Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
DIAPREL MR
60 mg, modified-release tablets
Gliclazidum
Please read carefully the entire leaflet before taking this 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, 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 another person, 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.

Table of 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. 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), to other medicines of the same group (sulfonylurea derivatives), or to other derivatives (hypoglycaemic sulfonamides);
if the patient has insulin-dependent diabetes (type 1);
if ketone bodies and sugar are present in the urine (this may indicate that the patient has 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 should 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, perform physical exercise, and, when necessary, reduce body weight.
During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) levels is necessary, as well as monitoring of glycated haemoglobin (HbA1c).
The risk of low blood glucose (hypoglycaemia) may be increased during the first weeks of treatment. Therefore, close medical supervision is particularly important.
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 takes other medicines or natural supplements at the same time;
the patient takes excessive doses of gliclazide;
the patient has specific 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
visual disturbances, tremors, sensory disturbances, dizziness, weakness.
Additional symptoms may include: sweating, clammy skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain that may radiate (angina pectoris).
If blood glucose continues to decrease, significant 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 rapidly when the patient consumes some sugar, e.g. glucose tablets, sugar cubes, sweetened juice, or sweetened tea.
Therefore, it is advisable to always carry sugar-containing products (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 appear, may be mild or develop slowly, or the patient may not be aware that blood glucose has decreased. This may happen if the patient is elderly or taking certain medicines (e.g. 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 (hyperglycaemia) may occur when 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 "Diaprel MR, modified-release tablet and 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.
When gliclazide is taken concomitantly with antibiotics belonging to the fluoroquinolone group, 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 congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) has been diagnosed in the patient or in a family member (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
Inform your doctor or pharmacist about all medicines you are currently taking or have 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 one of the following medicines is 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 gastric 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 central nervous system disorders (chlorpromazine);
anti-inflammatory medicines (corticosteroids);
medicines used to treat asthma or administered 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 taken concomitantly with antibiotics belonging to the fluoroquinolone group, especially in elderly patients, disturbances in glucose levels (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 other medicine. If you are admitted 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 can be taken with food and non-alcoholic beverages.
Alcohol consumption is not recommended, as it may unpredictably alter 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 plans 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 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 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 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, lifestyle changes, stress) or improvement in blood glucose 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 a whole tablet whole, without chewing or crushing. A meal should always be consumed 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-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 glucose levels despite taking the medicine as prescribed, they should consult their doctor or pharmacist.

Taking more Diaprel MR, modified-release tablet than prescribed
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, eating sugar (4 to 6 sugar cubes) or drinking a sugary drink, followed by a snack or meal, may help. If the patient is unconscious, contact a doctor immediately and call emergency services. The same applies if someone (e.g. a child) accidentally takes this medicine. Food or drinks must not be given to unconscious patients.
Ensure that someone close 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 optimal 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 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 glucose levels (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.
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 the reduction in blood glucose is significant or prolonged, even if temporarily controlled by
administration of sugar, medical advice should be sought 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, medical advice should be sought immediately. Symptoms usually resolve after discontinuation of the medicine.
The physician 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, mouth, tongue or throat, which may cause difficulty in breathing) have been observed.
The rash may progress to extensive blistering lesions or lead to skin exfoliation.
If these symptoms occur in a patient, Diaprel MR should be discontinued immediately and urgent medical advice sought, informing the physician 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
Reduced number 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, dyspepsia, diarrhoea and constipation. These symptoms may be reduced by taking Diaprel MR modified-release tablets with food, as recommended.

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

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform 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
Phone: +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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging 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 are: lactose monohydrate, 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 dividing groove and engraved marking "DIA 60" on both sides. The tablets are available in blister packs contained in cardboard boxes of 30, 60 and 90 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Lithuania, 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 Ltd, Gorey Road, Arklow - Co. Wicklow, Ireland
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A., ul. Annopol 6B, 03-236 Warsaw, Poland
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation numbers in Lithuania, country of export: LT/1/05/0200/017
LT/1/05/0200/019
LT/1/05/0200/020
LT/1/05/0200/022
LT/1/05/0200/024
LT/1/05/0200/026
LT/1/05/0200/027
LT/1/05/0200/029
LT/1/05/0200/030
LT/1/05/0200/031
Parallel import authorisation number: 418/22
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