Diaprel Mr

Leaflet accompanying the packaging: patient information

DIAPREL MR

30 mg, modified-release tablets

Gliclazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• -Keep this leaflet, you may need to read it again.
• -If you have any further questions, ask your doctor or pharmacist.
• -This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• -If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Diaprel MR and what is it used for
• 2. Important information before taking Diaprel MR
• 3. How to take Diaprel MR
• 4. Possible side effects
• 5. How to store Diaprel MR
• 6. Contents of the pack and other information

1. What is Diaprel MR and what is it used for

Diaprel MR is a medicine that lowers blood sugar levels (it is an oral antidiabetic medicine belonging to the sulfonylurea group). Diaprel MR is used to treat a certain type of diabetes (type 2 diabetes) in adults, when diet, exercise, and weight loss alone are not enough to control blood sugar levels.

2. Important information before taking Diaprel MR

When not to take Diaprel MR:

• if you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), other medicines from the same group (sulfonylureas), other derivatives (sulfonamides);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this may indicate that you have diabetic ketoacidosis), pre-coma, or diabetic coma;
• if you have severe kidney or liver disease;
• if you are taking medicines used to treat fungal infections (miconazole, see section "Diaprel MR and other medicines");
• if you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to take Diaprel MR, you should discuss it with your doctor. You should follow your doctor's recommendations for treatment to achieve proper blood sugar control. This means that, in addition to taking the tablets regularly, you should follow a diet, exercise, and, if necessary, lose weight. During treatment with gliclazide, it is necessary to regularly check your blood sugar levels (and possibly urine) and also check your glycosylated hemoglobin (HbA1c) levels. The risk of low blood sugar (hypoglycemia) may be increased during the first few weeks of treatment. Therefore, close medical monitoring is particularly necessary. Low blood sugar (hypoglycemia) may occur if:

• you take your meals irregularly or skip meals;
• you fast;
• you are undernourished;
• you change your diet;
• you increase your physical activity, and your carbohydrate intake is not sufficient;
• you consume alcohol, especially if you skip meals;
• you take other medicines or natural products at the same time;
• you take too high a dose of gliclazide;
• you have certain hormonal disorders (thyroid, pituitary, or adrenal disorders);
• your kidney or liver function is severely impaired.

If you have low blood sugar, you may experience the following symptoms: headache, strong hunger, nausea, vomiting, fatigue, sleep disturbances, anxiety, aggression, decreased concentration, decreased alertness and reaction time, depression, disorientation, speech or vision disturbances, tremors, sensory disturbances, dizziness, weakness. You may also experience the following symptoms: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain that may radiate (angina pectoris). If your blood sugar levels continue to decrease, you may experience severe confusion (delirium), seizures, loss of self-control, shallow breathing, slow heartbeat, and you may lose consciousness. In most cases, the symptoms of low blood sugar disappear very quickly when you consume some sugar, e.g., glucose tablets, sugar cubes, or a sweet drink. Therefore, you should always carry some sugar products with you (e.g., glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. You should contact your doctor or the nearest hospital if consuming sugar does not help or if the symptoms return. The symptoms of low blood sugar may not occur, may be mild, or may develop very slowly, or you may not be aware that your blood sugar levels have decreased. This can happen if you are elderly and taking certain medicines (e.g., those that act on the central nervous system and beta-blockers). In stressful situations (accidents, surgeries, fever, etc.), your doctor may temporarily change your treatment to insulin therapy. High blood sugar symptoms (hyperglycemia) may occur if gliclazide has not yet sufficiently lowered your blood sugar levels, if you do not follow the treatment plan prescribed by your doctor, if you take products containing St. John's Wort (Hypericum perforatum) (see section "Diaprel MR and other medicines"), or in special stressful situations. This can be thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased activity. If you experience these symptoms, you must contact your doctor or pharmacist. When taking gliclazide at the same time as medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, blood sugar level disorders (low and high blood sugar) may occur. In this case, your doctor will remind you how important it is to monitor your blood sugar levels. If someone in your family or you have been diagnosed with a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells), a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur. You should contact your doctor before taking this medicinal product. In patients with porphyria (a genetic disease characterized by the accumulation of porphyrins or their precursors in the body), cases of porphyria exacerbation have been described after taking some other sulfonylurea derivatives.

Children and adolescents

Diaprel MR is not recommended for use in children due to a lack of data.

Diaprel MR and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. The blood sugar-lowering effect of gliclazide may be enhanced, and low blood sugar symptoms may occur when taking one of the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetic medicines, 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);
• analgesic or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may reduce the effect of gliclazide and cause high blood sugar:

• medicines used to treat central nervous system disorders (chlorpromazine);
• anti-inflammatory medicines (corticosteroids);
• medicines used to treat asthma or used during childbirth (intravenously administered salbutamol, rytodryna, terbutalina);
• medicines used to treat breast diseases, heavy menstrual bleeding, and endometriosis (danazol);
• products containing St. John's Wort (Hypericum perforatum).

When taking Diaprel MR at the same time as medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, blood sugar level disorders (low and high blood sugar) may occur. Diaprel MR may increase the effect of anticoagulant medicines (warfarin). You should consult your doctor before starting to take another medicinal product. If you are going to the hospital, you should inform the medical staff that you are taking Diaprel MR.

Diaprel MR with food, drinks, and alcohol

Diaprel MR can be taken with food and non-alcoholic beverages. It is not recommended to drink alcohol, as it may change diabetes control in an unpredictable way.

Pregnancy and breastfeeding

Diaprel MR should not be used during pregnancy. If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. You should not take Diaprel MR while breastfeeding.

Driving and using machines

If your blood sugar levels are too low (hypoglycemia) or too high (hyperglycemia), or if you experience vision disturbances as a result of abnormal blood sugar levels, your ability to concentrate or react may be impaired. You should remember that you may be a risk to yourself or others (e.g., while driving a car or operating machines). You should ask your doctor about the possibility of driving:

• if you experience low blood sugar (hypoglycemia) frequently;
• if the symptoms of low blood sugar (hypoglycemia) are very mild or absent.

3. How to take Diaprel MR

Dose

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The dose is determined by your doctor, depending on your blood sugar levels. Any changes related to external factors (weight loss, lifestyle changes, stress) or improvement in blood sugar control may require a change in gliclazide doses. The recommended daily dose is from one to four tablets (maximum 120 mg), taken orally in a single dose during breakfast. The dose depends on the body's response to treatment. Diaprel MR is intended for oral use. The tablet(s) should be swallowed with a glass of water during breakfast (preferably at the same time every day). The tablets should be swallowed whole. Do not chew them. You should always eat a meal after taking the tablet(s). In combination therapy with Diaprel MR and metformin, an alpha-glucosidase inhibitor, thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, the dose will be individually adjusted by your doctor. If you notice that your blood sugar levels are high, even though you are taking the medicine as prescribed, you should contact your doctor or pharmacist.

Taking a higher dose of Diaprel MR than recommended

If you have taken too many tablets, you should immediately contact your doctor or go to the nearest hospital. The symptoms of overdose are the symptoms of low blood sugar (hypoglycemia) and are described in section 2. In such situations, eating sugar (4 to 6 sugar cubes) or drinking a sweet drink, followed by a snack or meal, may help. If you are unconscious, you should immediately inform your doctor and call emergency services. The same applies if someone, e.g., a child, has taken this medicine by mistake. Unconscious patients should not be given food or drink. You should make sure that someone who can call a doctor in case of an emergency is always informed in advance.

Missing a dose of Diaprel MR

It is important to take the medicine every day, as regular treatment works better. However, if you forget to take a dose of Diaprel MR, you should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Diaprel MR

Since diabetes treatment usually lasts a lifetime, you should consult your doctor before stopping treatment with this medicine. Stopping treatment may cause high blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications. If you have any further questions about taking this medicine, ask your doctor or pharmacist. Stopping treatment may cause high blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.

4. Possible side effects

Like all medicines, Diaprel MR can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycemia). The objective and subjective symptoms are described in the "Warnings and precautions" section. If these symptoms are left untreated, they may lead to drowsiness, loss of consciousness, or coma. If the decrease in blood sugar levels is significant or prolonged, even if it is temporarily controlled by administering sugar, you should contact your doctor immediately. Liver disorders Single cases of impaired liver function have been observed, which can cause yellowing of the skin and eyes. If you experience these symptoms, you should immediately contact your doctor. The symptoms usually disappear after discontinuing the medicine. Your doctor will decide whether to stop treatment. Skin disorders Skin reactions, such as rash, redness, itching, urticaria, blisters, angioedema (rapid swelling of tissues, such as eyelids, face, lips, mouth, or throat, which can cause breathing difficulties), have been observed. The rash may develop into widespread skin lesions or lead to skin peeling. If you experience these symptoms, you should stop taking Diaprel MR and immediately contact your doctor and inform them that you are taking this medicine. Exceptionally, symptoms of severe hypersensitivity reactions (DRESS, Drug Rash with Eosinophilia and Systemic Symptoms) have been reported: initially in the form of flu-like symptoms and a rash on the face, which then spread, and a high fever. Blood disorders A decrease in the 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 disappear after discontinuing treatment. Gastrointestinal disorders Stomach pain, nausea, vomiting, indigestion, diarrhea, and constipation. These symptoms can be reduced by taking Diaprel MR with food as recommended. Eye disorders Vision disturbances may occur, especially at the beginning of treatment. This effect is related to changes in blood sugar levels. As with other sulfonylurea derivatives, the following adverse events have been observed: significant changes in blood cell counts and allergic vasculitis, decreased sodium levels in the blood (hyponatremia), signs of liver damage (e.g., jaundice), which in most cases disappeared after discontinuing sulfonylurea derivatives, but in single cases may lead to life-threatening liver failure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects directly to the Department of Medicinal Product Monitoring, 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diaprel MR

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP" (the expiry date stated on the packaging). The expiry date refers to the last day of the month. The batch number on the packaging is the marketing authorization number of the medicine. Store in a temperature below 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Diaprel MR contains

• The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• The other ingredients are calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose, magnesium stearate, colloidal anhydrous silica.

What Diaprel MR looks like and contents of the pack

Diaprel MR is available in the form of white, oblong, modified-release tablets with the marking "DIA 30" on one side and "
" on the other side. Diaprel MR is available in packs containing 60 tablets (2 blisters of 30 tablets) or 90 tablets (5 blisters of 18 tablets or 3 blisters of 30 tablets) in a cardboard box.

Marketing authorization holder and manufacturer

ANPHARM Pharmaceutical Company S.A., Annopol 6B, 03-236 Warsaw

For more information, contact the representative of the marketing authorization holder: Servier Polska Sp. z o.o., phone number: (22) 594-90-00

Date of last revision of the leaflet: