Diaprel Mr

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

DIAPREL MR

60 mg, tablets with modified release

Gliclazide

Before taking the medicine, you should carefully read the contents of the leaflet, 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, you should consult a doctor or pharmacist.
• 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 listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

used
Diaprel MR, tablet with modified release is a medicine that reduces blood sugar levels (contains an oral antidiabetic drug belonging to the group of sulfonylurea derivatives).
Diaprel MR, tablet with modified release 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, tablet with modified release

release

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

Warnings and precautions

Before starting to take Diaprel MR, tablet with modified release, 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 blood sugar levels (and possibly in urine) and also check glycated hemoglobin (HbA1c).
The risk of low blood sugar (hypoglycemia) may be increased during the first few weeks of treatment. For this reason, 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 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,
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 recommended to always carry some sugary products (glucose tablets, sugar cubes). It should be remembered 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 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-adrenergic blockers).
In stressful situations (accidents, surgeries, 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 "Diaprel MR, tablet with modified release 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, tablet with modified release, with medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood sugar) may occur. In this case, the doctor will remind the patient of the importance of monitoring blood glucose 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 breakdown of red blood cells (hemolytic anemia) may occur. Before taking this medicine, you should consult your doctor.
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 other sulfonylurea derivatives.
Diaprel MR, tablet with modified release, is not recommended for use in children due to the lack of data.

Diaprel MR, tablet with modified release, and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, 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 antidiabetic drugs, GLP-1 receptor agonists, or insulin);
• antibiotics (sulfonamides, clarithromycin);
• medicines used to treat high blood pressure or heart failure (beta-adrenergic 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 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 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, tablet with modified release, with medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood sugar) may occur.
Diaprel MR, tablet with modified release, may increase the effect of anticoagulant medicines (warfarin).
You should consult your doctor before taking any other medicine. If you are going to the hospital, you should inform the medical staff that you are taking Diaprel MR, tablet with modified release.

Diaprel MR, tablet with modified release, with food, drink, and alcohol

Diaprel MR, tablet with modified release, 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, tablet with modified release, is not recommended during pregnancy.
If you are pregnant, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
Diaprel MR, tablet with modified release, should not be taken during breastfeeding.

Driving and using machines

If blood glucose 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. You should remember that you may pose 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:

Diaprel MR, tablet with modified release, contains lactose monohydrate

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

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

Dose

This medicine should always be taken as directed by your doctor or pharmacist.
In case of doubts, you should consult your 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 improvement in 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 halves.
Diaprel MR, tablet with modified release, 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). You should swallow half a tablet or whole tablet(s) at once. Do not chew or crush the tablets. You should always eat a meal after taking the tablet(s).
In combination therapy with Diaprel MR, tablet with modified release, and metformin, alpha-glucosidase inhibitor, thiazolidinedione, dipeptidyl peptidase IV inhibitor, GLP-1 receptor agonist, or insulin, the appropriate dose of each medicine will be individually selected by the doctor.
If you notice that your blood sugar levels are high, even though you are taking the medicine as prescribed, you should consult your doctor or pharmacist.

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

In case of taking too many tablets, you should immediately contact your doctor or go to the nearest hospital.
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, you should immediately inform the 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.

Missing a dose of Diaprel MR, tablet with modified release

It is important to take the medicine every day, as regular treatment works better.
However, if you miss a dose of Diaprel MR, tablet with modified release, 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, tablet with modified release

Since diabetes treatment usually lasts a lifetime, you should consult your doctor before stopping this medicine.
Stopping treatment may cause an increase in blood sugar levels (hyperglycemia), which increases the risk of developing diabetes complications.
If you have any further doubts about taking this medicine, you should consult your 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 adverse reaction is low blood sugar (hypoglycemia).
Subjective and objective 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 immediately consult your 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, you should immediately contact your doctor. The symptoms usually disappear after the medicine is discontinued. The doctor will decide whether to stop the treatment.
Skin disorders
Skin reactions, such as rash, redness, itching, hives, blisters, and angioedema (rapid swelling of tissues, such as eyelids, face, lips, mouth, tongue, 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, tablet with modified release, 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 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, throat pain, and fever. These symptoms usually disappear after the treatment is discontinued.
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These symptoms can be reduced by taking Diaprel MR, tablet with modified release, with meals as recommended.
Eye 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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
By reporting side effects, you can help gather more information on the safety of this medicine.

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

The medicine should be stored 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 specified month.
There are no special precautions for storage.
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 packaging and other information

What Diaprel MR, tablet with modified release, contains

• The active substance of the medicine is gliclazide. Each tablet with modified release contains 60 mg of gliclazide.
• The other ingredients are: lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silica.

What Diaprel MR, tablet with modified release, looks like and what the packaging contains

Diaprel MR, tablet with modified release, is available in the form of white, elongated tablets with 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 packaged in cardboard boxes containing 30, 60, and 90 tablets.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, 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

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Lithuanian license number: LT/1/05/0200/017
LT/1/05/0200/019
LT/1/05/0200/020
LT/1/05/0200/022
LT/1/05/0200/024
LT/1/05/0200/026
LT/1/05/0200/027
LT/1/05/0200/029
LT/1/05/0200/030
LT/1/05/0200/031

Parallel import license number: 418/22

This medicinal product is authorized 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
Date of leaflet approval: 28.11.2022
[Information about the trademark]