Australian Product Information

DIAMICRON® 60 mg MR TABLET, MODIFIED RELEASE

AUSTRALIAN PRODUCT INFORMATION

DIAMICRON® 60 mg MR TABLET, MODIFIED RELEASE

1 NAME OF THE MEDICINE

Gliclazide

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each DIAMICRON 60 mg MR tablet contains 60 mg of gliclazide.

Gliclazide is an oral hypoglycaemic sulphonylurea which differs from other related compounds by
an N-containing heterocyclic ring with an endocyclic bond.

Excipient with known effect: each tablet contains 71.36 mg of lactose monohydrate.

For the full list of excipients, see section 6.1 - List of excipients.

3 PHARMACEUTICAL FORM
Tablet, modified release: white, oblong, scored with a break bar on both sides with an engraving of
"DIA 60" on both faces.

4 CLINICAL PARTICULARS

4.1 THERAPEUTIC INDICATIONS

Type II diabetes in association with dietary measures when dietary measures alone are inadequate
to control blood glucose.

During controlled clinical trials in patients with type II diabetes, a modified release formulation of
gliclazide (30 mg - 120 mg), taken as a single daily dose, was shown to be effective long term in
controlling blood glucose levels, based on monitoring of HbA1c.

4.2 DOSE AND METHOD OF ADMINISTRATION

For adult use only.

DIAMICRON 60 mg MR tablets have a break bar and may be administered as whole or as half
tablets (see section 5.2 – Pharmacokinetic properties). So that the modified release properties of
the product can be maintained, tablets should not be chewed or crushed.

Whole or half tablets of DIAMICRON 60 mg MR should be taken with food because there is an
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. It is recommended that the medication be taken at
breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased.

A single daily dose provides an effective blood glucose control. The daily dose may vary from half
a tablet to two tablets per day i.e. 30 mg to 120 mg taken orally. The initial recommended dose is

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half a tablet (30 mg), even in elderly patients (≥ 65 years). The daily dose should not exceed two
tablets (120 mg).

As with all hypoglycaemic agents, the dose should be titrated according to the individual patient's
response. Titration should be carried out in steps of 30 mg, according to the fasting blood glucose
response. Each step should last for at least two weeks.

Previously untreated patients should commence with half a tablet of DIAMICRON 60 mg MR (30
mg) dose and will benefit from dose titration until the appropriate dose is reached.

DIAMICRON 60 mg MR may be used to replace other antidiabetic treatments without any

transitional period. If a patient is switched from a hypoglycaemic sulphonylurea with a prolonged
half-life he/she should be carefully monitored (for one to two weeks) in order to avoid
hypoglycaemia due to possible residual effects of the previous therapy.

DIAMICRON 60 mg MR may be given in combination with biguanides, alpha glucosidase inhibitors

or insulin.

Elderly patients

The efficacy and tolerance of the modified release formulation of gliclazide (30 mg - 120 mg) has
been confirmed in clinical trials in patients over 65 years who were given the same dosage
regimen as the general population. The dosage is therefore identical to that recommended for
adults under the age of 65 years.

Renal impairment

The efficacy and tolerance of the modified release formulation of gliclazide (30 mg - 120 mg) has
been confirmed in clinical trials of patients with mild to moderate renal failure (creatinine clearance
of between 15 and 80 mL/min) who were given the same dosage regimen as the general
population. No dosage adjustment is therefore required in patients with mild to moderate renal
impairment. Use of DIAMICRON 60 mg MR in patients with severe renal impairment is
contraindicated (see section 4.3 - Contraindications).

4.3 CONTRAINDICATIONS
This medication is contra-indicated in the following cases:
− hypersensitivity to gliclazide, other sulphonylureas, sulfonamides, or to any of the excipients.
− Type I diabetes, diabetic keto-acidosis, diabetic pre-coma and coma.
− severe renal or hepatic impairment : in these cases the use of insulin is recommended.
− treatment with miconazole (see section 4.5 - Interactions with other medicines and other forms
of interactions).
− pregnancy and lactation (see section 4.6 - Fertility, pregnancy and lactation).

4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE

The risks of hypoglycaemia, together with its symptoms, 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.

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Hypoglycaemia
Hypoglycaemia may occur following administration of sulphonylureas. Rarely cases may be severe
and prolonged. This may involve hospitalisation and glucose infusion may need to be continued for
several days.

Careful selection of patients and of the dose used, as well as provision of adequate information to
the patient are necessary to avoid hypoglycaemic episodes. The following factors may increase the
risk of hypoglycaemia:
- patient does not follow the doctor’s treatment advice (particularly elderly patients)
- malnutrition
- irregular mealtimes, skipping meals, periods of fasting or dietary changes
- imbalance between physical exercise and carbohydrate intake
- renal impairment
- severe hepatic impairment
- overdose of anti-diabetic agents
- certain endocrine disorders: thyroid disorders, hypopituitarism and adrenal impairment,
concomitant administration of certain other medicines (see section 4.5 - Interactions with other
medicines and other forms of interactions).

Gliclazide should only be prescribed 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 delayed, an inadequate amount of food is consumed or the food is low
in carbohydrate. Hypoglycaemia is more likely to occur during periods of low-calorie diet, following
prolonged or strenuous exercise, following alcohol intake or during treatment with a combination of
hypoglycaemic agents.

Poor blood glucose control

Blood glucose control in treated patients may be affected by St. John's Wort (Hypericum
perforatum) preparations (see section 4.5 - Interactions with other medicines and other forms of
interactions), fever, trauma, infection or surgical intervention. It may be necessary to discontinue
treatment and to administer insulin in these cases.

The efficacy of oral antidiabetic agents often decreases in the long term. 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 and should be distinguished from primary failure, when
the drug is ineffective as first-line treatment. However, before classifying the patient as a
secondary failure, dose adjustment and reinforcement of dietary measures should be considered.

Unstable blood glucose level (Dysglycaemia)

Disturbances in blood glucose, including hypoglycaemia and hyperglycaemia have been reported,
in diabetic patients receiving concomitant treatment with fluoroquinolones, especially in elderly
patients. Indeed, carefull monitoring of blood glucose is recommended in all patients receiving
gliclazide and a fluoroquinolone at the same time.

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Renal and hepatic impairment

Severe renal or hepatic impairment may affect the distribution of gliclazide and hepatic impairment
may also reduce the capacity for neoglucogenesis. These two effects increase the risk of severe
hypoglycaemic reactions. A hypoglycaemic episode in these patients may be prolonged and
appropriate management should be initiated.

Glucose-6-phosphate dehydrogenase deficiency (G6PD)

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

Lactose intolerance
Due to the presence of lactose, patients with rare hereditary problems of galactose intolerance,
glucose galactose malabsorption, or the Lapp lactase deficiency should not take this medicinal
product.

Patients with porphyria

Cases of acute porphyria have been described with the class of sulfonylurea drugs, in patients who
have porphyria.

Use in elderly
See sections 4.2 - Dose and method of administration and 5.2 - Pharmacokinetic properties.

Paediatric use
Not recommended for paediatric use, see section 4.2 - Dose and method of administration.

Effects on laboratory tests

Glycated haemoglobin should be monitored regularly. Blood glucose measurement may also be
useful.

4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS

Blood glucose monitoring during and after treatment is necessary when DIAMICRON 60 mg MR is
used with medicines which can interact with gliclazide. It may also be necessary to adjust the dose
of DIAMICRON 60 mg MR during and after treatment with such medicines.

1) The following medications are likely to increase the risk of hypoglycaemia

Concomitant use which is contraindicated:

Miconazole (systemic route, oromucosal gel)

Increases the hypoglycaemic effect with possible onset of hypoglycaemia symptoms, or even
coma.

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Concomitant use which is not recommended:

Phenylbutazone (systemic route)

Increases the hypoglycaemic effect of sulphonylureas (displaces their binding to plasma proteins
and/or reduces their elimination). It is preferable to use a different anti-inflammatory agent, or else
to warn the patient and emphasise the importance of self-monitoring. Where necessary, adjust the
dose during and after treatment with the anti-inflammatory agent.

Alcohol

Acute alcohol intoxication potentiates the hypoglycaemic action of all sulphonylurea agents by
inhibiting compensatory reactions. This can lead to the onset of hypoglycaemic coma. Ingestion of
alcohol may also cause a disulfiram-like reaction with characteristic flushing of the face, throbbing
headache, giddiness, tachypnoea, tachycardia or angina pectoris. Chronic alcohol abuse may, as
a result of liver enzyme induction, increase the metabolism of sulphonylurea drugs, shortening the
plasma half life and duration of action.

Avoid alcohol or medicines containing alcohol.

Concomitant use which requires special care:

Potentiation of the blood glucose lowering effect and therefore in some instances,
hypoglycaemia may occur when one of the following medications is taken:

Other antidiabetic agents (insulins, acarbose, biguanides, metformin, thiazolidinediones, dipeptidyl

peptidase-4 inhibitors, GLP-1 receptor agonists), sulfonamides, clarithromycin, clofibrate,
salicylates (high doses), chloramphenicol, MAOIs, -blockers, H2-receptor antagonists, ACE
inhibitors, fluconazole and nonsteroidal anti-inflammatory agents.

2) The following medications may cause an increase in blood glucose levels

Advise the patient and emphasise the importance of glucose monitoring.
Concomitant use which is not recommended:

Danazol

If the use of danazol cannot be avoided, it may be necessary to adjust the dose of DIAMICRON 60
mg MR during and after treatment with danazol.

Concomitant use which requires special care:

Chlorpromazine

High doses (>100 mg per day of chlorpromazine) can increase blood glucose levels (reduced
insulin release). Advise the patient and emphasise the importance of glucose monitoring. It may be
necessary to adjust the dose of DIAMICRON 60 mg MR during and after treatment with
chlorpromazine.

Glucocorticoids (systemic and local route: intra-articular, cutaneous and rectal preparations) and
tetracosactrin

Concomittant use may increase blood glucose levels with possible ketosis (glucocorticoids cause
reduced tolerance to carbohydrates). Emphasise the importance of blood glucose monitoring,

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particularly at the start of treatment. It may be necessary to adjust the dose of DIAMICRON 60 mg
MR during and after treatment with glucocorticoids.

Salbutamol, terbutaline (intravenous)

May cause increased blood glucose levels due to beta-2 agonist effects. If necessary, switch to
insulin.

Barbiturates, Oestrogens and progestogens

May adversely affect blood sugar control with hypoglycaemic agents in some patients by causing
increased blood glucose levels.

St John's Wort (Hypericum perforatum) preparations:

Gliclazide exposure is decreased by St John's Wort (Hypericum perforatum).

3) The following products may cause unstable blood glucose

Concomitant use which requires special care:

Fluoroquinolones

In case of a concomitant use of gliclazide and a fluoroquinolone, the patient should be warned of
the risk of unstable blood glucose, and the importance of blood glucose monitoring should be
emphasised.

Concomitant use to be taken into consideration:

Anticoagulant therapy (Warfarin)

Sulphonylureas may lead to potentiation of anticoagulation during concurrent treatment.

Adjustment of warfarin may be necessary.

4.6 FERTILITY, PREGNANCY AND LACTATION

Effects on fertility
No data available.

Use in pregnancy
Australian Pregnancy Categorisation (Category C).

In animal studies embryo-toxicity and/or birth defects have been demonstrated with some
sulfonylureas.

Gliclazide should not be used in pregnant women. From a clinical point of view, there are limited
data (less than 300 pregnancies) to allow evaluation of the possible malformative or foetotoxic
effects of gliclazide, when administered during pregnancy. Animal studies of gliclazide have not
shown any teratogenic effect.

DIAMICRON 60 mg MR is contra-indicated during pregnancy and insulin is the drug of first choice
for treatment of diabetes during pregnancy. Treatment should be changed from DIAMICRON 60
mg MR to insulin therapy before pregnancy is attempted, or as soon as pregnancy is discovered.
Control of diabetes should be achieved before the time of conception to reduce the risk of
congenital abnormalities linked to uncontrolled diabetes.

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Use in lactation
It is not known whether gliclazide or its metabolites are excreted in breast milk. Given the risk of
neonatal hypoglycaemia, DIAMICRON 60 mg MR is contraindicated in women who are breast
feeding. A risk to newborns/infants cannot be excluded.

4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Patients should be made aware of the symptoms of hypoglycaemia and should be careful if driving
or operating machinery, especially at the beginning of treatment.

4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)

Reporting suspected adverse effects
Reporting suspected adverse reactions after registration of the medicinal product is important. It
allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-
problems.

Good clinical acceptability of gliclazide, has been established in many studies as well as in medical
practice.

The safety of a modified release formulation of gliclazide (30 mg - 120 mg) has been evaluated in
controlled clinical trials in 955 patients, of which 728 patients were treated in long-term
comparative trials, against a gliclazide immediate release formulation (80 mg - 320 mg), for up to
ten months. In these comparative trials, the overall incidence and type of adverse events were
similar in both groups. Adverse events were generally mild and transient, not requiring
discontinuation of therapy.

However, where patients did discontinue due to adverse events, the percentage was lower in the
modified release group (2.9 %) than in the immediate release group (4.5 %).

Hypoglycaemia (see sections 4.3 - Contraindications and 4.4 - Special warnings and
precautions for use)
The most frequent adverse reaction with gliclazide is hypoglycaemia.

As is the case with all sulphonylurea drugs, hypoglycaemic reactions have been reported following
gliclazide administration. However, a number of studies have shown that hypoglycaemia is less
common with gliclazide than with glibenclamide.

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/or
death. 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 intake of carbohydrate such as sugar (artificial sweeteners
have no effect). Experience with other sulphonylureas shows that hypoglycaemia can recur even
when these measures are initially effective. If a hypoglycaemic episode is severe or prolonged, and

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even if it is temporarily controlled by intake of sugar, immediate medical treatment or even

hospitalisation is required.

In long-term comparative studies, the percentage of patients experiencing hypoglycaemic episodes

was similar between patients treated with the modified release formulation of gliclazide (11.6 %)
and those treated with the immediate release formulation of gliclazide (11.1 %). However, the
number of hypoglycaemic episodes per 100 patient months was lower in the modified release
group (3.5) than in the immediate release group (4.8).

Analysis of elderly patients (over 65 years old) showed less hypoglycaemia than in the general
population, with a prevalence of hypoglycaemic episodes lower in the modified release group
(2.6 hypoglycaemic episodes for 100 patient months) than in the immediate release group (4.1).

The percentage of patients experiencing hypoglycaemic episodes in the sub-population with renal
failure, was similar to that observed in the general population.

Adverse events reported during controlled clinical trials with the modified release formulation of
gliclazide were those expected in an ageing population with diabetes.

Adverse events that were reported in at least 2.0 % of patients, in long-term controlled clinical
studies, are presented in the following table. The most frequent adverse events were not
specifically related to the disease (such as respiratory infections or back pain).

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Treatment emergent adverse events* (listed by body system) occurring in ≥ 2.0 % of

patients in long-term controlled clinical trials

Gliclazide modified release Gliclazide immediate release

tablets (30 mg - 120 mg) tablets (80 mg - 320 mg)
(n=728) (n=734)
% %
Resistance mechanism
Infection, viral 7.7 5.6
Respiratory
Rhinitis 4.4 4.6
Bronchitis 4.4 4.6
Pharyngitis 4.3 3.5
Upper respiratory infection 3.3 3.7
Coughing 2.1 2.0
Musculo-skeletal
Back pain 5.2 4.1
Arthralgia 3.0 3.5
Arthrosis 2.2 2.2
Secondary term
Inflicted injury 4.3 4.5
Body as a whole
Headache 3.8 4.6
Asthenia 2.2 2.6
Cardiovascular
Hypertension 3.2 3.7
Angina pectoris 2.1 2.2
Urinary
Urinary tract infections 2.6 3.0
Gastrointestinal
Diarrhoea 2.5 2.0
Central, periph., nervous
system
Dizziness 2.2 2.3
Metabolism and nutrition
Hyperglycaemia 1.9 2.2
*whatever the relationship to treatment

Analysis of adverse events in sub-populations showed a similar pattern to that seen in the general
population. Gender, age and renal impairment had no significant influence on the safety profile of
the modified release formulation of gliclazide.

Other adverse effects

Gastrointestinal disturbances (reported with gliclazide), including nausea, dyspepsia, diarrhoea,

abdominal pain, vomiting and constipation may be avoided or minimised if gliclazide is taken with
breakfast.

The following adverse effects have been rarely reported:

Skin and subcutaneous tissue disorders: pruritus, urticaria, maculopapular rashes, rash,
angioedema, erythema and bullous reactions (such as Stevens-Johnson Syndrome (SJS) and
toxic epidermal necrolysis (TEN) (as with other sulfur-containing medications) and autoimmune
bullous disorders and exceptionally, drug rash with eosinophilia and systemic symptoms (DRESS).

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Blood and lymphatic system disorders (as with other sulphonylurea medications): anaemia,
leucopenia, thrombocytopenia and agranulocytosis. These are in general reversible upon
discontinuation of medication.

Hepatobiliary disorders: elevations of serum bilirubin and hepatic enzymes (AST, ALT, alkaline
phosphatase) levels, and exceptionally, hepatitis (isolated reports). Treatment should be
discontinued if cholestatic jaundice appears. These symptoms usually disappear after
discontinuation of treatment.

Investigations: occasional elevations of serum creatinine, blood urea nitrogen.

Eye disorders: transient visual disturbances may occur due to changes in blood glucose levels,
particularly on initiation of treatment.l As with any glucose-lowering medication, transient visual
disturbances may occur on initiation of treatment due to changes in blood glucose levels.

Class effects
The following adverse events have been observed with sulphonylureas: cases of erythrocytopenia,
agranulocytosis, haemolytic anaemia, pancytopenia and allergic vasculitis, hyponatremia, elevated
liver enzyme levels and even impairment of liver function (e.g. with cholestasis and jaundice) and
hepatitis which regressed after withdrawal of the sulphonylurea or led to life-threatening liver failure
in isolated cases.

4.9 OVERDOSE
Advice on overdose management can be obtained from the national Poisons Information
Centre by telephoning 131126.
Overdose of sulphonylureas may cause hypoglycaemia.

Moderate symptoms of hypoglycaemia (without loss of consciousness or neurological signs),

should be corrected by carbohydrate intake, dose adjustment and/or modification of diet. Strict
monitoring should be continued until the doctor is sure that the patient is out of danger.

Severe hypoglycaemic reactions are possible (with coma, convulsions or other neurological
disorders) and must be treated as a medical emergency, requiring immediate hospitalisation.

If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection
of 50 mL of concentrated glucose solution (20 to 30 %). This should be followed by continuous
infusion of a more dilute glucose solution (10 %) at a rate necessary to maintain blood glucose
levels above 5 mmol/L. It is recommended that patients should be monitored closely for a 48 hour
period at least.

Plasma clearance of gliclazide may be prolonged in patients with hepatic disease. However, due to
the strong binding of gliclazide to proteins, dialysis is not effective in these patients.

5 PHARMACOLOGICAL PROPERTIES

5.1 PHARMACODYNAMIC PROPERTIES

Pharmacodynamics
Gliclazide reduces blood glucose levels by stimulating insulin secretion from the -cells of the islets
of Langerhans. Gliclazide shows high affinity, strong selectivity and reversible binding to the -cell

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KATP channels with a low affinity for cardiac and vascular KATP channels. Increased postprandial
insulin and C-peptide secretion persists after two years of treatment.

In type II diabetes, gliclazide restores the first peak of insulin secretion in response to glucose and
increases the second phase of insulin secretion. A significant increase in insulin release is seen in
response to stimulation induced by a meal or glucose.

Gliclazide also has extra-pancreatic effects and haemovascular properties.

It has been shown to increase peripheral insulin sensitivity:

− In muscle, euglycaemic hyperinsulinaemic clamp studies with gliclazide have demonstrated
significantly increased (35 %) insulin mediated glucose uptake which may improve diabetes
control. Gliclazide potentiates insulin action on muscle glycogen synthase. These effects are
consistent with a post-transcriptional action of gliclazide on GLUT4 glucose transporters.
− Studies on glucose turnover have further shown that gliclazide decreases hepatic glucose
production, leading to an improvement in fasting blood glucose levels.

Gliclazide has been shown in some studies to have actions independent of that on glucose levels.
These haemovascular effects of gliclazide include:
− Partial inhibition of platelet aggregation and adhesion with a decrease in markers of platelet
activation (beta thromboglobulin, thromboxane B2).
− Increased vascular endothelial fibrinolytic activity (increased tPA activity).
− Anti-oxidant properties, notably a reduction in plasma lipid peroxides and increased erythrocyte
superoxide dismutase activity.
− Inhibition of the increased adhesiveness of type II diabetic patient’s monocytes to endothelial
cells in vitro.

The anti-oxidant, platelet inhibiting and fibrinolytic actions of gliclazide involve processes which
have been implicated in the pathogenesis of vascular complications of type II diabetes. There is no
clinical evidence that the haemovascular effects of gliclazide are of therapeutic benefit in type II
diabetes patients.

5.2 PHARMACOKINETIC PROPERTIES

Pharmacokinetic studies have demonstrated bioequivalence between a DIAMICRON 60 mg MR
tablet and two halves (each half containing 30 mg gliclazide) of one DIAMICRON 60 mg MR tablet.

Absorption
Hydration of the tablets induces formation of a gel to activate drug release. Plasma levels increase
progressively, resulting in a plateau-shaped curve from the sixth to the twelfth hour after
administration. Intra-individual variability is low. Gliclazide is completely absorbed and food intake
does not affect the rate or degree of absorption.

Distribution
Plasma protein binding is approximately 95 %. The relationship between the dose administered
and the area under the concentration curve as a function of time is linear for doses of gliclazide up
to 90 mg/day. At the highest evaluated dose (135 mg/day), the AUC increases slightly more than
proportionally to the dose.

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Metabolism
Gliclazide is mainly metabolised in the liver, the products of which are extensively excreted in the
urine.

Excretion
Less than 1 % of unchanged drug is recovered in the urine. No active metabolites have been
detected in plasma. The clearance of gliclazide has been found to be slightly reduced as a function
of age. This reduction, however, is not considered to be clinically significant. The elimination half-
life of gliclazide is approximately 16 hours.

Use in elderly
No clinically significant modifications in the pharmacokinetic parameters have been observed in
elderly patients.

6 PHARMACEUTICAL PARTICULARS

6.1 LIST OF EXCIPIENTS

Lactose monohydrate
Colloidal anhydrous silica
Hypromellose
Magnesium stearate
Maltodextrin.

6.2 INCOMPATIBILITIES
Incompatibilities were either not assessed or not identified as part of the registration of this
medicine.

6.3 SHELF LIFE

In Australia, information on the shelf life can be found on the public summary of the Australian
Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 SPECIAL PRECAUTIONS FOR STORAGE

Store below 30 oC.

6.5 NATURE AND CONTENTS OF CONTAINER

DIAMICRON 60 mg MR modified release tablets are supplied in aluminium/PVC blister strips
containing either 20 or 60 tablets enclosed in an outer carton.

6.6 SPECIAL PRECAUTIONS FOR DISPOSAL

In Australia, any unused medicine or waste material should be disposed of by taking to your local
pharmacy.

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6.7 PHYSICOCHEMICAL PROPERTIES

Gliclazide has the chemical name 1-(3-azabicyclo[3.3.0]oct-3-yl)-3-p-tolylsulphonylurea. It is a
white or almost white powder, practically insoluble in water, freely soluble in dichloromethane,
sparingly soluble in acetone and slightly soluble in ethanol 96 %. The melting point of gliclazide is
approximately 168 °C.

Molecular formula:

C15H21N3O3S

Chemical structure
O O O
S N
N N
H H
H3C

CAS number

21187-98-4

7 MEDICINE SCHEDULE (POISONS STANDARD)

S4 - Prescription only medicine

8 SPONSOR
Servier Laboratories (Aust.) Pty. Ltd.
servier.com.au
Level 4, Building 9
588A Swan Street
Burnley, 3121, Victoria

9 DATE OF FIRST APPROVAL

11 November 2009

10 DATE OF REVISION
27 July 2022

SUMMARY TABLE OF CHANGES

Section(s)
Summary of new information
Changed
8 Address change

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