Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
DIAPREL MR (DIAMICRON)
60 mg, modified-release tablets
Gliclazidum
DIAPREL MR and DIAMICRON are different trade names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, 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:

What Diaprel MR, modified-release tablet is and what it is used for
Important information before taking Diaprel MR, modified-release tablet
How to take Diaprel MR, modified-release tablet
Possible side effects
How to store Diaprel MR, modified-release tablet
Contents of the pack and other information

1. What Diaprel MR, modified-release tablet is and what it is used for

Diaprel MR, modified-release tablet is a medicine that lowers blood glucose levels (contains an oral antidiabetic agent belonging to the sulfonylurea derivatives group).
Diaprel MR, modified-release tablet is used in the treatment of a certain type of diabetes (type 2 diabetes) in adults, when diet alone, physical exercise, and weight reduction are insufficient to maintain normal blood glucose levels.

2. Important information before using Diaprel MR, modified-release tablet

When not to use Diaprel MR, modified-release tablet:

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 sulfonamide derivatives with blood glucose-lowering activity;
if the patient has insulin-dependent diabetes (type 1 diabetes);
if ketone bodies and sugar are present in the urine (this may indicate diabetic ketoacidosis), pre-comatose or comatose states;
if the patient has severe kidney or liver disease;
if the patient is taking medicines used to treat fungal infections (miconazole, see section "Diaprel MR, modified-release tablet and other medicines");
if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Diaprel MR, modified-release tablet, discuss this 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 proper diet, engage in physical exercise, and, if necessary, reduce body weight.
During treatment with gliclazide, regular monitoring of blood glucose levels (and, if necessary, urine glucose) and measurement of glycated hemoglobin (HbA1c) are required.
The risk of low blood glucose (hypoglycemia) may be increased during the first weeks of treatment. Therefore, particularly close medical supervision is essential.
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;
the patient increases physical activity without adequate carbohydrate intake;
the patient consumes alcohol, especially when skipping meals;
the patient is taking other medicines or natural supplements at the same time;
the patient takes too high a dose of gliclazide;
the patient has certain hormonal disorders (thyroid, pituitary, 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, anxiety, aggression,
reduced concentration, decreased alertness and reaction time, depression, disorientation, speech or vision disturbances, trembling, sensory disturbances, dizziness, weakness.
Additional symptoms may include: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain radiating to other areas (angina pectoris).
If blood glucose continues to drop, severe confusion (delirium), seizures, loss of self-control, shallow breathing, slow heartbeat, or loss of consciousness may occur.
In most cases, symptoms of low blood glucose disappear quickly when the patient consumes sugar, e.g. glucose tablets, sugar cubes, sweetened fruit juice, or sweetened tea.
Therefore, always carry some sugar-containing products (glucose tablets, sugar cubes) with you. Remember that artificial sweeteners are ineffective. Contact your doctor or nearest hospital if sugar intake does not help or if symptoms recur.
Symptoms of low blood glucose may not appear, may be mild or develop slowly, or the patient may not be aware that blood glucose has dropped. This may occur in elderly patients or those taking certain medications (e.g. central nervous system agents 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 yet 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 "Diaprel MR, modified-release tablet and other medicines"), or during particularly stressful situations. Symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced activity.
If these symptoms occur, the patient must contact their doctor or pharmacist.
When gliclazide is used concomitantly with antibiotics known as fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (both low and high blood glucose) may occur. In such cases, the doctor will remind the patient of the importance of monitoring blood glucose levels.
If a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells) has been diagnosed in the patient or a family member, hemoglobin levels may decrease and red blood cells may break down (hemolytic anemia). Before taking this medicine, consult your doctor.
In patients with porphyria (a hereditary genetic disorder involving accumulation of porphyrins or their precursors in the body), cases of porphyria exacerbation have been reported after using certain other sulfonylurea derivatives.
Diaprel MR, modified-release tablet is not recommended for use in children due to lack of data.

Diaprel MR, modified-release tablet and other medicines
Inform your doctor or pharmacist about all medicines currently 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 hypoglycemia may occur, when one of the following medicines is taken:

other medicines used to treat high blood glucose (oral antidiabetic drugs, GLP-1 receptor agonists, or insulin);
antibiotics (sulfonamides, clarithromycin);
medicines used to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or 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);
painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen);
medicines containing alcohol.

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

medicines used to treat central nervous system disorders (chlorpromazine);
anti-inflammatory drugs (corticosteroids);
medicines used to treat asthma or administered during childbirth (intravenous salbutamol, ritodrine, terbutaline);
medicines used to treat breast diseases, severe menstrual bleeding, and endometriosis (danazol);
preparations containing St. John's wort (Hypericum perforatum).

When Diaprel MR is used concomitantly with antibiotics known as fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (both low and high blood glucose) may occur.
Diaprel MR, modified-release tablet may enhance the effect of anticoagulant medicines (warfarin).
Consult your doctor before starting any new medicine.
If the patient is admitted to hospital, they should inform medical staff that they are taking Diaprel MR, modified-release tablet.

Diaprel MR, modified-release tablet with food, drink, and alcohol
Diaprel MR, modified-release tablet can be taken with food and non-alcoholic beverages.
Drinking alcohol is not recommended, as it may unpredictably affect diabetes control.

Pregnancy and breastfeeding
Diaprel MR, modified-release tablet is not recommended during pregnancy.
If the patient is pregnant, suspects she may be pregnant, or is planning a pregnancy, she should consult her doctor before using this medicine.
Diaprel MR, modified-release tablet must not be used during breastfeeding.

Driving and operating machinery
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 react may be impaired. Remember that the patient may pose a risk to themselves or others (e.g. when driving a car or operating machinery).
Ask your doctor whether you are allowed to drive:

if hypoglycemia occurs frequently;
if symptoms of hypoglycemia are very mild or absent.

Diaprel MR, modified-release tablet contains monohydrate 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 use Diaprel MR, modified-release tablet

Dosage
This medicine should always be used exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The dosage is determined by the doctor, depending on blood and urine glucose levels.
Any changes related to external factors (weight loss, change in lifestyle, stress) or improved control of blood glucose levels may require adjustment of gliclazide dosage.
The recommended daily dose ranges from half a tablet to two tablets (maximum 120 mg), taken once daily with breakfast. The dose depends on the body's response to treatment.
The tablet may be divided into halves.
Diaprel MR, modified-release tablet, is intended for oral administration.
The tablet(s) should be taken with a glass of water at breakfast time (preferably at the same time every day). Swallow half or the whole tablet whole, without chewing or crushing. Always eat a meal after taking the tablet(s).
In combination therapy with Diaprel MR, modified-release tablet and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, the appropriate dosage of each medicine will be individually determined by the doctor.
If the patient notices high blood glucose levels despite taking the medicine as prescribed, the patient should consult their doctor or pharmacist.

Taking more than the recommended dose of Diaprel MR, modified-release tablet
In case of overdose, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose are those of low blood glucose (hypoglycaemia), as described in section 2. In such cases, consuming sugar (4 to 6 sugar cubes) or drinking a sweet beverage, followed by a snack or meal, may help. If the patient is unconscious, contact the doctor immediately and call emergency services. The same action should be taken if someone (e.g. a child) accidentally ingests this medicine. Do not give food or drink to unconscious patients.
Ensure that someone close to you is always informed and able to contact a doctor in case of an emergency.

Missing a dose of Diaprel MR, modified-release tablet
It is important to take the medicine every day, as regular use ensures better effectiveness.
However, if the patient forgets to take a dose of Diaprel MR, modified-release tablet, the next dose should be taken at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Diaprel MR, modified-release tablet
Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping this medicine.
Discontinuing treatment may lead to increased blood glucose levels (hyperglycaemia), increasing the risk of diabetes-related complications.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most commonly observed adverse effect is low blood sugar (hypoglycaemia).
Subjective and objective 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 hypoglycaemia is significant or prolonged, even if temporarily controlled by sugar intake, contact a doctor immediately.

Liver disorders
Isolated cases of impaired liver function have been observed, which may cause yellowing of the skin and eyes (jaundice). If these symptoms occur, contact a doctor immediately. Symptoms usually resolve after discontinuation of the medicine. The doctor will decide whether treatment should be discontinued.

Skin disorders
Skin reactions such as rash, redness, itching, urticaria, blisters and angioedema (rapid swelling of tissues such as eyelids, face, lips, oral cavity, tongue or throat, which may cause breathing difficulties) have been observed. The rash may progress to extensive blistering or lead to skin exfoliation.
If these symptoms occur in a patient, Diaprel MR must be discontinued immediately and urgent medical advice sought, informing the doctor about use of this medicine.

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 subsequently spreads, along with high fever.

Blood disorders
Reduced numbers of blood cells (e.g. platelets, red and white blood cells) may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve after discontinuation of treatment.

Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation. These symptoms may be reduced by taking Diaprel MR modified-release tablet with food, as recommended.

Eye disorders
Vision may be disturbed, especially at the beginning of treatment. This effect is related to changes in blood glucose levels.

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also 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,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Diaprel MR, modified release tablet

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
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 package and other information

What Diaprel MR modified-release tablet contains

The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
Other ingredients: monohydrate lactose, maltodextrin, hypromellose, magnesium stearate, colloidal anhydrous silica.

What Diaprel MR modified-release tablet looks like and contents of the pack
Diaprel MR is a white, elongated modified-release tablet, 15 mm long and 7 mm wide, with a central break line and engraved marking "DIA 60" on both sides.
Tablets are available in blister packs contained in cardboard boxes of 30, 60 and 90 tablets.
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, country of export:
Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
Manufacturer:
Les Laboratoires Servier Industrie, 905, route de Saran, 45520 Gidy, France
Servier (Ireland) Industries Limited, Gorey Road, Arklow, Co. Wicklow, Ireland
Anpharm Przedsiebiorstwo Farmaceutyczne S.A., ul. Annopol 6B, 03-236 Warsaw, Poland
Laboratorios Servier S.L., Avenida de Los Madronos, 33, 28043 Madrid, Spain
Parallel importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorisation number in France, country of export: 34009 338 233 8 2
Parallel import authorisation number: 375/22
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria DIAMICRON MR 60 mg
Belgium UNI DIAMICRON 60 mg
Bulgaria DIAPREL MR 60 mg
Croatia DIAPREL MR 60 mg
Cyprus DIAMICRON MR 60 mg
Czech Republic DIAPREL MR 60 mg
Denmark DIAMICRON UNO 60 mg
Estonia DIAPREL MR 60 mg
France DIAMICRON 60 mg
Germany DIAMICRON UNO 60 mg
Greece DIAMICRON MR 60 mg
Hungary DIAPREL MR 60 mg
Ireland DIAMICRON MR 60 mg
Italy DIAMICRON 60 mg
Latvia DIAPREL MR 60 mg
Lithuania DIAPREL MR 60 mg
Luxembourg DIAMICRON 60 mg
Malta DIAMICRON MR 60 mg
Netherlands DIAMICRON MR 60 mg
Poland DIAPREL MR
Portugal DIAMICRON LM 60 mg
Romania DIAPREL MR 60 mg
Slovak Republic DIAPREL MR 60 mg
Slovenia DIAPREL MR 60 mg
Spain DIAMICRON 60 mg