Madras MR 30 mg. 60 tablets
MADRAS MR is a medicine that lowers blood glucose (an oral antidiabetic medicine belonging to the group of sulphonylureas). Madras MR is used in adults to treat certain types of diabetes (type 2 diabetes mellitus) when only dietary measures,
Madras MR 30 mg. 60 tablets
What is MADRAS MR and what it is used for
MADRAS MR is a medicine that lowers blood glucose (an oral antidiabetic medicine belonging to the group of sulphonylureas). Madras MR is used in adults to treat certain types 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 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 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 your urine (this may mean you have diabetic ketoacidosis), a diabetic hypersomnia or a 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 MADRAS MR);
if you are breast-feeding (see section "Pregnancy and breast-feeding").
Warnings and precautions
Talk to your doctor before taking MADRAS MR.
You must follow the healing plan prescribed by your doctor to reach normal blood sugar levels.
This means that, in addition to taking regular tablets, you have to follow a dietary regimen, exercise, and, if necessary, lower your body weight.
During glycemic treatment, regular blood glucose (and possibly urinary sugar), as well as glycated hemoglobin (HbA1c), is required.
During the first weeks of treatment, the risk of lowering blood sugar (hypoglycaemia) is increased. Therefore, strict medical control is required.
Low blood sugar (hypoglycaemia) may occur:
if you eat irregularly or miss major meals;
if you are hungry
if you are malnourished
if you change your diet,
if you increase your physical activity, and the amount of carbs you take does not match this increase
if you drink alcohol, especially in combination with omitting main meals
if you are taking other medicines or natural medicines at the same time if you are taking too much gliclazide
if you suffer from specific hormone-dependent diseases (impaired thyroid, pituitary gland or kidney cortex)
if your kidney or liver function is severely reduced.
If you have low blood sugar, you may experience the following symptoms: headache, severe hunger, nausea, vomiting, fatigue, sleep disturbance, nervousness, aggression, decreased concentration, decreased alertness and delayed reactions, depression, confusion, visual disturbance or speech tremor, sensory disturbances, dizziness and feeling helpless.
The following symptoms may also occur: sweating, cold and damp skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain that can spread to adjacent areas (angina).
If blood sugar continues to fall, you may experience a state of intense confusion (delirium), develop convulsions, lose control, your breathing may become superficial, and your heartbeat may slow down, you may become unconscious.
In most cases, symptoms of low blood sugar pass very quickly when you consume sugar in some form, glucose tablets, sugar lumps, sweet juice, sweetened tea.
For this reason, you should always carry some type of sugar with you (glucose tablets, lumps of sugar). 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, 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 (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 change this medicine to insulin.
Symptoms of high blood sugar (hyperglycaemia) may be present when gliclazide has not sufficiently reduced blood sugar when you have not followed the healing plan prescribed by
Your doctor if you are taking products containing St John's wort (Hypericum perforatum) (see section 2. Other medicines and Madras MR) or in specific stressful situations. These symptoms may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections and decreased ability to work.
painkillers or anti-rheumatic agents (phenylbutazone, ibuprofen)
medicines containing alcohol.
The blood glucose lowering effect of gliclazide may be diminished and there may be an increase in blood sugar when one of the following medicines is used:
medicines for the treatment of central nervous system diseases (chlorpromazine)
medicines to reduce inflammation (corticosteroids)
medicines for the treatment of asthma or those that are used during a generic activity: (intravenous salbutamol, ritodrine and terbutaline)
medicines for the treatment of breast disorders, severe menstrual bleeding and endometriosis (danazol)
products containing St John's wort.
A blood sugar (low or high blood sugar) disorder may occur when Madras MR 30 mg is taken concomitantly with a medicine belonging to a class of antibiotics called fluoroquinolones, especially from the elderly.
Madras MR 30 mg modified-release tablets may enhance 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, tell the medical staff that you are taking Madras MR 30 mg modified-release tablets.
MADRAS MR with crane, beverages and alcohol
MADRAS MR 30 mg modified-release tablets can be taken with crane 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
MADRAS MR 30 mg modified-release tablets are not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or planning a pregnancy, talk to your doctor so that he or she can prescribe more appropriate treatment.
You should not take MADRAS MR 30 mg modified-release tablets as 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 excessively high (hyperglycaemia), or if visual disturbances occur as a result of these conditions. Keep in mind that you could endanger yourself or others (eg when driving or using machines). Please ask your doctor if you can drive:
if you have frequent episodes of low blood sugar (hypoglycaemia)
if your low blood pressure (hypoglycaemia) signals are weak or lacking.
3. How to take MADRAS 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 your doctor depending on your blood sugar and possibly urine sugar.
Changes in external factors (eg, weight reduction, lifestyle changes, stress) or improvement in blood glucose control may require a change in gliclazide doses.
The recommended daily dose is one to four tablets (up to 120 mg) taken at breakfast. It depends on the response to the treatment.
MADRAS MR 30 mg modified-release tablets may be used to replace another medicinal product for the treatment of diabetes. If a combined treatment with MADRAS MR 30 mg modified-release tablets with metformin, an alpha-glucosidase inhibitor or insulin is started, your doctor will individually determine the appropriate dose for each individual drug.
Please talk to your doctor or pharmacist if you have the impression that MADRAS MR 30 mg modified-release tablets are acting severely or not strongly.
If you notice that your blood sugar levels are high, although you are taking MADRAS MR, you should tell your doctor or pharmacist.
Method and routes of administration
Take your tablet (s) with a glass of water at breakfast (and preferably at the same time each day). Swallow the tablets whole. Do not chew or crush.
You should always eat after taking the tablet (s).
If you take more MADRAS MR 30 mg modified-release tablets than you should
If you take more than the required number of tablets, contact your doctor or emergency department immediately with the nearest hospital. Overdose symptoms are those in the blood glucose lowering (hypoglycaemia) described in point 2. They can be controlled by taking immediate sugar (4 to 6 lump) or liquids containing sugar followed by a hearty breakfast or main meal.
If the patient is unconscious, call a doctor immediately or call for help. The same should be done if someone else, such as a child, has swallowed unintentionally and accidentally the medicinal product. Unconscious patients should not be given food or drink.
Always provide a sufficiently informed person who can call a doctor in case of urgency.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most common adverse drug reaction observed is low blood sugar (hypoglycaemia). For symptoms and signs see "Warnings and Precautions" in section 2.
If not treated, these symptoms could progress to drowsiness, loss of consciousness, or even coma. If the blood sugar lowering episode is severe or prolonged, even if you have temporarily controlled it by taking sugar, you should seek immediate medical attention.
There are single reports of impaired hepatic function that may cause yellowing of the skin and eyes. If this happens to you, talk to your doctor immediately. These symptoms usually disappear after stopping the drug. Your doctor will decide whether to stop your treatment.
There have been reports of skin reactions such as:
angioedema (rapid swelling of the tissues, such as eyelids, face, lips, mouth, tongue or throat, which may cause difficulty breathing). The rash may progress and lead to blistering and flaking of the skin.
In exceptional cases, symptoms of acute hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and rash, followed by rash and fever.
Reducing the number of cells in the blood (eg platelets, erythrocytes and leukocytes).
This may cause:
inflammation of the throat
These symptoms usually disappear after discontinuation of treatment.
Problems with digestion
a sense of fatigue
These reactions occur more slowly when taken 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.
When taking a sulphonylurea, the following are described: severe changes in blood cell count and allergic inflammation of the blood vessel wall, decrease in blood sodium (hyponatraemia), hepatic impairment (eg jaundice) most cases disappear after stopping the use of sulphonylureas, but in some cases may lead to life-threatening liver failure.
How to Store MADRAS MR
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after the expiry date. The expiry date refers to the last day of that month.
Store below 25 ° C.
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 contains MADRAS MR
The active substance is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
The other ingredients (excipients) are: calcium hydrogen phosphate dihydrate, Povidone K30, hypromellose and magnesium stearate (E470b).
What MADRAS MR looks like and contents of the pack
MADRAS MR 30 mg modified-release tablets are white to off-white biconvex capsule-shaped tablets measuring 9.8 mm x 4.3 mm, marked with "30" on one side and smooth on the other.
MADRAS MR 30 mg modified-release tablets are available in blister packs containing 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98, 100, 112, 120, 180 and 500 tablets boxes.
Not all types of packaging can be placed on the market.