Diazidan

Package leaflet: Information for the patient

Diazidan, 80 mg, tablets
Gliclazide
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Diazidan is and what it is 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 pack and other information

1. What Diazidan is and what it is used for

Diazidan contains the active substance gliclazide, which belongs to a group of medicines called
sulfonylurea derivatives. It is an oral antidiabetic agent (a medicine that lowers blood glucose levels).
Diazidan is used to maintain normal blood glucose levels in adults with non-insulin-dependent
diabetes mellitus (type 2 diabetes), in whom diet, physical exercise, and weight reduction alone are
insufficient to maintain adequate blood glucose control.

2. Information before using Diazidan

When not to use Diazidan

• if the patient is allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), other medicines of the same group (sulfonylurea derivatives), or other sulfonamides with blood glucose-lowering action,
• if the patient has insulin-dependent diabetes (type 1),
• if ketones and glucose are present in the urine (this 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 with other medicines"),
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Diazidan, discuss it with your doctor.
You must follow your doctor's advice regarding treatment to achieve proper blood glucose levels. This means that in addition to taking the tablets regularly, you should follow a diet, exercise, and, if necessary, lose weight.
During treatment with gliclazide, regular monitoring of blood glucose (and, if possible, urine glucose) is necessary, as well as measurement of glycated hemoglobin (HbA1c).
The risk of low blood glucose (hypoglycemia) may be increased during the first few 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 malnourished,
• the patient changes their diet,
• the patient increases physical activity without sufficient carbohydrate intake,
• the patient consumes alcohol, especially if meals are skipped,
• the patient takes other medicines or natural supplements at the same time,
• the patient takes too high a dose of gliclazide,
• the patient has specific hormonal disorders (thyroid, pituitary gland, or adrenal cortex dysfunction),
• kidney or liver function is severely impaired.

If the patient has low blood glucose, the following symptoms may occur:
headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression,
reduced concentration, decreased alertness and reaction time, depression, disorientation, speech or
visual disturbances, trembling, sensory disturbances, dizziness, weakness.
Other symptoms may also occur: sweating, clammy skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain radiating to adjacent body parts (angina pectoris).
If blood glucose continues to fall, significant confusion (delirium), seizures, loss of consciousness, shallow breathing, slow heartbeat, or even loss of consciousness may occur.
In most cases, symptoms of low blood glucose resolve quickly when the patient consumes sugar in any form, e.g. glucose tablets, sugar cubes, sweetened juice, or sweetened tea. Therefore, it is important to always carry a source of sugar (e.g. glucose tablets, sugar cubes). Note that artificial sweeteners are ineffective.
Contact your doctor or nearest hospital if consuming sugar does not help or if symptoms recur.
Symptoms of low blood glucose may not occur, may be mild or develop slowly, or the patient may not be aware that blood glucose has dropped. This may happen if the patient is elderly or taking certain medicines (e.g. those acting on the central nervous system or beta-blockers).
In stressful situations (accidents, surgery, fever, etc.), your doctor may temporarily switch treatment to insulin therapy.
Symptoms of high blood glucose (hyperglycemia) may occur if gliclazide has not sufficiently lowered blood glucose, if the patient has not followed the treatment plan recommended by the doctor, if the patient is taking preparations containing St. John's wort ( Hypericum perforatum ) (see section "Diazidan with other medicines"), or during particularly stressful situations. These 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 regular eating habits: it is important to eat regular meals, including breakfast, and never skip or delay meals,
• take the medicine regularly (see section "How to take Diazidan"),
• regularly check blood glucose levels as advised by the doctor.

When gliclazide is taken simultaneously with antibiotics belonging to the group called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood glucose) may occur. In this case, the doctor will remind the patient how important it is to monitor blood glucose levels.
If a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells) has been diagnosed in the patient or in a family member, consult your doctor before taking this medicine.

Children and adolescents
Diazidan should not be used in children and adolescents.

Diazidan with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
The blood glucose-lowering effect of gliclazide 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 medicines, GLP-1 receptor agonists, or insulin): concomitant use with caution ;
• antibiotics (sulfonamides, clarithromycin): concomitant use with caution ;
• medicines used to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril): concomitant use with caution ;
• medicines used to treat fungal infections (miconazole): concomitant use contraindicated ; (fluconazole): concomitant use with caution ;
• medicines used to treat stomach or duodenal ulcers (H2-receptor blockers): concomitant use with caution ;
• medicines used to treat depression (MAO inhibitors): concomitant use with caution ;
• painkillers or anti-rheumatic medicines (phenylbutazone): concomitant use not recommended ; (ibuprofen): concomitant use with caution ;
• medicines containing alcohol: concomitant use not recommended .

The following medicines may reduce the effect of gliclazide and cause increased blood glucose:

• medicines used to treat central nervous system disorders (chlorpromazine): concomitant use with caution ;
• anti-inflammatory medicines (corticosteroids): concomitant use with caution ;
• medicines used to treat asthma or administered during childbirth (intravenous salbutamol, ritodrine, terbutaline): concomitant use with caution ;
• medicines used to treat breast disorders, severe menstrual bleeding, and endometriosis (danazol): concomitant use not recommended ;
• preparations containing St. John's wort (Hypericum perforatum) : concomitant use with caution .

When Diazidan is taken simultaneously with antibiotics belonging to the group called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood glucose) may occur: concomitant use with caution .
Diazidan may enhance the effect of anticoagulant medicines (warfarin): concomitant use after risk assessment .
Consult your doctor before starting any other medicine. If you go to hospital, inform the medical staff that you are taking Diazidan.

Diazidan with food, drink, and alcohol
Diazidan may be taken with food and non-alcoholic drinks.
Alcohol consumption is not recommended, as it may alter diabetes control in an unpredictable way.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Use of Diazidan during pregnancy is not recommended.
Diazidan must not be used during breastfeeding.

Driving and operating machinery
If blood glucose is well controlled during treatment with Diazidan, the ability to drive and operate machinery should not be impaired. However, if blood glucose is too low, concentration may be impaired, and thus also the ability to drive and operate machinery.
Ask your doctor about the possibility of driving:

• if low blood glucose (hypoglycemia) occurs frequently,
• if there are few or no warning symptoms of low blood glucose (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 consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Diazidan

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Any changes related to external factors (reduced body weight, changes in lifestyle,
stress) or improved blood glucose control may require adjustment of gliclazide doses.
Dosage
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 taken with a glass of water
(preferably at the same time each day). Tablets must be swallowed whole. Do not chew them.
Always eat a meal after taking the tablet(s).
In combination therapy with Diazidan and metformin, an alpha-glucosidase inhibitor,
thiazolidinedione, dipeptidyl peptidase-IV inhibitor, GLP-1 receptor agonist, or insulin,
the appropriate dose of each medicine will be individually determined by the doctor.
If the patient notices high blood glucose levels despite taking the medicine as prescribed,
they should consult their doctor or pharmacist.
Taking more Diazidan than recommended
If too many tablets have been taken, contact your doctor immediately or go to the emergency department of the nearest hospital.
Symptoms of overdose are those of low blood glucose (hypoglycaemia), as described in section 2.
In such situations, eating sugar (4 to 6 sugar cubes) or drinking a sweet beverage, followed by a substantial snack or meal, may help.
If the patient is unconscious, seek immediate medical assistance and call an ambulance.
Missing a dose of Diazidan
It is important to take the medicine every day, as regular use ensures better effectiveness. However,
if a dose of Diazidan is missed, the next dose should be taken at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Diazidan
Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping this medicine.
Discontinuing treatment may lead to increased blood glucose (hyperglycaemia), increasing the risk of diabetes complications.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common adverse effects (may affect up to 1 in 10 people):

• low blood sugar (hypoglycaemia). The most commonly observed adverse effect is low blood sugar (hypoglycaemia). 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 reduction in blood sugar is significant or prolonged, even if temporarily controlled by sugar intake, you should contact your doctor immediately.

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

• gastrointestinal disturbances: abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation. These symptoms may be reduced by taking Diazidan with food, as recommended.

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

• blood 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;
• eye disorders: transient visual disturbances may occur, especially at the beginning of treatment. These are due to changes in blood glucose concentration;
• liver disorders: isolated cases of impaired liver function have been observed, which may cause jaundice (yellowing of the skin and eyes). If these symptoms occur, contact your doctor immediately. Symptoms usually resolve after discontinuation of the medicine. Your doctor will decide whether treatment should be discontinued;
• skin disorders: skin reactions such as rash, redness, itching, urticaria, and 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 progress to extensive blistering lesions or lead to skin peeling. Rarely, symptoms of severe hypersensitivity reactions (DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms) have been reported: initially presenting as influenza-like symptoms and facial rash, which then spreads with the development of high fever.

As with other sulphonylurea derivatives, the following adverse events have been observed:
cases of significant changes in blood cell counts and allergic vasculitis, decreased sodium concentration in the blood (hyponatraemia), symptoms of liver damage (e.g. jaundice), which in most cases resolved after discontinuation of sulphonylurea derivatives; however, in isolated cases, they may lead to life-threatening liver failure.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl

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

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

5. How to store Diazidan

Store below 25°C. Keep in the original packaging.
Store in a place 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diazidan contains
The active substance is glyclopyramide. Each tablet contains 80 mg of glyclopyramide.
Other ingredients are: monohydrate lactose, microcrystalline cellulose (E 460), povidone,
sodium carboxymethyl starch (type A), magnesium stearate (E 572).
What Diazidan looks like and contents of the pack
White or slightly cream-coloured, round, biconvex tablets with bevelled edges and a division line on one side.
The tablet can be divided into equal doses.
Diazidan tablets are packed in blisters made of Aluminium/PVC foil. Each blister contains 20 tablets.
The cardboard box contains 60 tablets together with the package leaflet.
Marketing Authorisation Holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów
Poland