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What Gliclazid Zentiva is and what it is used for
Gliclazid Zentiva 60 mg modified-release tablets are a medicine that lowers blood glucose levels (an oral antidiabetic medicine belonging to the group of sulphonylureas).
Gliclazid Zentiva 60 mg is used in adults to treat a certain form of diabetes (type 2 diabetes mellitus) when only dietary measures, exercise and weight reduction are not enough to maintain normal blood glucose levels.
2. What you need to know before you take Gliclazid Zentiva
Do not take Gliclazid Zentiva:
If you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), or to other medicines in the same group (sulphonylurea) or to other similar medicines (hypoglycaemic sulphonamides);
If you suffer from insulin-dependent diabetes (type 1);
If you have ketone bodies and sugar in the urine (this may mean you have diabetic ketoacidosis), diabetic overcombe or coma;
If you suffer from severe kidney or liver disease;
If you are taking medicines to treat fungal infections (miconazole, see "Other medicines and Gliclazid Zentiva");
If you are breast-feeding (see section "Pregnancy, breast-feeding and fertility").
Warnings and precautions
You must follow the healing plan prescribed by your doctor to achieve normal blood glucose levels. This means that, in addition to taking regular tablets, you must adhere to dietary regimen, eat regular and sufficient (carbohydrates), including breakfast, exercise, and if necessary, reduce your body weight.
During glycemic treatment, regular blood glucose (and possibly sugar in the urine) and also hemoglobin (HbA1c) are required.
During the first weeks of treatment, the risk of lowering blood sugar (hypoglycaemia) is increased. Therefore, strict medical follow-up is required.
Low blood sugar (hypoglycaemia) may occur:
If you eat irregularly or miss meals;
If you are hungry;
If you are malnourished;
If you change your diet;
If you increase your physical activity and the amount of carbohydrate intake does not match this increase;
If you drink alcohol, especially in combination with missed meals;
If you are taking other medicines or natural medicines at the same time;
If you take too much gliclazide;
If you suffer from specific hormone-dependent diseases (impaired function of the thyroid gland, pituitary gland or adrenal cortex);
If kidney or liver function is severely impaired.
If you have low blood sugar, you may have the following complaints:
Headache, severe hunger, nausea, vomiting, fatigue, sleep disturbance, nervousness, aggression, decreased concentration, reduced alertness and delayed reactions, depression, confusion, vision and speech disorders, tremor, sensory disturbances, dizziness and feeling helplessness.
The following symptoms may also occur: sweating, cold and damp skin, anxiety, accelerated or irregular heartbeat, high blood pressure, sudden severe chest pain that may spread to adjacent areas (angina pectoris).
If blood sugar continues to fall, you may experience a lot of confusion (delirium), get convulsions, lose control, your breathing may become superficial and your heartbeat slow down, you may become unconscious.
In most cases, symptoms of low blood sugar go very fast when consuming sugar in some form, glucose tablets, sugar cubes, sweet juice, sweetened tea.
For this reason, you should always carry some type of sugar with you (glucose tablets, sugar lumps). Remember that artificial sweeteners are not effective. Please contact your doctor or nearest hospital if the intake of sugar does not help or the symptoms reappear.
Symptoms of low blood sugar may be absent, may be less pronounced or you may not feel in time that your blood sugar has fallen. This can happen if you are elderly and you are taking certain medicines (such as those acting on the central nervous system and beta blockers).
If you are in a state of stress (eg, accidents, surgery, fever, etc.), your doctor may temporarily replace your insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet reduced blood sugar to the desired levels when you have not followed the treatment plan prescribed by your doctor or in specific stressful situations. These may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections and decreased ability to work.
If such symptoms occur, you should contact your doctor or pharmacist.
If in your family or you know,
Other medicines and Gliclazid Zentiva
Tell your doctor or pharmacist if you are taking or have recently taken or can take any other medicines.
When using any of the following medicines, the effect of gliclazide may be increased and low blood sugar may occur:
other medicines that are used to treat high blood sugar (oral antidiabetic medicines, GLP-1 receptor agonists or insulin);
antibiotics (e.g., 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 for the treatment of gastric or duodenal ulcer (H2 receptor antagonists);
medicines to treat depression (monoamine oxidase inhibitors);
painkillers or antiarrhythmics (phenylbutazone, ibuprofen);
medicines containing alcohol.
When using any of the following medicines, the effect of gliclazide may be reduced and blood sugar increased:
medicines for the treatment of diseases of the central nervous system (chlorpromazine);
inflammatory drugs (corticosteroids);
medicines for the treatment of asthma or used during a generic activity (intravenous salbutamol, ritodrine or terbutaline);
medicines for the treatment of breast diseases, severe menstrual bleeding and endometriosis (danazol).
Gliclazid Zentiva can potentiate the effect of drugs that inhibit blood clotting (eg warfarin).
Ask your doctor for advice before taking any other medicine. If you go to a hospital, inform the medical staff that you are taking Gliclazid Zentiva.
Gliclazid Zentiva with food, beverages and alcohol
Gliclazid Zentiva can be taken with food and non-alcoholic beverages.
Drinking alcohol is not recommended as it may disrupt the control of your diabetes in an unpredictable way.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before taking this medicine.
Gliclazide Zentiva is not recommended during pregnancy. If you are planning to become pregnant or become pregnant, tell your doctor to advise you on more appropriate treatment.
You should not take Gliclazid Zentiva while 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. You could endanger yourself or others (eg when driving or operating machines).
Please ask your doctor if you can drive if:
you have frequent episodes of low blood sugar (hypoglycaemia);
warning signs of low blood sugar (hypoglycaemia) are weak or lacking.
Gliclazide Zentiva contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicinal product.
3. How to take Gliclazid Zentiva
Always take this medicine exactly as your doctor has told you. If you are not sure ask your doctor or pharmacist.
The dose is determined by the physician based on blood sugar and possibly urine sugar.
Changes in other factors (eg, weight loss, lifestyle changes, stress) or improvement in blood glucose control may require a change in gliclazide doses.
The recommended dose is one to four tablets (up to 120 mg) taken at breakfast. It depends on the response to the treatment.
If a combination treatment with Gliclazid Zentiva and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin is initiated, your doctor will individually determine the appropriate dose of each individual drug.
If you notice that your blood sugar levels are high despite taking the medicine, talk to your doctor or pharmacist.
Roads and ways of application
Swallow your half or whole tablet at once. Do not chew or crush.
Take your 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).
The tablet Gliclazid Zentiva 60 mg can be divided into equal doses.
If you take more Glyclavide Zentiva than you should
If you have taken more tablets than those recommended, contact your doctor or emergency department immediately with the nearest hospital. Overdose manifestations are hypoglycemic hypoglycemia described in section 2. Symptoms can be controlled by taking immediate sugar (4 to 6 lump) or sweetened fluids, followed by a hearty breakfast or main meal.
If you stop taking Gliclazid Zentiva
Since diabetes is a lifelong treatment, you should consult your doctor before stopping taking this medicine. Stopping it may result in increased blood sugar (hyperglycaemia), which increases the risk of developing complications of diabetes.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines and this medicine can cause side effects, although not everyone gets them.
The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs see section "Warnings and precautions" in section 2 "What you need to know before you take Gliclazid Zentiva".
If not treated, these symptoms may progress to drowsiness, loss of consciousness, or even coma. If the blood sugar lowering episode is severe or prolonged, even if you have taken control of it temporarily by taking sugar, you should immediately seek medical attention.
A decrease in the number of cells in the blood (eg platelets, erythrocytes and leukocytes) has been reported. It may cause:
These symptoms usually disappear after stopping the drug.
There are single reports of impaired hepatic function, which may cause yellowing of the skin and eyes. If this happens, talk to your doctor immediately. These symptoms usually disappear if the drug stops. Your doctor will decide whether to stop your treatment.
Skin reactions such as:
angioedema (rapid edema of the eyelids, face, lips, mouth, tongue or throat, which may cause difficulty in breathing).
Stomach pain or discomfort, nausea or vomiting, indigestion, diarrhea, constipation (constipation).
These effects decrease when taking Gliclazid Zentiva with food as recommended.
Your vision may be affected for a short time, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.
As with other sulphonylureas, the following side effects have been observed: cases of severe changes in blood cell count and allergic inflammation of the blood vessel wall, reduction of sodium in the blood (hyponatraemia), symptoms of liver damage (eg jaundice) , which in most cases pass after stopping the sulphonylurea but in some cases may lead to life-threatening liver failure.
How to store Gliclazid Zentiva
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Gliclazid Zentiva contains
The active substance is gliclazide.
Gliclazid Zentiva 60 mg: Each modified-release tablet contains 60 mg of gliclazide.
The other ingredients are:
Intra-granular: Lactose monohydrate, hypromellose (HPMC K100 LV), hypromellose (HPMC K4M CR);
Extragranular: Hypromellose (HPMC K100 LV), Hypromellose (HPMC K4M CR), Magnesium stearate.
What Gliclazid Zentiva looks like and what the package contains
The modified-release tablets of 60 mg are oval-shaped, biconvex, biconvex, white, scored on both sides and engraved with "GLI" and "60" on both sides of the score line and on the tablet, measuring 15.0 x 7 , 0 mm.
Gliclazid Zentiva 60 mg can be divided into equal doses.
Gliclazid Zentiva 60 mg modified-release tablets are supplied in blister packs of 30, 90 tablets.
Not all pack sizes may be marketed.
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