Symazide mr 60 mg

Package leaflet: Information for the user

Symazide MR 60 mg, 60 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, 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.

Contents of the leaflet

1. What Symazide MR 60 mg is and what it is used for
2. What you need to know before you take Symazide MR 60 mg
3. How to take Symazide MR 60 mg
4. Possible side effects
5. How to store Symazide MR 60 mg
6. Contents of the pack and other information

1. What Symazide MR 60 mg is and what it is used for

Symazide MR 60 mg is a blood glucose-lowering agent (an oral antidiabetic drug belonging to the sulfonylurea derivatives group).
Symazide MR 60 mg is used in the treatment of a certain form of diabetes (type 2 diabetes) in adults, when diet, physical exercise, and weight reduction alone are insufficient to maintain normal blood glucose levels.

2. Important information before using Symazide MR 60 mg

When not to use Symazide MR 60 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 (hypoglycemic sulfonamides);
• if the patient has insulin-dependent diabetes (type 1 diabetes);
• 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 60 mg and other medicines");
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Symazide MR 60 mg, discuss this with your doctor.
The patient should follow the doctor's recommendations for 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) is necessary.
During the first few weeks of treatment, the risk of low blood glucose (hypoglycemia) may be increased. Therefore, close medical supervision is particularly important.
Low blood glucose (hypoglycemia) may occur if:

• the patient eats irregularly or skips meals;
• the patient is fasting;
• the patient is malnourished;
• 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 hormonal disorders (thyroid, pituitary or adrenal cortex dysfunction);
• 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,
reduced concentration, decreased alertness and reaction time, depression, disorientation, speech or
visual disturbances, trembling, 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 to adjacent areas (angina pectoris).
If blood glucose continues to fall, significant 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 quickly after consuming sugar (e.g. glucose tablets, sugar cubes, sweet juice or sweetened tea).
Therefore, the patient should always carry sugar-containing products (glucose tablets, sugar cubes). Note that artificial sweeteners are ineffective. Contact a doctor or the 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 very slowly, or the patient may not be aware that blood glucose has decreased. This may happen when the patient is elderly and taking certain medications (e.g. those acting on the central nervous system and beta-blockers).
In stressful situations (accident, surgery, fever, etc.), the doctor may temporarily switch treatment to insulin therapy.
Symptoms of high blood glucose (hyperglycemia) may occur if gliclazide does not sufficiently lower blood glucose, if the patient does not follow the treatment plan recommended by the doctor, if the patient takes preparations containing St. John's wort (Hypericum perforatum) (see section "Symazide MR 60 mg and other medicines"), or in particularly stressful situations. Symptoms may include: thirst, frequent urination, dry mouth, dry, itchy skin, skin infections, and reduced activity.
If these symptoms occur, the patient must contact a doctor or pharmacist.
When gliclazide is taken concomitantly with antibiotics belonging to the fluoroquinolone group, 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) (abnormal red blood cells) has been diagnosed in the patient or a family member, hemoglobin levels may decrease and red blood cells may break down (hemolytic anemia). Consult a doctor before using this medicine.
In patients with porphyria (a hereditary genetic disorder characterized by 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
Symazide MR 60 mg is not recommended for use in children due to insufficient data.

Symazide MR 60 mg and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 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 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 may cause increased blood glucose:

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

When Symazide MR 60 mg is taken concomitantly with antibiotics belonging to the fluoroquinolone group, especially in elderly patients, disturbances in blood glucose levels (low and high blood glucose) may occur.
Symazide MR 60 mg may enhance the effect of anticoagulant medicines (warfarin).
Consult your doctor before starting any other medicine.
If the patient is admitted to hospital, they should inform the medical staff that they are taking Symazide MR 60 mg.

Symazide MR 60 mg with food, drink and alcohol
Symazide MR 60 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
Symazide MR 60 mg is not recommended during pregnancy. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Symazide MR 60 mg 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. The patient should be aware that they may pose a risk to themselves or others (e.g. when driving a car or operating machinery).
Ask your doctor whether you may drive:

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

Symazide MR 60 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 60 mg

Dosage
This medicine should always be taken as directed by a doctor or pharmacist. In case of
doubt, consult a doctor or pharmacist.
The dosage is determined by the doctor, depending on blood and urine glucose levels.
Changes in external factors (weight loss, lifestyle changes, stress) or improved blood glucose control may require adjustment of the gliclazide dose.
The recommended daily dose is from half a tablet to two 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 60 mg and metformin, an alpha-glucosidase inhibitor, thiazolidinedione, dipeptidyl peptidase-IV inhibitor, GLP-1 receptor agonist, or insulin, the appropriate dosage of each medicine will be individually determined by the doctor.
If the patient notices that blood glucose levels are too high despite taking the medicine as prescribed, they should consult a doctor or pharmacist.

Route and method of administration
Oral administration.
Swallow half or one whole tablet without crushing or chewing. The tablet may be divided into equal doses.
The tablet(s) should be taken with a glass of water at breakfast time (preferably every day at the same time).
After taking the tablet(s), the patient must always eat a meal.

Taking more than the recommended dose of Symazide MR 60 mg
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 sweetened 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. Food or drinks must not be given to unconscious patients.
Inform another person about your condition so that they can seek medical help if necessary.

Missing a dose of Symazide MR 60 mg
It is important to take the medicine every day, as regular use ensures better effectiveness.
However, if a dose of Symazide MR 60 mg is missed, the next dose should be taken at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Symazide MR 60 mg
Since diabetes treatment usually lasts a lifetime, consult a doctor before stopping this medicine. Discontinuing treatment may lead to increased blood glucose (hyperglycaemia), increasing the risk of diabetes-related complications.
If you have any further doubts about using 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 not treated, drowsiness, loss of consciousness or coma may develop.
If hypoglycaemia 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). If these symptoms occur, medical advice should be sought immediately.
Symptoms usually resolve after discontinuation of the medicine. The physician 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, oral cavity, tongue or throat, which may cause breathing difficulties). The rash may progress to extensive blistering or lead to skin peeling. If these symptoms occur, treatment with Symazide MR 60 mg should be discontinued immediately and a doctor should be contacted urgently, informing them about the use of this medicine.
• Rarely, severe hypersensitivity reactions (DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms) have been reported: initially presenting as influenza-like symptoms and facial rash, which subsequently spreads, along with high fever.

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

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

Gastrointestinal disorders

• abdominal pain,
• nausea,
• vomiting,
• dyspepsia,
• diarrhoea,
• constipation. These symptoms may be reduced by taking Symazide MR 60 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 concentration.

As with other sulfonylurea derivatives, the following adverse events have been observed: cases of marked blood cell count changes and allergic vasculitis, decreased blood sodium concentration (hyponatraemia), and signs of liver injury (e.g. jaundice), which resolved in most cases after discontinuation of sulfonylurea derivatives, 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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Symazide MR 60 mg

Keep this medicine out of the 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 conditions 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Symazide MR 60 mg contains

• The active substance is gliclazide. One tablet contains 60 mg of gliclazide in the form of a modified-release tablet.
• Other ingredients are: lactose monohydrate, hypromellose, magnesium stearate.

What Symazide MR 60 mg looks like and contents of the pack
Symazide MR 60 mg is a white, oval, biconvex tablet with a break line and embossed with
"GLI & 60" on both sides. 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 for sale in the Member States of the European Economic Area under the following names:
Poland: Symazide MR 60 mg