea alternative should be considered.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Care should be taken when giving Diaclide with drugs which are known to alter the diabetic state or potentiate the action of gliclazide. Chloramphenicol, miconazole (oral forms),ketoconazole, clofibrate, disopyramide, probenecid, insulin, biguanides,fluconazole, phenylbutazone, salicylates, long-acting sulphonamides, coumarin derivatives, beta-blockers, monoamine oxidase inhibitors and cimetidine may potentiate the hypoglycaemic effect of gliclazide. Corticosteroids, oral contraceptives, phenothiazine derivatives, thyroid hormones, thiazide diuretics and abuse of laxatives may diminish the effect of Diaclide .Fibrates (patients stabilized on Diaclide should be very closely monitored when starting or ending a therapy with fibrates). Intolerance to alcohol (disulfram like reaction: flushing, sensation of warmth, giddiness, nausea and occasionally tachycardia) may occur. Chronic alcohol abuse may as a result of liver enzyme induction stimulate the metabolism of sulphonylurea drugs and shorten plasma half-life and duration of action.

Rare cases of leucopenia, agranulocytosis, thrombocytopenia and anaemia have been reported. Cases of porphyria cutanea tarda and of photosensitivity have also been reported with sulphonylurea drugs.

Diaclide should not be used in pregnancy or during breast feeding.

Although it is not known whether gliclazide is excreted in milk, other sulphonylureas have been detected in milk and there is no evidence that gliclazide differs in this respect.

None known, but the patient should be stabilised on treatment before driving.

At dosages used in the treatment of maturity onset diabetes mellitus, the most frequently reported side effect is hypoglycaemia, which in most cases is the result of overdose or inadequate diet rather than an adverse effect of the drug and therefore can be corrected by dosage reduction.

The following frequencies are used for the description of the occurrence of adverse reactions: 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).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

* Hypoglycaemia

All sulphonylureas can produce hypoglycaemia. This can be prolonged by gliclazide and may lead to severe hypoglycaemia with life-threatening coma. In cases of very slow progression of nervous lesion (autonomous neuropathy) or sympatholytic concomitant therapy (see “Special warning and precautions for use” and “Interactions”), typical premonitory symptoms of hypoglycaemia may be weaker or absent.

Hypoglycaemia is characterised by decrease in blood sugar to less than approx. 50 to 40 mg/dl.

The following premonitory symptoms can alert the patient or her/his surroundings of a too great blood sugar decrease: sudden sweating, palpitation, tremor, sensation of hunger, restlessness, tingling sensation in the mouth area, paleness, headache, somnolence, sleep disorder, anxiety, depression, touchiness, altered behaviour, unsteady movements, transient neurological symptoms (e.g. speech and visual disorders, paralytic symptoms or sensitivity disorders). In severe hypoglycaemia the patient may loose self-control and consciousness. In this case the patient's skin is often cool and she/he tends to have cramps.

For treatment of hypoglycaemia see “Overdose”.

Accidental or deliberate overdose of sulphonylureas, including gliclazide, can produce hypoglycaemia (for symptoms see 4.8).

Treatment:

Mild hypoglycaemia symptoms, without loss of consciousness or neurological finding, should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated(50%) glucose solution. This should be followed by a continous infusion of a more diluted (10%) glucose solution at a rate which will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 48h,and,depending on the status of the patient at this time, the physician should decide whether further monitoring is required

ATC Code: A10BB09

Gliclazide acts primarily by enhancing the release of insulin from the pancreatic beta cells although it also has some extra pancreatic hypoglycaemic actions (potentiation of the effects of insulin and reduction of hepatic glucose output).

Gliclazide also has beneficial vascular effects, including a reduction in platelet adhesiveness and aggregation and increased fibrinolysis.

The rate of absorption of gliclazide from the gastrointestinal tract varies considerably. Gliclazide is extensively bound to plasma proteins. The plasma half-life is approximately 6-14 hours, the average being about 10 hours. Gliclazide is extensively metabolised in the liver and both unchanged drug and metabolites are excreted in the urine and the faeces.

No toxicological changes were noted in guinea pigs, dogs, rats and monkeys treated with gliclazide for up to one year at doses 50 fold higher than the therapeutic dose in man.

Lactose monohydrate

Microcrystalline Cellulose

Povidone K29/32

Sodium starch glycolate

Talc

Magnesium stearate

Not applicable.

3 years.

Do not store above 25°C.

Diaclide tablets are available in PVC/PVdC blister packs of 60 tablets.

No special requirements.

McDermott Laboratories Ltd

Trading as:

Gerard Laboratories

35-36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

PA 577/30/1

Date of first authorisation: 21 July 2000

Date of last renewal: 31st March 2008

September 2010