Diaprel mr

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
DIAPREL MR (DIAMICRON MR)
60 mg, modified-release tablets
Gliclazidum
DIAPREL MR and DIAMICRON MR are different trade names for the same medicinal product.
Please read this leaflet carefully before taking 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, 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 (it 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 following a 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 action;
• 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 ketoacidosis), pre-comatose or comatose states due to diabetes;
• 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, you should discuss this with your doctor.
You must follow your doctor's advice regarding treatment in order to achieve proper blood glucose control. 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) and measurement of glycated hemoglobin (HbA1c) are necessary.
The risk of low blood glucose (hypoglycemia) may be increased during the first weeks of treatment. Therefore, close medical supervision is particularly important.
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 herbal preparations 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, restlessness, aggression,
reduced concentration, decreased alertness and reaction time, depression, disorientation, speech or
visual disturbances, tremor, sensory disturbances, dizziness, weakness.
Additional symptoms may include: sweating, moist 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 rapidly when the patient consumes some sugar, e.g. glucose tablets, sugar cubes, sweet juice, or sweetened tea.
Therefore, it is advisable to always carry sugar-containing products (glucose tablets, sugar cubes). 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 occur in elderly patients or in those taking certain medications (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 (hyperglycemia) 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 during particularly stressful situations. Symptoms 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 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) has been diagnosed in the patient or in a family member, hemolytic anemia (decreased hemoglobin and breakdown of red blood cells) may occur. Consult your doctor before taking this medicine.
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 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 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:

• medicines used to treat disorders of the central nervous system (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 known as fluoroquinolones, disturbances in blood glucose levels (both 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 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 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 a pregnancy, she should consult her doctor before using this medicine.
Diaprel MR, modified-release tablet must not be used during breastfeeding.

Driving and using machines
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 may drive:

• if low blood glucose (hypoglycemia) occurs frequently;
• if symptoms of low blood glucose (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 the 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 related to external factors (weight loss, lifestyle changes, stress) or improved control of blood sugar levels may require adjustment of gliclazide dosage.
The recommended daily dose ranges from half a tablet to two tablets (maximum 120 mg), taken once 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 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, do not chew or crush. 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-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 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 are 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 a doctor immediately and call emergency services. The same applies 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.

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 a 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 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 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 reactions

Like all medicines, this medicine can 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.
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, 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, the patient should stop taking Diaprel MR and contact a physician immediately, informing them 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 then spreads, along with high fever.

Blood disorders
Reduction in blood cell counts (e.g. platelets, red and white blood cells) may cause pallor, 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 levels.

As with other sulfonylurea derivatives, the following adverse events have been observed:
cases of significant blood cell count abnormalities and allergic vasculitis, reduction in blood sodium levels (hyponatremia), symptoms of liver damage (e.g. jaundice), which in most cases resolved after discontinuation of sulfonylurea 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 a 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, Poland, 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 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 specified month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer 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 markings "DIA 60" on both sides.
The tablets are available in blister packs, packed in cardboard boxes containing 30, 60, or 90 tablets.

For further detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Ireland, 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

Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorisation Number in Ireland, country of export: PA 568/013/002
Parallel Import Licence Number: 215/24

This medicinal product is authorised 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