Diaprel mr

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
DIAPREL MR
60 mg, modified-release tablets
Gliclazide
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Diaprel MR modified-release tablets are and what they are used for
2. What you need to know before taking Diaprel MR modified-release tablets
3. How to take Diaprel MR modified-release tablets
4. Possible side effects
5. How to store Diaprel MR modified-release tablets
6. Contents of the pack and other information

1. What Diaprel MR modified-release tablets are and what they are used for

Diaprel MR modified-release tablets are a blood glucose-lowering agent (containing an oral antidiabetic drug belonging to the sulfonylurea derivatives group). Diaprel MR modified-release tablets are used in the treatment of a certain type of diabetes (type 2 diabetes) in adults when diet, physical exercise, and weight reduction alone are insufficient to maintain adequate blood glucose control.

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

When not to use 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 of the same group (sulfonylurea derivatives), or other sulfonamides with blood glucose-lowering activity;
• if the patient has insulin-dependent diabetes (type 1);
• if ketones and sugar are present in the urine (which may indicate that the patient has ketoacidosis), pre-comatose states 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 treatment with Diaprel MR, modified-release tablet,
discuss this with your doctor.
You must follow your doctor's advice regarding treatment to achieve proper blood glucose levels.
This means that in addition to taking the tablets regularly, you should follow a diet, engage in physical exercise, and, if necessary, reduce body weight.
During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) and measurement of glycated hemoglobin (HbA1c) are required.
The risk of low blood glucose (hypoglycemia) may be increased during the first weeks of treatment.
Therefore, careful medical supervision is particularly necessary.
Low blood glucose (hypoglycemia) may occur if:

• the patient eats irregularly or skips meals;
• the patient is fasting;
• the patient is undernourished;
• the patient changes their diet;
• the patient increases physical activity without adequate carbohydrate intake;
• the patient consumes alcohol, especially when skipping meals;
• the patient is taking other medicines or natural supplements at the same time;
• the patient takes too high a dose of gliclazide;
• the patient has certain hormonal disorders (thyroid, pituitary or adrenal cortex dysfunction);
• kidney or liver function is severely impaired.

If the patient has low blood glucose, the following symptoms may occur:
headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression,
reduced concentration, decreased alertness and reaction time, depression, disorientation,
speech or vision disturbances, tremor, sensory disturbances, dizziness, weakness.
Other symptoms may also occur: sweating, clammy skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden, severe chest pain radiating (angina pectoris).
If blood glucose continues to drop, severe confusion (delirium), seizures, loss of self-control, shallow breathing, slow heartbeat, or loss of consciousness may occur.
In most cases, symptoms of low blood glucose disappear quickly when the patient consumes some sugar, e.g., glucose tablets, sugar lumps, sweet juice, or sweetened tea. Therefore, it is important to always carry some sugary products (glucose tablets, sugar lumps). Note that artificial sweeteners are not effective.
Contact your doctor or nearest hospital if consuming sugar does not help or if symptoms recur.
Symptoms of low blood glucose may not appear, may be mild or develop very slowly, or the patient may not be aware that blood glucose has dropped. This may happen when the patient is elderly or taking certain medicines (e.g., acting on the central nervous system and beta-blockers).
In stressful situations (accidents, surgical operations, fever, etc.), your doctor may temporarily switch treatment to insulin therapy.
Symptoms of high blood glucose (hyperglycemia) may occur when gliclazide has not sufficiently lowered blood glucose, if the patient has not followed the treatment plan recommended by the doctor, if the patient is taking preparations containing St. John's wort (Hypericum perforatum) (see section "Diaprel MR, modified-release tablet and other medicines"), or during particularly stressful situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections, and reduced activity.
If these symptoms occur, the patient must contact their doctor or pharmacist.
When gliclazide is used concomitantly with medicines belonging to the group of antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood glucose) may occur. In this case, the doctor will remind the patient of the importance of monitoring blood glucose levels.
If a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells) has been diagnosed in the patient or in a family member, a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia) may occur. Before taking this medicinal product, consult your doctor.
Cases of porphyria exacerbation have been reported in patients with porphyria (a hereditary genetic disorder characterized by accumulation of porphyrins or their precursors in the body) after administration of certain other sulfonylurea derivatives.
Diaprel MR, modified-release tablet is not recommended for use in children due to lack of data.

Diaprel MR, modified-release tablet and other medicines
Inform 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 glucose-lowering effect of gliclazide may be enhanced, and symptoms of low blood glucose may occur, when one of the following medicines is taken:

• other medicines used to treat high blood glucose (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);
• painkillers or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may reduce the effect of gliclazide and cause increased blood glucose:

• medicines used to treat central nervous system disorders (chlorpromazine);
• anti-inflammatory medicines (corticosteroids);
• medicines used to treat asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline);
• medicines used to treat breast diseases, severe menstrual bleeding, and endometriosis (danazol);
• preparations containing St. John's wort (Hypericum perforatum).

When Diaprel MR is used concomitantly with antibiotics called fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood glucose) may occur.
Diaprel MR, modified-release tablet may enhance the effect of anticoagulant medicines (warfarin).
Consult your doctor before starting any other medicinal product. If you go to hospital, 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 drinks.
Drinking alcohol is not recommended, as it may alter diabetes control in an unpredictable way.

Pregnancy and breastfeeding
Diaprel MR, modified-release tablet is not recommended during pregnancy. If the patient is pregnant, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Diaprel MR, modified-release tablet must not be used during breastfeeding.

Driving and operating machinery
If blood glucose is too low (hypoglycemia) or too high (hyperglycemia), or if vision disturbances occur due to abnormal blood glucose levels, the ability to concentrate or react may be impaired.
Keep in mind that the patient may pose a risk to themselves or others (e.g., when driving a car or operating machinery). Ask your doctor about the possibility of driving:

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

Diaprel MR, modified-release tablet contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

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

Dosage
This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The dosage is determined by the doctor according to blood and urine glucose levels.
Any changes in external factors (weight loss, change in lifestyle, stress) or improvement in blood glucose control may require adjustment of gliclazide dosage.
The recommended daily dose ranges from half a tablet to two tablets (maximum 120 mg), taken once with breakfast. The dose depends on the body's response to treatment. The tablet may be divided in half.
Diaprel MR, modified-release tablet, is intended for oral use. The tablet(s) should be taken with a glass of water at breakfast time (preferably at the same time every day). Swallow half or the whole tablet whole, do not chew or crush. Always eat a meal after taking the tablet(s).
When Diaprel MR, modified-release tablet, is used in combination with 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 high blood glucose levels despite taking the medicine as prescribed, they should consult their doctor or pharmacist.

Taking more Diaprel MR, modified-release tablet than prescribed
If too many tablets have been taken, contact a doctor immediately or go to the nearest hospital.
Symptoms of overdose are those of low blood glucose (hypoglycaemia), as described in section 2.
In such cases, eating sugar (4 to 6 sugar cubes) or drinking a sugary drink, followed by a snack or meal, may help. If the patient is unconscious, contact a doctor immediately and call emergency services. The same action should be taken if someone (e.g. a child) accidentally takes this medicine. Do not give food or drink to unconscious patients.
Ensure that someone close is always informed and able to contact a doctor in case of an emergency.

Missed dose of Diaprel MR, modified-release tablet
It is important to take the medicine every day, as regular use ensures better effectiveness. However, if a patient forgets to take a dose of Diaprel MR, modified-release tablet, they should take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping Diaprel MR, modified-release tablet
As diabetes treatment usually lasts a lifetime, consult your doctor before stopping this medicine.
Discontinuing treatment may lead to increased blood glucose levels (hyperglycaemia), increasing the risk of diabetes-related complications.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

The most commonly observed adverse effect is low blood sugar (hypoglycaemia). 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 hypoglycaemia is significant or prolonged, even if temporarily controlled by sugar intake, you should contact your doctor immediately.

Liver disorders
Isolated cases of impaired liver function have been observed, which may cause yellowing of the skin and eyes (jaundice).
If these symptoms occur, contact your doctor immediately. Symptoms usually resolve after discontinuation of the medicine. Your doctor will decide whether treatment should be stopped.

Skin disorders
Skin reactions such as rash, redness, itching, urticaria, blisters, and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat, which may cause breathing difficulties) have been observed. The rash may progress to extensive blistering or lead to skin peeling.
If any of these symptoms occur, stop taking Diaprel MR and contact your doctor urgently, informing them that you are taking this medicine.

Rarely, symptoms of severe hypersensitivity reactions (DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms) have been reported: initially presenting as influenza-like symptoms and facial rash, which then spreads, accompanied by high fever.

Blood disorders
Reduction in blood cell counts (e.g. platelets, red and white blood cells) may cause pallor, prolonged bleeding, bruising, sore throat and fever. These symptoms usually resolve after stopping treatment.

Gastrointestinal disorders
Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea and constipation. These symptoms may be reduced by taking Diaprel MR, modified release tablet, with food as recommended.

Eye disorders
Vision disturbances may occur, especially at the beginning of treatment. This effect is related to changes in blood glucose levels.

As with other sulphonylurea derivatives, the following adverse events have been observed:

• significant blood cell count abnormalities,
• allergic vasculitis,
• decreased sodium concentration in blood (hyponatraemia),
• signs of liver damage (e.g. jaundice), which in most cases resolved after discontinuation of sulphonylurea derivatives; however, in isolated cases, these may lead to life-threatening liver failure.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diaprel MR, modified release tablet

Keep this medicine out of the 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 stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Diaprel MR, modified-release tablet contains

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

What Diaprel MR, modified-release tablet looks like and contents of the pack
Packaging
Diaprel MR is available as white, elongated modified-release tablets, 15 mm long and 7 mm wide, with a central dividing score line and engraved markings “DIA 60” on both sides. The tablets are available in blisters packed in cardboard boxes containing 30, 60 or 90 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Romania, the country of export:
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer:
Servier (Ireland) Industries Ltd.
Gorey Road
Arklow – Co. Wicklow
Ireland
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
Anpharm Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B
03-236 Warsaw
Poland

Parallel Importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czesky Tesin
Czech Republic

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków

Marketing Authorisation Number in Romania, the country of export: 8054/2015/09
Parallel Import Authorisation Number: 426/22

This medicinal product is authorised for sale 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