DIABREZIDE 80 mg Tablets

Contents of the leaflet

1. What is Diabrezide and what is it used for
   1. Indications for use:
2. Important information before taking Diabrezide
   1. When not to take Diabrezide
   2. Warnings and precautions
   3. Low blood sugar (hypoglycemia) may occur if:
   4. High blood sugar (hyperglycemia) may occur if:
   5. Symptoms of high blood sugar are:
   6. Diabrezide and other medicines
   7. Diabrezide with food and drink
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Diabrezide contains lactose
3. How to take Diabrezide
   1. Recommended dose
   2. Method of administration
   3. Use in children
   4. Taking a higher dose of Diabrezide than recommended
   5. Missing a dose of Diabrezide
   6. Stopping Diabrezide treatment
4. Possible side effects
   1. Reporting side effects
5. How to store Diabrezide
6. Contents of the packaging and other information
   1. What Diabrezide contains
   2. What Diabrezide looks like and what the pack contains
   3. Marketing authorization holder and manufacturer

1. What is Diabrezide and what is it used for

Diabrezide is an oral anti-diabetic medicine that reduces blood sugar levels.
It contains the active substance gliclazide, which belongs to the group of sulfonylurea derivatives.

Indications for use:

• Treatment of type 2 diabetes (not requiring insulin therapy) in adults, when diet, physical exercise, and weight loss are not sufficient to maintain normal blood sugar levels.

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 has a pre-coma or diabetic coma.
• If the patient has ketoacidosis (diabetic ketoacidosis) - an accumulation of excessive amounts of acidic substances in the blood.
• If the patient has severe kidney or liver failure (in these cases, insulin is recommended).
• If the patient is taking medicines used to treat fungal infections (miconazole, see section: Diabrezide and other medicines).
• If the patient is pregnant or breastfeeding (see section: Pregnancy, breastfeeding, and fertility).
• In children, due to the lack of data.

Warnings and precautions

Before starting to take Diabrezide, you should discuss it with your doctor or pharmacist.
To achieve proper blood sugar levels, you should follow your doctor's recommendations for treatment.
This means that, in addition to taking the tablets regularly, you should follow a diet, exercise, and, if necessary, lose weight.
During treatment with this medicine, it is necessary to regularly check blood sugar levels (and possibly in urine) and measure glycated hemoglobin (HbA1c).
The risk of low blood sugar (hypoglycemia) may increase during the first weeks of treatment.
Therefore, particularly close medical monitoring is necessary.

Low blood sugar (hypoglycemia) may occur if:

• the patient eats irregularly or skips meals;
• the patient fasts;
• the patient is undernourished;
• the patient changes their diet;
• there are prolonged nausea and vomiting;
• the patient increases physical activity, and carbohydrate intake is not sufficient;
• the patient drinks alcohol;
• the patient takes too high a dose of Diabrezide;
• the patient has specific hormonal disorders (thyroid, pituitary, or adrenal disorders);
• kidney or liver function is severely impaired;
• the patient is taking other medicines that lower blood sugar levels.

If the patient has low blood sugar, the following symptoms may occur:
headache, strong hunger, nausea, vomiting, fatigue, drowsiness, sleep disorders, anxiety,
aggression, impaired concentration, reduced alertness and reaction time, depression, feeling of confusion
and disorientation (disorders of time, place, situation, or self-orientation), speech and vision disorders, tremors, dementia (reduced mental fitness), sensory disorders, dizziness,
and significant weakness.
Other symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain that may radiate (angina pectoris).
If blood sugar levels continue to decrease, severe confusion (delirium), convulsions, loss of self-control, shallow breathing, slow heartbeat, or loss of consciousness may occur.
In most cases, the symptoms of low blood sugar disappear very quickly when the patient consumes some sugar, e.g., glucose tablets, sugar cubes, or a sweet drink.
Therefore, you should always carry sugar-containing products with you.
It should be remembered that artificial sweeteners are not effective.
You should contact a doctor or the nearest hospital if consuming sugar does not help or if the symptoms recur.
Certain stressful situations (e.g., injury, surgery, fever, infection, etc.) may affect blood sugar levels.
In such cases, the doctor may recommend insulin.

High blood sugar (hyperglycemia) may occur if:

Diabrezide has not yet sufficiently reduced blood sugar levels, if the patient does not follow the treatment plan recommended by the doctor, or in special stressful situations mentioned above.

Symptoms of high blood sugar are:

thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and reduced activity.
If such symptoms occur, the patient must contact a doctor or pharmacist.
Diabrezide should not be taken if the patient has a rare hereditary intolerance to certain sugars (galactose), lactase deficiency (Lapp lactase deficiency), or glucose-galactose malabsorption syndrome).

Diabrezide and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The blood sugar-lowering effect of Diabrezide may be enhanced, and symptoms of low blood sugar may occur when any of the following medicines are taken:

• other medicines used to treat high blood sugar (oral anti-diabetic medicines, such as acarbose, biguanides, or insulin);
• medicines used to treat high blood pressure or heart failure (beta-adrenergic blockers, ACE inhibitors, such as captopril, enalapril);
• medicines used to treat fungal infections (miconazole, fluconazole);
• medicines used to treat stomach or duodenal ulcers (H2 receptor blockers);
• medicines used to treat depression (MAO inhibitors);
• non-steroidal anti-inflammatory drugs (NSAIDs) - used to relieve pain, e.g., ibuprofen;
• phenylbutazone (a medicine with a very strong anti-inflammatory effect, used to treat, among others, ankylosing spondylitis and rheumatoid arthritis);
• sulfonamides (medicines used to treat bacterial infections);
• medicines containing alcohol.

The following medicines may weaken the effect of Diabrezideand cause high blood sugar:

• medicines used to treat breast diseases, heavy menstrual bleeding, and endometriosis (e.g., danazol);
• chlorpromazine (a psychotropic medicine used, among others, to treat schizophrenia);
• glucocorticosteroids (also known as steroids, used to treat, among others, rheumatic disease);
• ritodrine, salbutamol, terbutaline (medicines administered intravenously to treat asthma or during childbirth).

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

Diabrezide with food and drink

Diabrezide can be taken with food and non-alcoholic beverages.
It is not recommended to drink alcohol, as its effect may change blood sugar levels in an unpredictable way.
People treated with this medicine should follow the recommended diet.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

• Diabrezide should not be used during pregnancy.
• If the patient plans to become pregnant or is pregnant, they should inform their doctor, who may recommend appropriate treatment.
• Diabrezide should not be used during breastfeeding. It is not known whether the medicine passes into breast milk.

Driving and using machines

If blood glucose levels are too low (hypoglycemia) or too high (hyperglycemia), or if vision disorders occur as a result of abnormal blood sugar levels, the ability to concentrate or react quickly may be reduced.
This can be dangerous while driving or operating machines.
You should discuss with your doctor the recommendations that will allow you to avoid hypoglycemia while driving.

Diabrezide contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.

3. How to take Diabrezide

This medicine should always be taken exactly as directed by your doctor.
If you have any doubts, you should consult your doctor or pharmacist.

Recommended dose

The dose is determined by the doctor, depending on blood sugar levels and urine tests.
Any changes related to external factors (e.g., weight loss, lifestyle changes, stress) or improved blood sugar control may require a change in gliclazide doses.
Adults:
the usual initial dose is half to 1 tablet per day (40 to 80 mg) before breakfast.
Do not take more than 4 tablets per day (320 mg per day).
The maintenance dose is usually 1 to 2 tablets (80 to 160 mg) in two divided doses (taken before breakfast and before dinner).
Elderly patients (over 65 years):
the usual initial dose is half a tablet (40 mg) before breakfast.
In agreement with the doctor, the dose can 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 information leaflet or as directed by your doctor.
If you have any doubts, you should consult your doctor or pharmacist.

Method of administration

Tablets should be swallowed without chewing, with a glass of water.
The medicine should be taken preferably 30 minutes before a meal.
You should always eat a meal after taking Diabrezide.
The tablet can be divided into equal doses.

Use in children

Diabrezide should not be used in children.

Taking a higher dose of Diabrezide than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately contact your doctor or go to the nearest hospital.
Overdose of the medicine may cause hypoglycemia (low blood sugar) - see section 2: Warnings and precautions.
In such situations, 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, you should immediately call for emergency assistance and inform the doctor.
Similarly, if someone, e.g., a child, has taken this medicine by mistake.
Unconscious patients should not be given food or drink.
It is necessary to ensure that there is an informed person around the patient who can call for help in case of an emergency.

Missing a dose of Diabrezide

It is important to take the medicine every day, as regular use gives the best effects.
In case of missing a dose, you should take the medicine as soon as possible.
If it is almost time for the next dose, you should skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Diabrezide treatment

Diabetes treatment usually lasts for the rest of your life.
You should consult your doctor before stopping this treatment.
Stopping treatment may cause high blood sugar (hyperglycemia).
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diabrezide can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as follows:

• very common: (occurring in more than 1 in 10 people);
• common: (occurring in 1 to 10 people in 100);
• uncommon: (occurring in 1 to 10 people in 1,000);
• rare: (occurring in 1 to 10 people in 10,000);
• very rare: (occurring in less than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data). The following side effects may occur:
• Metabolic and nutritional disorders: hypoglycemia(symptoms of low blood sugar are described in section 2: Warnings and precautions). If hypoglycemia symptoms are left untreated, they may lead to drowsiness, loss of consciousness, or coma.
  If blood sugar levels are significantly or persistently reduced, even if the symptoms have been controlled by administering sugar, you should immediately consult a doctor (common).
• Gastrointestinal disorders: abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation.
  These symptoms can be reduced by taking Diabrezide before a meal, as recommended (uncommon).
• Hepatobiliary disorders(increased activity of liver enzymes AST, ALT, alkaline phosphatase) or jaundice (yellowing of the skin and eyes).
  If symptoms of jaundice occur, you should immediately contact your doctor.
  Symptoms usually disappear after discontinuation of the medicine.
  The doctor will decide whether to discontinue treatment (rare).
• Eye disorders:transient vision disorders (especially at the beginning of treatment) caused by changes in blood sugar levels (rare).
• Skin and subcutaneous tissue disorders:rash (itchy, red bumps on the skin), itching, and urticaria (pink, itchy blisters on the skin).
  Severe skin reactions, such as erythema (local skin redness), maculopapular rash, or bullous reactions, may also occur (rare).
  Angioedema (sudden, severe swelling of tissues, e.g., eyelids, face, lips, mouth, tongue, or throat, which may cause breathing difficulties) may also occur.
• Blood and lymphatic system disorders:decreased blood cell count (e.g., platelets, red and white blood cells), which may cause pallor, prolonged bleeding, bruising, sore throat, and fever.
  These symptoms usually disappear after discontinuation of the medicine (rare).

In the case of sulfonylurea derivatives, other side effects have been reported, such as anemia, agranulocytosis, hemolytic anemia, pancytopenia (significant reduction in the number of red and white blood cells), allergic vasculitis, liver damage (e.g., jaundice), and hepatitis.
These symptoms usually disappeared after discontinuation of sulfonylurea derivatives.
In individual cases, they led to life-threatening liver failure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49 21 301, fax (22) 49 21 309.
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diabrezide

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the carton after the words: Expiry date (EXP).
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste.
You should ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the packaging and other information

What Diabrezide contains

• The active substance of the medicine is gliclazide.
  1 tablet contains 80 mg of gliclazide.
  The other ingredients are: microcrystalline cellulose, povidone, sodium carboxymethylcellulose, magnesium stearate, and lactose monohydrate.

What Diabrezide looks like and what the pack contains

Diabrezide is a white, round tablet with a dividing line.
The dividing line makes it easier to divide the tablet into equal doses.
The tablets are packaged in blisters of 20 tablets.
The packaging contains 40 tablets (2 blisters) placed in a cardboard box with a patient information leaflet.

Marketing authorization 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 more detailed information on this medicine, you should contact the representative of the marketing authorization holder:
Molteni Farmaceutici Polska Sp. z o.o.
ul. Józefa Korzeniowskiego 39
30-214 Kraków
Phone: (12) 653 15 71 or 653 15 72
Date of last revision of the leaflet:04/2022