Madras 30 mg. 60 tablets

What Madras MR and what it is used
Madras MR is a medicine that lowers blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Madras MR is used in adults to treat a certain form diabetes (type 2 diabetes mellitus) when diet, exercise and weight loss alone are not sufficient to maintain normal blood glucose.

2. What you need to know before taking Madras MR
Do not take Madras MR:
if you are allergic (hypersensitive) to gliclazide or any of the other ingredients of this medicine, or to other drugs in the same group (sulphonylureas), or to similar drugs (sulfonamides);
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 pre-coma or coma;
if you suffer from severe liver or kidney disease;
if you are currently taking medicines to treat fungal infections (miconazole, see section "Other medicines and Madras MR");
if you are breastfeeding (see section "Pregnancy and lactation").
Warnings and Precautions
Talk to your doctor or pharmacist before taking Madras MR.
You have to follow the treatment plan prescribed by your doctor to reach normal blood glucose.
This means that apart from regular tablet intake, you observe the dietary regimen, have physical exercise and, if necessary, reduce 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 lowering blood sugar (hypoglycemia) is increased. It is therefore necessary for medical monitoring.

Low blood sugar (hypoglycemia) can occur:
If 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 intake of carbohydrates you do not correspond to this increase;
if you drink alcohol, especially in combination with skipped meals;
if you are taking other medicines or natural remedies at the same time if you take too high doses of gliclazide;
if you suffer from particular hormone-dependent diseases (impaired function of the thyroid, pituitary gland or peel over the kidney);
if your liver or kidney 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, reduced concentration, reduced alertness and slowed reactions, depression, confusion, impairment of vision or speech , tremor (shaking), sensory (sensory) disorders, dizziness and feeling of helplessness.
May occur following symptoms: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden severe pain in the chest that can spread to neighboring areas (angina).
If blood sugar levels continue to fall, you may find yourself in 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 dropped. This can happen if you are elderly and taking certain medications (eg. Those acting on the central nervous system or beta-blockers).
If you are in a state of stress (eg. Accidents, surgery, temperature, 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 specific stressful situations. These symptoms may include thirst, frequent urination, dry mouth, dry 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 hemoglobin and breakdown of red blood cells (hemolytic anemia). Talk to your doctor before you start taking this medicine.

Children and adolescents
Madras MR 30 mg modified-release tablets are not recommended for use in children due to lack of data.

Other medicines and Madras MR 30 mg modified release
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 stronger and occur symptoms of low blood sugar when used any of the following medications:
other medicines used to treat high blood sugar (oral antidiabetics or insulin);
antibiotics (e. 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 for the treatment of depression (monoamine oxidase inhibitors);
painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen);
medicines containing alcohol.
Blood glucose lowering effect of gliclazide may be weakened and occur high blood sugar when using one of the following:
drugs for the treatment of a disease of the central nervous system (chlorpromazine);
drugs that reduce inflammation (glucocorticoids);
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).
Madras MR 30 mg modified release may enhance the effect 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 Madras MR 30 mg modified release.

Madras MR with food, drinks and alcohol
Madras MR 30 mg modified-release tablets 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
pregnancy
Madras MR 30 mg modified-release tablets are not recommended for use during pregnancy. If you are pregnant, you think you might be pregnant or planning to become pregnant, talk to your doctor so he can prescribe a proper treatment.

breastfeeding
You should not take Madras MR 30 mg modified release while breastfeeding.
If you are breastfeeding, ask your doctor or pharmacist before taking this medicine.

Driving and using machines
Your ability to concentrate or to react may be impaired if your blood sugar is too low (hypoglycemia) or too high (hyperglycaemia) or if you develop visual problems 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 have frequent episodes of low blood sugar (hypoglycemia);
if signs of low blood sugar (hypoglycaemia) when they are weak or absent.
Children and adolescents under 18 years
Madras MR 30 mg modified-release tablets are not recommended for use in children and adolescents.

3. How to take Madras MR
dosage
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
The dose is determined by the doctor depending on your blood sugar and possibly urine sugar levels.
Changes in external factors (eg. Weight reduction, change in life style, stress) or improvements in the blood sugar control may require the adjustment of doses of gliclazide.
The recommended daily dose is from one to four tablets (maximum 120 mg) taken once daily at breakfast. It depends on the response to treatment.
Madras MR 30 mg modified-release tablets can be used to replace another medicine to treat diabetes. If started combination therapy with Madras MR 30 mg modified-release metformin, an inhibitor of alpha-glucosidase or insulin, your doctor will determine individually for you right dose of each drug.
Please tell your doctor or pharmacist if you have the impression that Madras MR 30 mg modified release you act too strong or not strong enough.
If you notice that your blood sugar is high, although taking Madras MR, you should tell your doctor or pharmacist.

Method and routes of administration
Oral administration.
Swallow the tablets whole. Do not be chewed or crushed.
Take your tablet (s) with a glass of water at breakfast time (and preferably at the same time each day).
You should always eat after taking the tablet (s).

If you take more than the amount of Madras MR 30 mg modified release
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 (hypoglycaemia) described in Section 2. They can be controlled by taking sugar (4 to 6 lumps) or liquids containing sugar, followed by a hearty breakfast or main meal.
If the patient is unconscious, call a physician immediately or call an ambulance. The same should be done if someone, for example a child has swallowed unconsciously and accidentally medicine. Unconscious patients must not be given food or water.
You should always provide enough informed person that can call a doctor in case of emergency.

If you forget to take Madras MR 30 mg modified release
It is important to take your medicine every day as regular treatment works better.
If you do forget to take a dose of 30 mg Madras modified-release tablets, take your next dose at the usual time. Do not take a double dose to make up the missed dose.

If you stop taking Madras MR 30 mg modified release
As the treatment for diabetes is usually life long, you should consult with your doctor before you stop taking this medicine. The suspension can lead to high blood sugar (hyperglycemia), leading to a high risk of complications in diabetes.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common adverse reaction is low blood sugar (hypoglycemia). For symptoms and signs see "Warnings and Precautions" in paragraph 2. "What you should know before taking Madras MR".
If left untreated, these symptoms may progress to drowsiness, loss of consciousness or even coma. If an episode of low blood sugar is severe or prolonged, even temporarily've mastered it you take sugar, you should seek immediate medical attention.

Blood
Reducing the number of cells in the blood (eg. Platelet erythrocytes and leukocytes).
This can cause:
pallor;
prolonged bleeding;
bruising;
sore throat;
fever.
These symptoms usually disappear after discontinuation of treatment.

liver disorders
There are isolated reports of 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.

Skin
There are reports of skin reactions, such as:
rash;
redness;
itching;
hives;
angioedema (rapid swelling of the tissues such as the eyelids, face, lips, mouth, tongue or throat, which may lead to difficulty in breathing). The rash may progress and cause blistering and peeling of the skin.
Digestive problems
abdominal pain and discomfort;
a feeling of weakness;
indigestion;
diarrhea;
constipation.
These reactions occur more easily when taken together with food as recommended. See section 3. "How to take".

Eye disorders
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 describes the following cases: severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, lowering blood sodium (hyponatremia), symptoms of liver injury (eg. Jaundice) have been observed in most cases disappear after cessation of use of sulphonylureas, but in rare cases can lead to life-threatening liver failure.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Madras MR
Keep out of reach of children.
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 store above 25 ° C.