Diazidan

Leaflet accompanying the packaging: patient information

Diazidan, 80 mg, tablets

Gliclazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Diazidan and what is it used for

Diazidan contains the active substance gliclazide, which belongs to a group of medicines called sulfonylurea derivatives. It is an oral hypoglycemic medicine (reducing blood sugar levels).
Diazidan is used to maintain normal blood sugar levels in adults with non-insulin-dependent diabetes (type 2), in whom diet, physical exercise, and weight loss alone are not sufficient to maintain normal blood sugar levels.

2. Important information before taking Diazidan

When not to take Diazidan

• if the patient is allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), other medicines from the same group (sulfonylurea derivatives), other derivatives (sulfonamides with a hypoglycemic effect),
• if the patient has insulin-dependent diabetes (type 1),
• if the patient has ketone bodies and sugar in the urine (which may indicate diabetic ketoacidosis), pre-coma, or diabetic coma,
• if the patient has severe kidney or liver disease,
• if the patient is taking miconazole (a medicine used to treat fungal infections) (see section "Diazidan and other medicines"),
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to take Diazidan, the patient should discuss it with their doctor.
The patient should follow the doctor's recommendations for treatment to achieve proper blood sugar levels. This means that, in addition to taking the tablets regularly, the patient should follow a diet, exercise, and, if necessary, lose weight.
During treatment with gliclazide, it is necessary to regularly check blood sugar levels (and, if possible, urine) and hemoglobin A1c levels.
The risk of low blood sugar (hypoglycemia) may be increased during the first few weeks of treatment. Therefore, 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,
• the patient increases physical activity, and carbohydrate intake is not sufficient,
• the patient consumes alcohol, especially if they skip meals,
• the patient takes other medicines or natural products at the same time,
• the patient takes too high a dose of gliclazide,
• the patient has specific hormonal disorders (thyroid, pituitary, or adrenal disorders),
• kidney or liver function is severely impaired.

If the patient has low blood sugar, the following symptoms may occur:
headache, strong hunger, nausea, vomiting, fatigue, sleep disturbances, anxiety, aggression,
impaired concentration, reduced alertness and reaction time, depression, disorientation, speech or vision disorders, tremors, sensory disturbances, dizziness, weakness.
The following symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain that may radiate to adjacent parts of the body (angina pectoris).
If blood sugar levels continue to decrease, significant 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 sugar in some form, e.g., glucose tablets, sugar cubes, or a sweet drink. Therefore, the patient should always carry some form of sugar with them (e.g., glucose tablets, sugar cubes). The patient should remember that artificial sweeteners are not effective.
The patient should contact their doctor or the nearest hospital if consuming sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may not occur, may be weakly marked, or may develop very slowly, or the patient may not be aware that their blood sugar levels have decreased. This can happen when the patient is elderly and taking certain medicines (e.g., those acting on the central nervous system and beta-adrenergic blockers).
In stressful situations (accidents, surgical operations, fever, etc.), the doctor may temporarily change the treatment to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur if gliclazide does not sufficiently reduce blood sugar levels, if the patient does not follow the treatment plan recommended by the doctor, if the patient takes products containing St. John's wort (Hypericum perforatum) (see section "Diazidan and other medicines"), or in particularly stressful situations. They may include thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and reduced activity.
If these symptoms occur, the patient must contact their doctor or pharmacist.
While taking Diazidan, the patient should:

• maintain a regular diet: it is essential to eat regular meals, including breakfast, and never skip or delay a meal,
• take the medicine regularly (see section "How to take Diazidan"),
• regularly check their blood sugar levels, as recommended by their doctor.

When taking Diazidan with medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar) may occur: concomitant use with caution.
Diazidan may enhance the effect of anticoagulant medicines (warfarin): concomitant use after considering the risk.
The patient should consult their doctor before starting to take another medicine. If the patient is going to the hospital, they should inform the medical staff that they are taking Diazidan.

Diazidan with food, drink, and alcohol

Diazidan can be taken with food and non-alcoholic beverages.
It is not recommended to consume alcohol, as it may change diabetes control in an unpredictable way.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Diazidan is not recommended during pregnancy.
Diazidan should not be taken during breastfeeding.

Driving and using machines

If blood sugar levels are properly controlled during Diazidan treatment, the ability to drive and use machines should not be impaired. However, if blood sugar levels are too low, the ability to concentrate may be impaired, and thus the ability to drive and use machines.
The patient should ask their doctor about the possibility of driving:

• if they frequently experience low blood sugar (hypoglycemia);
• if they have few or no warning symptoms of low blood sugar (hypoglycemia).

Diazidan contains lactose monohydrate and sodium.

If the patient has previously been diagnosed with intolerance to certain sugars (e.g., glucose, lactose, galactose), they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Diazidan

This medicine should always be taken exactly as the doctor or pharmacist has told the patient.
In case of doubt, the patient should consult their doctor or pharmacist.
Any changes related to external factors (weight loss, lifestyle changes, stress) or improvement in blood sugar control may require a change in gliclazide doses.

Dose

The recommended daily dose is from half to four tablets. The dose depends on the body's response to treatment and is determined by the doctor. If the total daily dose exceeds two tablets, it should be divided into two equal doses taken in the morning and evening.
Diazidan is intended for oral use. The tablet(s) should be swallowed with a glass of water (preferably at the same time every day). The tablets should be swallowed whole. They should not be chewed.
The patient should always eat a meal after taking the tablet(s).
In combination therapy with Diazidan and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, the appropriate dose of each medicine will be individually determined by the doctor.
If the patient notices that their blood sugar levels are high, even though they are taking the medicine as prescribed, they should consult their doctor or pharmacist.

Taking a higher dose of Diazidan than recommended

In case of taking too many tablets, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital.
The symptoms of overdose are the symptoms of low blood sugar (hypoglycemia) and are described in section 2.
In such situations, eating sugar (4 to 6 sugar cubes) or drinking a sweet drink, followed by eating a snack or a meal, may help. If the patient is unconscious, they should immediately inform their doctor and call for emergency assistance.

Missing a dose of Diazidan

It is essential to take the medicine every day, as regularly taken medicine works better. However, if the patient forgets to take a dose of Diazidan, they should take the next dose at the usual time.
The patient should not take a double dose to make up for the missed dose.

Stopping Diazidan treatment

Since diabetes treatment usually lasts a lifetime, the patient should consult their doctor before stopping this medicine. Stopping treatment may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Diazidan can cause side effects, although not everybody gets them.

Frequent side effects (may affect up to 1 in 10 people):

• low blood sugar (hypoglycemia). The most commonly observed side effect is low blood sugar (hypoglycemia). The objective and subjective symptoms are described in the section "Warnings and precautions". If these symptoms are left untreated, they may progress to drowsiness, loss of consciousness, or coma. If the decrease in blood sugar is significant or prolonged, even if it is temporarily controlled by administering sugar, the patient should immediately consult their doctor.

Uncommon side effects (may affect up to 1 in 100 people):

• gastrointestinal disorders: abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These symptoms can be reduced by taking Diazidan with food, as recommended.

Rare side effects (may affect up to 1 in 1000 people):

• blood 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 stopping treatment;
• eye disorders: transient vision disturbances may occur, especially at the beginning of treatment. This is due to changes in blood sugar levels.
• liver disorders: isolated cases of liver function disorders have been observed, which may cause yellowing of the skin and eyes. If these symptoms occur, the patient should immediately contact their doctor. The symptoms usually disappear after stopping the medicine. The doctor will decide whether to stop treatment.
• skin disorders: skin reactions such as rash, redness, itching, urticaria, angioedema (sudden swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat, which may cause breathing difficulties), have been observed. The rash may develop into widespread blistering or lead to skin peeling. Exceptionally, symptoms of severe hypersensitivity reactions (DRESS, Drug Rash with Eosinophilia and Systemic Symptoms) have been reported: initially with flu-like symptoms and a rash on the face, which then spread with a high temperature.

As with other sulfonylurea derivatives, the following adverse events have been observed:
cases of significant changes in blood cell count and allergic vasculitis, decreased sodium levels in the blood (hyponatremia), symptoms of liver damage (e.g., jaundice), which in most cases disappeared after stopping sulfonylurea derivatives, but in isolated cases may lead to life-threatening liver failure.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 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, more information can be collected on the safety of the medicine.

5. How to store Diazidan

Store in a temperature below 25°C. Store in the original packaging.
Store out of sight and reach of children.
Do not use Diazidan after the expiry date stated on the label.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Diazidan contains

The active substance of Diazidan is gliclazide. Each tablet contains 80 mg of gliclazide.
The other ingredients are: lactose monohydrate, microcrystalline cellulose (E 460), povidone, sodium carboxymethylcellulose (type A), magnesium stearate (E 572).

What Diazidan looks like and contents of the pack

The tablets are white or slightly creamy, round, flat on both sides, with a beveled edge, and a dividing line on one side. The tablet can be divided into equal doses.
Diazidan tablets are packaged in aluminum/PVC blisters. Each blister contains 20 tablets.
A cardboard box contains 60 tablets, along with the patient information leaflet.

Marketing authorization holder:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-105 Rzeszów
Date of last revision of the leaflet:May 2025