DIAPREL MR

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
DIAPREL MR (UNI DIAMICRON 60 mg)
60 mg, modified-release tablets
Gliclazidum
DIAPREL MR and UNI DIAMICRON 60 mg are different trade names for the same medicinal product.
Please read the 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 further questions, please consult 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.

Leaflet contents:

1. What Diaprel MR, modified-release tablet is and what it is used for
2. Important information before taking Diaprel MR, modified-release tablet
3. How to take Diaprel MR, modified-release tablet
4. Possible side effects
5. How to store Diaprel MR, modified-release tablet
6. 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 sugar 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 sugar 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 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 states or diabetic coma;
• 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.
Follow your doctor's advice regarding treatment to achieve proper blood glucose levels. This means that in addition to taking tablets regularly, you should follow a diet, 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 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 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 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 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,
impaired concentration, reduced alertness and reaction time, depression, disorientation, speech or
vision disturbances, tremor, 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 fall, 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 quickly when the patient consumes some sugar, e.g. glucose tablets, sugar cubes, sweetened juice, or sweetened tea.
Therefore, it is advisable to always carry some sugary products (glucose tablets, sugar cubes). 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 occur, 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. those acting on the central nervous system and beta-blockers).
In stressful situations (accidents, surgery, fever, etc.), the 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 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 in particular 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 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 of the importance of monitoring blood glucose levels.
If a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) has been diagnosed in a family member or in the patient (abnormal red blood cells), a decrease in haemoglobin concentration and breakdown of red blood cells (haemolytic anaemia) may occur. 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 worsening porphyria after using certain other sulfonylurea derivatives have been reported.
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 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 stomach or duodenal ulcers (H--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 used 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 belonging to the group called fluoroquinolones, especially in elderly patients, disturbances in blood 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 the patient is admitted to hospital, they should inform the 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 drinks.
Drinking alcohol is not recommended, as it may alter diabetes control in an unpredictable way.

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 to have a baby, 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 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 (reduced body weight, lifestyle changes, 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 during 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 a tablet or the whole tablet(s) whole, once daily. Do not chew or crush the tablets. Always eat a meal after taking the tablet(s).
In combination therapy with Diaprel MR, modified-release tablet, together 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 glucose 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 glucose (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 a doctor immediately and call emergency services. The same applies if someone (e.g. a child) has accidentally taken this medicine. Do not give food or drink to unconscious patients.
Ensure that a responsible person who can contact a doctor in case of emergency is always informed in advance.

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, they should take the next dose 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-related complications.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, 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, 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).
In case 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 breathing difficulties) have been observed.
Rash may progress to extensive blistering or lead to skin peeling.
If a patient experiences any of these symptoms, Diaprel MR should be discontinued immediately and the patient should urgently contact a physician and inform him/her about taking 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 then spreads, accompanied by 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 tablet with food, as recommended.

Eye disorders
Visual disturbances may occur, particularly 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:
cases of severe blood cell count changes and allergic vasculitis, reduced blood sodium concentration (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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department for 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 to provide more information on the safety of the medicine.

5. How to store DIAPREL MR, modified-release tablet

Keep this medicine out of the 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack 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, anhydrous colloidal 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 breakline and engraved "DIA 60" on both sides. The tablets are available in blister packs contained in cardboard cartons of 30, 60 and 90 tablets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing Authorisation Holder in Belgium, country of export:
Servier Benelux SA
Bd International 57
1070 Anderlecht (Brussels)
Belgium
Manufacturer:
Les Laboratoires Servier Industrie (LSI)
905 route de Saran, 45520 Gidy, France
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Belgium, country of export: BE354137
Parallel Import Authorisation Number: 5/25
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
Slovak Republic DIAPREL MR 60 mg
Slovenia DIAPREL MR 60 mg
Spain DIAMICRON 60 mg