Madras MR 60 mg. 30 tablets

€14

Madras MR 60 mg modified-release tablets are a medicine that contains the active substance gliclazide that lowers blood glucose (an oral antidiabetic medicine belonging to the group of sulphonylureas).

Quantity

Madras MR 60 mg. 30 tablets

What is Madras MR and what it is used for

Madras MR 60 mg modified-release tablets are a medicine that contains the active substance gliclazide that lowers blood glucose (an oral antidiabetic medicine belonging to the group of sulphonylureas).

Madras MR 60 mg modified-release tablets are used to treat certain types of diabetes (type 2 diabetes mellitus) in adults where only dietary measures, exercise and weight reduction are not enough to maintain normal blood glucose levels.

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 medicines in the same group (sulphonylureas) 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 needed if necessary.

During the first weeks of treatment, the risk of lowering blood sugar (hypoglycaemia) is increased. Therefore more frequent medical control is needed.

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 take too much gliclazide
if you suffer from specific hormone-dependent illnesses (impaired thyroid, pituitary gland or adrenal 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 may 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 treatment plan prescribed by your doctor if you are taking products containing St John's wort (Hypericum perforatum) (see 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.

If such symptoms occur, you should contact your doctor or pharmacist.

A blood sugar (low or high blood sugar) disorder may occur when gliclazide is prescribed concomitantly with medicines belonging to a class of antibiotics called fluoroquinolones, especially in the elderly. In this case, your doctor will remind you of the importance of monitoring your blood sugar.

If your family has or you know that you have a deficiency of glucose-6-phosphate dehydrogenase (GFD) deficiency (erythrocyte anomaly), a decrease in hemoglobin and erythrocyte breakdown (haemolytic anemia) may occur. Contact your doctor before taking this medicinal product.

Children and adolescents
Madras MR 60 mg modified-release tablets are not recommended for use in children due to a lack of data.

Other medicines and Madras MR 60 mg modified-release tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The blood glucose lowering effect of gliclazide may become stronger and low blood sugar occur when any of the following medicines are used:

other medicines that are used to treat high blood sugar (oral antidiabetic agents, 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 to treat 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 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 (glucocorticoids)
medicines for the treatment of asthma or which are used during a generic activity (intravenous salbutamol, ritodrine and terbutaline)
medicines for the treatment of breast diseases, 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 mg is taken concomitantly with a medicine belonging to a class of antibiotics called fluoroquinolones, especially from the elderly.

Madras MR 60 mg modified-release tablets may enhance the effect of blood-clotting drugs (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 60 mg modified-release tablets.

Madras MR with food, beverages and alcohol
Madras MR 60 mg modified-release tablets 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 and breastfeeding
Pregnancy
Madras MR 60 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 60 mg modified-release tablets until you are breast-feeding.

You should not take Madras MR if 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 operating 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.
How to take Madras MR

Dosage
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 count 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 from half to two tablets (up to 120 mg) taken at once during breakfast. It depends on the response to the treatment.

If a combined treatment with Madras MR 60 mg modified-release tablets with metformin, alpha-glucosidase inhibitor, thiazolidinedione, dipeptidyl peptidase-4 inhibitor, 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, although you are taking Madras MR 60 mg, you should tell your doctor or pharmacist.

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

If you take more Madras MR MR 60 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 water.

Always provide a sufficiently informed person who can call a doctor in case of urgency.

If you forget to take Madras MR 60 mg modified-release tablets
It is important to take your medicine every day, as regular treatment has a better effect. If you still miss a dose of Madras MR 60 mg modified-release tablets, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Madras MR 60 mg modified-release tablets
Since diabetes usually lasts for a long time, you should consult your doctor before stopping taking this medicine. Stopping it can lead to an increase in blood sugar (hyperglycaemia), which leads 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 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.

Hepatic disorders
There are single reports of impaired hepatic function, which 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.

Skin disorders

There have been reports of skin reactions such as:
rash
redness
itching
hives
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 severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and rash, followed by rash and fever.

Blood disorders

Reducing the number of cells in the blood (eg platelets, erythrocytes and leukocytes). This may cause:
blurring
prolonged bleeding
bruises
inflammation of the throat
fever
These symptoms usually disappear after discontinuation of treatment
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 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 does Madras MR contain?

The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
The other ingredients (excipients) are:
Tablet core: lactose monohydrate, hypromellose (HPMC K 100 LV) (E464), hypromellose (HPMC K4M CR) (E464).
Coating: Hypromellose (HPMC K 100 LV) (E464), Hypromellose (HPMC K4M CR) (E464), Magnesium stearate (E572).
What Madras MR looks like and what the pack contains
Madras MR 60 mg modified-release tablets are white, biconvex oval tablets with a deep scored line on both sides marked "GLI" and "60" on either side of the score line on both sides of the tablet, 15 mm x 7 mm.

Madras MR 60 mg modified-release tablets are available in blister packs containing 10, 28, 30, 56, 60, 90, 120, 150 and 180 tablets packed in cartons.

Not all types of packaging can be placed on the market.











 

 

New product