Diaprel Mr

Leaflet attached to the packaging: patient information

DIAPREL MR

60 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, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Diaprel MR, modified-release tablet and what is it 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 is Diaprel MR, modified-release tablet and what is it used for

to take
Diaprel MR, modified-release tablet is a medicine that reduces blood sugar levels (contains an oral anti-diabetic drug belonging to the sulfonylurea group).
Diaprel MR, modified-release tablet 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, modified-release tablet

to take
When not to take Diaprel MR, modified-release tablet:

• 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 with a hypoglycemic effect);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (which may indicate 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, modified-release tablet and other medicines");
• if you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to take Diaprel MR, modified-release tablet, 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) can 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,
impaired concentration, reduced alertness and reaction time, depression, disorientation, speech or vision disorders, 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), convulsions, 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 (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 recur.
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, surgery, fever, etc.), your doctor may temporarily change your treatment to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) can occur if gliclazide does not reduce your blood sugar levels sufficiently, if you do not follow your doctor's recommended treatment plan, if you take products containing St. John's Wort (Hypericum perforatum) (see section "Diaprel MR, modified-release tablet and other medicines"), or in certain stressful situations. This can cause thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased activity.
If you experience these symptoms, you should contact your doctor or pharmacist.
When taking Diaprel MR, modified-release tablet with fluoroquinolone antibiotics, especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar) may occur. In this case, your doctor will remind you of the importance of monitoring your blood sugar levels.
If you or a family member have been diagnosed with a deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells), you may experience a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia). You should contact your doctor before taking this medicine.
In patients with porphyria (a genetic disorder characterized by the accumulation of porphyrins or their precursors in the body), cases of porphyria exacerbation have been reported after taking certain sulfonylurea derivatives.
Diaprel MR, modified-release tablet is not recommended for use in children due to the lack of data.

Diaprel MR, modified-release tablet 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 symptoms of low blood sugar may occur when taking one of the following medicines:

• other medicines used to treat high blood sugar (oral anti-diabetic 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 antagonists);
• 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 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 disorders, heavy menstrual bleeding, and endometriosis (danazol);
• products containing St. John's Wort (Hypericum perforatum).

When taking Diaprel MR, modified-release tablet with fluoroquinolone antibiotics, especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar) may occur.
Diaprel MR, modified-release tablet may increase the effect of anticoagulant medicines (warfarin).
You should consult your doctor before taking any other medicine.
If you are hospitalized, you should inform the medical staff that you 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.
It is not recommended to drink alcohol, as it may affect blood sugar control in an unpredictable way.

Pregnancy and breastfeeding

Diaprel MR, modified-release tablet should not be used during pregnancy.
If you are pregnant, think you may be pregnant, or plan to have a baby, you should consult your doctor before taking this medicine.
Diaprel MR, modified-release tablet should not be used during breastfeeding.

Driving and using machines

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

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

Diaprel MR, modified-release tablet contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Diaprel MR, modified-release tablet

Dose

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
If you are unsure, you should consult your doctor or pharmacist.
The dose is determined by your doctor, depending on your blood sugar levels and urine tests.
Any changes related to external factors (weight loss, lifestyle changes, stress) or improved blood sugar control may require changes in gliclazide doses.
The recommended daily dose is from half a tablet to two tablets (maximum 120 mg), taken once during breakfast. The dose depends on the body's response to treatment.
The tablet can be divided into two halves.
Diaprel MR, modified-release tablet 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). You should swallow half a tablet or one tablet whole. Do not chew or crush the tablets. You should 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-4 inhibitor, a GLP-1 receptor agonist, or insulin, the appropriate dose of each medicine will be individually determined 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, modified-release tablet 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 for emergency assistance. 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 ensure that someone who can call a doctor in case of an emergency is always informed beforehand.

Missing a dose of Diaprel MR, modified-release tablet

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

Stopping treatment with Diaprel MR, modified-release tablet

Since diabetes treatment usually lasts for the rest of your life, you should consult your doctor before stopping this treatment.
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, you should contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diaprel MR, modified-release tablet can cause side effects, although not everybody gets them.
The most commonly observed side effect is low blood sugar (hypoglycemia).
Subjective and objective symptoms are described in the section "Warnings and precautions".
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 immediately consult your doctor.
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 discontinue treatment.
Skin disorders
Skin reactions, such as rash, redness, itching, hives, blisters, and 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 blistering or lead to skin peeling.
If you experience these symptoms, you should stop taking Diaprel MR, modified-release tablet and immediately contact your doctor and inform them that you are taking this medicine.
Exceptionally, symptoms of severe hypersensitivity reactions (DRESS, Drug Rush 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) can cause pallor, prolonged bleeding, bruising, sore throats, and fever. These symptoms usually disappear after discontinuing treatment.
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These symptoms can be reduced by taking Diaprel MR, modified-release tablet with food as recommended.
Eyes disorders
Vision may be impaired, 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:
cases of significant changes in blood cell counts and allergic vasculitis, decreased sodium levels in the blood (hyponatremia), symptoms 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 inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported 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, modified-release tablet

Medicines should be kept 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 is the last day of the month). The batch number is stated on the packaging as "Lot".
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Diaprel MR, modified-release tablet contains

• The active substance of the medicine is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The 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, modified-release tablet is a white, oblong tablet with a modified release, 15 mm long and 7 mm wide, with a score line and the imprint "DIA 60" on both sides. The tablets are available in blisters packaged in cardboard boxes containing 30, 60, and 90 tablets.

Marketing authorization holder

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 Pharmaceutical Company S.A.
Annopol 6 B
03-236 Warsaw
LABORATORIOS SERVIER S.L.
Avenida de Los Madroños, 33
28043 Madrid
Spain
To obtain detailed information, you should contact the representative of the marketing authorization holder:
Servier Polska Sp. z o.o.
Phone: (22) 594-90-00

This medicinal product is authorized in the countries of 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

Date of last revision of the leaflet: