Diaprel mr

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Diaprel MR (Diaprel MR 60 mg)
60 mg, modified-release tablets
Gliclazidum
Diaprel MR and Diaprel MR 60 mg are different trade names for the same medicine
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 doubts, 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 another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Diaprel MR, modified-release tablet is and what it is used for
2. What you need to know 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, 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 (type 1) diabetes;
• if ketone bodies 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 advice regarding treatment to achieve proper blood glucose levels. This means that in addition to taking the tablets regularly, you must 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) and glycated haemoglobin (HbA1c) is necessary.
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 is taking other medicines or natural supplements 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, impaired concentration, reduced alertness and reaction time, depression, disorientation, speech or vision disturbances, tremor, sensory disturbances, dizziness, weakness.
Other symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain radiating (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 very quickly when the patient consumes some sugar, e.g. glucose tablets, sugar cubes, sweet juice, or sweetened tea. Therefore, always carry some sugary products (glucose tablets, sugar cubes) with you. 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 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 and taking certain medicines (e.g. 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 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 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 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) (abnormal red blood cells) has been diagnosed in the patient or a family member, a decrease in haemoglobin levels and breakdown of red blood cells (haemolytic anaemia) may occur. Consult your doctor before taking this medicinal product.
In patients with porphyria (a hereditary genetic disorder characterised by 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 currently or 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 medicines (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 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, 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 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.
Drinking alcohol 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 (hypoglycaemia) or too high (hyperglycaemia), or if visual 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 (hypoglycaemia) occurs frequently;
• if symptoms of low blood glucose (hypoglycaemia) 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 taken exactly as directed 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 in external factors (weight loss, change in lifestyle, stress) or improvement in blood glucose control may require adjustment of gliclazide dosage.
The recommended daily dose is 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 use. The tablet(s) should be swallowed with a glass of water at breakfast time (preferably at the same time every day). Swallow half 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 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 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 sugary drink, followed by a snack or meal, may help. If the patient is unconscious, seek medical help immediately and call an ambulance. 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 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 the 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 effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.

The most commonly observed adverse effect is low blood sugar (hypoglycaemia). Objective and subjective 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, 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 lesions or lead to skin peeling.
If a patient experiences these symptoms, Diaprel MR should be discontinued immediately and medical advice should be urgently 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 then spreads, accompanied by 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 tablet 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 sulphonylurea derivatives, the following adverse events have been observed:
cases of severe blood cell count abnormalities and allergic vasculitis, hyponatraemia (low blood sodium levels), symptoms of liver damage (e.g. jaundice), which in most cases resolved after discontinuation of sulphonylurea derivatives, although in isolated cases potentially leading 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 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 following the abbreviation
"EXP" (the term used to describe expiry date). The expiry date refers to the last day of the
stated month. The abbreviation "Lot" on the packaging indicates the batch number.
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 required. 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: monohydrate lactose, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silicon dioxide.

What Diaprel MR, modified-release tablet looks like and contents of the pack
The medicine Diaprel MR is available as white, elongated modified-release tablets, 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 blisters packed in cardboard boxes containing 30, 60 or 90 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Lithuania, the exporting country:
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 6B
03-236 Warsaw
Poland
Laboratorios Servier S.L.
Avenida de Los Madroños, 33
28043 Madrid
Spain

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Parallel import authorisation number: 232/23

Marketing authorisation numbers in Lithuania, the exporting country:
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/1/05/0200/029
LT/1/05/0200/030

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