Package leaflet: Information for the patient

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

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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, physical exercise, and weight reduction alone 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 sulfonamides with blood glucose-lowering activity;
if the patient has insulin-dependent diabetes (type 1);
if ketones and sugar are present in the urine (this may indicate that the patient has 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 diet, engage in physical exercise, and, if necessary, reduce body weight.
During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) levels is required, as well as measurement of glycated hemoglobin (HbA1c).
The risk of low blood glucose (hypoglycaemia) may be increased during the first weeks of treatment. Therefore, particularly careful medical supervision is necessary.
Low blood glucose (hypoglycaemia) 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 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 is taking 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 vision disturbances, tremor, sensory disturbances, dizziness, weakness.
Other symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain which may radiate (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 very 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 some sugary products (glucose tablets, sugar cubes). Please note that artificial sweeteners are not effective. 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 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, surgical operations, fever, etc.), your doctor may temporarily switch treatment to insulin therapy.
Symptoms of high blood glucose (hyperglycaemia) may occur if gliclazide has not sufficiently lowered blood glucose, if the patient has not followed the treatment plan advised 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 in 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.
When gliclazide is used concomitantly with medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (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 patient or a family member has previously been diagnosed with congenital glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormal red blood cells), haemoglobin levels may decrease and red blood cells may break down (haemolytic anaemia). 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 derivative medicines.
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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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);
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 medicines (phenylbutazone, ibuprofen);
medicines containing alcohol.

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

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

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

Diaprel MR, modified release tablet with food, drink, and alcohol
Diaprel MR, modified release tablet may be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended, as it may alter diabetes control in an unpredictable way.

Pregnancy and breastfeeding
Use of Diaprel MR, modified release tablet is not recommended during pregnancy.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, 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 (hypoglycaemia) or too high (hyperglycaemia), or if vision disturbances occur as a result of 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 may drive:

if low blood glucose (hypoglycaemia) occurs frequently;
if symptoms of low blood glucose (hypoglycaemia) 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 taken exactly as prescribed 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 sugar levels.
Any changes in external factors (weight loss, lifestyle changes, stress) or improvement in blood sugar control 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 individual response to treatment.
The tablet may be divided in half.
Diaprel MR, modified-release tablet, is intended for oral use. 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(s) whole, once daily. Do not chew or crush the tablets. Always eat a meal after taking the tablet(s).
When Diaprel MR, modified-release tablet, is used in combination with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-IV 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 sugar levels despite taking the medicine as prescribed, they should consult their doctor or pharmacist.

Taking more Diaprel MR, modified-release tablet than prescribed
If too many tablets have been taken, contact a doctor immediately or go to the nearest hospital.
Symptoms of overdose are those of low blood sugar (hypoglycaemia), as described in section 2. In such cases, eating 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 takes this medicine. Do not give food or drink to unconscious patients.
Ensure that someone close is always informed and able to contact a doctor in case of an emergency.

Missed dose of Diaprel MR, modified-release tablet
It is important to take the medicine every day, as regular use ensures better effectiveness.
However, if a 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 the missed dose.

Stopping Diaprel MR, modified-release tablet
Since diabetes treatment usually lasts a lifetime, consult your doctor before stopping this medicine.
Discontinuation of treatment may lead to increased blood sugar 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 effects

Like all medicines, this medicine may cause adverse effects, although not everybody 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 severe or prolonged, even if temporarily controlled by sugar intake, you should immediately contact your doctor.

Liver disorders
Isolated cases of impaired liver function have been observed, which may cause yellowing of the skin and eyes.
If these symptoms occur, you should immediately contact your doctor. 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, 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 peeling.
If any of these symptoms occur in a patient, Diaprel MR should be discontinued immediately and urgent contact should be made with a doctor, informing him or her about the 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
Reduction in blood cell counts (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 tablets with food, as recommended.

Eye disorders
Vision disturbances may occur, especially at the beginning of treatment. This effect is related to changes in blood sugar concentration.

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects helps to provide more information on the safety of the 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 conditions are required.
Medicines should 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. Package contents and other information

What Diaprel MR, modified-release tablet contains

The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
The other ingredients are: 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 available as white, elongated modified-release tablets, 15 mm long and 7 mm wide, with a central dividing groove and engraved markings "DIA 60" on both sides. The tablets are available in blister packs, packed in cardboard boxes containing 30, 60, or 90 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, the 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 Przedsiębiorstwo Farmaceutyczne S.A., Annopol 6 B, 03-236 Warsaw, Poland
LABORATORIOS SERVIER S.L., Avenida de Los Madroños, 33, 28043 Madrid, Spain
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation numbers in France, the country of export: 34009 338 233 8 2
34009 338 232 1 4
34009 338 146 8 7
34009 338 107 2 6
Parallel import authorisation number: 324/22
This medicinal product is authorised for sale in the European Economic Area 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
Slovakia DIAPREL MR 60 mg
Slovenia DIAPREL MR 60 mg
Spain DIAMICRON 60 mg