Symazide mr 30

Package leaflet: Information for the user

Symazide MR 30 mg, 30 mg, modified-release tablets
Gliclazide
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please 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, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Symazide MR 30 mg is and what it is used for
2. What you need to know before taking Symazide MR 30 mg
3. How to take Symazide MR 30 mg
4. Possible side effects
5. How to store Symazide MR 30 mg
6. Contents of the pack and other information

1. What Symazide MR 30 mg is and what it is used for

Symazide MR 30 mg is a blood glucose-lowering agent (an oral antidiabetic drug belonging to the sulfonylurea derivatives group).
Symazide MR 30 mg is 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 Symazide MR 30 mg

When not to use Symazide MR 30 mg:

• if the patient is allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), or to other medicines of the same group (sulfonylurea derivatives), or to other similar medicines (hypoglycaemic sulfonamides);
• if the patient has insulin-dependent diabetes (type 1);
• if the patient has ketones 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 "Symazide MR 30 mg and other medicines");
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Symazide MR 30 mg, discuss this with your doctor.
The patient should follow the doctor's recommendations regarding treatment to achieve proper blood glucose levels. This means that in addition to taking the tablets regularly, the patient should adhere to a diet, perform physical exercise, and, if necessary, reduce body weight.
During treatment with gliclazide, regular monitoring of blood glucose (and possibly urine glucose) as well as glycated hemoglobin (HbA1c) levels is necessary.
During the first few weeks of treatment, the risk of low blood glucose (hypoglycaemia) may be increased. Therefore, particularly close medical supervision is essential.
Low blood glucose (hypoglycaemia) 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 remedies at the same time;
• the patient takes too high a dose of gliclazide;
• the patient has certain diseases caused by hormonal disorders (dysfunctions of the thyroid gland, pituitary gland, or adrenal cortex);
• kidney or liver function is severely impaired.

If the patient experiences low blood glucose, the following symptoms may occur: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, impaired concentration, reduced alertness and reaction time, depression, disorientation, speech or vision disturbances, trembling, sensory disturbances, dizziness, weakness.
Additional symptoms may include: sweating, clammy skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain radiating to adjacent areas (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 resolve rapidly after consuming sugar, e.g., glucose tablets, sugar cubes, sweet juice, or sweet tea.
Therefore, the patient should always carry sugar-containing products (glucose tablets, sugar cubes). Note that artificial sweeteners are ineffective. Contact your doctor or nearest hospital if sugar intake does not help or if symptoms recur.
Symptoms of low blood glucose may not occur, may go unnoticed by the patient, may develop slowly, or the patient may not be aware that blood glucose has decreased. This may happen if the patient is elderly or taking certain medications (e.g., those acting on the central nervous system and beta-blockers). In stressful situations (e.g., accident, surgery, fever, etc.), the doctor may temporarily switch treatment to insulin therapy.
Symptoms of high blood glucose (hyperglycaemia) may occur if 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 "Symazide MR 30 mg and other medicines"), or during particularly stressful situations. Symptoms may include: thirst, frequent urination, dry mouth, dry itchy skin, skin infections, and reduced activity.
If any of the above symptoms occur, the patient must contact their doctor or pharmacist.
When gliclazide is used concomitantly with antibiotics known as fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood glucose) may occur. In such cases, the doctor will remind the patient of the importance of monitoring blood glucose levels.
If a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell disorder) has been diagnosed in the patient or in a family member, haemolytic anaemia (decreased haemoglobin and destruction of red blood cells) may occur.
Before using this medicine, consult your doctor.
In patients with porphyria (a hereditary genetic disorder involving accumulation of porphyrins or their precursors in the body), cases of porphyria exacerbation have been reported after using certain other sulfonylurea derivatives.

Children and adolescents
Use of Symazide MR 30 mg is not recommended in children due to insufficient data.

Symazide MR 30 mg and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
The following medicines may enhance the blood glucose-lowering effect of gliclazide and may cause symptoms of low blood glucose:

• other medicines used to treat high blood glucose (oral antidiabetic agents, 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 peptic ulcer disease (H2-receptor blockers);
• medicines used to treat depression (monoamine oxidase inhibitors);
• painkillers or anti-rheumatic medicines (phenylbutazone, ibuprofen);
• medicines containing alcohol.

The following medicines may reduce the effect of gliclazide and lead to increased blood glucose levels:

• medicines used to treat central nervous system disorders (chlorpromazine);
• anti-inflammatory medicines (corticosteroids);
• medicines used to treat asthma or 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 Symazide MR 30 mg is used concomitantly with antibiotics known as fluoroquinolones, especially in elderly patients, disturbances in blood glucose levels (low and high blood glucose) may occur.
Symazide MR 30 mg may enhance the effect of anticoagulant medicines (e.g., warfarin).
Consult your doctor before starting any new medicine.
If the patient is admitted to hospital, they should inform medical staff that they are taking Symazide MR 30 mg.

Symazide MR 30 mg with food, drink, and alcohol
Symazide MR 30 mg can be taken with food and non-alcoholic beverages.
Alcohol consumption is not recommended, as it may unpredictably affect diabetes control.

Pregnancy and breastfeeding
Use of Symazide MR 30 mg is not recommended during pregnancy. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
Symazide MR 30 mg must not be used during breastfeeding.

Driving and operating machinery
If blood glucose is too low (hypoglycaemia) or too high (hyperglycaemia), or if vision disturbances occur due to abnormal blood glucose levels, the ability to concentrate or react may be impaired. Remember that the patient may pose a risk to themselves or others (e.g., while driving a car or operating machinery).
Ask your doctor whether it is safe to drive:

• if low blood glucose (hypoglycaemia) occurs frequently;
• if there are few or no symptoms of low blood glucose (hypoglycaemia).

Symazide MR 30 mg contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Symazide MR 30 mg

Dosage
This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The doctor determines the dosage according to blood and urine glucose levels.
Changes in external factors (e.g. weight loss, lifestyle changes, stress) as well as improved control of blood glucose levels may require adjustment of gliclazide dosage.
The recommended daily dose ranges from one to four tablets (maximum 120 mg), taken once during breakfast. The number of tablets depends on the patient's response to treatment.
In combination therapy with Symazide MR 30 mg 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 high blood glucose levels despite taking the medicine as prescribed, they should consult a doctor or pharmacist.

Route and method of administration
Oral administration.
The tablets should be swallowed whole. Do not chew or crush them.
The tablet(s) should be taken with a glass of water at breakfast time (preferably at the same time every day).
After taking the tablet(s), the patient must always eat a meal.

Overdose of Symazide MR 30 mg
In case of taking too many tablets, contact a doctor immediately or go to the nearest hospital. Symptoms of overdose are those of low blood sugar (hypoglycaemia), as described in section 2. In such cases, eating sugar (4 to 6 sugar cubes) or drinking a sweet beverage, followed by a snack or meal, may help. If the patient is unconscious, contact a doctor immediately and call emergency services. The same applies in case of accidental ingestion, for example by a child. Do not give food or drinks to unconscious patients.
The patient should inform another person about their condition so that, if necessary, they can seek medical help.

Missed dose of Symazide MR 30 mg
It is important to take the medicine every day, as it works better when taken regularly.
However, if the patient forgets to take a dose of Symazide MR 30 mg, they should take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Symazide MR 30 mg
Diabetes treatment usually lasts a lifetime; therefore, consult a doctor before stopping this medicine. Discontinuing treatment may lead to increased blood glucose levels (hyperglycaemia), increasing the risk of diabetes complications.
If there are any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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 not treated, they may progress to drowsiness, loss of consciousness or coma.
If low blood sugar is severe or prolonged, even if temporarily controlled by sugar intake, medical advice should be sought immediately.

Liver disorders
Isolated cases of liver function disorders have been observed, which may cause yellowing of the skin and eyes (jaundice). In the event of these symptoms, consult a doctor immediately.
Symptoms usually resolve after discontinuation of the medicine. The doctor will decide whether treatment should be discontinued.

Skin disorders
Skin reactions observed include:

• rash,
• redness,
• itching,
• urticaria,
• blisters,
• angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat, which may cause difficulty breathing). The rash may progress to extensive blistering lesions or lead to skin peeling. If any of these symptoms occur, treatment with Symazide MR 30 mg should be discontinued immediately and urgent medical advice sought, informing the doctor about use of 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 a facial rash, which then spreads, accompanied by high fever.

Blood disorders
Decreased numbers of blood cells (e.g. platelets, red and white blood cells), which may cause:

• pale skin,
• prolonged bleeding,
• bruising,
• sore throat,
• fever. These symptoms usually resolve after stopping treatment.

Gastrointestinal disorders

• abdominal pain,
• nausea,
• vomiting,
• dyspepsia,
• diarrhoea,
• constipation. These symptoms may be reduced by taking Symazide MR 30 mg with food, as recommended.

Eye disorders
Transient visual disturbances may occur, especially at the beginning of treatment. These symptoms are related to changes in blood glucose levels.

As with other sulfonylurea derivatives, the following adverse events have been observed: cases of marked blood cell count changes and allergic vasculitis, hyponatraemia (low blood sodium levels), and signs of liver damage (e.g. jaundice), which in most cases resolved after discontinuation of sulfonylurea treatment, but in rare cases 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 Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Symazide MR 30 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Symazide MR 30 mg contains

• The active substance is gliclazide. One tablet contains 30 mg of gliclazide in the form of a modified-release tablet.
• The other ingredients are: monohydrate lactose, hypromellose, magnesium stearate.

What Symazide MR 30 mg looks like and contents of the pack
Symazide MR 30 mg is a white, oval, biconvex tablet, embossed with "GLI 30" on one side and smooth on the other.
The tablets are available in blisters packed in cardboard boxes containing 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
e-mail: [email protected]

Manufacturer/Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Symazide MR 30 mg