GLICLAZIDE 80 mg Таблетки

Содержание инструкции

1. GLICLAZIDE PENSA 80 mg tablets
   1. WHAT IS GLICLAZIDE PENSA AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLICLAZIDE PENSA
   3. HOW TO TAKE GLICLAZIDE PENSA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE GLICLAZIDE PENSA
   6. PACKAGE CONTENTS AND OTHER INFORMATION

GLICLAZIDE PENSA 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 they have the same symptoms as you, as it may 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 PENSA is and what it is used for
• 2. What you need to know before you take 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 IS GLICLAZIDE PENSA AND WHAT IS IT USED FOR

GLICLAZIDE PENSA contains the active ingredient gliclazide which belongs to the class of
sulfonylureas, oral hypoglycemic drugs (administered orally to reduce blood sugar concentration), used for the treatment of diabetes (a metabolic disorder characterized
by high blood sugar levels).
This medicine is used in adults for the treatment of symptomatic, non-
insulin-dependent diabetes mellitus (caused by decreased insulin synthesis and failure to respond to
it, not by total absence of insulin), even associated with problems at the level of the vessels.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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 suffer from severe hepatic insufficiency (reduced liver function).
• If you suffer from severe renal insufficiency (reduced kidney function).
• If you are affected by juvenile and infantile diabetes (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 are affected by severe diabetes with malnutrition and acidosis (increased blood acidity).
• If you are in a state of diabetic coma and pre-coma (a complication of diabetes that causes loss of consciousness).
• If you have suffered serious traumas.
• If you have an infection.
• If you have severe ketosis (high presence of ketone bodies in the blood that cause 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 can only take oral hypoglycemic drugs of the sulfonylurea group if you have symptomatic and non-ketogenic diabetes mellitus that cannot be controlled with diet, and for which insulin administration is not indicated.
Contact your doctor before taking GLICLAZIDE PENSA if your doctor has told you that you do not have the glucose 6-phosphate dehydrogenase enzyme (or G6PD, a condition known as favism) as treatment with sulfonylureas can lead to hemolytic anemia (reduction of hemoglobin in the blood caused by the destruction of red blood cells).
Take particular care and consider the possibility of reducing the dosage if:

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

You must be aware of the importance of following a diet, the need to avoid sources of infection and to adhere to the doctor's prescription regarding laboratory 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 conjunction with surgery, metabolic decompensation, infectious diseases and fever, it may be necessary to temporarily start therapy based on insulin (hormone produced by the pancreas that lowers blood sugar levels) to maintain adequate metabolic control (blood sugar levels).

Children and adolescents
Use of the medicine is not recommended in children and adolescents up to 18 years of age (see section “Do not take GLICLAZIDE PENSA”).

Other medicines and GLICLAZIDE PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Stop any therapy based on miconazole (antifungal drug) before starting treatment with a sulfonylurea (such as gliclazide) as, following the association between miconazole and other drugs belonging to the sulfonylurea group (glibenclamide), 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 drugs with hypoglycemic action used in type 2 diabetes) or with insulin is possible instead.
Be aware that the hypoglycemic action (reduction of blood sugar) of gliclazide can be increased by:

• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as salicylates (drugs used as anti-inflammatory and analgesic).
• Chloramphenicol (antibiotic drug).
• Alcohol (see section “GLICLAZIDE PENSA with alcohol”).
• Sulfonamides (antibacterial drugs).
• Monoamine Oxidase Inhibitors or MAOIs (drugs used as antidepressants).
• Pyrazolones (anti-inflammatory, analgesic, antipyretic).
• Diazepam (drug with anxiolytic, sedative, anticonvulsant action).
• Tetracyclines (antibiotic drugs).
• Perexiline maleate (drug used in cardiac pathologies).
• Clofibrate (drug that reduces the level of fats in the blood).
• Beta-blockers (drugs used for various diseases including: angina, high blood pressure, heart attack, alteration of heart rhythm, heart failure).
• Dicoumarol and coumarin derivatives (drugs used to reduce blood coagulation).

Conversely, the action of gliclazide is decreased by:

• Thiazide diuretics (drugs used for the treatment of high blood pressure, which increase the elimination of fluids with urine).
• Adrenaline (substance used as an emergency drug for example for anaphylactic reactions, edema, bronchospasm and in some cases of low pressure).
• Corticosteroids (drugs used as anti-inflammatory and in some cases of allergic reactions).
• Oral contraceptives (the pill).

GLICLAZIDE PENSA with alcohol
Alcohol can increase the hypoglycemic action of gliclazide (see section “Other medicines and GLICLAZIDE PENSA”). Do not drink alcohol during treatment with gliclazide.
You should 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 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 PENSA is contraindicated in pregnancy and during breastfeeding (see section “Do not take GLICLAZIDE PENSA”).

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

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

3. HOW TO TAKE GLICLAZIDE PENSA

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 drug dosage must however be established by the treating doctor in relation to the degree of
diabetes.
Swallow the tablet with water, without chewing, and preferably take it 30 minutes before
the meal.

If you take more GLICLAZIDE PENSAthan you should
Taking an excessive dose of the medicine essentially leads to manifestations of
hypoglycemia (decrease in blood sugar levels) whose first symptoms may
include headache, irritability, nervous depression, sleep disturbances, heavy sweating
(see paragraph “Warnings and precautions”).
In severe cases, if disturbances of consciousness (confusional states) appear, administer
immediately a glucose solution (sugar solution) intravenously (in a vein) and
proceed with hospitalization.

If you forget to take GLICLAZIDE PENSA
If you forget to take a dose of the medicine, take it as soon as you remember, unless it is
almost time to take the next dose. Do not take a double dose to compensate for the
forgotten dose.

If you stop taking GLICLAZIDE PENSA
Do not stop treatment with GLICLAZIDE PENSA suddenly or without first having
agreed with your doctor.
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.
A serious side effect that may occur following the use of GLICLAZIDE PENSA is
hypoglycemia (decrease in blood sugar levels), which is rare, and can manifest with
irritability, tremors, headache, heavy sweating, palpitations, intense hunger, pallor, excessive
saliva production and convulsions. It 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.

If you experience this serious or potentially serious side effect, stop
taking the medicine and immediately inform your doctor or go to the nearest hospital.
Other side effects that may occur with the intake of GLICLAZIDE PENSA are:

• Photosensitization (exaggerated reaction to light).
• Disulfiram-like effects (feeling of general malaise, difficulty breathing, palpitations, headache, nausea and vomiting) after ingestion of alcoholic beverages.
• Transient disorders at the level of the stomach and intestines.
• Skin and subcutaneous tissue disorders: rash, itching, urticaria, angioedema, erythema, maculopapular eruptions, blistering reactions (such as Stevens-Johnson Syndrome and toxic epidermal necrolysis). Changes at the level of the various blood elements such as leukopenia and agranulocytosis (diseases characterized by a decrease in the number of white blood cells and granulocytes in the blood), thrombocytopenia (decrease in the number of platelets in the blood), anemia (reduction of hemoglobin levels in the blood), generally reversible, in subjects sensitive to sulfonamides .

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
http://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 PENSA

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 after “Exp”.
The expiry date refers to the last day of that month and to 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. PACKAGE CONTENTS AND OTHER INFORMATION

What GLICLAZIDE PENSA contains
One tablet contains:

Active ingredient:gliclazide 80 mg.

Other ingredients:lactose monohydrate, povidone, dibeenoyl glycerol, anhydrous colloidal silica,
magnesium stearate

Description of the appearance of GLICLAZIDE PENSA and package contents
Tablets.
Blister of 40 divisible tablets inserted in a cardboard box.

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

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