GLICLAZIDE PENSA

Package leaflet: Information for the user

GLICLAZIDE PENSA 80 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 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 PENSA is and what it is used for
2. What you need to know before taking GLICLAZIDE PENSA
3. How to take GLICLAZIDE PENSA
4. Possible side effects
5. How to store GLICLAZIDE PENSA
6. Contents of the pack and other information

1. WHAT GLICLAZIDE PENSA IS AND WHAT IT IS USED FOR

GLICLAZIDE PENSA contains the active substance gliclazide, which belongs to the class of
sulfonylureas, oral hypoglycemic agents (administered by mouth to reduce blood sugar levels), used in the treatment of diabetes (a metabolic disorder characterized by high blood sugar levels).
This medicinal product is used in adults for the treatment of symptomatic non-insulin-dependent diabetes mellitus (caused by reduced insulin production and impaired response to insulin, rather than by a complete absence of insulin), even when associated with vascular complications.

2. WHAT YOU SHOULD KNOW BEFORE TAKING GLICLAZIDE PENSA

Do not take GLICLAZIDE PENSA

• If you are allergic to the active substance (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 juvenile or childhood diabetes (a specific form of the disease in which the pancreas is no longer able to produce insulin, the substance that regulates blood glucose levels).
• If you have severe diabetes with malnutrition and acidosis (increased acidity of the blood).
• If you are in a state of diabetic coma or pre-coma (a diabetes complication causing loss of consciousness).
• If you have suffered severe trauma.
• If you have an infection.
• If you have severe ketosis (high levels of ketone bodies in the blood causing a decrease in pH to very acidic values).
• If you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
• If you are being treated with miconazole (a medicine used for fungal infections).

Warnings and precautions
Talk to your doctor or pharmacist before taking GLICLAZIDE PENSA.
You may take oral hypoglycemic agents of the sulfonylurea class only if you have symptomatic, non-ketogenic diabetes mellitus that cannot be controlled by diet alone, and for which insulin administration is not indicated.
Contact your doctor before taking GLICLAZIDE PENSA if your doctor has informed you that you lack the enzyme glucose-6-phosphate dehydrogenase (or G6PD, a condition known as favism), as treatment with sulfonylureas may lead to hemolytic anemia (reduction in hemoglobin in the blood caused by destruction of red blood cells).
Exercise particular caution and consider the possibility of reducing the dose if:

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

You must be aware of the importance of following your prescribed diet, avoiding sources of infection, and adhering to your doctor's instructions regarding laboratory tests to promptly detect any abnormal results.
In special circumstances (hospitalization after an accident, illness while traveling, etc.), always inform your doctor that you have diabetes.
During surgical procedures, metabolic decompensation, infectious or febrile illnesses, it may become necessary to temporarily initiate insulin therapy (a hormone produced by the pancreas that lowers blood sugar levels) to maintain adequate metabolic control (blood glucose levels).

Children and adolescents
The use of this medicine is not recommended in children and adolescents under 18 years of age (see section “Do not take GLICLAZIDE PENSA”).

Other medicines and GLICLAZIDE PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Discontinue any ongoing treatment with miconazole (an antifungal drug) before starting treatment with a sulfonylurea (such as gliclazide), as hypoglycemia (low blood sugar causing irritability, headache, tremor, profuse sweating), even of marked intensity, has been observed following the association of miconazole with other sulfonylurea drugs (e.g., glibenclamide).
Combination of gliclazide with biguanides (other hypoglycemic agents used in type 2 diabetes) or with insulin is possible.
Please note that the hypoglycemic effect (lowering of blood sugar) of gliclazide may be enhanced by:

• Non-steroidal anti-inflammatory drugs (NSAIDs), such as salicylates (medicines used as anti-inflammatory and pain-relieving agents).
• Chloramphenicol (an antibiotic).
• Alcohol (see section “GLICLAZIDE PENSA with alcohol”).
• Sulfonamides (antibacterial agents).
• Monoamine oxidase inhibitors (MAOIs) (medicines used as antidepressants).
• Pyrazoles (anti-inflammatory, analgesic, antipyretic agents).
• Diazepam (a drug with anxiolytic, sedative, and anticonvulsant properties).
• Tetracyclines (antibiotics).
• Perhexiline maleate (a medicine used in cardiac conditions).
• Clofibrate (a drug that reduces blood lipid levels).
• Beta-blockers (medicines used for various conditions including angina, high blood pressure, heart attack, cardiac arrhythmias, and heart failure).
• Dicumarol and coumarin derivatives (medicines used to reduce blood coagulation).

Conversely, the effect of gliclazide is reduced by:

• Thiazide diuretics (medicines used to treat high blood pressure that increase fluid elimination in urine).
• Adrenaline (a substance used as an emergency drug, e.g., for anaphylactic reactions, edema, bronchospasm, and in some cases of low blood pressure).
• Corticosteroids (medicines used as anti-inflammatory agents and in some allergic reactions).
• Oral contraceptives (birth control pills).

GLICLAZIDE PENSA with alcohol
Alcohol may enhance the hypoglycemic action of gliclazide (see section “Other medicines and GLICLAZIDE”). Do not consume alcohol during treatment with gliclazide.
Be aware of the possibility of photosensitization and disulfiram-like effects after ingestion of alcoholic beverages (see section 4 “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 PENSA is contraindicated during pregnancy and breastfeeding (see section “Do not take GLICLAZIDE PENSA”).

Driving and using machines
GLICLAZIDE PENSA does not affect the ability to drive vehicles or operate machinery.

GLICLAZIDE PENSA contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE GLICLAZIDE PENSA

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.
However, the actual dose must be determined by your treating doctor according to the severity of your diabetes.
Swallow the tablet with water, without chewing, preferably 30 minutes before a meal.

If you take more GLICLAZIDE PENSA than you should
Taking an excessive dose of this medicine may lead primarily to symptoms of hypoglycaemia (reduction in blood sugar levels), the early signs of which may include headache, irritability, nervous depression, sleep disturbances, and profuse sweating (see section “Warnings and precautions”).
In severe cases, if disturbances of consciousness (confusional states) occur, administer immediately a glucose solution (sugar solution) intravenously (into a vein) and proceed with hospitalization.

If you forget to take GLICLAZIDE PENSA
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking GLICLAZIDE PENSA
Do not stop treatment with GLICLAZIDE PENSA suddenly or without first consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
A serious adverse reaction that may occur following the use of GLICLAZIDE PENSA is hypoglycaemia (reduction in blood sugar levels), which is rare and may present as irritability, tremors, headache, profuse sweating, palpitations, intense hunger, pallor, excessive salivation, and seizures. This reaction is more likely to occur if you are debilitated, elderly, undergoing unusual physical exertion, have irregular eating habits, consume alcoholic beverages, or have impaired kidney and/or liver function.
If you experience this serious or potentially serious adverse reaction, stop taking the medicine immediately and contact your doctor or go to the nearest hospital without delay.
Other adverse reactions that may occur with the use of GLICLAZIDE PENSA include:

• Photosensitization (exaggerated reaction to light).
• Disulfiram-like effects (generalized malaise, breathing difficulties, palpitations, headache, nausea, and vomiting) after ingestion of alcoholic beverages.
• Transient gastrointestinal disturbances.
• Skin and subcutaneous tissue disorders: rash, pruritus, urticaria, angioedema, erythema, maculopapular eruptions, bullous reactions (such as Stevens-Johnson Syndrome and toxic epidermal necrolysis). Blood abnormalities such as leucopenia and agranulocytosis (conditions characterized by a reduced number of white blood cells and granulocytes in the blood), thrombocytopenia (reduced number of platelets in the blood), anaemia (reduced haemoglobin levels in the blood), generally reversible, in subjects sensitive to sulfonamides.

Following the instructions provided in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the following address:
http://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 PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month and to the product in its original packaging,
stored correctly.
No special storage precautions are required.
Do not dispose of any medicine 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 CONTENT AND OTHER INFORMATION

What GLICLAZIDE PENSA contains
One tablet contains:
Active substance: gliclazide 80 mg.
Other components: monohydrate lactose, povidone, glyceryl dibehenate, anhydrous colloidal silica,
magnesium stearate.

Description of the appearance of GLICLAZIDE PENSA and pack contents
Tablets.
Blister pack containing 40 divisible tablets, inserted in a cardboard carton.

Marketing Authorization Holder
Pensa Pharma S.p.A. – Via Ippolito Rosellini, 12 - 20124 Milan

Manufacturer
Special Product’s Line SpA – Via Campobello 15 – 00040 Pomezia (Rome)