Diaprel mr

Package leaflet: Information for the user

Warning! Keep this 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 entire leaflet carefully 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 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 as yours.
• If you experience any adverse effects, including any not listed in this leaflet, you must inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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 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 form 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 drugs 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 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, please 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 tablets regularly, you should follow a diet, perform 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 (hypoglycemia) may be increased during the first weeks of treatment. Therefore, particularly close medical supervision is necessary.
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 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,
poor concentration, reduced alertness and reaction time, depression, disorientation, speech or vision
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 (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 quickly when the patient consumes some sugar, e.g. glucose tablets, sugar lumps, sweet juice, or sweetened tea.
Therefore, you should always carry some sugar-containing products (glucose tablets, sugar lumps) with you. Please remember that artificial sweeteners are not effective. You should 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 very slowly, or the patient may not be aware that blood glucose has decreased. This may happen when the patient is elderly or taking certain medicines (e.g. acting on the central nervous system and beta-blockers).
In stressful situations (accidents, surgical operations, fever, etc.), your doctor may temporarily change treatment to insulin therapy.
Symptoms of high blood glucose (hyperglycemia) may occur when gliclazide has not yet sufficiently lowered blood glucose levels, 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 specific 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 fluoroquinolone group, 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 glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormal red blood cells) has been diagnosed in the patient or in a family member, hemoglobin levels may decrease and red blood cells may break down (hemolytic anemia). Before taking this medicinal product, consult your doctor.
Cases of porphyria exacerbation after administration of certain other sulfonylurea derivatives have been reported in patients with porphyria (a hereditary genetic disorder characterized by accumulation of porphyrins or their precursors in the body).
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 one of the following medicines is taken concomitantly:

• 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 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 diseases, 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 fluoroquinolone group, 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 medicinal product.
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.
Alcohol consumption is not recommended, as it may alter diabetes control in an unpredictable manner.

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 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 (hypoglycemia) or too high (hyperglycemia), 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 (hypoglycemia) occurs frequently;
• symptoms of low blood glucose (hypoglycemia) are very mild or absent.

Diaprel MR, modified-release tablet contains 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 prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The dose is determined by the doctor, depending on blood and urine glucose levels.
Any changes related to external factors (weight loss, 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
daily with breakfast. The dose depends on the body's 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 a tablet or the
whole tablet(s) whole, once daily. Do not chew or crush the tablets. A meal should always be eaten
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 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 Diaprel MR, modified-release tablet than prescribed
If too many tablets are 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 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 call 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 dose of Diaprel MR, modified-release tablet, 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 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 for use".
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). If these symptoms occur, consult a doctor immediately. Symptoms usually resolve after discontinuation of the medicine. The doctor will decide whether treatment should be stopped.

Skin disorders
Skin reactions such as rash, redness, itching, urticaria (hives), blisters and angioedema (rapid 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 or lead to skin exfoliation.
If a patient experiences any of these symptoms, Diaprel MR should be discontinued immediately and the patient should urgently contact a doctor and inform them 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 subsequently spreads, along with high fever.

Blood disorders
Reduction in the number of blood cells (e.g. platelets, red and white blood cells) may lead to pallor, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve after stopping 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
Vision disturbances may occur, especially at the beginning of treatment. This effect is related to changes in blood glucose concentration.

As with other sulphonylurea derivatives, the following adverse events have also been observed:
cases of marked blood cell count abnormalities and allergic vasculitis, decreased sodium concentration in blood (hyponatraemia), signs of liver damage (e.g. jaundice), which in most cases resolved after discontinuation of sulphonylurea derivatives; however, in isolated cases, these 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 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 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 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.
There are no special storage instructions for this medicine.
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 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.
• 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 in length and 7 mm in width, with a central dividing score line and embossed marking “DIA
60” on both sides. The tablets are supplied in PVC/Aluminium blisters packed in cardboard cartons containing 30, 60 or 90 tablets.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Belgium, country of export:
Servier Benelux SA
Boulevard International, 57
1070 Anderlecht (Brussels)
Belgium
Manufacturer:
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
Servier (Ireland) Industries Ltd.
Gorey Road
Arklow – Co. Wicklow
Ireland
Anpharm Przedsiebiorstwo Farmaceutyczne S.A.
Annopol Street 6B
03-236 Warsaw
Poland
LABORATORIOS SERVIER S.L.
Avenida de Los Madronos, 33
28043 Madrid
Spain
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing Authorisation Number in Belgium, country of export: BE354137
Parallel Import Licence Number: 121/25
This medicinal product is authorised for marketing 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