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GLICLAZIDE 4.2 Posology and method of


MODIFIED RELEASE TABLETS administration
Posology
30MG / 60MG / 80MG
TAJ PHARMA The daily dose may vary from 1 to 4 tablets
per day, i.e. from 30 to 120 mg taken orally
in a single intake at breakfast time.
1. NAME OF THE MEDICINAL
PRODUCT If a dose is forgotten, there must be no
increase in the dose taken the next day.
Gliclazide modified-release tablets 30mg
Taj Pharma As with any hypoglycaemic agent, the dose
Gliclazide modified-release tablets 60mg should be adjusted according to the
Taj Pharma individual patient's metabolic response
Gliclazide modified-release tablets 80mg (blood glucose, HbAlc).
Taj Pharma Initial dose
2. QUALITATIVE AND The recommended starting dose is 30 mg
QUANTITATIVE COMPOSITION daily.

a) Each uncoated modified-release tablet If blood glucose is effectively controlled,


contains: this dose may be used for maintenance
Gliclazide BP 30mg treatment. If blood glucose is not adequately
Excipients q.s. controlled, the dose may be increased to 60,
90 or 120 mg daily, in successive steps. The
b) Each uncoated modified-release tablet interval between each dose increment should
contains: be at least 1 month except in patients whose
Gliclazide BP 60mg blood glucose has not reduced after two
Excipients q.s. weeks of treatment. In such cases, the dose
may be increased at the end of the second
c) Each uncoated modified-release tablet week of treatment.
contains: The maximum recommended daily dose is
Gliclazide BP 80mg 120 mg.
Excipients q.s.
Switching from gliclazide 80 mg tablets to
For the full list of excipients, see section 6.1. Gliclazide30mg/60mg/80mg modified-
release tablets
3. PHARMACEUTICAL FORM
1 tablet of gliclazide 80 mg is comparable to
Modified-release tablet. 1 tablet of Gliclazide 30
4. CLINICAL PARTICULARS mg modified-release. Consequently, the
switch can be performed provided careful
4.1 Therapeutic indications
blood monitoring is undertaken.
Non insulin-dependent diabetes (type 2) in
adults when dietary measures, physical Switching from another oral anti-diabetic
exercise and weight loss alone are not agent to Gliclazide
sufficient to control blood glucose.
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Gliclazide can be used to replace other oral These data have been confirmed in clinical
anti-diabetic agents. The dosage and the trials.
half-life of the previous anti-diabetic agent
Patients at risk of hypoglycaemia
should be taken into account when switching
to Gliclazide. - Undernourished or malnourished patients
A transitional period is not generally - Patients with severe or poorly compensated
necessary. A starting dose of 30mg should endocrine disorders (hypopituitarism,
be used and this should be adjusted to suit hypothyroidism, adrenocorticotrophic
the patient's blood glucose response, as insufficiency)
described above. When switching from a
- Following withdrawal of prolonged and/or
hypoglycaemicsulphonylurea with
high dose corticosteroid therapy
a prolonged half-life, a treatment free period
of a few days may be necessary to avoid an - Patients with severe vascular disease
additive effect of the two products, which (severe coronary heart disease, severe
might cause hypoglycaemia. carotid impairment or diffuse vascular
disease)
The procedure described for initiating
treatment should also be used when It is recommended that the minimum daily
switching to treatment with Gliclazide, i.e. a starting dose of 30mg is used.
starting dose of 30 mg/day, followed by a
stepwise increase in dose, depending on the Paediatric population
metabolic response. The safety and efficacy of Gliclazide in
Combination treatment with other anti- children and adolescents has not been
diabetic agents established. No data and clinical studies are
available in children.
Gliclazide can be given in combination with
biguanides, alpha glucosidase inhibitors or Method of administration
insulin. In patients not adequately controlled Oral use.
with Gliclazide. concomitant insulin therapy
can be initiated under close medical It is recommended that the tablet(s) be
supervision. swallowed whole.

Special Populations 4.3 Contraindications


- Hypersensitivity to gliclazide or to any of
Elderly the excipients listed in section 6.1, other
Gliclazide should be prescribed using the sulfonylureas, sulfonamides.
same dosing regimen recommended for - Type 1 diabetes
patients under 65 years of age.
- Diabetic pre-coma and coma, diabetic
Renal impairment keto-acidosis
In patients with mild to moderate renal - Severe renal or hepatic insufficiency. In
insufficiency the same dosing regimen can these cases the use of insulin is
be used as in patients with normal renal recommended
function with careful patient monitoring.
- Treatment with miconazole (see section
4.5)
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- Lactation (see section 4.6) - Certain endocrine disorders: thyroid


disorders, hypopituitarism and adrenal
4.4 Special warnings and precautions for
insufficiency
use
Hypoglycaemia - Concomitant administration of certain
other medicines (see section 4.5)
This treatment should be prescribed only if
the patient is likely to have a regular food Renal and hepatic insufficiency
intake (including breakfast). It is important
The pharmacokinetics and/or
to have a regular carbohydrate intake due to
pharmacodynamics of gliclazide may be
the increased risk of hypoglycaemia if a
altered in patients with hepatic insufficiency
meal is taken late, if an inadequate amount
or severe renal failure. A hypoglycaemic
of food is consumed or if the food is low in
episode occurring in these patients may be
carbohydrate. Hypoglycaemia is more likely
prolonged, so appropriate management
to occur during low-calorie diets, following
should be initiated.
prolonged or strenuous exercise, alcohol
intake or if a combination of hypoglycaemic Patient information
agents is being used.
The risks of hypoglycaemia, along with its
Hypoglycaemia may occur following symptoms (see section 4.8), treatment and
administration of sulphonylureas (see conditions that predispose to its
section 4.8). Some cases may be severe and development, should be explained to the
prolonged. Hospitalisation may be necessary patient and to family members. The patient
and glucose administration may need to be should be informed of the importance of
continued for several days. following dietary advice, of taking regular
exercise, and of regular monitoring of blood
Careful selection of patients, of the dose
glucose levels.
used, and clear patient directions are
necessary to reduce the risk of Poor blood glucose control
hypoglycaemic episodes.
Blood glucose control in a patient receiving
Factors which increase the risk of anti-diabetic treatment may be affected by
hypoglycaemia: any of the following: St. John's Wort
(Hypericumperforatum) preparations (see
- Patient refuses or (particularly in elderly
section 4.5), fever, trauma, infection or
subjects) is unable to co-operate
surgical intervention. In some cases, it may
- Malnutrition, irregular mealtimes, skipping be necessary to administer insulin.
meals, periods of fasting or dietary changes
The hypoglycaemic efficacy of any oral
- Imbalance between physical exercise and anti-diabetic agent, including gliclazide, is
carbohydrate intake attenuated over time in many patients. This
may be due to progression in the severity of
- Renal insufficiency
the diabetes, or to a reduced response to
- Severe hepatic insufficiency treatment. This phenomenon is known as
secondary failure, which is distinct from
- Overdose of Gliclazide
primary failure, when an active substance is
ineffective as first-line treatment. Adequate
dose adjustment and dietary compliance
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should be considered before classifying the - Miconazole (systemic route, oromucosal


patient as secondary failure. gel): increases the hypoglycaemic effect
with possible onset of hypoglycaemic
Dysglycaemia:
symptoms, or even coma.
Disturbances in blood glucose, including
Combinations which are not recommended
hypoglycaemia and hyperglycaemia have
been reported, in diabetic patients receiving - Phenylbutazone (systemic route): increases
concomitant treatment with the hypoglycaemic effect of sulphonylureas
fluoroquinolones, especially in elderly (displaces their binding to plasma proteins
patients. Indeed, careful monitoring of blood and/or reduces their elimination). It is
glucose is recommended in all patients preferable to use a different anti-
receiving at the same time inflammatory agent, or else to warn the
Gliclazide30mg/60mg/80mg Modified- patient and emphasise the importance of
release Tablets and a fluoroquinolone. self-monitoring. Where necessary, adjust the
dose during and after treatment with the
Laboratory tests
anti- inflammatory agent.
Measurement of glycatedhaemoglobin levels
- Alcohol: increases the hypoglycaemic
(or fasting venous plasma glucose) is
reaction (by inhibiting compensatory
recommended in assessing blood glucose
reactions) that can lead to the onset of
control. Blood glucose self-monitoring may
hypoglycaemic coma. Avoid alcohol or
also be useful.
medicines containing alcohol.
Treatment of patients with glucose-6-
Combinations requiring precautions for use
phosphate (G6PD)-deficiency with
sulphonylurea agents can lead to Potentiation of the blood glucose lowering
haemolyticanaemia. Since gliclazide belongs effect and thus, in some instances,
to the chemical class of sulphonylurea hypoglycaemia may occur when one of the
drugs, caution should be used in patients following drugs is taken: Other anti-diabetic
with G6PD-deficiency and a non- agents (insulins, acarbose, metformin,
sulphonylurea alternative should be thiazolidinediones, dipeptidyl peptidase-4
considered. inhibitors, GLP-1 receptor agonists); beta-
blockers; fluconazole; angiotensin
Excipients
converting enzyme inhibitors (captopril,
Patients with rare hereditary problems of enalapril); H2-receptor antagonists;
galactose intolerance, total lactase monoamine oxidase inhibitors (MAOIs);
deficiency or glucose- sulphonamides; clarithromycin; and non-
galactosemalabsorption should not take this steroidal anti-inflammatory agents.
medicine.
2) The following products may cause an
4.5 Interaction with other medicinal increase in blood glucose levels
products and other forms of interaction
Combination which is not recommended
1) The following products are likely to
increase the risk of hypoglycaemia - Danazol: diabetogenic effect of danazol. If
the use of this active substance cannot be
Contra-indicated combination
avoided, warn the patient and emphasise the
importance of urine and blood glucose
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monitoring. It may be necessary to adjust the - Fluoroquinolones: in case of a concomitant


dose of the anti-diabetic agent during and use of Gliclazide30mg/60mg/80mg
after treatment with danazol. Modified-release Tablets and a
fluoroquinolone, the patient should be
Combinations requiring precautions during
warned of the risk of dysglycaemia, and the
use
importance of blood glucose monitoring
- Chlorpromazine (neuroleptic agent): High should be emphasised.
doses (>100 mg per day of chlorpromazine)
3) Combination which must be taken into
increase blood glucose levels (reduced
account
insulin release). Warn the patient and
emphasise the importance of blood glucose -- Anticoagulant therapy (e.g.
monitoring. It may be necessary to adjust the warfarin): Sulphonylureas may lead to
dose of the anti-diabetic active substance potentiation of anticoagulation during
during and after treatment with the concurrent treatment. Adjustment of the
neuroleptic agent. anticoagulant may be necessary.
- Glucocorticoids (systemic and local route: 4.6 Fertility, pregnancy and lactation
intra-articular, cutaneous and rectal Pregnancy
preparations) and tetracosactrin: increase
There is no or limited amount of data (less
blood glucose levels with possible ketosis
than 300 pregnancy outcomes) from the use
(reduced tolerance to carbohydrates due to
of gliclazide in pregnant women, even
glucocorticoids). Warn the patient and
though there are few data with other
emphasise the importance of blood glucose
sulfonylureas.
monitoring, particularly at the start of
treatment. It may be necessary to adjust the In animal studies, gliclazide is not
dose of the anti-diabetic active substance teratogenic (see section 5.3). As a
during and after treatment with precautionary measure, it is preferable to
glucocorticoids. avoid the use of Gliclazide during
pregnancy.
- Ritodrine, salbutamol and terbutaline
(I.V.): increased blood glucose levels due to Control of diabetes should be obtained
beta-2 agonist effects. Emphasise the before the time of conception to reduce the
importance of monitoring blood glucose risk of congenital abnormalities linked to
levels. If necessary, switch to insulin. uncontrolled diabetes.
- Saint John's Wort (Hypericumperforatum) Oral hypoglycaemic agents are not suitable.
preparations: Insulin is the drug of first choice for
treatment of diabetes during pregnancy. It is
Gliclazide exposure is decreased by Saint
recommended that oral hypoglycaemic
John's Wort-Hypericumperforatum.
therapy is changed to insulin before a
Emphasise the importance of blood glucose
pregnancy is attempted, or as soon as
levels monitoring.
pregnancy is discovered.
The following products may cause
Breast-feeding
dysglycaemia
It is not known whether gliclazide or its
Combinations requiring precautions during
metabolites are excreted in breast milk.
use
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Given the risk of neonatal hypoglycaemia, hypertension, palpitations, angina pectoris


the product is contra-indicated in breast- and cardiac arrhythmia.
feeding mothers. A risk to the
Usually, symptoms disappear after intake of
newborns/infants cannot be excluded.
carbohydrates (sugar). However, artificial
Fertility sweeteners have no effect. Experience with
other sulphonylureas shows that
No effect on fertility or reproductive
hypoglycaemia can recur even when
performance was noted in male and female
measures prove effective initially.
rats (see section 5.3).
If a hypoglycaemic episode is severe or
4.7 Effects on ability to drive and use
prolonged, and even if it is temporarily
machines
controlled by intake of sugar, immediate
Gliclazide has no known influence on the
medical treatment or even hospitalisation is
ability to drive and use machines. However,
required.
patients should be made aware of the
symptoms of hypoglycaemia and should be Gastrointestinal disturbances, including
careful if driving or operating machinery, abdominal pain, nausea, vomiting,
especially at the beginning of treatment. dyspepsia, diarrhoea and constipation have
been reported: if these should occur they can
4.8 Undesirable effects
be avoided or minimised if gliclazide is
Based on the experience with gliclazide, the
taken with breakfast.
following undesirable effects have to be
mentioned. The following undesirable effects have been
more rarely reported.
The most frequent adverse reaction with
gliclazide is hypoglycaemia. Skin and subcutaneous tissue disorders
As for other sulphonylureas, treatment with Rash, pruritus, urticaria, angioedema,
gliclazide can cause hypoglycaemia, if meal erythema, maculopapular rashes, and
times are irregular and, in particular, if bullous reactions (such as Stevens-Johnson
meals are skipped. Possible symptoms of syndrome and toxic epidermal necrolysis)
hypoglycaemia are: headache, intense and exceptionally, drug rash with
hunger, nausea, vomiting, lassitude, sleep eosinophilia and systemic symptoms
disorders, agitation, aggression, poor (DRESS).
concentration, reduced awareness and
Blood and lymphatic system disorders
slowed reactions, depression, confusion,
visual and speech disorders, aphasia, tremor, Changes in haematology are rare. They may
paresis, sensory disorders, dizziness, feeling include anaemia, leucopenia,
of powerlessness, loss of self-control, thrombocytopenia, granulocytopenia. These
delirium, convulsions, shallow respiration, are in general reversible upon
bradycardia, drowsiness and loss of discontinuation of medication.
consciousness, possibly resulting in coma
Hepato-biliary disorders
and lethal outcome.
Raised hepatic enzyme levels (AST, ALT,
In addition, signs of adrenergic counter-
alkaline phosphatase) and hepatitis (isolated
regulation may be observed: sweating,
reports). Discontinue treatment if cholestatic
clammy skin, anxiety, tachycardia,
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jaundice appears. These symptoms usually If hypoglycaemic coma is diagnosed or


disappear after discontinuation of treatment. suspected, the patient should be given a
rapid I.V. injection of 50 ml of concentrated
Eye disorders
glucose solution (20 to 30 %). This should
Transient visual disturbances may occur, be followed by continuous infusion of a
especially on initiation of treatment, due to more dilute glucose solution (10 %) at a rate
changes in blood glucose levels. that will maintain blood glucose levels
above 1 g/l. Patients should be monitored
Class attribution effects
closely and, depending on the patient's
As for other sulfonylureas, the following condition after this time, the doctor will
adverse events have been observed: cases of decide if further monitoring is necessary.
erythrocytopenia; agranulocytosis;
Dialysis is of no benefit to patients due to
haemolyticanaemia; pancytopenia; allergic
the strong binding of gliclazide to proteins.
vasculitis; hyponatraemia; elevated liver
enzyme levels; and even impairment of liver 5. PHARMACOLOGICAL
function (e.g. with cholestasis and jaundice) PROPERTIES
and hepatitis, which regressed after
5.1 Pharmacodynamic properties
withdrawal of the sulphonylurea or led to
Pharmacotherapeutic group: Blood glucose
life-threatening liver failure in isolated
lowering drugs, excl. insulins: Sulfonylureas
cases.
Mechanism of action
Reporting of suspected adverse reactions
Gliclazide is a hypoglycaemic,
Reporting suspected adverse reactions after
sulphonylurea, oral anti-diabetic active
authorisation of the medicinal product is
substance differing from other related
important. It allows continued monitoring of
compounds by an N-containing heterocyclic
the benefit/risk balance of the medicinal
ring with an endocyclic bond.
product.
Gliclazide reduces blood glucose levels by
4.9 Overdose
stimulating insulin secretion from the β-cells
An overdose of sulphonylureas may cause
of the islets of Langerhans. Increase in
hypoglycaemia. Moderate symptoms of
postprandial insulin and C-peptide secretion
hypoglycaemia, without any loss of
persists after two years of treatment.
consciousness or neurological signs, must be
corrected by carbohydrate intake, dose In addition to these metabolic properties,
adjustment and/or change of diet. Strict gliclazide has haemovascular properties.
monitoring should be continued until the
Pharmacodynamic effects
doctor is sure that the patient is out of
danger. Effects on insulin release
Severe hypoglycaemic reactions, with coma, In type 2 diabetics, gliclazide restores the
convulsions or other neurological disorders first peak of insulin secretion in response to
are possible and must be treated as a medical glucose and increases the second phase of
emergency, requiring immediate insulin secretion. A significant increase in
hospitalisation. insulin response is seen in response to
stimulation induced by a meal or glucose.
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Haemovascular properties The relationship between the dose


administered ranging up to 120 mg and the
Gliclazide decreases microthrombosis by
area under the concentration time curve is
two mechanisms which may be involved in
linear.
complications of diabetes:
Special populations
- A partial inhibition of platelet aggregation
and adhesion, with a decrease in the markers Elderly
of platelet activation (beta thromboglobulin,
No clinically significant changes in
thromboxane B2).
pharmacokinetic parameters have been
- An action on the vascular endothelium observed in elderly patients.
fibrinolytic activity with an increase in tPA
5.3 Preclinical safety data
activity.
Preclinical data reveal no special hazards for
5.2 Pharmacokinetic properties humans based on conventional studies of
Absorption repeated dose toxicity and genotoxicity.
Long term carcinogenicity studies have not
Plasma levels increase progressively during
been done. No teratogenic changes have
the first 6 hours, reaching a plateau which is
been shown in animal studies, but lower
maintained from the sixth to the twelfth hour
foetal body weight was observed in animals
after administration.
receiving doses 25 fold higher than the
Intra-individual variability is low. maximum recommended dose in humans.
Gliclazide is completely absorbed. Food Fertility and reproductive performance were
intake does not affect the rate or degree of unaffected after gliclazide administration in
absorption. animal studies.
Distribution 6. PHARMACEUTICAL
PARTICULARS
Plasma protein binding is approximately
95%. The volume of distribution is around 6.1 List of excipients
30 litres. A single daily intake of Gliclazide Lactose monohydrate, Hypromellose
maintains effective gliclazide plasma
Cellulose, microcrystalline, Silica, colloidal
concentrations over 24 hours.
anhydrous, Magnesium stearate.
Biotransformation
6.2 Incompatibilities
Gliclazide is mainly metabolised in the liver Not applicable.
and excreted in the urine: less than 1% of
6.3 Shelf life
the unchanged form is found in the urine.
3 years
No active metabolites have been detected in
plasma. 6.4 Special precautions for storage
Do not store above 30°C.
Elimination
6.5 Nature and contents of container
The elimination half-life of gliclazide varies
PVC/PVDC/Al blisters.
between 12 and 20 hours.
Pack sizes:
Linearity/non-linearity
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Blisters: 7, 14, 28, 30, 50, 90, 100 and


500mg modified-release tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and
other handling
No special requirements.
Any unused medicinal product or waste
material should be disposed of in accordance
with local requirements.
7. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.


Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai - 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-
800-222-825)
Monday through Saturday 9:00 a.m. to 7:00
p.m. EST
E-mail: tajgroup@tajpharma.com