GLICLAZIDE 80 mg Tablets

Зміст інструкції

1. GLICLAZIDE DOC Generici 80 mg tablets
   1. WHAT IS GLICLAZIDE DOC GENERICI AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING GLICLAZIDE DOC GENERICI
   3. HOW TO TAKE GLICLAZIDE DOC Generici
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE GLICLAZIDE DOC Generici
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

GLICLAZIDE DOC Generici 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• 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 DOC Generici is and what it is used for
• 2. What you need to know before you take GLICLAZIDE DOC Generici
• 3. How to take GLICLAZIDE DOC Generici
• 4. Possible side effects
• 5. How to store GLICLAZIDE DOC Generici
• 6. Contents of the pack and other information

1. WHAT IS GLICLAZIDE DOC GENERICI AND WHAT IT IS USED FOR

GLICLAZIDE DOC Generici contains the active ingredient gliclazide which belongs to the class of
sulfonylureas, drugs used to reduce blood sugar levels.
GLICLAZIDE DOC Generici is used to treat type 2 diabetes mellitus in adults, caused by decreased insulin synthesis and a lack of response to it,
also associated with problems at the vascular level. Treatment is started when diabetes is not
controlled by diet, exercise and weight loss alone.

2. WHAT YOU NEED TO KNOW BEFORE TAKING GLICLAZIDE DOC GENERICI

Do not take GLICLAZIDE DOC Generici

• If you are allergic to gliclazide, to sulfonylureas in general, or to any of the other components of this medicine (listed in section 6).
• If you suffer from severe hepatic insufficiency (reduced liver function).
• If you suffer from severe renal insufficiency (reduced kidney function).
• If you suffer from juvenile and infantile diabetes type I (a particular form of the disease in which the pancreas is no longer able to produce insulin, a substance that regulates blood glucose levels).
• If you suffer from severe diabetes with malnutrition and acidosis (increased blood acidity).
• If there is a risk of pre-coma or diabetic coma.
• If you have suffered severe trauma.
• If you have an infection.
• If you have severe ketosis (high presence of ketone bodies in the blood).
• If you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking GLICLAZIDE DOC Generici.
Contact your doctor before taking GLICLAZIDE DOC GENERICI if your doctor has diagnosed you with
a deficiency in the glucose-6-phosphate dehydrogenase enzyme (or G6PD, a condition known as favism)
because treatment with sulfonylureas can lead to hemolytic anemia (reduction
of hemoglobin in the blood caused by the destruction of red blood cells).
Your doctor may decide to reduce the dose if:

• Your kidney or adrenal function is reduced.
• You have severe liver disease.
• You are malnourished.
• You are elderly.

Follow your doctor's recommendations regarding the importance of the diet to follow, the need to
avoid sources of infection and the tests to be performed, in order to promptly report the
presence of any altered data.
In particular situations (hospitalization after an accident, illness on vacation, etc.),
always inform your doctor that you have diabetes.
In case of surgical interventions, metabolic decompensation, infectious diseases and fever, temporary
therapy with insulin (a substance produced by the pancreas that
lowers blood sugar levels) may be necessary to maintain adequate control of blood sugar levels.

Children and adolescents
GLICLAZIDE DOC GENERICI should not be used for the treatment of diabetes in children and
adolescents (see “Do not take GLICLAZIDE DOC GENERICI”).

Other medicines and GLICLAZIDE DOC GENERICI
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The blood sugar lowering effect of gliclazide may be increased and
signs of reduced blood sugar levels may appear when taken simultaneously:

• Anti-inflammatory and pain relievers (NSAIDs, salicylates, pyrazole derivatives)
• Chloramphenicol and tetracyclines (antibiotics).
• Sulfonamides (antibacterial medicines).
• Monoamine oxidase inhibitors (medicines used to treat depression).
• Diazepam (medicine for treating sleep problems, anxiety and muscle spasms)
• Perexiline maleate (medicine used to treat heart problems).
• Clofibrate (medicine that reduces the level of fats in the blood).
• Beta-blockers (medicines for treating high blood pressure or heart problems).
• Coumarin derivatives (medicines used to inhibit blood coagulation).
• Alcohol (see “GLICLAZIDE DOC Generici with food, beverages and alcohol”).

Your doctor may have you stop any therapy with miconazole (antifungal drug) or
other sulfonylureas before starting treatment with gliclazide because, following
the association between miconazole and other drugs belonging to the sulfonylurea group, hypoglycemia (reduction of blood sugar that manifests with irritability,
headache, tremor, profuse sweating), even of considerable intensity, has been observed.
The association of gliclazide with biguanides (other hypoglycemic drugs
used in type 2 diabetes) or with insulin is possible instead.
The blood sugar lowering effect of gliclazide may be reduced and an increase in blood sugar levels may occur when taking one of the following
medicines:

• Thiazide diuretics (medicines used to treat high blood pressure by increasing the elimination of fluids with urine).
• Adrenaline (a substance used as an emergency medicine in cases of, for example, anaphylactic reactions, edema, bronchospasm and in some cases of low blood pressure).
• Corticosteroids (medicines used to reduce inflammation).
• Oral contraceptives (birth control pill).

GLICLAZIDE DOC Generici with food, beverages and alcohol
Take GLICLAZIDE DOC Generici preferably 30 minutes before a meal.
It is recommended not to drink alcohol during treatment with GLICLAZIDE DOC Generici because it may
manifest hypoglycemia and affect the control of your diabetes (see “Other medicines and
GLICLAZIDE”). In addition, photosensitization and disulfiram-like effects may occur after
ingestion of alcoholic beverages (see section “Possible side effects”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The use of GLICLAZIDE DOC GENERICI is contraindicated in pregnancy and during breastfeeding (see
“Do not take GLICLAZIDE DOC GENERICI”).

Driving and operating machinery
GLICLAZIDE DOC GENERICI does not impair the ability to drive vehicles or operate machinery.

GLICLAZIDE DOC Generici 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 DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 tablets per day in one or two administrations.
The doctor will establish the dose for you in relation to the degree of diabetes.
Swallow the tablet with water, without chewing, preferably 30 minutes before the meal.

If you take more GLICLAZIDE DOC Genericithan you should
If you take more GLICLAZIDE DOC Generici than you should, your blood sugar level may
drop too low (hypoglycemia) and you may experience the following symptoms:
headache, irritability, nervous depression, sleep disturbances, excessive sweating.
Severe cases of hypoglycemia, accompanied by abnormal behavior or loss of consciousness
require immediate treatment and hospitalization.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely, during therapy with GLICLAZIDE DOC Generici, hypoglycaemia
(low blood sugar) may occur, which can manifest with irritability, tremors, headache,
excessive sweating, irregular or accelerated heartbeat, intense hunger, paleness, excessive
saliva production and convulsions. This effect is more likely to occur if you are debilitated,
elderly, if you are undergoing unusual physical exertion, if you have an irregular diet or
consume alcoholic beverages, or if you have impaired kidney and/or liver function.
The following skin reactions have also been reported:

• skin rash
• urticaria (hives)
• pruritus (itching)
• swelling of the face, lips, mouth, tongue or throat which can cause difficulty swallowing and breathing (angioedema)
• skin redness (erythema)
• a reaction causing skin eruptions with macules (flat, light-colored spots) and papules (small bumps);
• formation of blisters, bubbles or peeling of the skin or mucous membranes (toxic epidermal necrolysis and Stevens-Johnson syndrome).

Other side effects that may occur with the intake of GLICLAZIDE DOC Generici are:

• Photosensitisation (exaggerated reaction to light).
• Disulfiram-like effects (general feeling of unwellness, difficulty breathing, palpitations, headache, nausea and vomiting) after ingestion of alcoholic beverages.
• Transient disturbances at the level of the stomach and intestines.
• Transient skin eruptions of allergic origin.
• leucopenia and agranulocytosis (decrease in the number of white blood cells and granulocytes in the blood), thrombocytopenia (decrease in the number of platelets in the blood), anaemia (reduction in the level of haemoglobin in the blood), generally reversible, in subjects sensitive to sulphonamides.

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
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE GLICLAZIDE DOC Generici

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 blister and the packaging.
The expiry date refers to the last day of that month.
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 DOC Generici contains
The active ingredient is gliclazide. Each tablet contains 80 mg of gliclazide.
The other ingredients are: lactose monohydrate, povidone, dibeenate glycerol, colloidal anhydrous
silica, magnesium stearate.

Description of the appearance of GLICLAZIDE DOC Generici and contents of the pack
The tablets of GLICLAZIDE DOC Generici are ivory white in colour, with a median fracture
line.
The tablets are available in blisters of 40 divisible tablets.

Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milano (MI).

Manufacturer
Special Product’s line S.p.A - Strada Paduni, 240 - 03012 Anagni (FR) – Italy.