Gliclazide Doc Generici

Patient Information Leaflet: Information for the User

GLICLAZIDE DOC Generici 80 mg tablets

Generic medicine
Please read all of 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, 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 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

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

GLICLAZIDE DOC GENERICS contains the active substance gliclazide, which belongs to the class of sulfonylureas, medicines used to reduce blood sugar levels.
GLICLAZIDE DOC GENERICS is used in adults to treat non-insulin-dependent diabetes mellitus, caused by reduced insulin production and lack of response to insulin, even when associated with vascular problems. Treatment is initiated when diabetes is not controlled by diet, physical exercise, and weight loss alone.

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

Do not take GLICLAZIDE DOC GENERICS

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

Warnings and precautions
Talk to your doctor or pharmacist before taking GLICLAZIDE DOC GENERICS.
Contact your doctor before taking GLICLAZIDE DOC GENERICS if you have been diagnosed with
glucose-6-phosphate dehydrogenase (G6PD) deficiency (a condition also known as favism),
because treatment with sulfonylureas may cause hemolytic anemia (reduction in blood hemoglobin due to 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 diet, the need to avoid sources of infection, and required tests, in order to promptly detect any abnormal findings.
In special circumstances (hospitalization after an accident, illness while on holiday, etc.), always inform your doctor that you have diabetes.
In case of surgery, metabolic decompensation, infectious diseases, or fever, temporary insulin therapy (a substance produced by the pancreas that lowers blood sugar levels) may be necessary to maintain adequate control of blood glucose levels.

Children and adolescents
GLICLAZIDE DOC GENERICS must not be used for the treatment of diabetes in children and adolescents (see "Do not take GLICLAZIDE DOC GENERICS").

Other medicines and GLICLAZIDE DOC GENERICS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood glucose-lowering effect of gliclazide may be increased, and signs of low blood sugar may occur when taken concomitantly with:

• Anti-inflammatory and pain-relieving drugs (NSAIDs, salicylates, pyrazole derivatives)
• Chloramphenicol and tetracyclines (antibiotics)
• Sulfonamides (antibacterial medicines)
• Monoamine oxidase inhibitors (medicines used to treat depression)
• Diazepam (a medicine used to treat sleep problems, anxiety, and muscle spasms)
• Perhexiline maleate (a medicine used to treat heart conditions)
• Clofibrate (a medicine that reduces blood lipid levels)
• Beta-blockers (medicines used to treat high blood pressure or heart problems)
• Coumarin derivatives (medicines used to inhibit blood coagulation)
• Alcohol (see "GLICLAZIDE DOC GENERICS with food, drink, and alcohol")

Your doctor will ask you to stop any treatment with miconazole (an antifungal medicine) or other sulfonylureas before starting gliclazide, as hypoglycemia (low blood sugar causing irritability, headache, tremor, profuse sweating), sometimes severe, has been observed following the combination of miconazole and other sulfonylurea drugs.
However, combination of gliclazide with biguanides (other blood glucose-lowering medicines used in type 2 diabetes) or with insulin is possible.
The blood glucose-lowering effect of gliclazide may be reduced, leading to increased blood sugar levels, when taking any of the following medicines:

• Thiazide diuretics (medicines used to treat high blood pressure by increasing fluid elimination through urine)
• Adrenaline (a medicine used in emergencies, e.g., for anaphylactic reactions, edema, bronchospasm, and in some cases of low blood pressure)
• Corticosteroids (medicines used to reduce inflammation)
• Oral contraceptives (birth control pills)

GLICLAZIDE DOC GENERICS with food, drink, and alcohol
Take GLICLAZIDE DOC GENERICS preferably 30 minutes before a meal.
You are advised not to drink alcohol during treatment with GLICLAZIDE DOC GENERICS, as it may cause hypoglycemia and affect control of your diabetes (see "Other medicines and GLICLAZIDE"). In addition, photosensitivity 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 may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of GLICLAZIDE DOC GENERICS is contraindicated during pregnancy and breastfeeding (see "Do not take GLICLAZIDE DOC GENERICS").

Driving and using machines
GLICLAZIDE DOC GENERICS does not impair the ability to drive or operate machinery.

GLICLAZIDE DOC GENERICS contains lactose.
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE GLICLAZIDE DOC Generici

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 tablets daily, taken in one or two doses.
Your doctor will determine the appropriate dose for you depending on the severity of your diabetes.
Swallow the tablet with water, without chewing, preferably 30 minutes before a meal.
If you take more GLICLAZIDE DOC Generici than you should
If you take more GLICLAZIDE DOC Generici than prescribed, your blood sugar level may drop too low (hypoglycaemia), and you may experience the following symptoms:
headache, irritability, nervous depression, sleep disturbances, excessive sweating.
Severe cases of hypoglycaemia, accompanied by abnormal behaviour or loss of consciousness, require immediate treatment and hospitalisation.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
Hypoglycemia (reduction of blood sugar levels) may rarely occur during treatment with GLICLAZIDE DOC Generici, manifesting as irritability, tremors, headache, excessive sweating, irregular or rapid heartbeat, intense hunger, pallor, excessive salivation, and seizures. This effect is more likely to occur if you are debilitated, elderly, undergoing unusual physical exertion, have irregular eating habits or consume alcoholic beverages, or have impaired kidney and/or liver function.

The following skin reactions have also been reported:

• Skin rash
• Urticaria
• Pruritus
• Swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing and breathing (angioedema)
• Skin redness (erythema)
• Reaction causing skin eruptions with macules (flat, light-colored spots) and papules (small raised bumps)
• Formation of blisters, bullae, or skin or mucosal peeling (toxic epidermal necrolysis and Stevens-Johnson syndrome)

Other adverse reactions that may occur with GLICLAZIDE DOC Generici include:

• Photosensitization (exaggerated reaction to light)
• Disulfiram-like effects (generalized malaise, breathing difficulty, palpitations, headache, nausea, and vomiting) after ingestion of alcoholic beverages
• Transient gastrointestinal disturbances
• Transient allergic skin eruptions
• Leukopenia and agranulocytosis (reduction in the number of white blood cells and granulocytes in the blood), thrombocytopenia (reduction in the number of platelets in the blood), anemia (reduction in hemoglobin levels in the blood), generally reversible, in subjects sensitive to sulfonamides

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, 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 stated on the blister pack and packaging.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What GLICLAZIDE DOC Generici contains
The active substance is gliclazide. Each tablet contains 80 mg of gliclazide.
The other components are: monohydrate lactose, povidone, glyceryl dibehenate, colloidal anhydrous silica, magnesium stearate.

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

Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan (MI).
Manufacturer
Special Product’s line S.p.A - Strada Paduni, 240 - 03012 Anagni (FR) – Italy.