GLICLAZIDE 80 mg Tablet

Зміст інструкції

1. GLICLAZIDE ZENTIVA 80 mg tablets
   1. What is Gliclazide Zentiva and what it is used for
   2. What you need to know before taking Gliclazide Zentiva
   3. How to take Gliclazide Zentiva
   4. Possible side effects
   5. How to store Gliclazide Zentiva
   6. Contents of the pack and other information

GLICLAZIDE ZENTIVA 80 mg tablets

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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Gliclazide Zentiva and what it is used for

Gliclazide Zentiva contains the active substance gliclazide, which belongs to the class of sulfonylureas. Sulfonylureas are oral hypoglycemic drugs administered by mouth to lower the amount of
sugar in the blood, and they are used for the treatment of diabetes mellitus, a disease characterized by
high levels of sugar in the blood.
This medicine is used in adults for the treatment of non-insulin-dependent diabetes mellitus, a
type of diabetes that is not treated with insulin (also called type 2), when diet, exercise and
weight loss alone are not sufficient to maintain a correct level of sugar in the blood.

2. What you need to know before taking Gliclazide Zentiva

Do not take Gliclazide Zentiva

• If you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6) or to other medicines of the same group (sulphonylureas), or to other related medicines (sulphonamide hypoglycaemics).
• If you suffer from severe liver failure (severe reduction of liver function).
• If you suffer from severe kidney failure (severe reduction of kidney function).
• If you suffer from juvenile and infantile diabetes, also known as type 1 diabetes (a particular form of diabetes in which patients are no longer able to produce insulin, a substance that regulates blood sugar levels).
• If you are in a state of diabetic coma and pre-coma (a complication of diabetes that causes loss of consciousness).
• If you are taking miconazole, a medicine for the treatment of fungal infections (see section “Other medicines and Gliclazide Zentiva”);
• If you have ketone bodies and sugar in your urine (this may mean that you suffer from diabetic keto-acidosis);
• If you are breastfeeding (see section “Pregnancy and breastfeeding”).

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Warnings and precautions
Consult your doctor or pharmacist before taking Gliclazide Zentiva.
During treatment with gliclazide, constant monitoring of blood levels (and possibly in urine) of glycated haemoglobin is necessary.
You can only take oral hypoglycaemic medicines of the sulphonylurea group if:

• you have type 2 diabetes mellitus (see section “What is Gliclazide Zentiva and what it is used for”);
• you are an adult;
• you have diabetes that cannot be treated with diet alone and for which insulin administration is not indicated;
• your body does not produce ketone bodies (see section “Do not take Gliclazide Zentiva”).

Follow the treatment plan prescribed by your doctor to achieve adequate blood sugar levels.
Therefore, in addition to regularly taking the tablet, observe a dietary regime, never skip a meal including breakfast, engage in physical activity and, if necessary, reduce your weight.
prescription
In the very first weeks of treatment, the risk of decreased blood sugar levels (hypoglycaemia) may increase. For this reason, careful medical monitoring is necessary.
A lowering of blood sugar levels (hypoglycaemia) can occur:

• 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 if alcohol consumption is while fasting;
• if you take 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 (dysfunction of the thyroid gland, or the pituitary gland or the adrenal cortex),
• if your kidney or liver function is reduced (do not take the medicine if you suffer from kidney or liver failure, see “Do not take Gliclazide Zentiva”).

If you have a low blood sugar level, the following symptoms may occur:
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 inefficiency (ability to perform actions).
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, rapid or irregular heartbeat, increased blood pressure, sudden severe chest pain that radiates to surrounding areas (angina pectoris).
If blood sugar levels continue to decrease, you may experience severe confusion (delirium), develop convulsions, lose control, breathing may become labored and the heart may beat slowly, you may lose consciousness.
In most cases, the symptoms of a low blood sugar level disappear very quickly by taking sugar in various forms, for example glucose tablets, sugar lumps, sugary juices, sweetened tea.
Therefore, always carry sugar in various forms 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.
The symptoms of a low blood sugar level may not appear, be less noticeable, appear very slowly or you may not notice in time that your blood sugar level has 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).
Symptoms of high blood sugar levels (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced blood sugar levels, when you have not followed your doctor's instructions or in situations of particular stress. These may include thirst, frequent urination, dry mouth, dry skin and itching, skin infections and reduced efficiency.
If these symptoms occur, you should contact your doctor or pharmacist.
Tell your doctor before taking Gliclazide Zentiva if you suffer from glucose-6-phosphate dehydrogenase deficiency (or G6PD, a disease known as favism) as treatment with sulphonylureas in patients with this disease may lead to haemolytic anaemia (reduction of haemoglobin in the blood caused by the destruction of red blood cells).
Take this medicine with caution and always under the supervision of your doctor who will prescribe you a reduced dose if:

• your kidney or adrenal function (glands located above the kidneys) is reduced.
• you have severe liver disease.
• you are malnourished.
• you are elderly.

In particular situations (hospitalization after an accident, illness on vacation, etc.), always tell your doctor that you have diabetes.
In conjunction with surgery, accident, metabolic decompensation, infectious diseases and fever, your doctor may prescribe you insulin (a medicine used to treat certain types of diabetes) temporarily to maintain adequate blood glucose control (amount of sugar in the blood).

Children and adolescents
Gliclazide Zentiva is not recommended for use in children and adolescents due to lack of data.

Other medicines and Gliclazide Zentiva
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 symptoms of low blood sugar levels (hypoglycaemia) 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 (e.g. sulphonamides, 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 blood glucose-lowering effect of gliclazide may be weakened and blood sugar levels may increase if you take one of the following medicines:

• medicines for the treatment of disorders of the central nervous system (chlorpromazine);
• medicines for the reduction of inflammation (corticosteroids);
• medicines for the treatment of asthma or used during labour (salbutamol intravenous, ritodrine and terbutaline);
• medicines for the treatment of breast disorders, heavy menstrual bleeding and endometriosis (danazol).

Gliclazide Zentiva may increase the effects of medicines that reduce blood clotting (for example warfarin).
Consult your doctor before starting to take another medicine. If you are hospitalized, inform the medical staff that you are taking Gliclazide Zentiva.

Gliclazide Zentiva with food, drinks and alcohol
Gliclazide Zentiva can be taken with food and non-alcoholic beverages.
Drinking alcohol is not recommended as it can alter diabetes control.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
The use of Gliclazide Zentiva is not recommended during pregnancy. If you are planning a pregnancy, or are pregnant, inform your doctor before taking this medicine.
The use of Gliclazide Zentiva is contraindicated during breastfeeding (see section “Do not take Gliclazide Zentiva”).

Driving and using machines
If blood sugar levels are maintained satisfactorily under control by Gliclazide Zentiva, your ability to drive vehicles or operate machinery is not impaired. However, if blood sugar levels are too low, this may impair your concentration and ability to drive.
Ask your doctor if you can drive vehicles if you have:

• frequent episodes of low blood sugar levels (hypoglycaemia);
• minimal, or no, signs of a low blood sugar level (hypoglycaemia).

Gliclazide Zentiva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Gliclazide Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Changes in external factors (e.g. weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require adjustments to the dose of gliclazide.
The recommended dose is from half to four tablets per day, based on the response to treatment.
The drug dosage must still be established by the attending physician based on your diabetes.
When the total daily dose is greater than 2 tablets, the dose must be divided into two equivalent administrations to be taken in the morning and evening.
Swallow the tablet with water, without chewing, and take it preferably before a meal.
If you have started combination therapy with Gliclazide Zentiva and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase 4 inhibitor, a GLP-1 receptor agonist or insulin, your doctor will need to determine the correct doses of each individual medicine. If blood glucose levels are high despite correct intake as prescribed by your doctor, contact your doctor or pharmacist.

If you take more Gliclazide Zentiva than you should
If you (or someone else) have ingested an excessive dose of Gliclazide Zentiva or if you think a child may have taken this medicine, immediately notify a doctor or go to the Emergency Room of the nearest hospital.
Taking an excessive dose of medicine essentially leads to manifestations of hypoglycemia (decreased blood sugar level) whose first symptoms may include headache, irritability, depression, sleep disturbances, heavy sweating (see section “Warnings and precautions”).
Symptoms can be relieved by immediately taking sugar (4 – 6 lumps) or sugary drinks, followed by a substantial snack or meal.
In severe cases, if disturbances of consciousness (confusion) occur, the patient must be taken immediately to the nearest hospital.

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

If you stop taking Gliclazide Zentiva
Since diabetes treatment 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 this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Low blood sugar level (hypoglycemia)
The most commonly observed side effect is a lowering of the blood sugar level
(hypoglycemia). For signs and symptoms see “ 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 by taking sugar, contact your doctor immediately.

Other side effects
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation. These
effects are reduced when the medicine is taken with meals, as recommended.
Skin conditions: Skin reactions such as rash, redness, itching and
urticaria, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, throat or the
tongue which can cause difficulty breathing) have been reported. The rash may progress with spreading of
blisters all over the body or peeling of the skin. In exceptional cases, signs of severe
hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and rash on the
face that spreads with high fever.
Blood disorders: Symptoms such as pallor, prolonged bleeding, bruising, sore throat and fever have been reported following a decrease in the number of blood cells (e.g.
platelets, red blood cells and white blood cells). These symptoms usually resolve when treatment is stopped.
Liver disorders: Isolated cases of abnormal liver function 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 stopped. The doctor will decide whether to discontinue the
treatment.
Eye disorders: Visual impairment may be altered 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 alterations in the number of
blood cells and allergic inflammation of the blood vessel walls, reduced sodium in the blood
(hyponatremia), weight gain, symptoms of impaired liver function (e.g. jaundice) which in most
cases resolved after discontinuation of the sulfonylurea, but which in isolated cases can lead to
life-threatening liver failure.

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Gliclazide Zentiva

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 packaging. The expiry date refers to the last day of that month and the product in intact packaging, correctly stored.
No special storage precautions are necessary.
Do not dispose of any medicine in waste water 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 Zentiva contains
One tablet contains:

Active substance:gliclazide 80 mg.

Other components:lactose monohydrate, povidone, dibeenate glycerol, anhydrous colloidal silica, magnesium
stearate.

Description of the appearance of Gliclazide Zentiva and contents of the pack
Ivory-colored tablets with a score line.
Blister of 40 divisible tablets inserted in a cardboard box.

Marketing authorisation holder
Zentiva Italia S.r.l. – Viale L. Bodio, 37/b, 20158 Milano

Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno 48, Quinto de’ Stampi, 20089 Rozzano (MI)