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What Diab MR and what it is used
Diab MR is a drug that reduces the level of blood sugar (oral anti-diabetic drug belonging to the sulphonylurea group). Diab MR 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 normal blood glucose values.
2. What you need to know before taking Diab MR
Do not take Diab MR:
are allergic (hypersensitivity) to gliclazide or any of the other ingredients of Gliclazide MR or to other drugs of the same group (sulphonylureas), or 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 liver or kidney disease;
if you are currently taking medicines to treat fungal infections (miconazole, see Other medicines and Diab MR);
if you are breastfeeding (see. section Pregnancy and lactation).
Warnings and Precautions
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 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 peel over the kidney);
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 (shaking), sensory (sensory) disorders, dizziness and feeling of helplessness.
Can occur following 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 you are 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. They 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 dehydrogenase (G6PD) deficiency (abnormality of red blood cells) may appear lower values etc.
The 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 or insulin);
antibiotics (eg. sulphonamides);
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 for the treatment of 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 which are used during labor activity (intravenous salbutamol, terbutaline and ritodrine);
drugs for the treatment of diseases of the breast, severe menstrual bleeding and endometriosis (danazol).
Diab MR 30 mg modified-release tablets may increase the effects of drugs that inhibit blood clotting (eg. Warfarin).
Diab MR 30 mg modified-release tablets are not recommended for use in children due to lack of data.
Diab MR with food and drink
Diab MR 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 and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Diab MR is not recommended for use during pregnancy. If you are planning to become pregnant, inform your doctor so that he can prescribe a proper treatment. You should not take Gliclazide MR, if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycemia) or too high (hyperglycaemia) 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);
if signs of low blood sugar (hypoglycaemia) are weak or absent.
3. How to take Diab MR
Always take Diab MR exactly as your doctor or healthcare professional. If you're not sure, ask your doctor or pharmacist.
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 dose is from one-half to two tablets (maximum 120 mg), taken once daily at breakfast. It depends on the response to treatment.
If initiated concomitant with Gliclazide MR and metformin, an inhibitor of alpha-glucosidase or insulin Your doctor will determine individually to search the appropriate dose of each drug.
If you take more than the amount of Diab MR
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 as those of low blood sugar (hypoglycaemia) described in section 2. They can be followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the ambulance. The same should be done if someone, for example. child accidentally ingested this product. Unconscious patients must not be given food or drink. It should always provide enough informed person that can call a doctor in case of emergency.
If you forget to take Diab MR
Take your tablets as soon as you remember. Do not take two doses in one day.
Do not take a double dose to make up for a missed dose.
If you stop taking Diab MR
As the treatment for diabetes is usually life long, you should discuss with your doctor before you stop taking this medicine. The suspension can lead to high blood sugar (hyperglycemia).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Diab MR 30
The most frequently observed side effect is low blood sugar (hypoglycemia). For symptoms and signs see Warnings and Precautions. If left untreated, these symptoms may progress to drowsiness, unconsciousness or even coma. If an episode of low blood sugar is severe or prolonged, even if temporarily've mastered you take sugar, you should seek immediate medical attention.
There are rare reports of hepatic dysfunction, 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 and hives. May occur and severe skin reactions.
Reduction in the number of cells in the blood (eg. Platelet erythrocytes and leukocytes), which can cause pallor, prolonged bleeding, bruising, there are reports of sore throat and fever. These symptoms usually disappear after cessation of treatment.
Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation. These effects reduce the acceptance of Gliclazide MR with food, as recommended.
Your vision may be affected for a short time, especially in early treatment. This effect is due to changes in blood glucose levels.
Upon acceptance of sulphonylurea described cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels. They were observed and symptoms of hepatic impairment (eg. Jaundice), which in most cases disappeared after withdrawal of the sulphonylurea, but in individual cases may lead to life-threatening liver failure.
If you get any side effects, contact your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
5. How to store Diab MR
Keep out of reach of children.
Store at a temperature below 25 ° C.
Diab MR should be stored in its original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
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 Diab MR
The active ingredient is gliclazide. Each tablet contains 30 mg of active substance.
The other ingredients are calcium phosphate dibasic anhydrous, povidone K30, hypromellose, magnesium stearate.
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