Diaprel mr

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
Gliclazide
Please read carefully all the information in this leaflet 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 give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, 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 form 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 diabetes);
• if ketones and sugar are present in the urine (this may indicate 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.
Follow your doctor's recommendations for treatment 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) 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, 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 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 takes 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, poor concentration, reduced alertness and reaction time, depression, disorientation, speech or vision disturbances, trembling, sensory disturbances, dizziness, weakness.
Additional symptoms may include: sweating, clammy skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain radiating to other areas (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 resolve quickly 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). 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 dropped. This may occur in elderly patients or those taking certain medications (e.g., central nervous system agents or beta-blockers).
In stressful situations (e.g., accidents, surgery, fever, etc.), the doctor may temporarily switch treatment to insulin therapy.
Symptoms of high blood glucose (hyperglycemia) may occur if gliclazide has not yet 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. Symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced activity.
If these symptoms occur, the patient should contact their doctor or pharmacist.
When gliclazide is used 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 patient or a family member has previously been diagnosed with congenital glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormal red blood cells), hemoglobin levels may decrease and red blood cells may break down (hemolytic anemia). Consult your doctor before taking this medicinal product.
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 concomitantly:

• other medicines used to treat high blood glucose (oral antidiabetic agents, 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 administered during childbirth (intravenous salbutamol, ritodrine, terbutaline);
• medicines used to treat breast disorders, severe menstrual bleeding, or endometriosis (danazol);
• preparations containing St. John's wort (Hypericum perforatum).

When DIAPREL MR, modified-release tablet is used concomitantly with antibiotics known as fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (both 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 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, 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 affect diabetes control.

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 (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. The patient should be aware that they 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 taken as prescribed by a doctor or pharmacist.
If in doubt, consult a 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 improvement in blood glucose control may require adjustment of gliclazide doses.
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 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 or a whole tablet(s) whole, once daily. Do not chew or crush the tablets. 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 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, the patient should consult a doctor or pharmacist.

Taking more DIAPREL MR, modified-release tablet than prescribed
In case of overdose, contact a doctor immediately or go to the nearest hospital.
Symptoms of overdose are symptoms of low blood glucose (hypoglycaemia) as described in section 2. In such situations, 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 who is informed and able to call a doctor in case of an emergency is always available.

Missed dose of DIAPREL MR, modified-release tablet
It is important to take the medicine every day, as regular use ensures better efficacy.
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 a doctor before stopping this medicine.
Discontinuation of treatment may lead to increased blood glucose levels (hyperglycaemia), increasing the risk of diabetes complications.
If there are any further doubts regarding the use of this medicine, consult a 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 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, contact a doctor immediately. Symptoms usually resolve after discontinuation of the medicine. The 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, mouth, 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, treatment with DIAPREL MR, modified release tablet, should be discontinued immediately and a doctor should be urgently consulted. The doctor must be informed 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 stopping treatment.

Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, 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 sulfonylurea derivatives, the following adverse events have been observed: significant changes in blood cell counts, allergic vasculitis, reduced sodium concentration in blood (hyponatremia), and 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 effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. 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 the medicine DIAPREL MR, modified release tablet

Keep the medicine in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP" (abbreviation used to describe the expiry date). The expiry date refers to the last day of
the stated month. The "Lot" abbreviation on the packaging indicates the batch number of the medicine.
No special storage instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This practice 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.
• The other ingredients are: monohydrate lactose, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silicon dioxide.

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 break line and engraved markings "DIA 60" on both sides.
The tablets are available in blisters packed in cardboard boxes containing 30 tablets.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Romania, 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.
Annopol Street 6B,
03-236 Warsaw
Poland

Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
Jagiellońska Street 76
03-301 Warsaw
Poland
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska Street 58
87-100 Toruń
Poland
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka Street 190
91-610 Łódź
Poland

Marketing Authorisation Number in Romania, country of export: 8054/2015/09
Parallel Import Authorisation Number: 52/22

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