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MELIZIDE 60 mg. 30 tablets

Product Code: MELIZIDE 60 mg. 30 tablets
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What is Melizide and what it is used
Melizide is a drug that lowers blood sugar levels (oral antidiabetic medicine belonging to the group of sulfonylurea product).
Melizide is used in adults to treat a particular form mellitus (type 2 diabetes), when diet, physical exercise and reductions in body weight are not enough to maintain normal blood glucose values.

2. What you need to know before taking Melizid
Do not take Melizide:
if you are allergic to gliclazide or any of the other ingredients of this medicine (listed in Section 6) or to other drugs of the same group (sulphonylureas), or to other similar drugs (hypoglycaemic sulphonamides);
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 pre-coma or coma;
suffer from severe renal or hepatic disease;
if you are taking medicines to treat fungal infections (miconazole, see section "Other medicines and Melizide");
if you are breastfeeding (see. section "Pregnancy, breast-feeding and fertility").
Warnings and Precautions
Talk to your doctor or pharmacist before taking Melizide.
You have to follow the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means that apart from regular tablet intake, you need to follow a diet, doing exercise and, if necessary, to reduce body weight.
During treatment with gliclazide require regular blood glucose (and optionally the sugar in the urine), as well as of glycosylated hemoglobin (HbAlc).
During the first weeks of treatment the risk of a decrease in blood sugar (hypoglycemia) is increased. It therefore needs more frequent medical monitoring.

Low blood sugar (hypoglycemia) can occur:
If you eat irregularly or skip meals;
if hungry
if you are malnourished;
if you change your diet;
if you increase your physical activity and the amount of your carbohydrates intake does not correspond to this increase;
if you drink alcohol, especially in combination with skipped meals;
if you take other medicines or natural remedies at the same time;
if you take too high doses of gliclazide;
if you have a specific hormone-dependent diseases (impaired function of the thyroid, of the pituitary gland or the adrenal cortex);
if renal or liver function is severely reduced.
If you have low blood sugar, you may experience the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disorders, nervousness, aggressiveness, poor concentration, reduced alertness and slowed reactions, depression, confusion, impairment of vision or speech , tremor, sensory disturbances, dizziness and feeling of helplessness.
Can occur following signs and symptoms: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden severe chest pain, which can spread to adjacent areas (angina).
If blood sugar levels continue to fall, you can fall into a state of severe confusion (delirium), develop convulsions, lose self control, your breathing may be shallow and your heart beat to slow down, may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, for example. glucose tablets, sugar cubes, sweet juice, sweetened tea. For this reason, you should always carry some form of sugar (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, be less pronounced or may not be aware in time that your blood sugar has dropped. This can happen if the elderly and taking certain drugs (eg. Those acting on the central nervous system or beta-blockers). If you are in a state of stress (eg. Accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycemia) can exist when gliclazide has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor or in special stress situations. These may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections and reduced performance.
If these symptoms occur, you should contact your doctor or pharmacist.
If your family is or you know you have the hereditary condition glucose-6-phosphate
Children and adolescents
Melizide not recommended for use in children due to lack of data.

Other medicines and Melizide
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.

Blood glucose lowering effect of gliclazide may become more intense and occur signs of low blood sugar when used any of the following medications:
other drugs that are used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin);
antibiotics (eg. sulphonamides, clarithromycin);
drugs to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors, eg., captopril or enalapril);
drugs for the treatment of fungal infections (miconazole, fluconazole);
drugs for the treatment of ulcers of the stomach or duodenum (H2 receptor antagonists);
drugs used to treat depression (monoamine oxidase inhibitors);
painkillers or antirheumatics (phenylbutazone, ibuprofen);
medicines containing alcohol.
The blood glucose lowering effect of gliclazide may be weakened and occur high blood sugar for use in one of the following:
drugs for the treatment of disorders of the central nervous system (chlorpromazine);
drugs that reduce inflammation (corticosteroids);
drugs for the treatment of asthma or used during labor activity (intravenous salbutamol, terbutaline and ritodrine);
drugs for the treatment of diseases of the breast, severe menstrual bleeding and endometriosis (danazol).
Melizid may increase the effects of drugs that inhibit blood clotting (eg. Warfarin).

Ask your doctor before you start taking another medicinal product. If you go into hospital, tell the medical staff that you are taking Melizide.

Melizide with food, beverages and alcohol
Melizide can be taken with food and soft drinks.
Alcohol consumption is not recommended because it can disrupt the control of your diabetes in an unpredictable manner.

Pregnancy, lactation and fertility
Melizid not recommended for use during pregnancy.
If you are pregnant, you think you might be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Do not take Melizid while breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if the blood sugar is too low (hypoglycemia) or too high (hyperglycemia), or if there are visual disturbance as a result of these conditions. Keep in mind that you could endanger yourself or others (eg. When driving or operating machinery). Please ask your doctor whether you can drive if:
you have frequent episodes of low blood sugar (hypoglycemia);
signs of low blood sugar (hypoglycemia) are weak or absent.
3. How to take Melizid
Always take this medicine exactly as you told your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Only adults can take this medicine.
The dose is determined by the doctor depending on the values of blood sugar, and optionally the sugar in the urine. Changes in external factors (eg. Decreasing body weight, changes in lifestyle, stress) or improvements in the control of blood glucose may require the adjustment of the dosage of gliclazide.
The usual daily dose is one-half to two tablets (maximum 120 mg) taken once daily at breakfast. It depends on the response to treatment.
If initiated concomitant with Melizide and metformin, an inhibitor of alpha-glucosidase, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, GLP-1 receptor agonist or insulin Your doctor will determine individually to search the appropriate dose of each drug.
If you notice that your blood sugar is high despite taking the medication as prescribed, you should talk with your doctor or pharmacist.

Method of administration
Oral use.
Swallow half or the whole tablet (s) once. Do not chew or crush. Take the tablet (s) with a glass of water at breakfast time (and preferably at the same time each day).
You should always eat after taking your tablet (s). The tablet can be divided into equal doses.

If you take more than the amount Melizid
If you take more than the required number of tablets, contact your doctor or the emergency department of the nearest hospital.
Manifestations of overdose are those of low blood sugar (hypoglycemia) described in paragraph 2. These may be controlled by taking sugar (4 to 6 lumps) or liquids containing sugar, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call "ambulance." The same should be done if someone, for example.

Other side effects that may occur while taking this drug are:
Rare: may affect up to 1 in 1000 people:
Reducing the number of cells in the blood (eg. Platelet red and white blood cells), which may cause pallor, prolonged bleeding, bruising, there are reports of sore throat and fever.
These symptoms usually disappear after discontinuation of treatment.
Not known: from the available data can not be estimated:
Abnormal liver function, which can cause yellowing of the skin and eyes. If this happens to you, contact your doctor immediately. These symptoms usually disappear after discontinuation of the drug. Your doctor will decide whether to stop your treatment;
There are reports of skin reactions, eg. rash, flushing, itching, hives and angioedema (rapid swelling of the tissues such as eyelids, face, lips, tongue or throat that may cause difficulty breathing). The rash may progress to blistering or peeling of large areas of the skin. In exceptional cases were reported symptoms of severe hypersensitivity reactions (DRESS): initially as flu-like symptoms and a rash on the face, followed by an extension of the rash and fever;
Abdominal pain or discomfort, nausea or vomiting, indigestion, diarrhea and constipation. These effects are reduced when Melizid of food as recommended (see. Section 3 "How to take Melizid");
Vision problems - your vision may be affected for a short time, especially in early treatment. This effect is due to changes in blood glucose levels.
As with other sulphonylureas, the following adverse reactions were observed:
severe changes in blood cell counts;
allergic inflammation in the wall of blood vessels;
reducing the sodium in the blood (hyponatremia);
symptoms of liver damage (eg. jaundice), which in most cases disappeared after withdrawal of the sulfonylurea product, but in individual cases may lead to life-threatening liver failure.

5. How to store Melizide
Keep out of 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 that month.
Do not store above 25 ° C.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Melizide
The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
Other ingredients are: calcium hydrogen phosphate dihydrate, povidone K30, hypromellose K100, hypromellose K4M and magnesium stearate.

Melizid looks like and contents of the pack
White to off white uncoated tablets with length 13,5 mm, a width of 6,5 mm and a thickness of 4,2 mm, scored on both sides and engraved "60" on one ctrana the score on one side tablet.

Transparent PVC-aluminum blister.
Transparent PVC / Aclar-aluminum blister.
Packs of 10, 30, 60, 90, 100 and 180 modified-release tablets.
Not all pack sizes may be marketed.

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