Diabrezide

PACKAGE LEAFLET: INFORMATION FOR THE USER

DIABREZIDE, 80 mg, tablets
(Gliclazidum)
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Diabrezide is and what it is used for
2. Important information before taking Diabrezide
3. How to take Diabrezide
4. Possible side effects
5. How to store Diabrezide
6. Contents of the pack and other information

1. What Diabrezide is and what it is used for

Diabrezide is an oral antidiabetic medicine that lowers blood glucose levels.
It contains the active substance gliclazide, which belongs to the sulfonylurea derivatives group.
Indications:

• Treatment of type 2 diabetes (non-insulin-dependent) in adults when diet, physical exercise, and weight reduction are insufficient to maintain adequate blood glucose control.

2. Important information before taking Diabrezide

When not to take Diabrezide

• If the patient is allergic to gliclazide, other sulfonylurea derivatives, sulfonamides, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has type 1 diabetes (insulin-dependent diabetes).
• If the patient is in a pre-coma state or has diabetic coma.
• If the patient has diabetic ketoacidosis – an accumulation in the blood of excessive amounts of acidic substances.
• If the patient has severe renal or hepatic impairment (in such cases insulin therapy is recommended).
• If the patient is taking medications used to treat fungal infections (miconazole, see section: Diabrezide with other medicines).
• If the patient is pregnant or breastfeeding (see section: Pregnancy, breastfeeding and fertility).
• In children due to lack of data.

Warnings and precautions
Before starting treatment with Diabrezide, discuss this with your doctor or pharmacist.
To achieve proper blood glucose levels, it is essential to follow your doctor's treatment recommendations. This means that in addition to taking the tablets regularly, you should adhere to a diet, perform physical exercise, and if necessary, reduce body weight.
During treatment with this medicine, regular monitoring of blood glucose (and possibly urine glucose) and glycated hemoglobin (HbA1c) is necessary.
The risk of low blood glucose (hypoglycemia) may increase during the first weeks of treatment. Therefore, particularly careful medical supervision is required.
Low blood glucose (hypoglycemia) may occur if:

• the patient eats irregularly or skips meals;
• the patient is fasting;
• the patient is undernourished;
• the patient changes their diet;
• prolonged nausea and vomiting occur;
• the patient increases physical activity without adequate carbohydrate intake;
• the patient drinks alcohol;
• the patient takes too high a dose of Diabrezide;
• the patient has specific hormonal disorders (thyroid, pituitary gland, or adrenal cortex dysfunction);
• kidney or liver function is severely impaired;
• the patient is taking other blood glucose-lowering medicines.

If the patient has low blood glucose, the following symptoms may occur:
headache, intense hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, impaired concentration, reduced alertness and reaction time, depression, confusion and disorientation (impaired orientation in time, place, situation, or self), speech and vision disturbances, tremor, stupor (reduced mental function), sensory disturbances, dizziness, marked weakness.
Other symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain radiating (angina pectoris).
If blood glucose continues to decrease, marked confusion (delirium), seizures, loss of consciousness, shallow breathing, and slow heartbeat may occur.
In most cases, symptoms of low blood glucose disappear quickly when the patient consumes some sugar, e.g., glucose tablets, sugar cubes, sweet juice, or sweetened tea. Therefore, it is important to always carry sugary products. Note that artificial sweeteners are ineffective.
Contact your doctor or nearest hospital if consuming sugar does not help or if symptoms recur.
Certain stressful conditions (e.g., trauma, surgery, fever, infection, etc.) may affect blood glucose levels. In such cases, your doctor may recommend insulin therapy.
High blood glucose (hyperglycemia) may occur if Diabrezide has not sufficiently lowered blood glucose, if the patient has not followed the treatment plan recommended by the doctor, or during particularly stressful situations mentioned above.
Symptoms of high blood glucose include:
thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced activity. If such symptoms occur, the patient must contact their doctor or pharmacist.
Do not take Diabrezide if the patient has a rare inherited intolerance to certain sugars (galactose), lactase deficiency (Lapp type), or glucose-galactose malabsorption syndrome.

Diabrezide with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The blood glucose-lowering effect of Diabrezide may be enhanced, and symptoms of low blood glucose may occur, when any of the following medicines are taken:

• other medicines used to treat high blood glucose (oral antidiabetic agents such as acarbose, biguanides, or insulin);
• medicines used to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril, enalapril);
• medicines used to treat fungal infections (miconazole, fluconazole);
• medicines used to treat stomach or duodenal ulcers (H--receptor blockers);
• medicines used to treat depression (MAO inhibitors);
• non-steroidal anti-inflammatory drugs – NSAIDs (used to relieve pain, e.g., ibuprofen);
• phenylbutazone (a potent anti-inflammatory drug used to treat, among others, ankylosing spondylitis and rheumatoid arthritis);
• sulfonamides (antibacterial agents used to treat infections);
• medicines containing alcohol.

The following medicines may weaken the effect of Diabrezide and cause increased blood glucose:

• medicines used to treat breast diseases, severe menstrual bleeding, and endometriosis (e.g., danazol);
• chlorpromazine (a psychotropic drug used, among others, in the treatment of schizophrenia);
• glucocorticosteroids (steroids used to treat, among others, rheumatic disease);
• ritodrine, salbutamol, terbutaline (drugs administered intravenously to treat asthma or during childbirth).

Diabrezide may enhance the effect of anticoagulant medicines (e.g., warfarin) – your doctor may decide to change the anticoagulant therapy.
If the patient is unsure whether they are taking any of the above-mentioned medicines, they should consult their doctor or pharmacist.

Diabrezide with food and drink
Diabrezide may be taken with food and non-alcoholic beverages.
Alcohol consumption is not recommended, as its effect may alter blood glucose levels unpredictably.
Patients treated with this medicine should follow the recommended diet.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.

• Diabrezide is not recommended during pregnancy.
• If the patient plans to become pregnant or is pregnant, she should inform her doctor, who may recommend appropriate treatment.
• Diabrezide must not be used during breastfeeding. It is not known whether the drug passes into human milk.

Driving and using machines
If blood glucose is too low (hypoglycemia) or too high (hyperglycemia), or if vision disturbances occur due to abnormal blood glucose levels, the ability to concentrate or reaction speed may be reduced. This may be dangerous when driving or operating machinery.
Discuss with your doctor recommendations to avoid low blood glucose while driving.

Diabrezide contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Diabrezide
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult your doctor or pharmacist.

Recommended dose
The dose is determined by the doctor, depending on blood and urine glucose levels.
Any changes in external factors (e.g., weight loss, lifestyle changes, stress) or improvement in glucose control may require adjustment of gliclazide dosage.

Adults:
The usual starting dose is half to one tablet daily (40 to 80 mg) taken before breakfast.
Do not take more than 4 tablets daily (320 mg per day).
The usual maintenance dose is 1 to 2 tablets (80 to 160 mg) divided into two doses (taken before breakfast and before dinner).

Elderly patients (over 65 years):
The usual starting dose is half a tablet (40 mg) before breakfast.
In consultation with the doctor, the dose may be increased by 40 mg (half a tablet) every 7 to 14 days.

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor. In case of doubt, consult your doctor or pharmacist.

Method of administration
Tablets should be swallowed whole, with water. The medicine should preferably be taken 30 minutes before a meal.
Always eat a meal after taking Diabrezide.
The tablet may be divided into equal doses.

Use in children
Diabrezide must not be used in children.

Taking more than the recommended dose of Diabrezide
If more than the recommended dose is taken, contact your doctor immediately or go to the nearest hospital.
Overdose may cause hypoglycemia (low blood glucose) – see section 2: Warnings and precautions.
In such cases, eating sugar (4 to 6 sugar cubes) or drinking a sweet drink, followed by a snack or meal, may help. If the patient is unconscious, emergency medical help must be called immediately and the doctor informed. The same applies if someone, e.g., a child, accidentally takes this medicine. Do not give food or drink to unconscious patients. A responsible person should always be nearby who can call for help in an emergency. Ensure such a person is available.

Missed dose of Diabrezide
It is important to take the medicine daily, as regular use provides the best results.
If a dose is missed, take the medicine as soon as possible. If it is almost time for the next dose, skip the missed dose. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping Diabrezide
Diabetes treatment usually lasts a lifetime. Consult your doctor before stopping this medicine.
Discontinuing treatment may lead to increased blood glucose (hyperglycemia).
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
The frequency of the possible adverse reactions listed below is defined as follows:

• very common: (affects more than 1 in 10 people);
• common: (affects 1 to 10 in 100 people);
• uncommon: (affects 1 to 10 in 1,000 people);
• rare: (affects 1 to 10 in 10,000 people);
• very rare: (affects fewer than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data).

The following adverse effects may occur:

• Metabolism and nutrition disorders: hypoglycaemia (symptoms of low blood sugar are described in section 2: Warnings and precautions). If hypoglycaemic symptoms are left untreated, they may progress to drowsiness, loss of consciousness or coma. If blood sugar levels are significantly or persistently reduced, even if symptoms are controlled by administering sugar, you should contact a doctor immediately ( occurs commonly ).
• Gastrointestinal disorders: abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation. These symptoms may be reduced by taking Diabrezide before a meal, as recommended ( occur uncommonly ).
• Hepatobiliary disorders: increased liver enzyme activity (AspAT, AlAT, alkaline phosphatase) or jaundice (yellowing of the skin and eyes). If symptoms of jaundice occur, you should contact a doctor immediately. Symptoms usually resolve after discontinuation of the medicine. Your doctor will decide whether treatment should be discontinued ( occur rarely ).
• Eye disorders: transient visual disturbances (especially at the beginning of treatment) caused by changes in blood glucose concentration ( occur rarely ).
• Skin and subcutaneous tissue disorders: rash (itchy, red lumps on the skin), pruritus and urticaria (pinkish, itchy wheals on the skin). Severe skin reactions may also occur, such as erythema (localised redness of the skin), maculopapular eruptions, or vesicular reactions ( occur rarely ). Angioedema (sudden swelling of tissues, e.g. eyelids, face, lips, oral cavity, tongue or throat, which may cause breathing difficulties) may also occur. Rash may lead to the formation of extensive blisters and skin peeling.
• Blood and lymphatic system disorders: decreased number of blood cells (e.g. platelets, red and white blood cells), which may cause pallor, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve after discontinuation of treatment ( occur rarely ).

When using sulfonylurea derivatives, other adverse reactions have been reported, such as: anaemia, agranulocytosis, haemolytic anaemia, pancytopenia (marked decrease in red and white blood cells), allergic vasculitis, liver damage (e.g. jaundice), and hepatitis. These symptoms usually resolved after discontinuation of sulfonylurea derivatives. In isolated cases, they led to life-threatening liver failure.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: (22) 49 21 301, fax: (22) 49 21 309. Website: https://smz.ezdrowie.gov.pl .

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Diabrezide

Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Diabrezide contains

• The active substance in Diabrezide is gliclazide. One tablet contains 80 mg of gliclazide.
  Other ingredients: microcrystalline cellulose, povidone, sodium carboxymethyl starch, magnesium stearate, and lactose monohydrate.

What Diabrezide looks like and contents of the pack
Diabrezide is a white, round tablet with a dividing groove. The break line facilitates splitting the tablet into equal doses.
Tablets are packed in blisters of 20 tablets. The package contains 40 tablets (2 blisters) in a cardboard box together with a patient leaflet.

Marketing Authorisation Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
Strada Statale 67, Località Granatieri
50018 Scandicci (Florence), Italy

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Molteni Farmaceutici Polska Sp. z o.o.
Józefa Korzeniowskiego 39
30-214 Kraków
Tel.: (12) 653 15 71 or 653 15 72