Diaprel Mr

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

DIAPREL MR

60 mg, modified-release tablets

Gliclazide

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should inform 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 packaging 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 antidiabetic drug belonging to the group of sulfonylurea derivatives).
DIAPREL MR, modified-release tablet, is used to treat a certain form 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

release
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 (sulfonylurea derivatives), 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 (this may indicate that the patient has 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 doctor should be consulted.
The doctor's recommendations regarding treatment should be followed 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 also check glycated hemoglobin (HbA1c).
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 meals are skipped;
• the patient takes other medicines or natural products at the same time;
• the patient takes too high a dose of gliclazide;
• the patient has specific hormonal disorders (thyroid, pituitary, or adrenal cortex 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,
impaired concentration, reduced alertness and reaction time, depression, disorientation, speech or vision disorders, tremors, sensory 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, significant confusion (delirium), seizures, 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, it is essential to always carry some sugar products (glucose tablets, sugar cubes). It should be remembered that artificial sweeteners are not effective. The doctor or the nearest hospital should be contacted if sugar consumption does not help or if symptoms recur.
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-adrenolytics).
In stressful situations (accidents, surgical operations, fever, etc.), the doctor may temporarily change the treatment to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may occur if gliclazide does not reduce blood sugar levels sufficiently, if the patient does not follow the treatment plan recommended by the 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 specific 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 antibiotics from the fluoroquinolone group, 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 or their family (abnormal red blood cells), a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia) may occur. The doctor should be consulted 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 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

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The blood sugar-reducing 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-adrenolytics, ACE inhibitors, such as captopril or enalapril);
• medicines used to treat fungal infections (miconazole, fluconazole);
• medicines used to treat stomach or duodenal ulcers (H receptor blockers);
• medicines used to treat depression (MAO inhibitors);
• pain relievers or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may reduce the effect of gliclazide and cause an increase in blood sugar levels:

• 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, rytodrine, terbutaline);
• medicines used to treat breast diseases, heavy menstrual bleeding, and endometriosis (danazol);
• products containing St. John's Wort (Hypericum perforatum).

When taking DIAPREL MR, modified-release tablet, with antibiotics from the fluoroquinolone group, 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 doctor should be consulted before taking any other medicinal product.
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 beverages.
It is not recommended to drink alcohol, as it may change diabetes control in an unpredictable way.

Pregnancy and breastfeeding

DIAPREL MR, modified-release tablet, should not be used 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 used during breastfeeding.

Driving and using machines

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

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

DIAPREL MR, modified-release tablet, contains lactose monohydrate

If the patient has previously 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 according to the doctor's or pharmacist's recommendations.
In case of doubts, the doctor or pharmacist should be consulted.
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 taken with a glass of water during breakfast (preferably at the same time every day). The half tablet or whole tablet(s) should be swallowed whole. The tablets should not be chewed or crushed. A meal should always be eaten 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-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 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 doctor or the nearest hospital should be contacted immediately.
The symptoms of overdose are 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, the doctor and emergency services should be notified immediately. The same procedure should be followed if someone (e.g., a child) has taken this medicine by mistake. Unconscious patients should not be given food or drink.
It is essential to ensure that someone who can call the doctor in case of an emergency is always informed.

Missing a dose of DIAPREL MR, modified-release tablet

It is essential to take the medicine every day, as regular treatment works better.
However, if the patient forgets to take a dose of DIAPREL MR, modified-release tablet, the next dose should be taken at the usual time.
A double dose should not be taken to make up for the missed dose.

Stopping treatment with DIAPREL MR, modified-release tablet

Since diabetes treatment usually lasts a lifetime, the doctor should be consulted before stopping this medicine.
Stopping treatment may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed adverse reaction 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 progress 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 doctor should be notified immediately.
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 doctor should be contacted immediately. 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, 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 the patient experiences these symptoms, they should stop taking DIAPREL MR, modified-release tablet, and urgently contact their doctor and inform them about 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 a meal 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 reactions 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 the sulfonylurea derivatives were discontinued, but in single cases may lead to life-threatening liver failure.

Reporting side effects

If any side effects occur, including any side effects not mentioned in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 side effects will help gather more information on the safety of the medicine.

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

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after the abbreviation "EXP" (abbreviation used to describe the expiry date). The expiry date refers to the last day of the specified month. The abbreviation "Lot" on the packaging indicates the batch number of the medicine.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging 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, anhydrous colloidal silica.

What DIAPREL MR, modified-release tablet, looks like and contents of the packaging

DIAPREL MR, modified-release tablet, is available in the form of white, elongated tablets with a modified release, 15 mm long and 7 mm wide, with a dividing line and the inscription "DIA 60" on both sides. The tablets are available in blisters packed in cardboard boxes of 30 tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Romania, the country of export:

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.
Ul. Annopol 6B,
03-236 Warsaw
Poland

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Number of the marketing authorization in Romania, the country of export: 8054/2015/09
Number of the parallel import authorization: 52/22

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 leaflet approval: 19.01.2022
[Information about the trademark]