DIAMICRON 30 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. DIAMICRON 30 mg
3. 30 mg, tablets with modified release
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Diamicron 30 mg and what is it used for
5. Important information before taking Diamicron 30 mg
   1. When not to take Diamicron 30 mg:
   2. Warnings and precautions
   3. Children and adolescents
   4. Diamicron 30 mg and other medicines
   5. Diamicron 30 mg with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Diamicron 30 mg
   1. Dose
   2. Taking a higher dose of Diamicron 30 mg than recommended
   3. Missing a dose of Diamicron 30 mg
   4. Stopping treatment with Diamicron 30 mg
7. Possible side effects
   1. Reporting side effects
8. How to store Diamicron 30 mg
9. Contents of the packaging and other information
   1. What Diamicron 30 mg contains
   2. What Diamicron 30 mg looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the countries of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

DIAMICRON 30 mg

30 mg, tablets with modified release

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 specifically for you, 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 Diamicron 30 mg and what is it used for
• 2. Important information before taking Diamicron 30 mg
• 3. How to take Diamicron 30 mg
• 4. Possible side effects
• 5. How to store Diamicron 30 mg
• 6. Contents of the packaging and other information

1. What is Diamicron 30 mg and what is it used for

Diamicron 30 mg is a medicine that reduces blood sugar levels (it is an oral antidiabetic medicine belonging to the sulfonylurea group).
Diamicron 30 mg is used to treat a certain type of diabetes (type 2 diabetes) in adults, when diet, physical exercise, and weight loss alone are not sufficient to maintain normal blood sugar levels.

2. Important information before taking Diamicron 30 mg

When not to take Diamicron 30 mg:

• 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 hypoglycemic action);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this may indicate that you have 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 "Diamicron 30 mg and other medicines");
• if you are breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting to take Diamicron 30 mg, 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).
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:

• you take 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 gland 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 drop, 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 drink a sweet juice or sweetened tea.
Therefore, you should always carry some sugary products with you (e.g., 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.
The symptoms of low blood sugar may not appear, may be mild, or may develop very slowly, or you may not be aware that your blood sugar levels have dropped. 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, surgeries, fever, etc.), your doctor may temporarily change your treatment to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) may 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 "Diamicron 30 mg 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 you experience these symptoms, you should contact your doctor or pharmacist.
When taking Diamicron 30 mg 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 how important it is to monitor your blood sugar levels.
If you or a family member has been diagnosed with a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells), a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia) may occur. You should consult your doctor 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 worsening porphyria have been reported after taking certain sulfonylurea derivatives.

Children and adolescents

Diamicron 30 mg is not recommended for use in children due to a lack of data.

Diamicron 30 mg 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-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 medicines, 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);
• analgesic 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 diseases, heavy menstrual bleeding, and endometriosis (danazol);
• products containing St. John's Wort (Hypericum perforatum) .

When taking Diamicron 30 mg with fluoroquinolone antibiotics, especially in elderly patients, disturbances in blood sugar levels (low and high blood sugar) may occur.
Diamicron 30 mg may increase the effect of anticoagulant medicines (warfarin).
You should consult your doctor before starting to take another medicinal product.
If you are going to the hospital, you should inform the medical staff that you are taking Diamicron 30 mg.

Diamicron 30 mg with food, drink, and alcohol

Diamicron 30 mg can be taken with food and non-alcoholic beverages.
It is not recommended to drink alcohol, as it may change your diabetes control in an unpredictable way.

Pregnancy and breastfeeding

Diamicron 30 mg should not be used during pregnancy. If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
Diamicron 30 mg 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 as a result of abnormal blood sugar levels, your ability to concentrate or react may be impaired. 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:

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

3. How to take Diamicron 30 mg

Dose

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the dose based on your 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 one to four tablets (maximum 120 mg), taken orally in a single dose during breakfast. The dose depends on the body's response to treatment.
Diamicron 30 mg 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 tablets should be swallowed whole. Do not chew them.
You should always eat a meal after taking the tablet(s).
In combination therapy with Diamicron 30 mg and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, the correct 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 Diamicron 30 mg 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 emergency services. You should do the same 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 in advance.

Missing a dose of Diamicron 30 mg

It is important to take the medicine every day, as regular treatment works better.
However, if you forget to take a dose of Diamicron 30 mg, you should take the next dose at the usual time.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Diamicron 30 mg

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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diamicron 30 mg 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 may cause yellowing of the skin and eyes. If you experience these symptoms, you should immediately contact your doctor. The symptoms usually disappear after the medicine is discontinued. Your 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, or throat, which may 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 Diamicron 30 mg 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 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 the treatment is discontinued.
Gastrointestinal disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea, and constipation. These symptoms can be reduced by taking Diamicron 30 mg with a meal 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 sulfonylureas, 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 the sulfonylurea was discontinued, 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, please inform your doctor or pharmacist. You can report side effects 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
You can also report side effects 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 Diamicron 30 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP" (expiry date). The expiry date refers to the last day of the month.
The batch number on the packaging is the marketing authorization number of the medicine.
There are no special precautions for storing the medicine.
Medicines should 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 Diamicron 30 mg contains

• The active substance of the medicine is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• The other ingredients are: calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose 100 cP, hypromellose 4000 cP, magnesium stearate, colloidal anhydrous silica.

What Diamicron 30 mg looks like and contents of the pack

Diamicron 30 mg is available in the form of white, oblong tablets with modified release, with the inscription "DIA 30" on one side and "
" on the other side. The tablets are available in blisters packed in cardboard boxes containing 60 or 90 tablets.

Marketing authorization holder

Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer

Les Laboratoires Servier Industrie (LSI)
905 route de Saran
45520 Gidy
France
Servier (Ireland) Industries Ltd (SII)
Gorey Road Arklow, Co. Wicklow
Ireland
ANPHARM Pharmaceutical Company S.A.
Annopol 6 B
03-236 Warsaw
To obtain detailed information, please 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 30 mg
Belgium
UNI DIAMICRON
Cyprus
DIAMICRON MR 30 mg
Czech Republic
DIAPREL MR
Denmark
DIAMICRON UNO 30 mg
Estonia
DIAPREL MR
France
DIAMICRON 30 mg
Greece
DIAMICRON MR
Hungary
DIAPREL MR
Iceland
DIAMICRON UNO 30 mg
Ireland
DIAMICRON MR 30 mg
Italy
DIAMICRON 30 mg
Lithuania
DIAPREL MR
Luxembourg
DIAMICRON 30 mg
Netherlands
DIAMICRON MR 30 mg
Poland
DIAMICRON 30 mg
Portugal
DIAMICRON LM 30 mg
Slovakia
DIAPREL MR
Slovenia
DIAPREL MR
Spain
DIAMICRON 30 mg
United Kingdom
DIAMICRON 30 mg MR

Date of last revision of the leaflet: