Diaprel mr

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
DIAPREL MR (UNI DIAMICRON)
60 mg, modified-release tablets
Gliclazidum
DIAPREL MR and UNI DIAMICRON 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, 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 another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any 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. 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 specific 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 sulfonamide derivatives (sulfonamides with hypoglycaemic 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, discuss this with your doctor.

You should 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) and measurement of glycated haemoglobin (HbA1c) are 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 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, reduced concentration, decreased alertness and reaction time, depression, disorientation, speech or vision 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 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, it is important to always carry some sugary products (glucose tablets, sugar cubes). Note 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 occur in elderly patients or in those taking certain medicines (e.g. those 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 (hyperglycaemia) may occur when 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, 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 medicines belonging to the group of antibiotics called fluoroquinolones, 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 glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormal red blood cells) has been diagnosed in the patient or in a family member, haemolysis (breakdown of red blood cells) and decreased haemoglobin levels (haemolytic anaemia) may occur. Consult your doctor before taking this medicine.

Cases of porphyria (a hereditary genetic disorder involving accumulation of porphyrins or their precursors in the body) worsening after use of 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
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 any of the following medicines are 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 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 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 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.

Alcohol consumption 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 a pregnancy, 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. Bear in mind 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 are allowed to 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 used as directed by a physician or pharmacist.
If in doubt, consult a physician or pharmacist.
The dose is determined by the physician according to blood and urine glucose levels.
Any changes related to external factors (weight loss, lifestyle changes, stress) or improved blood glucose control 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 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 the 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 of Diaprel MR, modified-release tablet 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 physician.
If the patient notices high blood glucose levels despite taking the medicine as prescribed, the patient should consult a physician or pharmacist.

Overdose of Diaprel MR, modified-release tablet
In case of accidental overdose, contact a physician immediately or go to the nearest hospital.
Symptoms of overdose are those of low blood glucose (hypoglycemia) and are described in section 2. In such cases, it may help to consume sugar (4 to 6 sugar cubes) or drink a sweetened beverage, followed by a snack or meal. If the patient is unconscious, seek immediate medical attention and call emergency services. The same action should be taken if someone (e.g. a child) accidentally ingests this medicine. Do not give food or drink to unconscious patients.
Ensure that a responsible person is always informed and available to call a physician 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 optimal effectiveness.
However, if a 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 the missed dose.

Stopping Diaprel MR, modified-release tablet
Since diabetes treatment usually lasts a lifetime, consult a physician before discontinuing this medicine.
Stopping treatment may lead to increased blood glucose levels (hyperglycemia), increasing the risk of diabetes-related complications.
If there are any further doubts regarding the use of this medicine, consult a physician 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".
If these symptoms are left untreated, they may progress to drowsiness, loss of consciousness or coma.
If the low blood sugar is significant 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, 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 should be stopped immediately and urgent medical advice sought.
Inform the physician about the use of this medicine.

Rarely, symptoms of severe hypersensitivity reactions (DRESS, Drug Rash with Eosinophilia and Systemic Symptoms) have been reported, initially presenting as influenza-like symptoms and facial rash, which subsequently spreads, accompanied by high fever.

Blood disorders
Decreased 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, 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:
cases of significant blood cell count changes and allergic vasculitis, decreased blood sodium concentration (hyponatraemia), and signs of liver injury (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 or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions,
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309,
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 stated 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 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 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 marking “DIA
60” on both sides. Tablets are available in blisters packed in cardboard boxes containing 30, 60 or 90
tablets.
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Belgium, country of export:
Servier Benelux S.A.
Boulevard International, 57
1070 Brussels, Belgium
Manufacturer:
Servier (Ireland) Industries Ltd.
Gorey Road
Arklow – Co. Wicklow, Ireland
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy, France
Anpharm Przedsiebiorstwo Farmaceutyczne S.A.
ul. Annopol 6B
03-236 Warsaw, Poland
Laboratorios Servier S.L.
Avenida de Los Madronos, 33
28043 Madrid, Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Belgium, country of export: BE354137
Parallel import authorisation number: 271/22
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
Slovakia DIAPREL MR 60 mg
Slovenia DIAPREL MR 60 mg
Spain DIAMICRON 60 mg