Diaprel Mr

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

DIAPREL MR (UNI DIAMICRON)

60 mg, modified-release tablets

Gliclazide
DIAPREL MR and UNI DIAMICRON are different trade names for the same medicine.

You should carefully read the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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

What it is used for
Diaprel MR, modified-release tablet, is a medicine that lowers blood sugar levels (contains an oral antidiabetic 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 following a diet, exercising, and losing weight are not enough to maintain a normal blood sugar level.

2. Important information before taking Diaprel MR, modified-release tablet

When not to take 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 from the same group (sulfonylureas), other derivatives (sulfonamides with a hypoglycemic effect);
• if the patient has insulin-dependent diabetes (type 1);
• if the patient has ketone bodies and sugar in the urine (which may indicate diabetic ketoacidosis), pre-coma, or diabetic coma;
• 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 to take Diaprel MR, modified-release tablet, the patient should discuss it with their doctor.
The patient should follow the doctor's recommendations for treatment to achieve proper blood sugar control. This means that, in addition to taking the tablets regularly, the patient should follow a diet, exercise, and, if necessary, lose weight.
During treatment with gliclazide, it is necessary to regularly check blood sugar levels (and possibly urine) and hemoglobin A1c 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:

• the patient takes meals irregularly or skips meals;
• the patient fasts;
• the patient is undernourished;
• the patient changes their diet;
• the patient increases physical activity, and carbohydrate intake is not sufficient;
• the patient consumes alcohol, especially if they skip meals;
• the patient takes other medicines or natural products at the same time;
• the patient takes too high a dose of gliclazide;
• the patient has certain hormonal disorders (thyroid, pituitary, or adrenal disorders);
• kidney or liver function is severely impaired. If the patient has low blood sugar, the following symptoms may occur: headache, strong hunger, nausea, vomiting, fatigue, sleep disturbances, anxiety, aggression, decreased concentration, decreased alertness and reaction time, depression, disorientation, speech or vision disturbances, tremors, sensation disturbances, dizziness, weakness. The following symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain that may radiate (angina pectoris).

If blood sugar levels continue to decrease, severe confusion (delirium), convulsions, loss of self-control, shallow breathing, slow heartbeat, or loss of consciousness may occur.
In most cases, the symptoms of low blood sugar disappear very quickly when the patient consumes some sugar, e.g., glucose tablets, sugar cubes, or a sweet drink. Therefore, the patient should always carry some sugar products with them (glucose tablets, sugar cubes). The patient should remember that artificial sweeteners are not effective. The patient should contact their 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 the patient may not be aware that their blood sugar level has decreased. This can happen when the patient is elderly and taking certain medicines (e.g., those acting on the central nervous system and beta-blockers).
In stressful situations (accidents, surgery, fever, etc.), the doctor may temporarily change the treatment to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur if gliclazide does not decrease blood sugar levels sufficiently, if the patient does not follow the treatment plan recommended by their doctor, if the patient takes products containing St. John's Wort (Hypericum perforatum) (see section "Diaprel MR, modified-release tablet and other medicines"), or in special stressful situations. This may cause thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and decreased activity. If these symptoms occur, the patient should contact their doctor or pharmacist.
When taking Diaprel MR, modified-release tablet, with medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar) may occur. In this case, the doctor will remind the patient of the importance of monitoring blood sugar levels.
If there is a history of congenital glucose-6-phosphate dehydrogenase deficiency (G6PD) in the patient's family or in the patient (abnormal red blood cells), a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur. The patient should consult their 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 other 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 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);
• pain or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may decrease 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 medicines belonging to the group of antibiotics called fluoroquinolones, 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).
The patient should consult their doctor before taking any other medicine.
If the patient is hospitalized, they should inform the 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 drinks.
It is not recommended to drink alcohol, as it may change blood sugar control in an unpredictable way.

Pregnancy and breastfeeding

Diaprel MR, modified-release tablet, is not recommended during pregnancy.
If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Diaprel MR, modified-release tablet, should not be taken during breastfeeding.

Driving and using machines

If blood sugar levels are too low (hypoglycemia) or too high (hyperglycemia), or if vision is disturbed due to abnormal blood sugar levels, the ability to concentrate or react may be impaired. The patient should remember that they may pose a risk to themselves or others (e.g., while driving or operating machines).
The patient should ask their doctor about the possibility of driving:

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

Diaprel MR, modified-release tablet contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult their 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 the doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
The dose is determined by the doctor, depending on 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). The patient should swallow half a tablet or one tablet whole. The patient should not chew or crush the tablets. The patient 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 proper dose of each medicine will be individually determined by the doctor.
If the patient notices that their blood sugar levels are high, even though they are taking the medicine as prescribed, they should consult their doctor or pharmacist.

Taking a higher dose of Diaprel MR, modified-release tablet than recommended

In case of taking too many tablets, the patient should immediately contact their 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 the patient is unconscious, they should immediately inform their doctor and call emergency services. The same applies if someone (e.g., a child) has taken this medicine by accident. Unconscious patients should not be given food or drink.
The patient 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, modified-release tablet

It is essential to take the medicine every day, as regularly taken medicine works better.
However, if the patient forgets to take a dose of Diaprel MR, modified-release tablet, they should take the next dose at the usual time.
The patient 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 a lifetime, the patient should consult their doctor before stopping this medicine.
Stopping treatment may cause high blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, the patient should immediately consult their doctor.
Liver disorders
Single cases of impaired liver function have been observed, which may cause yellowing of the skin and eyes. If these symptoms occur, the patient should immediately contact their doctor. The symptoms usually disappear after the medicine is discontinued. The doctor will decide whether to stop treatment.
Skin disorders
Skin reactions, such as rash, redness, itching, hives, blisters, or angioedema (rapid swelling of tissues, such as eyelids, face, lips, mouth, or throat, which may cause breathing difficulties), have been observed. The rash may develop into widespread blistering or lead to skin peeling. If the patient experiences these symptoms, they should stop taking Diaprel MR, modified-release tablet, and immediately contact their doctor and inform them that they 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 occurred.
Blood disorders
A decrease in the number of blood cells (e.g., platelets, red and white blood cells) may cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear after treatment is discontinued.
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 disturbed, 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 the sulfonylurea derivatives were discontinued, but in single cases may lead to life-threatening liver failure.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Diaprel MR, modified-release tablet

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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, prolonged-release tablet, 15 mm long and 7 mm wide, with a score line and the inscription "DIA 60" on both sides. The tablets are available in blisters packed in cardboard boxes of 30, 60, and 90 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the 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 Pharmaceutical Company S.A.
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.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Belgian marketing authorization number:BE354137

Parallel import authorization number: 271/22

This medicinal product is authorized in the European Economic Area countries 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 leaflet approval: 29.06.2022
[Information about the trademark]