GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Gliclazide Tablets 40mg (GLICLATAJ) Taj Pharma
b) Gliclazide Tablets 80mg (GLICLATAJ) Taj Pharma

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Each Tablet Contains:
Gliclazide 40mg
Excipients q.s.
b) Each Tablet Contains:
Gliclazide 80mg
Excipients q.s.

THERAPEUTIC INDICATIONS:

Gliclazide Tablets (GLICLATAJ) is for oral use. Take your tablet(s) with a glass of water (and preferably at the same time each day).

DIRECTION OF USE:

Gliclazide Tablets (GLICLATAJ) is for oral use. Take your tablet(s) with a glass of water (and preferably at the same time each day).

CAUTION & SCHEDULE

Keep medication out of reach and sight of children.
SCHEDULE: SCHEDULE ‘H’ DRUG – To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Store at temperature bellow 30°C. Protect from light and moisture.

Gliclazide Tablets 80mg (GLICLATAJ) Taj Pharma

Overview

Introduction of Gliclataj Tablet

Gliclataj 80 mg Tablet is a medicine used to treat type 2 diabetes mellitus in adults. It belongs to a group of medicines called sulfonylureas and helps control blood sugar levels in people with diabetes. This helps to prevent serious complications of diabetes like kidney damage and blindness.

Gliclataj 80 mg Tablet may be used by itself or along with other medicines. It should be taken with food. Take it regularly at the same time each day to get the most benefit. Your doctor will decide what dose is best for you and this may change from time to time according to how it is working.

Keep taking this medicine, even if you feel well or your blood sugar levels are controlled. If you stop it without consulting your doctor, your blood sugar levels could rise and put you at risk of kidney damage, blindness, nerve problems and loss of limbs. Remember that it is only part of a treatment program that should also include a healthy diet, regular exercise, and weight reduction as advised by your doctor. Your lifestyle plays a big part in controlling diabetes.

The most common side effects of taking this medicine include nausea, headache, and dizziness. It can also sometimes cause low blood glucose levels (hypoglycemia). Make sure you recognize the signs of having low blood glucose levels, such as sweating, dizziness, headache, and shaking and know how to deal with it. To prevent this, it’s important to have regular meals and always carry a fast-acting source of glucose such as sugary food or fruit juice with you. Drinking alcohol can also increase your risk of low blood sugar levels and should be avoided. Some people may find that they put on weight with this medicine.

You should not take it if you have type 1 diabetes mellitus, if you have diabetic ketoacidosis (high levels of acid in your blood), or if you have severe kidney or liver disease. Before taking this medicine, tell your doctor if you have ever had heart disease, thyroid disease or some hormonal conditions. It may not be suitable. Pregnant or breastfeeding women should also consult their doctor before taking it. Your blood sugar levels should be checked regularly and your doctor may also advise blood tests to monitor your blood cell counts and liver function.

Uses of Gliclataj Tablet

  • Type 2 diabetes mellitus

Gliclataj Tablet side effects

Common
  • Hypoglycemia (low blood sugar level)
  • Nausea
  • Headache
  • Dizziness

How to use Gliclataj Tablet

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Gliclataj 80 mg Tablet is to be taken with food.

How Gliclataj Tablet works

is an antidiabetic medication. It works by increasing the amount of insulin released by the pancreas in order to lower the blood sugar levels.

Gliclataj Tablet related warnings

warnings

Alcohol

UNSAFE
It is unsafe to consume alcohol with Gliclataj 80 mg Tablet
warnings

Pregnancy

CONSULT YOUR DOCTOR
Gliclataj 80 mg Tablet may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
warnings

Lactation

SAFE IF PRESCRIBED
Gliclataj 80 mg Tablet is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
warnings

Driving

SAFE
Gliclataj 80 mg Tablet does not usually affect your ability to drive.
warnings

Kidney

CAUTION
Gliclataj 80 mg Tablet should be used with caution in patients with severe kidney disease. Dose adjustment of Gliclataj 80 mg Tablet may be needed. Please consult your doctor.
These patients can experience very low blood sugar levels with this medicine, which may take a long time to come back to normal
warnings

Liver

CAUTION
Gliclataj 80 mg Tablet should be used with caution in patients with severe liver disease. Dose adjustment of Gliclataj 80 mg Tablet may be needed. Please consult your doctor.

What if you miss a dose of Gliclataj Tablet?

You should skip a dose of Gliclataj 80 mg Tablet, if a meal is skipped and add a dose of medicine if you eat an extra meal.

Gliclazide Tablets 80mg (GLICLATAJ) Taj Pharma

1. Name of the medicinal product
a) Gliclazide Tablets 40mg (GLICLATAJ) Taj Pharma
b) Gliclazide Tablets 80mg (GLICLATAJ) Taj Pharma

2. Qualitative and quantitative composition
a) Each Tablet Contains:
Gliclazide 40mg
Excipients q.s.
b) Each Tablet Contains:
Gliclazide 80mg
Excipients q.s.

3.Pharmaceutical form

Tablet

White, circular, flat.

  1. Clinical particulars

4.1 Therapeutic indications

Non insulin dependent diabetes mellitus (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.

4.2 Posology and method of administration

Posology

Adults

The total daily dose may vary from 40-320mg. The dose should be adjusted according to the individual’s response, commencing with 40-80mg (1 – 2 tablets) daily and increasing until adequate control is achieved. A single dose should not exceed 160mg. When higher doses are 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.

  • Switching from another oral antidiabetic agent to Gliclazide 40mg Tablets:

Gliclazide 40mg Tablets can be used to replace other oral antidiabetic agents.

The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Gliclazide 40mg Tablets.

A transitional period is not generally necessary. A starting dose of 40-80 mg (1 to 2 tablets) should be used and this should be adjusted to suit the patient’s blood glucose response, as described above.

When switching from a hypoglycaemic sulfonylurea with a prolonged half-life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which might cause hypoglycaemia.

  • Combination treatment with other antidiabetic agents:

Gliclazide 40mg Tablets can be given in combination with biguanides, alpha glucosidase inhibitors or insulin.

In patients not adequately controlled with Gliclazide 40mg Tablets, concomitant insulin therapy can be initiated under close medical supervision.

Special Populations

Elderly

Gliclazide 40mg Tablets should be prescribed using the same dosing regimen recommended for patients under 65 years of age.

Clinical experience in the elderly to date shows that gliclazide is effective and well tolerated. Care should be exercised however, when prescribing sulfonylureas in the elderly due to a possible age-related increased risk of hypoglycaemia.

Renal impairment

In patients with mild to moderate renal insufficiency, the same dosing regimen can be used as in patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials.

Patients at risk of hypoglycaemia

  • Undernourished or malnourished,
  • Severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency),
  • Withdrawal of prolonged and/or high dose corticosteroid therapy,
  • Severe vascular disease (severe coronary heart disease,severe carotid impairment, diffuse vascular disease).

It is recommended that the minimum daily starting dose of 40-80 mg is used.

Paediatric population

The safety and efficacy of Gliclazide 40mg Tablets in children and adolescents have not been established. No data are available.

Method of administration

For oral use.

4.3 Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, other sulfonylureas or sulfonamides
  • Type I diabetes
  • Diabetic pre-coma and coma, diabetic keto-acidosis
  • Severe renal or hepatic insufficiency: in these cases the use of insulin is recommended
  • Treatment with miconazole (see section 4.5)
  • Lactation (see section 4.6).

4.4 Special warnings and precautions for use

Hypoglycaemia

This treatment should be prescribed only 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 taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. Hypoglycaemia is more likely to occur during low-calorie diets, following prolonged or strenuous exercise, alcohol intake or if a combination of hypoglycaemic agents is being used.

Hypoglycaemia may occur following administration of sulfonylureas (see section 4.8). Some cases may be severe and prolonged. Hospitalisation may be necessary and glucose administration may need to be continued for several days.

Careful selection of patients, of the dose used, and clear patient directions are necessary to reduce the risk of hypoglycaemic episodes.

Factors which increase the risk of hypoglycaemia:

  • patient refuses or (particularly in elderly subjects) is unable to co-operate
  • malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes
  • imbalance between physical exercise and carbohydrate intake
  • renal insufficiency
  • severe hepatic insufficiency
  • overdose of Gliclazide
  • certain endocrine disorders: thyroid disorders, hypopituitarism and adrenal insufficiency
  • concomitant administration of certain other medicines (see section 4.5).

Renal and hepatic insufficiency

The pharmacokinetics and/or pharmacodynamics of gliclazide may be altered in patients with hepatic insufficiency or severe renal failure. A hypoglycaemic episode occurring in these patients may be prolonged, so appropriate management should be initiated.

Patient information

The risks of hypoglycaemia, together with its symptoms (see section 4.8), 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.

Poor blood glucose control

Blood glucose control in a patient receiving antidiabetic treatment may be affected by any of the following: St. John’s Wort (Hypericum perforatum) preparations (see section 4.5), fever, trauma, infection or surgical intervention. In some cases, it may be necessary to administer insulin.

The hypoglycaemic efficacy of any oral antidiabetic agent, including gliclazide, is attenuated over time in many patients. 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 which is distinct from primary failure, when an active substance is ineffective as first-line treatment. Adequate dose adjustment and dietary compliance should be considered before classifying the patient as secondary failure.

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, careful monitoring of blood glucose is recommended in all patients receiving at the same time Gliclazide 40mg Tablets and a fluoroquinolone.

Laboratory tests

Measurement of glycated haemoglobin levels (or fasting venous plasma glucose) is recommended in assessing blood glucose control. Blood glucose self-monitoring may also be useful.

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

4.5 Interaction with other medicinal products and other forms of interaction

The following products are likely to increase the risk of hypoglycaemia

Contraindicated combination

Miconazole (systemic route, oromucosal gel): increases the hypoglycaemic effect with possible onset of hypoglycaemic symptoms, or even coma.

Combinations which are not recommended

Phenylbutazone (systemic route): increases the hypoglycaemic effect of sulfonylureas (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: increases the hypoglycaemic reaction (by inhibiting compensatory reactions) that can lead to the onset of hypoglycaemic coma. Avoid alcohol or medicines containing alcohol.

Combinations requiring precautions for use

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when one of the following drugs is taken, for example:

Other antidiabetic agents (insulins, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists), beta-blockers, fluconazole, angiotensin converting enzyme inhibitors (captopril, enalapril), H2-receptor antagonists, MAOIs, sulfonamides, clarithromycin and nonsteroidal anti-inflammatory agents.

The following products may cause an increase in blood glucose levels

Combination which is not recommended

Danazol: diabetogenic effect of danazol.

If the use of this active substance cannot be avoided, warn the patient and emphasise the importance of urine and blood glucose monitoring. It may be necessary to adjust the dose of the antidiabetic agent during and after treatment with danazol.

Combinations requiring precautions during use

Chlorpromazine (neuroleptic agent): high doses (> 100 mg per day of chlorpromazine) increase blood glucose levels (reduced insulin release).

Warn the patient and emphasise the importance of blood glucose monitoring. It may be necessary to adjust the dose of the antidiabetic active substance during and after treatment with the neuroleptic agent.

Glucocorticoids (systemic and local route: intra-articular, cutaneous and rectal preparations) and tetracosactrin: increase in blood glucose levels with possible ketosis (reduced tolerance to carbohydrates due to glucocorticoids).

Warn the patient and emphasise the importance of blood glucose monitoring, particularly at the start of treatment. It may be necessary to adjust the dose of the antidiabetic active substance during and after treatment with glucocorticoids.

Ritodrine, salbutamol, terbutaline: I.V.

Increased blood glucose levels due to beta-2 agonist effects.

Emphasise the importance of monitoring blood glucose levels. If necessary, switch to insulin.

Saint John’s Wort (Hypericum perforatum) preparations:

Gliclazide exposure is decreased by Saint John’s Wort-Hypericum perforatum. Emphasise the importance of blood glucose levels monitoring.

The following products may cause dysglycaemia

Combinations requiring precautions during use

Fluoroquinolones: in case of a concomitant use of Gliclazide 40mg Tablets and a fluoroquinolone, the patient should be warned of the risk of dysglycaemia, and the importance of blood glucose monitoring should be emphasised.

Combination which must be taken into account

Anticoagulant therapy (e.g. warfarin):

Sulfonylureas may lead to potentiation of anticoagulation during concurrent treatment.

Adjustment of the anticoagulant may be necessary.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is no or limited amount of data (less than 300 pregnancy outcomes) from the use of gliclazide in pregnant women, even though there are few data with other sulfonylureas.

Studies in animals have shown reproductive toxicity (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Gliclazide during pregnancy.

Control of diabetes should be obtained before the time of conception to reduce the risk of congenital abnormalities linked to uncontrolled diabetes.

Oral hypoglycaemic agents are not suitable, insulin is the drug of first choice for treatment of diabetes during pregnancy. It is recommended that oral hypoglycaemic therapy is changed to insulin before a pregnancy is attempted, or as soon as pregnancy is discovered.

Breast-feeding

It is not known whether gliclazide or its metabolites are excreted in breast milk. Given the risk of neonatal hypoglycaemia, the product is contra-indicated in breast-feeding mothers.

A risk to the newborns/infants cannot be excluded.

Fertility

No effect on fertility or reproductive performance was noted in male and female rats (see section 5.3).

4.7 Effects on ability to drive and use machines

Gliclazide has no known influence on the ability to drive and use machines. However, patients should be informed that their concentration may be affected if their diabetes is not satisfactorily controlled, especially at the beginning of treatment (see section 4.4).

4.8 Undesirable effects

Based on the experience with gliclazide, the following undesirable effects have to be mentioned.

Hypoglycaemia

The most frequent adverse reaction with gliclazide is hypoglycaemia.

As for other sulfonylureas, treatment with Gliclazide can cause hypoglycaemia, if mealtimes are irregular and, in particular, if meals are skipped. 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 lethal outcome.

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 carbohydrates (sugar). However, artificial sweeteners have no effect. Experience with other sulfonylureas shows that hypoglycaemia can recur even when measures prove effective initially.

If a hypoglycaemic episode is severe or prolonged, and even if it is temporarily controlled by intake of sugar, immediate medical treatment or even hospitalisation are required.

Gastrointestinal disturbances, including abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation have been reported: if these should occur they can be avoided or minimised if gliclazide is taken with breakfast.

The following undesirable effects have been more rarely reported:

Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, angioedema, erythema, maculopapular rashes, bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis) and exceptionally, drug rash with eosinophilia and systemic symptoms (DRESS).

Blood and lymphatic system disorders: Changes in haematology are rare. They may include anaemia, leucopenia, thrombocytopenia, granulocytopenia. These are in general reversible upon discontinuation of gliclazide.

Hepatobiliary disorders: Raised hepatic enzyme levels (AST, ALT, alkaline phosphatase), hepatitis (isolated reports). Discontinue treatment if cholestatic jaundice appears.

These symptoms usually disappear after discontinuation of treatment.

Eye disorders: Transient visual disturbances may occur, especially on initiation of treatment, due to changes in blood glucose levels.

Class attribution effects

As for other sulfonylureas, the following adverse events have been observed: cases of erythrocytopenia, agranulocytosis, haemolytic anaemia, pancytopenia, 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 sulfonylurea or led to life-threatening liver failure in isolated cases.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

An overdose of sulfonylureas may cause hypoglycaemia.

Moderate symptoms of hypoglycaemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment and/or change of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.

Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible 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 that will maintain blood glucose levels above 1 g/l. Patients should be monitored closely and, depending on the patient’s condition after this time, the doctor will decide if further monitoring is necessary.

Dialysis is of no benefit to patients due to the strong binding of gliclazide to proteins.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeuticgroup: sulfonamides, urea

Mechanism of action

Gliclazide is a hypoglycaemic sulfonylurea antidiabetic active substance differing from other related compounds by an N-containing heterocyclic ring with an endocyclic bond.

Gliclazide reduces blood glucose levels by stimulating insulin secretion from the β-cells of the islets of Langerhans. Increase in postprandial insulin and C-peptide secretion persists after two years of treatment.

In addition to these metabolic properties, gliclazide has haemovascular properties.

Clinical efficacy and safety

Effects on insulin release

In type 2 diabetics, 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 response is seen in response to stimulation induced by a meal or glucose.

Haemovascular properties:

Gliclazide decreases microthrombosis by two mechanisms which may be involved in complications of diabetes:

  • a partial inhibition of platelet aggregation and adhesion, with a decrease in the markers of platelet activation (beta thromboglobulin, thromboxane B2),
  • an action on the vascular endothelium fibrinolytic activity with an increase in tPA activity.

5.2 Pharmacokinetic properties

Absorption

Plasma levels increase reaching maximal concentrations between 2 and 6 hours.

Gliclazide is well absorbed. Food intake does not affect the rate or degree of absorption.

Distribution

Plasma protein binding is approximately 95%. The volume of distribution is around 19 litres.

Biotransformation

Gliclazide is mainly metabolised in the liver and excreted in the urine; less than 1% of the dose is excreted unchanged in the urine. No active metabolites have been detected in plasma.

Elimination

The elimination half-life of gliclazide is between 10 and 12 hours.

Linearity/non-linearity

The relationship between the dose administered between 40 and 400mg and the mean plasma concentrations is linear.

Special populations

Elderly

No clinically significant changes in pharmacokinetic parameters have been observed in elderly patients.

5.3 Preclinical safety data

Preclinical data reveal no special hazards for humans based on conventional studies of repeated dose toxicity and genotoxicity. Long term carcinogenicity studies have not been done. No teratogenic changes have been shown in animal studies, but lower fetal body weight was observed in animals receiving doses 9.4 fold higher than the maximum recommended dose in humans.

Fertility and reproductive performance were unaffected after gliclazide administration in animal studies.

  1. Pharmaceutical particulars

6.1 List of excipients

Microcrystalline cellulose,

Pregelatinised starch

Maize starch

Stearic acid

Magnesium stearate

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions

6.5 Nature and contents of container

Blister packs of PVC with Aluminium foil containing 20, 28, 56, 60 84, 100 tablets

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LTD.
29, Xcelon Industrial Park-1,
Behind Intas Pharmaceuticals,
At & Po Vasna – Chacharwadi,
Tal- Sanand, Dist- Ahmedabad-382213,
Gujarat, India

Gliclazide Tablets 80mg (GLICLATAJ) Taj Pharma

a) Gliclazide Tablets 40mg (GLICLATAJ) Taj Pharma

b) Gliclazide Tablets 80mg (GLICLATAJ) Taj Pharma

(gliclazide)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

Gliclazide Tablets (GLICLATAJ) mg Tablets will be referred as to Gliclazide Tablets (GLICLATAJ) mg throughout.

  1. What Gliclazide Tablets (GLICLATAJ) mg is and what it is used for
    2. What you need to know before you take Gliclazide Tablets (GLICLATAJ) mg
    3. How to take Gliclazide Tablets (GLICLATAJ) mg
    4. Possible side effects
    5. How to store Gliclazide Tablets (GLICLATAJ) mg
    6. Contents of the pack and other information
  2. What Gliclazide Tablets (GLICLATAJ) mg is and what it is used for

Gliclazide Tablets (GLICLATAJ) mg contains the active substance gliclazide, one of a group of medicines called sulfonylureas. It is an oral hypoglycaemic medicine (blood sugar lowering drug). Gliclazide Tablets (GLICLATAJ) mg is used to keep blood sugar at the correct level in adults with non-insulin dependent diabetes when it is not controlled by diet, physical exercise and weight loss alone.

  1. What you need to know before you take Gliclazide Tablets (GLICLATAJ) mg

Do not take Gliclazide Tablets (GLICLATAJ) mg

  • if you are allergic to gliclazide or any of the other ingredients of Gliclazide Tablets (GLICLATAJ) mg (listed in section 6), to other medicines of the same group (sulfonylureas), to other related medicines (hypoglycaemic sulfonamides),
  • If you have insulin-dependent diabetes (type 1),
  • if you have ketone bodies and sugar in your urine (this may mean you have keto-acidosis), a diabetic pre-coma or coma,
  • if you have severe kidney or liver disease,
  • if you are taking miconazole (a treatment for fungal infections) (see section Other medicines and Gliclazide Tablets (GLICLATAJ)mg),
  • if you are breastfeeding (see section Pregnancy and breastfeeding).

Children and adolescents

Gliclazide Tablets (GLICLATAJ) mg is not recommended for use in children.

If you have been told by your doctor that you have an intolerance to some sugars (for instance glucose, lactose, galactose), contact your doctor before taking this medicinal product.

Warnings and precautions

Talk to your doctor before taking Gliclazide Tablets (GLICLATAJ) mg.

You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight.

During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary.

In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.

Low blood sugar (Hypoglycaemia) may occur:

  • if you take meals irregularly or skip meals altogether,
  • if you are fasting,
  • if you are malnourished,
  • if you change your diet,
  • if you increase your physical activity and carbohydrate intake does not match this increase,
  • if you drink alcohol, especially in combination with skipped meals,
  • if you take other medicines or natural remedies at the same time,
  • if you take too high doses of gliclazide,
  • if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex),
  • if your kidney function or liver function is severely decreased.

If you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness, and helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heart beat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).

If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self control, your breathing may be shallow and your heart beat slowed down, you may become unconscious. In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, for instance glucose tablets, sugar cubes, sweet juice, sweetened tea. You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective.

Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.

Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta blockers).

If you are in stress-situations (accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.

Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor, if you take St John’s Wort (Hypericum perforatum) preparations (see section “Other medicines and Gliclazide Tablets (GLICLATAJ) mg”), or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.

If these symptoms occur, you must contact your doctor or pharmacist.

While taking Gliclazide Tablets (GLICLATAJ) mg you should:

  • follow a regular diet: it is important to eat regular meals, including breakfast and never to miss or delay a meal,
  • take your medicine regularly (see How to take Gliclazide Tablets (GLICLATAJ) mg),
  • check your blood glucose regularly as recommended by your doctor.

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when gliclazide is prescribed at the same time as medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you the importance of monitoring your blood glucose.

If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), contact your doctor before taking this medicinal product.

Other medicines and Gliclazide Tablets (GLICLATAJ) mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken:

  • other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor inhibitors or insulin),
  • antibiotics (sulfonamides, clarithromycin),
  • medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril or enalapril),
  • medicines to treat fungal infections (miconazole, fluconazole),
  • medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
  • medicines to treat depression (monoamine oxidase inhibitors),
  • painkiller or antirheumatics (phenylbutazone, ibuprofen),
  • medicines containing alcohol.

The blood glucose lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:

  • medicines to treat disorders of the central nervous system (chlorpromazine),
  • medicines reducing inflammation (corticosteroids),
  • medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline),
  • medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol),
  • St John’s Wort -Hypericum perforatum-

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as Gliclazide Tablets (GLICLATAJ)mg, especially in elderly patients.

Gliclazide Tablets (GLICLATAJ) mg may increase the effects of medicines which reduce blood clotting (warfarin).

Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking Gliclazide Tablets (GLICLATAJ) mg.

Gliclazide Tablets (GLICLATAJ) mg with food, drink and alcohol

Gliclazide Tablets (GLICLATAJ) mg can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.

Pregnancy and breastfeeding

Gliclazide Tablets (GLICLATAJ) mg is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You must not take Gliclazide Tablets (GLICLATAJ) mg while you are breastfeeding.

Driving and using machines

Provided your blood glucose levels are satisfactorily controlled on Gliclazide Tablets (GLICLATAJ) mg, your ability to drive or use machines should not be affected. However, if your blood glucose levels become too low, this could adversely affect your concentration, and therefore your ability to perform these tasks.

Ask your doctor whether you can drive a car if you:

  • have frequent episodes of low blood sugar (hypoglycaemia),
  • have few or no warning signals of low blood sugar (hypoglycaemia).
  1. How to take Gliclazide Tablets (GLICLATAJ) mg

Dose

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Change in external factors (weight reduction, change in life style, stress) or improvements in the blood sugar control may require changed gliclazide doses.

The recommended daily dose is from one half to four tablets. This depends on the response to treatment. When the total daily dose exceeds two tablets, it should be divided into two equal doses taken morning and evening.

Gliclazide Tablets (GLICLATAJ) mg is for oral use. Take your tablet(s) with a glass of water (and preferably at the same time each day). Swallow your tablets whole. Do not chew them.

You must always eat a meal after taking your tablet(s).

If a combination therapy of Gliclazide Tablets (GLICLATAJ) mg with metformin, an alpha glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you.

If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.

If you take more Gliclazide Tablets (GLICLATAJ) mg than you should

If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately.

The signs of overdose are those of low blood sugar (hypoglycaemia) described in Section 2.

The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious, immediately inform a doctor and call the emergency services.

If you forget to take Gliclazide Tablets (GLICLATAJ) mg

It is important to take your medicine every day as regular treatment works better.

However, if you forget to take a dose of Gliclazide Tablets (GLICLATAJ) mg, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gliclazide Tablets (GLICLATAJ) mg

As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them.

Low blood sugar (Hypoglycaemia)

The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs see Section Warnings and Precautions).

If left untreated, these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.

Other side effects

  • Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation. These effects are reduced when Gliclazide Tablets (GLICLATAJ) mg is taken with a meal as recommended.
  • Skin disorders: Skin reactions such as rash, redness, itching, hives, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. The rash may progress to widespread blistering or peeling of the skin. Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
  • Blood disorders: Decrease in the number of cells in the blood (for instance platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually stop when the treatment is discontinued.
  • Liver disorders: There have been isolated reports of abnormal liver function which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the drug is stopped. Your doctor will decide whether to stop your treatment.
  • Eye disorders: Your vision may be affected for a short time, especially at the start of treatment. This effect is due to changes in blood sugar levels.

As for other sulfonylureas, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life threatening liver failure in isolated cases.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

  1. How to store Gliclazide Tablets (GLICLATAJ) mg

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister strip after Exp.

The expiry date refers to the last day of that month.

Store in the original package.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Gliclazide Tablets (GLICLATAJ) mg contains

The active substance is gliclazide. Each tablet contains 40mg or 80 mg of gliclazide. The other ingredients are: lactose monohydrate, maize starch, pregelatinised maize starch, talc, magnesium stearate.

What Gliclazide Tablets (GLICLATAJ) mg looks like and contents of the pack

Gliclazide Tablets (GLICLATAJ) mg is a white, circular tablet with flat bevelled edges and cross scoring on one face and comes in cartons of 28, 56, 60 and 112 tablets. Not all pack sizes may be marketed.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LTD.
29, Xcelon Industrial Park-1,
Behind Intas Pharmaceuticals,
At & Po Vasna – Chacharwadi,
Tal- Sanand, Dist- Ahmedabad-382213,
Gujarat, India