Ecozid MR 30 mg. 30 tablets

1. What Ecozid MR is and what it is used for

Ecoside MR is a medicine that lowers blood sugar levels (an oral antidiabetic medicine belonging to the group of sulphonylurea medicinal products).

Ecoside MR is used in adults to treat non-insulin-dependent diabetes (type 2 diabetes mellitus) when diet, exercise and weight loss alone are not sufficient to maintain normal blood sugar levels.

2. What you need to know before you take Ecozid MR

Do not take Ecozid MR:

if you are allergic (hypersensitive) to gliclazide, other sulphonylureas, sulphonamides or any of the other ingredients of this medicine (listed in section 6);

if you suffer from insulin-dependent diabetes (type 1);

if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), diabetic precoma or coma;

if you suffer from severe liver or kidney disease;

if you are currently taking medicines to treat fungal infections (miconazole) (see "Other medicines and Ecoside MR");

if you are breastfeeding.

If you think any of these conditions apply to you or have any doubts, please seek advice from your doctor or pharmacist.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ecozid MR.

During treatment with Ecosid MR, regular monitoring of blood sugar values (and possibly sugar in the urine) is necessary. Your doctor may also take blood to determine the so-called glycated hemoglobin (HbAlc) if needed.

You must follow the treatment prescribed by the doctor so that the blood sugar values are within the recommended norms. This means constant taking of the tablets, diet, physical activity and weight reduction if necessary.

During the first weeks of treatment, the risk of low blood sugar (hypoglycaemia) may be increased. Therefore, more frequent monitoring and control by your doctor is necessary.

Low blood sugar (hypoglycaemia) can occur if:

you eat irregularly or skip main meals;

you are starving;

you are malnourished;

change your diet;

increase your physical activity, and the amount of carbohydrates you take in does not correspond to this increase;

you consume alcohol, especially in combination with skipping main meals;

at the same time you are taking other medicines or natural healing products;

you are taking too much gliclazide;

you suffer from specific hormone-dependent diseases (impaired function of the thyroid gland, pituitary gland or adrenal cortex);

your liver or kidney function is severely reduced.

If you have low blood sugar, you may experience the following symptoms: headache, extreme hunger, nausea, vomiting, tiredness, sleep disturbance, agitation, aggression, decreased concentration, decreased alertness and delayed reactions, depression, confusion, impaired vision or speech, tremor (shaking), sensory (sense) disorders, vertigo, feeling of powerlessness.

The following symptoms may also occur: sweating, cool and clammy skin, restlessness, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain that may spread to neighboring areas (angina).

If your blood sugar continues to fall, you may become very confused (delirium), develop convulsions, lose self-control, your breathing may become shallow, your heart rate may slow, you may pass out.

In most cases, the symptoms of low blood sugar go away very quickly if you take sugar in some form, e.g. lumps of sugar, sweet juice, sweetened tea. For this reason, you should always carry some kind of sugar with you. Remember that artificial sweeteners are not effective. Contact your doctor or the nearest hospital if taking sugar does not help or the symptoms recur.

It is possible that the symptoms of low blood sugar are absent, less pronounced, or you may not feel in time that your blood sugar has dropped. This can happen if you are elderly and take certain medicines (eg those that act on the central nervous system and beta-blockers). If you are in a state of stress (e.g. accidents, surgery, infections accompanied by fever, etc.), your doctor may temporarily replace Ecoside MR with insulin.

Symptoms of high blood sugar (hyperglycemia) may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced ability to work. This is possible when gliclazide has not yet lowered blood sugar sufficiently, when you have not followed the treatment plan prescribed by your doctor, if you are taking products containing St. John's wort (Hypericum perforatum) (see section Other medicines and Ecozide MR) or in specific stressful situations.

Symptoms of high blood sugar (hyperglycemia) may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced ability to work. This is possible when gliclazide has not yet lowered blood sugar sufficiently, when you have not followed the treatment plan prescribed by your doctor, if you are taking products containing St. John's wort (Hypericum perforatum) (see section Other medicines and Ecozide MR) or in specific stressful situations. If such symptoms occur, you should inform your doctor or pharmacist.

Abnormalities in blood sugar values (low or high blood sugar) may occur when gliclazide is prescribed at the same time as antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you of the importance of blood sugar control.

If you have a family history or you know that you have a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell disease), a decrease in hemoglobin levels in the blood and breakdown of red blood cells (haemolytic anemia) may occur. . Consult your doctor before starting to take this medicine.

Children and adolescents

Ecoside MR is not recommended for the treatment of diabetes in children and adolescents under 18 years of age due to a lack of data.

Other medicines and Ecozid MR

You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The blood sugar-lowering effect of gliclazide may be enhanced and manifestations of low blood sugar may occur when any of the following medicines are used:

other medicines to treat high blood sugar (oral antidiabetic medicines, GLP-1 receptor agonists or insulin);

antibiotics (eg sulfonamides, clarithromycin);

medicines to treat high blood pressure or heart failure (beta blockers, ACE inhibitors such as captopril or enalapril);

medicines for the treatment of fungal infections (miconazole, fluconazole);

medicines to treat stomach or duodenal ulcers (H2-receptor antagonists);

medicines to treat depression (monoamine oxidase inhibitors);

pain relievers or anti-rheumatic drugs (phenylbutazone, ibuprofen);

drugs containing alcohol.

The blood sugar-lowering effect of gliclazide can be weakened and an increase in blood sugar can occur with the use of one of the following medicines:

drugs for the treatment of diseases of the central nervous system (chlorpromazine);

anti-inflammatory drugs (corticosteroids);

medicines for the treatment of asthma or which are used during labor (salbutam ol given intravenously, ritodrine and terbutaline given intravenously);

medicines to treat breast diseases, heavy menstrual bleeding and endometriosis (danazol);

products containing St. John's wort - Hypericum perforatum

Abnormalities in blood sugar values (low or high blood sugar) may occur with simultaneous use of fluoroquinolone antibiotics with Ecoside MR, especially in elderly patients.

Ecoside MR can increase the effect of medicines that suppress blood clotting (eg warfarin).

Consult your doctor before taking any other medicine. If you go to hospital, tell the medical staff that you are taking Ecozid MR.

Ecoside MR with food, drink and alcohol

Ecoside MR can be taken with food and soft drinks.

Alcohol consumption is not recommended as it can affect the control of your diabetes in unpredictable ways.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Ecoside MR is not recommended for use during pregnancy. If you are planning to become pregnant or become pregnant, inform your doctor. You should not take Ecosid MR if you are breast-feeding.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia) or too high (hyperglycaemia), or if visual disturbances occur as a result of these conditions. Be aware that you could endanger yourself or others (eg when driving or operating machinery). Ask your doctor if you can drive if:

you have frequent episodes of low blood sugar (hypoglycaemia);

your symptoms of low blood sugar (hypoglycaemia) are weak or absent.

3. How to take Ecozid MR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The dose is determined by the doctor depending on the values of your blood sugar and possibly on the sugar in the urine. Changes in external factors (e.g. weight loss, change in lifestyle and diet, stress) or improvement in blood glucose control m

3. How to take Ecozid MR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The dose is determined by the doctor depending on the values of your blood sugar and possibly on the sugar in the urine. Changes in external factors (eg, weight loss, changes in lifestyle and diet, stress) or improvement in blood glucose control may necessitate changes in gliclazide doses.

The recommended dose is 1 to 4 tablets daily (maximum 4 tablets) taken at one time during breakfast, depending on the response to treatment.

Ecoside MR is taken orally. Swallow the tablets whole. Do not chew or break them. Take the tablet(s) with a glass of water during breakfast and preferably at the same time each day. You should always eat after taking the tablet(s).

When starting combined treatment with Ecoside MR and other antidiabetic drugs (eg metformin, alpha-glucosidase inhibitor, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonist or insulin), your doctor will determine the appropriate dose of each drug individually for you.

Consult your doctor or pharmacist if you think Ecoside MR is working too hard or not hard enough for you.

If you have taken more than the required dose of Ecozid MR

If you have taken more tablets than you should, contact your doctor or the emergency department of the nearest hospital immediately. Symptoms of overdose are those of low blood sugar (hypoglycaemia) described in point 2. These can be controlled by immediately taking enough sugar (4-6 lumps of sugar, juice containing sugar, sweetened tea) and then a hearty breakfast or main meal. If the patient is unconscious, immediately inform a doctor or call an ambulance. The same should be done if someone, e.g. a child accidentally swallowed this medicine. Unconscious patients should not be given food or liquids.

Sufficiently informed person should always be provided to call a doctor in case of emergency.

If you forget to take Ecozid MR

It is important to take your medicine every day, as regular treatment has a better effect.

If you still miss a daily dose of Ecoside MR, take the next dose at the usual time the next day. Do not take a double dose to make up for a missed dose.

If you have stopped taking Ecozid MR

If you interrupt or stop your treatment, you will feel that your blood sugar control is getting worse. Stopping treatment can lead to an increase in blood sugar (hyperglycemia), which increases the risk of developing complications of diabetes. As diabetes treatment is usually lifelong, you should consult your doctor before stopping this medicine.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common adverse drug reaction is low blood sugar (hypoglycemia). For symptoms and signs, see "Warnings and precautions" in section 2 "What you need to know before you take Ecozid MR".

If left untreated, these symptoms could progress to drowsiness, loss of consciousness, or even coma. If the episode of low blood sugar is severe or prolonged, even if you have temporarily controlled it by taking sugar, you should seek immediate medical attention.

Blood disorders

A decrease in the number of cells in the blood (eg platelets, red blood cells and white blood cells) which can cause:

pallor

prolonged bleeding

bruises

sore throat

temperature

These symptoms usually disappear after stopping treatment.

Liver disorders

There are isolated reports of impaired liver function, which may cause yellowing of the skin and eyes. If this happens to you, contact your doctor immediately. These symptoms usually disappear after stopping the drug. Your doctor will decide whether to stop treatment.

Skin disorders

Skin reactions have been reported, for example:

rash

redness

itching

hives

angioedema (rapid swelling of tissues such as the eyelids, face, lips, tongue or throat which may lead to difficulty breathing). The rash may progress to blistering or peeling of large areas of skin.

Very rarely, signs of a severe hypersensitivity reaction (DRESS) have been reported: initially flu-like symptoms and facial rash, followed by an extensive rash with high fever.

Digestive disorders

stomach pain and discomfort

nausea

indigestion

diarrhea

constipation

These effects are reduced when taking Ecoside MR with food as recommended, see point 3 "How to take 

5. How to store Ecoside MR

Keep out of the reach of children.

To be stored at a temperature below 25°C.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Ecoside MR contains

Active substance: gliclazide. One extended-release tablet contains 30 mg of gliclazide.

Other ingredients lactose monohydrate, corn starch, hypromellose (Methocel K4M Premium), hypromellose (Methocel K15M Premium), povidone (PVP K-30), magnesium stearate, silicon dioxide, colloidal anhydrous (Aerosil-200), purified water.

What Ecozid MR looks like and what the package contains

Ecoside MR 30 mg extended-release tablets are white to off-white, oblong, biconvex, uncoated tablets marked "C12" on one side and plain on the other. The tablets have dimensions: 10.00 mm x 4.00 mm ± 0.20 mm.

Ecoside MR 30 mg prolonged-release tablets are supplied in transparent PVDC-coated PVC/Alu blisters, packed in a carton containing 10, 30 or 60 tablets.

Not all packages may be marketed.