Gliclazide Tecnigen

Patient Information Leaflet

GLICLAZIDE TECNIGEN 30 mg modified-release tablets

Gliclazide
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What GLICLAZIDE TECNIGEN is and what it is used for.
2. What you need to know before taking GLICLAZIDE TECNIGEN.
3. How to take GLICLAZIDE TECNIGEN.
4. Possible side effects.
5. How to store GLICLAZIDE TECNIGEN.
6. Contents of the pack and other information.

1. What GLICLAZIDE TECNIGEN is and what it is used for

GLICLAZIDE TECNIGEN is a medicine that lowers blood sugar levels (an oral antidiabetic agent belonging to the sulfonylurea group).
GLICLAZIDE TECNIGEN is indicated in adults for the treatment of certain types of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight loss alone are not sufficient to maintain adequate blood sugar levels.

2. What you need to know before taking GLICLAZIDE TECNIGEN

Do not take GLICLAZIDE TECNIGEN

• if you are allergic to gliclazide or any of the excipients of GLICLAZIDE TECNIGEN (listed in section 6), or to other drugs of the same group (sulfonylureas), or to related medicines (hypoglycemic sulfonamides);
• if you have insulin-dependent diabetes (type 1);
• if you have ketones and sugar in your urine (this may indicate diabetic ketoacidosis), if you are in pre-coma or diabetic coma;
• if you have severe kidney or liver disease;
• if you are taking medicines for fungal infections (miconazole) (see section “Other medicines and GLICLAZIDE TECNIGEN”);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor before taking GLICLAZIDE TECNIGEN.
Follow your doctor's advice to achieve appropriate blood sugar levels. In addition to taking the tablet regularly, adhere to a proper diet, engage in physical activity, and reduce weight if necessary.
Regular monitoring of blood glucose levels (and possibly urine glucose) and also glycated hemoglobin (HbA1c) is required during treatment with gliclazide. During the first weeks of treatment, there may be an increased risk of excessively low blood sugar levels (hypoglycemia). Therefore, careful medical monitoring is necessary.
Blood sugar levels may drop too low (hypoglycemia):

• if you eat irregularly or skip meals completely,
• if you are fasting,
• if you are malnourished,
• if you change your eating habits,
• if your physical activity increases and carbohydrate intake is not adjusted accordingly,
• if you consume alcohol, especially on an empty stomach,
• if you take other medicines or herbal remedies concurrently,
• if you take too high a dose of gliclazide,
• if you have certain hormonal disorders (thyroid gland dysfunction, pituitary gland or adrenal cortex disorders),
• if your kidney or liver function is severely impaired.

If your blood sugar level is too low, you may experience the following symptoms:
headache, intense hunger, nausea, vomiting, weakness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced attention and reaction time, depression, confusion, speech or vision disturbances, tremor, sensory disturbances, dizziness and feelings of weakness.
The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, increased blood pressure, sudden acute chest pain radiating to surrounding areas ( angina pectoris ).
If blood sugar continues to fall, you may experience severe confusion (delirium), seizures, loss of self-control, shortness of breath, slowed heartbeat, and loss of consciousness.
In most cases, symptoms of low blood sugar disappear quickly after taking sugar in any form, for example glucose tablets, sugar lumps, sugary juices or sweetened tea.
You should therefore always carry sugar with you (glucose tablets, sugar lumps). Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if taking sugar does not help or if symptoms recur.
Symptoms of low blood sugar may not appear, may be less obvious, may develop slowly, or you may not notice in time that your blood sugar level has dropped. This may occur if you are an elderly patient taking certain medicines (e.g. those acting on the central nervous system and beta-blockers).
If you are under stress (accidents, surgery, fever, etc.), your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur when gliclazide has not yet sufficiently lowered blood sugar levels, when you have not followed your prescribed treatment, when you take St John's wort ( Hypericum perforatum ) (see section “Other medicines and GLICLAZIDE TECNIGEN ”), or during periods of particular stress. These may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections, and reduced performance.
If you experience such symptoms, contact your doctor or pharmacist.
When gliclazide is prescribed together with medicines belonging to a class of antibiotics called fluoroquinolones, a disturbance in blood glucose (low and high blood sugar) may occur, especially in elderly patients. In such cases, your doctor will remind you of the importance of monitoring blood glucose levels.
If you have a family history or an inherited condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency (a red blood cell disorder), a drop in hemoglobin levels and rupture of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.
With the use of other sulfonylureas, cases of acute porphyria have been reported in patients with porphyria (inherited genetic disorders with accumulation of porphyrins or porphyrin precursors in the body).
Children and adolescents
The use of GLICLAZIDE TECNIGEN is not recommended in children due to lack of data.
Other medicines and GLICLAZIDE TECNIGEN
Inform 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 increased and signs of low blood sugar may occur when taking any of the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
• antibiotics (sulfonamides, clarithromycin),
• medicines for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines used to treat fungal infections (miconazole, fluconazole),
• medicines for gastric or duodenal ulcers (H2-receptor antagonists),
• medicines for depression (monoamine oxidase inhibitors),
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The blood glucose-lowering effects of gliclazide may be reduced and blood sugar levels may rise when taking any of the following medicines:

• medicines for disorders of the central nervous system (chlorpromazine),
• medicines to reduce inflammation (corticosteroids),
• medicines for asthma or used during labor (intravenous salbutamol, ritodrine, terbutaline),
• medicines for breast disorders, heavy menstrual bleeding, endometriosis (danazol),
• St John's wort preparations - Hypericum perforatum- .

When a medicine belonging to a class of antibiotics called fluoroquinolones is taken together with GLICLAZIDE TECNIGEN, a disturbance in blood glucose (low and high blood sugar) may occur, especially in elderly patients.
GLICLAZIDE TECNIGEN may enhance the effects of medicines that reduce blood clotting (e.g. warfarin).
Consult your doctor before taking other medicines. If you are admitted to hospital, inform the medical staff that you are taking GLICLAZIDE TECNIGEN.
GLICLAZIDE TECNIGEN with food, drinks and alcohol
GLICLAZIDE TECNIGEN may be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it may unpredictably affect diabetes control.
Pregnancy and breastfeeding
GLICLAZIDE TECNIGEN is not recommended during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
You must not take GLICLAZIDE TECNIGEN while breastfeeding.
Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycemia), too high (hyperglycemia), or if you develop vision problems as a result of these conditions. Be aware that you may harm yourself or others (e.g. when driving vehicles or operating machinery).
Ask your doctor whether you may drive if you have:

• frequent episodes of low blood sugar (hypoglycemia),
• minimal or not obvious signs of low blood sugar (hypoglycemia). Gliclazide contains lactose . If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take GLICLAZIDE TECNIGEN

Dosage
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose is determined by your doctor according to your blood sugar levels and, if possible, sugar levels in urine.
Changes in external factors (weight reduction, lifestyle changes, stress) or improvements in blood sugar control may require adjustments in gliclazide dosage.
The recommended daily dose ranges from one to four tablets (maximum 120 mg), taken as a single dose at breakfast time. This depends on your response to treatment.
GLICLAZIDE TECNIGEN is for oral use. Take the tablet(s) with a glass of water at breakfast time (preferably at the same time every day). Swallow the tablet(s) whole. Do not chew or crush them. You must always take a meal after taking the tablet(s).
If you are being treated with a combination of GLICLAZIDE TECNIGEN and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the appropriate dose for each medicine.
Contact your doctor or pharmacist if you feel that your blood sugar levels remain high despite taking this medicine.

If you take more GLICLAZIDE TECNIGEN than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. Signs of overdose are those of low blood sugar (hypoglycemia), as described in section 2. These symptoms may improve by immediately taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, contact a doctor immediately and call emergency services. The same applies if someone (for example, a child) has accidentally taken the product. Do not give food or drink to unconscious patients.
Ensure that there is always an informed person available who can call a doctor in case of emergency.

If you forget to take GLICLAZIDE TECNIGEN
It is important to take the medicine every day, as regular treatment is more effective.
If you forget a dose of GLICLAZIDE TECNIGEN, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking GLICLAZIDE TECNIGEN
Since diabetes treatment usually lasts a lifetime, you must consult your doctor before stopping treatment with this medicine. Stopping treatment may cause an increase in blood sugar levels (hyperglycemia), increasing the risk of developing diabetes-related complications.

If you have any doubts about how to use GLICLAZIDE TECNIGEN, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most commonly observed side effect is a drop in blood sugar levels (hypoglycaemia). For symptoms and signs, see section “Warnings and precautions”.
If left untreated, these symptoms may progress to drowsiness, loss of consciousness and possible coma.
If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by taking sugar, contact your doctor immediately.

Liver disorders
Isolated cases of liver function abnormalities have occurred, which may cause yellowing of the skin and eyes (jaundice). If these occur, contact your doctor immediately. Symptoms usually disappear if the medicine is discontinued. Your doctor will decide whether treatment should be stopped.

Skin disorders
Skin reactions have been reported, such as rash, redness, itching, hives (urticaria), blisters, and angioedema (rapid swelling of tissues such as the eyelids, face, lips, mouth, throat, or tongue, which may cause difficulty breathing). Skin rashes may progress to widespread blistering over the body or skin peeling.
If you develop these symptoms, stop taking GLICLAZIDE TECNIGEN, consult your doctor immediately, and inform them that you are being treated with this medicine.
In rare cases, signs of severe hypersensitivity reactions (DRESS syndrome) have been reported: initially as flu-like symptoms and facial rash, followed by widespread rash with high fever.

Blood disorders
Symptoms such as paleness, prolonged bleeding, bruising, sore throat, and fever have been reported following a decrease in blood cell counts (e.g. platelets, red and white blood cells). These symptoms usually resolve when treatment is discontinued.

Digestive disturbances
Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation.
These effects are reduced when GLICLAZIDE TECNIGEN is taken with a meal, as recommended.

Eye disorders
Vision may be temporarily disturbed, especially at the beginning of treatment.
This effect is due to changes in blood sugar levels.

As with other sulphonamides, the following adverse events have been observed: severe changes in blood cell counts and allergic inflammation of blood vessel walls (vasculitis), reduced sodium levels in the blood (hyponatraemia), and signs of liver dysfunction (e.g. jaundice), which in most cases resolved after discontinuation of sulphonylureas, but in rare cases may lead to life-threatening liver failure.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLICLAZIDE TECNIGEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What GLICLAZIDE TECNIGEN contains
The active substance is gliclazide. Each tablet contains 30 mg of gliclazide.
The other components are: monohydrate lactose, maize starch, povidone, hypromellose, colloidal anhydrous silica, magnesium stearate.

Description of the appearance of GLICLAZIDE TECNIGEN and package contents
GLICLAZIDE TECNIGEN are white to off-white, capsule-shaped, biconvex, uncoated tablets, marked "C12" on one side and smooth on the other.
GLICLAZIDE TECNIGEN is available in packages containing 10 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Tecnigen, S.r.l.
Via Galileo Galilei, 40 -
20092 Cinisello Balsamo
Milan, Italy.

Manufacturer
Tecnimede – Sociedade Técnico-Medicinal SA
Quinta da Cerca, Caixaria
2565-187 Dois Portos, Portugal.

Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande, 2, Abrunheira, 2710 – 089 Sintra
Portugal.

This medicinal product is authorized in the EEA Member States under the following names:
Italy: GLICLAZIDE TECNIGEN
Portugal: Gliclazida Farmoz LP
Spain: Gliclazida Tecnigen 30 mg comprimidos de liberación modificada EFG

Package leaflet: Information for the patient

GLICLAZIDE TECNIGEN 60 mg modified-release tablets

Gliclazide
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What GLICLAZIDE TECNIGEN is and what it is used for.
2. What you need to know before taking GLICLAZIDE TECNIGEN.
3. How to take GLICLAZIDE TECNIGEN.
4. Possible side effects.
5. How to store GLICLAZIDE TECNIGEN.
6. Package contents and other information.

1. What GLICLAZIDE TECNIGEN 30 mg is and what it is used for

GLICLAZIDE TECNIGEN is a medicine that lowers blood sugar levels (an oral antidiabetic agent belonging to the sulfonylurea group).
GLICLAZIDE TECNIGEN is indicated in adults for the treatment of certain types of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight loss alone are not sufficient to maintain adequate blood sugar levels.

2. What you need to know before taking GLICLAZIDE TECNIGEN

Do not take GLICLAZIDE TECNIGEN

• if you are allergic to gliclazide or to any of the excipients of GLICLAZIDE TECNIGEN (listed in section 6), or to other drugs of the same group (sulfonylureas), or to related medicines (hypoglycemic sulfonamides);
• if you have insulin-dependent (type 1) diabetes;
• if you have ketones and sugar in your urine (this may indicate diabetic ketoacidosis), or if you are in a pre-coma or diabetic coma state;
• if you have severe kidney or liver disease;
• if you are taking medicines for fungal infections (miconazole) (see section “Other medicines and GLICLAZIDE TECNIGEN”);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor before taking GLICLAZIDE TECNIGEN. Follow your doctor's instructions to achieve appropriate blood sugar levels. In addition to taking the tablet regularly, follow a proper diet, engage in physical activity, and reduce weight if necessary.

During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine sugar) and glycated hemoglobin (HbA1c) is required. In the first weeks of treatment, the risk of excessively low blood sugar levels (hypoglycemia) may increase. Therefore, careful medical monitoring is necessary.

Your blood sugar level may drop too low (hypoglycemia):

• if you eat meals irregularly or skip them completely,
• if you are fasting,
• if you are malnourished,
• if you change your eating habits,
• if your physical activity increases and carbohydrate intake is not adjusted accordingly,
• if you consume alcohol, especially on an empty stomach,
• if you take other medicines or herbal remedies simultaneously,
• if you take too high a dose of gliclazide,
• if you have certain hormonal disorders (thyroid, pituitary, or adrenal cortex dysfunction),
• if your kidney or liver function is severely reduced.

If your blood sugar level is too low, you may experience the following symptoms:
headache, intense hunger, nausea, vomiting, weakness, sleep disturbances, agitation, aggression, difficulty concentrating, reduced attention and reaction time, depression, confusion, speech or vision disturbances, tremor, sensory disturbances, dizziness, and a feeling of helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, rapid or irregular heartbeat, increased blood pressure, sudden sharp chest pain radiating to surrounding areas (angina pectoris).

If blood sugar continues to drop, you may experience severe confusion (delirium), seizures, shortness of breath, slowed heartbeat, and loss of consciousness.

In most cases, symptoms of low blood sugar resolve quickly by taking sugar in various forms, for example glucose tablets, sugar lumps, sugary juices, or sweetened tea.

You should therefore always carry sugar with you (glucose tablets, sugar lumps). Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if taking sugar does not help or if symptoms recur.

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

If you are under stress (accidents, surgery, fever, etc.), your doctor may temporarily switch you to insulin therapy.

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not yet sufficiently lowered your blood sugar, when you have not followed your prescribed treatment, when you take St. John's wort (Hypericum perforatum) (see section “Other medicines and GLICLAZIDE TECNIGEN 30 mg”), or during periods of particular stress. These may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections, and reduced efficiency.

If you experience such symptoms, contact your doctor or pharmacist.

When gliclazide is prescribed together with medicines belonging to a class of antibiotics called fluoroquinolones, blood sugar disturbances (low and high blood sugar) may occur, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring blood glucose levels.

If you have a family history or an inherited condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency (a red blood cell disorder), a drop in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.

Cases of acute porphyria have been reported with other sulfonylureas in patients with porphyria (inherited genetic disorders involving accumulation of porphyrins or porphyrin precursors in the body).

Children and adolescents

The use of GLICLAZIDE TECNIGEN is not recommended in children due to lack of data.

Other medicines and GLICLAZIDE TECNIGEN

Inform 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 increased, and signs of low blood sugar may occur, when taking any of the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (sulfonamides, clarithromycin),
• medicines for high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• medicines for fungal infections (miconazole, fluconazole),
• medicines for gastric or duodenal ulcers (H2-receptor antagonists),
• medicines for depression (monoamine oxidase inhibitors),
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol.

The blood sugar-lowering effects of gliclazide may be reduced, and blood sugar levels may rise, when taking any of the following medicines:

• medicines for disorders of the central nervous system (chlorpromazine),
• medicines to reduce inflammation (corticosteroids),
• medicines for asthma or used during labor (intravenous salbutamol, ritodrine, terbutaline),
• medicines for breast disorders, heavy menstrual bleeding, endometriosis (danazol),
• St. John's wort preparations - Hypericum perforatum.

When a medicine belonging to a class of antibiotics called fluoroquinolones is taken together with GLICLAZIDE TECNIGEN, a blood sugar disturbance (low and high blood sugar) may occur, especially in elderly patients.

GLICLAZIDE TECNIGEN may enhance the effects of medicines that reduce blood clotting (e.g., warfarin).

Consult your doctor before taking other medicines. If you are hospitalized, inform the medical staff that you are taking GLICLAZIDE TECNIGEN.

GLICLAZIDE TECNIGEN with food, drinks, and alcohol

GLICLAZIDE TECNIGEN may be taken with food and non-alcoholic drinks.

Drinking alcohol is not recommended, as it may unpredictably affect diabetes control.

Pregnancy and breastfeeding

GLICLAZIDE TECNIGEN is not recommended during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.

You must not take GLICLAZIDE TECNIGEN while breastfeeding.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycemia), too high (hyperglycemia), or if you develop vision problems as a result of these conditions. Be aware that you may harm yourself or others (e.g., when driving vehicles or operating machinery).

Ask your doctor whether you can drive if you have:

• frequent episodes of low blood sugar (hypoglycemia),
• minimal or not obvious signs of low blood sugar (hypoglycemia).

Gliclazide contains lactose. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take GLICLAZIDE TECNIGEN

Dosage
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose is determined by your doctor according to your blood sugar levels and, if possible, sugar levels in urine.
Changes in external factors (weight reduction, changes in lifestyle, stress) or improvements in blood sugar control may require adjustments in gliclazide dosage.
The recommended daily dose ranges from half a tablet to two tablets (maximum 120 mg), taken as a single dose at breakfast time. This depends on your response to treatment.
Tablets may be divided into equal doses.
GLICLAZIDE TECNIGEN is for oral use. Take the tablet(s) with a glass of water at breakfast time (and preferably every day at the same time). Swallow the tablet(s) whole.
Swallow half a tablet or the whole tablet in a single dose. Do not chew or crush them.
You must always take a meal after taking the tablet(s).
If you are being treated with a combination therapy of GLICLAZIDE TECNIGEN together with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the appropriate dose for each medicine.
Contact your doctor or pharmacist if you feel that your blood sugar levels are high despite taking this medicine.

If you take more GLICLAZIDE TECNIGEN than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. Signs of overdose are those of low blood sugar (hypoglycemia) described in section 2. These symptoms may improve by immediately taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, contact your doctor immediately and call emergency services.
The same applies if someone, for example a child, has accidentally taken the product.
Do not give food or drink to unconscious patients.
Ensure that there is always an informed person available who can call a doctor in case of emergency.

If you forget to take GLICLAZIDE TECNIGEN
It is important to take the medicine every day, as regular treatment is more effective.
However, if you forget a dose of GLICLAZIDE TECNIGEN 30 mg, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking GLICLAZIDE TECNIGEN
Since diabetes treatment usually lasts a lifetime, you must consult your doctor before stopping treatment with this medicine. Stopping treatment may cause increased blood sugar levels (hyperglycemia), increasing the risk of developing diabetes complications.
If you have any doubts about using GLICLAZIDE TECNIGEN, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most commonly observed adverse effect is a lowering of blood sugar levels (hypoglycaemia). For symptoms and signs, see section "Warnings and precautions".
If untreated, these symptoms may progress to drowsiness, loss of consciousness, and possible coma.
If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by taking sugar, contact your doctor immediately.

Liver disorders
Isolated cases of liver function abnormalities have occurred, which may cause yellowing of the skin and eyes (jaundice). If these symptoms occur, contact your doctor immediately. Symptoms usually resolve if the medicine is discontinued. Your doctor will decide whether treatment should be stopped.

Skin disorders
Skin reactions have been reported, such as rash, redness, itching, urticaria, blisters, and angioedema (rapid swelling of tissues such as the eyelids, face, lips, mouth, throat, or tongue, which may cause breathing difficulties). Skin rashes may progress to widespread blistering over the body or skin peeling.
If you develop these symptoms, stop taking GLICLAZIDE TECNIGEN, contact your doctor immediately, and inform them that you are being treated with this medicine.
In very rare cases, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and facial rash, followed by widespread rash with high fever.

Blood disorders
Symptoms such as paleness, prolonged bleeding, bruising, sore throat, and fever have been reported following a decrease in blood cells (e.g. platelets, red and white blood cells).
These symptoms usually resolve when treatment is discontinued.

Digestive disturbances
Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation.
These effects are reduced when GLICLAZIDE TECNIGEN is taken with a meal, as recommended.

Eye disorders
Vision may be temporarily disturbed, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulphonylureas, the following adverse events have been observed: severe changes in blood cell counts, allergic inflammation of blood vessel walls (vasculitis), reduced blood sodium levels (hyponatraemia), and signs of liver failure (e.g. jaundice). These usually resolve after discontinuation of sulphonylureas, but in rare cases may lead to life-threatening liver failure.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GLICLAZIDE TECNIGEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What GLICLAZIDE TECNIGEN contains
The active substance is gliclazide. Each tablet contains 60 mg of gliclazide.
The other components are: monohydrate lactose, maize starch, hypromellose, magnesium stearate.

Description of the appearance of GLICLAZIDE TECNIGEN and package contents
GLICLAZIDE TECNIGEN are white to off-white, oval, biconvex, uncoated tablets, marked with "C" on one side and "55" on the other side, with a score line.
GLICLAZIDE TECNIGEN is available in packages containing 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Tecnigen, S.r.l.
Via Galileo Galilei, 40 -
20092 Cinisello Balsamo
Milan, Italy.

Manufacturer
Tecnimede – Sociedade Técnico-Medicinal SA
Quinta da Cerca, Caixaria
2565-187 Dois Portos, Portugal.

Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande, 2, Abrunheira, 2710 – 089 Sintra
Portugal.

This medicinal product is authorized in the EEA Member States under the following names:
Italy: GLICLAZIDE TECNIGEN
Portugal: Gliclazida Farmoz LP
Spain: Gliclazida TecniGen 60 mg comprimidos de liberación modificada EFG