GLICLAZIDE 30 mg Extended-Release Tablet

Зміст інструкції

1. GLICLAZIDE TECNIGEN 30 mg modified-release tablets
   1. What is GLICLAZIDE TECNIGEN and what is it used for?
   2. What you need to know before you take 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
2. GLICLAZIDE TECNIGEN 60 mg modified-release tablets
   1. What is GLICLAZIDE TECNIGEN 30 mg and what is it 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

GLICLAZIDE TECNIGEN 30 mg modified-release tablets

Gliclazide

Generic medicine
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 pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is GLICLAZIDE TECNIGEN and what is it used for?

GLICLAZIDE TECNIGEN is a medicine that reduces blood sugar levels (an oral antidiabetic medicine 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, exercise and weight loss alone are not sufficient to
maintain a correct blood sugar level.

2. What you need to know before you take 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 medicines of the same group (sulfonylureas), or to other related medicines (sulfonamide hypoglycemic agents);
• if you have insulin-dependent diabetes (type 1);
• if you have ketones and sugar in your urine (this means you may have diabetic ketoacidosis), if you are in a pre-comatose or diabetic coma state;
• if you have a severe kidney or liver disease;
• if you are taking medicines for the treatment of 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
regularly taking the tablet, follow a dietary regime, exercise and if
necessary reduce weight.
During treatment with gliclazide, regular monitoring of blood sugar levels is necessary
(and possibly in the urine) and also of glycosylated hemoglobin (HbA1c). In the first weeks of
treatment, the risk of excessive decrease in blood sugar levels may increase
(hypoglycemia). For this reason, careful medical monitoring is necessary.
Blood sugar levels 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 the intake of carbohydrates is not adequate to this increase,
• if you drink alcohol, especially while fasting,
• if you are taking other medicines or natural remedies at the same time,
• if you take doses of gliclazide that are too high,
• if you suffer from particular hormonal disorders (thyroid gland dysfunction, or pituitary gland or adrenal cortex dysfunction),
• if your kidney or liver function is severely impaired.

In case of low blood sugar levels, 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 powerlessness.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, acceleration or
irregularity of the heartbeat, increased blood pressure, sudden acute chest pain
that radiates into the surrounding areas (angina pectoris).
If blood sugar levels continue to drop, you may experience severe confusion
(delirium), convulsions, loss of self-control, shortness of breath, slowed heartbeat and loss of
consciousness.
In most cases, the symptoms of low blood sugar levels disappear very
quickly by taking sugar in various forms, for example glucose tablets, sugar lumps,
juices or sweetened tea.
You should therefore always carry some 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 due to low blood sugar levels may not appear, be less
evident, appear slowly or you may not notice in time that blood sugar levels are
decreasing. This can happen if you are an elderly patient taking certain medicines (for
example those that act on the central nervous system and beta-blockers).
If you are in stressful situations (accidents, surgeries, fever, etc.) your doctor may
temporarily switch to insulin therapy.
Symptoms of high blood sugar levels (hyperglycemia) may appear when the
gliclazide has not yet sufficiently reduced blood sugar levels, when you have not followed the
treatment prescribed by your doctor, if you take preparations based on St. John's wort (Hypericum perforatum) (see section “Other medicines and GLICLAZIDE TECNIGEN”) or
in particularly stressful situations. These may include thirst, frequent urination,
dry mouth, dry skin and itching, skin infections and reduced efficiency.
If you experience these symptoms, contact your doctor or pharmacist.
When gliclazide is prescribed at the same time as medicines belonging to a class of
antibiotics called fluoroquinolones, a glycemic disorder (low blood sugar and high blood sugar) may occur, especially in elderly patients. In this case, the
doctor will remind you of the importance of monitoring blood glucose levels.
If you have a family history or a hereditary condition of glucose-6-phosphate
dehydrogenase (G6PD) deficiency (alteration of red blood cells), a decrease in hemoglobin levels and a breakdown of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking
this medicine.
Cases of acute porphyria have been reported with the use of other sulfonylureas, in patients affected by
porphyria (hereditary 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 the lack of data in this regard.

Other medicines and GLICLAZIDE TECNIGEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effect of reducing blood sugar levels of gliclazide may be increased and
signs of low blood sugar levels may appear when you take one of the following
medicines:

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

The blood sugar lowering effects of gliclazide may be
weakened and an increase in blood sugar levels may occur with the intake of one of the
following medicines:

• medicines for the treatment of disorders of the nervous system (chlorpromazine),
• medicines for reducing inflammation (corticosteroids),
• medicines for the treatment of asthma or used during labor (salbutamol intravenously, ritodrine and terbutaline),
• medicines for the treatment of breast diseases, heavy menstrual bleeding, endometriosis (danazol),
• preparations based on St. John's wort - Hypericum perforatum.

When a medicine belonging to a class of antibiotics called fluoroquinolones is taken
at the same time as GLICLAZIDE TECNIGEN, a glycemic disorder (low blood sugar and high blood sugar) may occur, especially in elderly patients.
GLICLAZIDE TECNIGEN may increase 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 can be taken with non-alcoholic foods and beverages.
Drinking alcohol is not recommended as it can alter diabetes control unpredictably.

Pregnancy and breastfeeding
GLICLAZIDE TECNIGEN is not recommended during pregnancy. If you are pregnant, if
you suspect or are planning a pregnancy, ask your doctor for advice before taking this medicine.
You should not take GLICLAZIDE TECNIGEN while breastfeeding.

Driving and operating machinery
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. Keep in mind that you may harm yourself or others (e.g. when
driving vehicles or using machinery).
Ask your doctor if you can drive if you have:

3. How to take GLICLAZIDE TECNIGEN

Dosage
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose is established by the doctor based on your blood sugar levels and possibly in the urine.
Changes in external factors (weight loss, changes in lifestyle, stress) or improvements in
blood sugar control may require changes in the doses of gliclazide.
The recommended daily dose is from one to four tablets (maximum 120 mg) in a single
administration at breakfast. This depends on the response to treatment.
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. Do not chew or crush them. You must always take a meal after taking the tablet(s).
In case of combined therapy of GLICLAZIDE TECNIGEN with metformin, an alpha-
glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or
insulin, the doctor will establish the appropriate dose of each medicine for you.
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 immediately or the nearest hospital emergency room.
The signs of overdose are those of a lowering of the blood sugar rate
(hypoglycemia) described in paragraph 2. These symptoms can improve by immediately taking some
sugar (from 4 to 6 lumps) or sugary drinks followed by a substantial snack or a meal. If the
patient is unconscious, contact your doctor immediately and call emergency services.
The same must be done if someone, for example a child, has taken the product
accidentally. Do not administer food or drinks to unconscious patients.
Make sure there is always an informed person able to call a doctor in case of emergency.

If you forget to take GLICLAZIDE TECNIGEN
It is important to take the medicine every day because regular treatment is more effective.
However, if you forget a dose of GLICLAZIDE TECNIGEN, take the next dose regularly at the
same time. Do not take a double dose to compensate for forgetting the dose.

If you stop taking GLICLAZIDE TECNIGEN
Since the treatment of diabetes usually lasts a lifetime, you should consult your doctor before
stopping treatment with this medicine. Interruption may cause an increase in blood sugar levels
(hyperglycemia), which increases the risk of developing complications of diabetes.
If you have any doubts about the use of GLICLAZIDE TECNIGEN, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effect is a lowering of blood sugar level (hypoglycemia). 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 been reported, which can cause yellowing
of the skin and eyes. If this occurs, contact your doctor immediately. Generally the symptoms
disappear if the medicine is discontinued. The doctor will decide whether to discontinue treatment.
Skin disorders
Skin reactions such as rash, redness, itching, hives, blisters,
angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, throat or tongue
which can cause difficulty breathing) have been reported. Rashes may progress to a spread
of blisters all over the body or to peeling of the skin.
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 exceptional cases, signs of severe hypersensitivity reactions (DRESS) have been reported: initially
as flu-like symptoms and rashes on the face, then widespread rashes with high fever.
Blood disorders
Reports have been made of symptoms such as paleness, prolonged bleeding, bruising, sore throat
and fever, following a decrease in the number of blood cells (for example platelets,
red blood cells and white blood cells). These symptoms usually disappear when treatment is stopped.
Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation.
These effects are reduced when GLICLAZIDE TECNIGEN is taken with a meal, as recommended.
Eye disorders
Visual impairment may be disturbed for a short period, especially at the beginning of treatment.
This effect is due to changes in blood sugar levels.
As with other sulfonylureas, the following adverse events have been observed: severe changes in the number
of blood cells and allergic inflammation of the blood vessel walls, reduction of sodium levels in
the blood (hyponatremia), symptoms of liver failure (for example jaundice) which in most
cases disappeared after discontinuation of sulfonylureas, but which in isolated cases can
lead to life-threatening liver failure.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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 which is stated on the package and on the blister after “Exp.”.
The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Medicines should 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. Contents of the pack and other information

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

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

Marketing Authorisation 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 authorised in the Member States of the EEA with the following denominations:
Italy: GLICLAZIDE TECNIGEN
Portugal: Gliclazida Farmoz LP
Spain: Gliclazida Tecnigen 30 mg modified-release tablets EFG

GLICLAZIDE TECNIGEN 60 mg modified-release tablets

Gliclazide

Generic medicine
Read this leaflet carefully before you start 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 pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is GLICLAZIDE TECNIGEN 30 mg and what is it used for

GLICLAZIDE TECNIGEN is a medication that reduces blood sugar levels (an oral antidiabetic medicine 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, exercise and weight loss alone are not sufficient to
maintain a correct level of blood sugar.

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 other related medicines (sulfonamide hypoglycemic agents);
• if you have insulin-dependent diabetes (type 1);
• if you present ketone bodies and sugar in your urine (this means you may have diabetic ketoacidosis), if you are in a pre-comatose or diabetic coma state;
• if you have a severe kidney or liver disease;
• if you are taking medicines for the treatment of fungal infections (miconazole) (see section “Other medicines and GLICLAZIDE TECNIGEN”);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”). Warnings and precautionsTalk to your doctor before taking GLICLAZIDE TECNIGEN. Follow your doctor’s instructions to achieve appropriate blood sugar levels. In addition to regularly taking the tablet, follow a dietary regime, engage in physical activity and, if necessary, reduce your weight.

During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly in the urine) and also of glycosylated hemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of excessive decrease in blood sugar levels (hypoglycemia) may increase. For this reason, careful medical monitoring is necessary.
Blood sugar levels may drop too low (hypoglycemia):

• if you take 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 the intake of carbohydrates is not adequate for this increase,
• if you drink alcohol, especially while fasting,
• 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 hormonal disorders (thyroid gland dysfunction, or pituitary gland or adrenal cortex dysfunction),
• if your kidney or liver function is severely impaired.

In case of low blood sugar levels, you may experience the following symptoms:
headache, intense hunger, nausea, vomiting, weakness, sleep disturbances, agitation, aggressiveness, difficulty concentrating, reduced attention and reaction time, depression, confusion, speech or vision disorders, tremor, sensory disturbances, dizziness and feeling of powerlessness.
The following signs and symptoms may also occur: sweating, moist skin, anxiety, acceleration or irregularity of the heartbeat, increased blood pressure, sudden acute chest pain that radiates to the surrounding areas (angina pectoris).
If blood sugar levels continue to decrease, you may experience severe confusion (delirium), convulsions, loss of self-control, shortness of breath, slowed heartbeat and loss of consciousness.
In most cases, the symptoms of low blood sugar levels disappear very quickly by taking sugar in various forms, for example glucose tablets, sugar lumps, sweetened juices or tea.
You should therefore always carry some sugar with you (glucose tablets, sugar lumps). Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if taking sugar is not helpful or if symptoms recur.
Symptoms due to low blood sugar levels may not appear, be less evident, appear slowly, or you may not notice in time that blood sugar levels have decreased. This can happen if you are an elderly patient taking certain medicines (for example those that act on the central nervous system and beta-blockers).
If you are in stressful situations (accidents, surgeries, fever, etc.), your doctor may temporarily switch to insulin therapy.
Symptoms of high blood sugar levels (hyperglycemia) may appear when gliclazide has not yet sufficiently reduced blood sugar levels, when you have not followed the treatment prescribed by your doctor, if you take preparations based on St. John's wort (Hypericum perforatum) (see section “Other medicines and GLICLAZIDE TECNIGEN 30 mg”) or in particularly stressful situations. These may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections and reduced efficiency.
If you experience such symptoms, you should contact your doctor or pharmacist.
When gliclazide is prescribed at the same time as medicines belonging to a class of antibiotics called fluoroquinolones, a glycemic disorder (low blood sugar levels and high blood sugar levels) may occur, especially in elderly patients. In this case, the 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 (alteration of red blood cells), a decrease in hemoglobin levels and a breakdown 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 the lack of data in this regard.

Other medicines and GLICLAZIDE TECNIGEN
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 increased and signs of low blood sugar levels may appear when you take one of the following medicines:

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

The effects of lowering blood glucose levels due to gliclazide may be weakened and an increase in blood sugar levels may occur with the intake of one of the following medicines:

• medicines for the treatment of disorders of the nervous system (chlorpromazine),
• medicines for reducing inflammation (corticosteroids),
• medicines for the treatment of asthma or used during labor (salbutamol intravenously, ritodrine and terbutaline),
• medicines for the treatment of breast diseases, heavy menstrual bleeding, endometriosis (danazol),
• preparations based on St. John's wort - Hypericum perforatum.

When a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as GLICLAZIDE TECNIGEN, a glycemic disorder (low blood sugar levels and high blood sugar levels) may occur, especially in elderly patients.
GLICLAZIDE TECNIGEN may increase 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 can be taken with non-alcoholic foods and beverages.
Drinking alcohol is not recommended as it can alter diabetes control unpredictably.

Pregnancy and breastfeeding
GLICLAZIDE TECNIGEN is not recommended during pregnancy. If you are pregnant, suspect or are planning a pregnancy, ask your doctor for advice before taking this medicine.
You should not take GLICLAZIDE TECNIGEN while breastfeeding.

Driving and operating machinery
Your ability to concentrate or react may be impaired if blood sugar levels are too low (hypoglycemia), too high (hyperglycemia) or if you develop vision problems as a result of these conditions. Keep in mind that you may harm yourself or others (e.g. when driving vehicles or using machinery).
Ask your doctor if you can drive if you have:

• frequent episodes of low blood sugar levels (hypoglycemia),
• minimal or no signs of low blood sugar levels (hypoglycemia). Gliclazide contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take GLICLAZIDE TECNIGEN

Dosage
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The dose is established by the doctor based on your blood sugar levels and possibly in the urine.
Changes in external factors (weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require adjustments in the doses of gliclazide.
The recommended daily dose is from half a tablet to two tablets (maximum 120 mg) in a single administration at breakfast. This depends on the response to treatment.
The tablets can be divided into equal doses.
GLICLAZIDE TECNIGEN is for oral use. Take the tablet(s) with a glass of water, at breakfast (and preferably every day at the same time). Swallow the tablet(s) whole.
Swallow the half tablet or the whole tablet at once. Do not chew or crush them.
You must always take a meal after taking the tablet(s).
In case of combined therapy of GLICLAZIDE TECNIGEN with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin, the doctor will establish the appropriate dose of each medicine for you.
If you feel that your blood sugar levels are high despite taking this medicine, contact your doctor or pharmacist.

If you take more GLICLAZIDE TECNIGEN than you should
If you take too many tablets, contact your doctor immediately or the nearest hospital emergency room. The signs of overdose are those of a lowering of the blood sugar rate (hypoglycemia) described in paragraph 2. These symptoms can improve by immediately taking sugar (from 4 to 6 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 must be done if someone, for example a child, has accidentally taken the product.
Do not administer food or drinks to unconscious patients.
Make sure there is always an informed person able to call a doctor in case of emergency.

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

If you stop taking GLICLAZIDE TECNIGEN
Since the treatment of diabetes usually lasts a lifetime, you should consult your doctor before stopping treatment with this medicine. Discontinuation may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.
If you have any doubts about the use of GLICLAZIDE TECNIGEN, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effect is a lowering of blood sugar level (hypoglycemia). For symptoms and signs see section “Warnings and precautions”.
If not treated, these symptoms can progress to drowsiness, loss of consciousness and possible coma.
If an episode of low blood sugar is severe or prolonged, even if temporarily controlled with the intake of sugar, contact your doctor immediately.
Liver disorders
Isolated cases of liver function abnormalities have been reported, which can cause yellowing of the skin and eyes. If these appear, contact your doctor immediately. Generally the symptoms disappear if the medicine is discontinued. The doctor will decide whether to discontinue treatment.
Skin disorders
Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, throat or tongue that can cause difficulty breathing) have been reported. Rashes may progress to a spread of blisters all over the body or to peeling of the skin.
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 exceptional cases, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and skin rashes on the face, then widespread rashes with high fever.
Blood disorders
Following a decrease in the number of blood cells (for example platelets, red blood cells and white blood cells), symptoms such as pallor, prolonged bleeding, bruising, sore throat and fever have been reported.
These symptoms usually disappear when treatment is stopped.
Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation.
These effects are reduced when GLICLAZIDE TECNIGEN is taken with a meal, as recommended.
Eye disorders
Vision may be disturbed for a short period, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.
As with other sulfonylureas, the following adverse events have been observed: severe changes in the number of blood cells and allergic inflammation of the walls of blood vessels, reduced levels of sodium in the blood (hyponatremia), symptoms of liver failure (for example jaundice) which in most cases disappeared after discontinuation of sulfonylureas, but which in isolated cases can lead to life-threatening liver failure.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package and on the blister after “Scad.”. The
expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines should 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. Contents of the pack and other information

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

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

Marketing Authorisation Holder
Tecnigen, S.r.l.
Via Galileo Galilei, 40 -
20092 Cinisello Balsamo
Milano, 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 authorised in the Member States of the EEA under the following denominations:
Italy: GLICLAZIDE TECNIGEN
Portugal: Gliclazida Farmoz LP
Spain: Gliclazida TecniGen 60 mg modified-release tablets EFG