AROMET-G

Category:

AROMET G1: Each film-coated tablet contains Metformin 500mg and Glimepiride 1mg. AROMET G2: Each film-coated tablet contains Metformin 500mg and Glimepiride 2mg. AROMET 1000 G1: Each film-coated tablet contains Metformin 100mg and Glimepiride 1mg. AROMET 1000 G2: Each film-coated tablet contains Metformin 100mg and Glimepiride 2mg.

In Treatment of Type 2 diabetes mellitus

AROMET G is a combination medication that boosts insulin production in your pancreas. This increased insulin helps to decrease your blood sugar levels. Managing blood sugar is crucial for diabetes care, as it reduces the risk of severe complications like kidney and eye damage, nerve issues, and limb loss. Consistently taking this medicine, along with a balanced diet and regular exercise, can help you maintain a normal, healthy lifestyle.

Description

AROMET G belongs to a category of medicines known as anti-diabetic drugs. It is a combination of two medicines: Metformin Hydrochloride and Glimepiride which is used to treat type 2 diabetes mellitus in adults. Metformin belongs to a group of medicines called Biguanides & Glimepiride is a drug belongs to a blood sugar lowering group of medicines called Sulfonylureas.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Metformin HCl & Glimepiride Tablets cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and get some regular exercise.

If you take insulin too, your doctor will tell you how to start Metformin HCl & Glimepride Tablets.

Monitoring

  • Your doctor will perform regular blood glucose test and adapt your dose of Metformin hydrochloride tablets to your blood glucose levels. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are an older person
  • Your doctor will also check at least once a year how well your kidneys work. You may need more frequent checks if you are an older person or if your kidneys are not working normally How to take Metformin hydrochloride tablets Take the tablets with or after a meal. This will avoid you having side effects affecting your digestion.

Do not crush or chew the tablets. Swallow each tablet with a glass of water.

Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Metformin hydrochloride. It is especially important to mention the following:

Medicines which increase urine production, medicines used to treat pain and inflammation, certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists), beta-2 agonists such as salbutamol or terbutaline, corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma), other medicines used to treat diabetes.

Medicines can increase the blood sugar lowering effect of Glimepiride: Medicines to treat pain and inflammation, Other medicines to treat diabetes mellitus, Medicines supporting muscle build up, Medicines to inhibit blood clotting, Medicines used to reduce weight, Medicines called anti-arrhythmic agents used to control abnormal heart beat, Medicines lowering high cholesterol level, Medicines lowering high blood pressure (ACE inhibitors), Medicines to treat depression (MAO inhibitors), Medicines to treat gout, Medicines to treat cancer, Medicines to treat bacterial and fungal infections, Medicines to treat nasal allergies such as hay fever, Medicines to increase circulation when given in a high dose intravenous infusion, Medicines to treat urinary infections (such as some long acting sulfonamides), Medicines used for male sex hormone replacement therapy, Medicines called sympatholytic to treat high blood pressure, heart failure, or prostate symptoms

Medicines may decrease the blood sugar lowering effect of Glimepiride: Medicines containing female sex hormones, Medicines to treat high blood pressure called thiazide diuretics, Medicines used to stimulate the thyroid gland, Medicines to treat allergies and inflammation, Medicines to treat severe mental disorders, Medicines used to raise heart beat, to treat asthma or nasal congestion, coughs and colds, used to reduce weight, or used in life-threatening emergencies (adrenaline and sympathomimetics), Medicines to treat high cholesterol level (nicotinic acid), Medicines to treat constipation when they are used long term (laxatives), Medicines to treat fits (phenytoin), Medicines to treat high blood pressure or lowering blood sugar (diazoxide), Medicines to treat severe low blood sugar levels (glucagon), Medicines to treat nervousness and sleep problems, Medicines to treat infections, tuberculosis, Medicines to treat increased pressure in the eye.

If you need to have an injection of contrast containing iodine, you must stop taking medicines before or at the time of the injection. Your doctor will decide to restart your treatment with Metformin.

For Glimepiride and Metformin Tablets; The use of a combination of both compounds, either as a free combination or as a fixed combination, is associated with the same safety characteristics as the use of each compound

For Glimepiride:

Metabolism and nutrition disorders As a result of the blood-glucose-lowering action of glimepiride, hypoglycemia may occur, which may also be prolonged. Possible symptoms of hypoglycemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, impaired alertness and reactions, depression, confusion, speech disorders, aphasia, visual disorders, tremor, paresis, sensory disturbances, dizziness, helplessness, loss of self-control, delirium, cerebral convulsions, somnolence and loss of consciousness up to and including coma, shallow respiration and bradycardia.

In addition, signs of adrenergic counter-regulation may be present such as sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris, and cardiac arrhythmias.

The clinical picture of a severe hypoglycaemic attack may resemble that of a stroke. The symptoms nearly always subside when hypoglycaemia is corrected.

  • Eye disorders: Especially at the start of treatment, there may be temporary visual impairment due to the change in blood glucose levels. The cause is a temporary alteration in the turgidity and hence the refractive index of the lens, this being dependent on blood glucose level.
  • Gastrointestinal disorders: In isolated cases, there may be hepatitis, elevation of liver enzyme levels and/or cholestasis and jaundice, which may progress to life-threatening liver failure but can regress after withdrawal of glimepiride.
  • Blood and lymphatic system disorders: Changes in the blood picture may occur: Rarely, thrombocytopenia and, in isolated cases, leucopenia, hemolytic anemia, erythrocytopenia, granulocytopenia, agranulocytosis or pancytopenia may develop. Cases of severe thrombocytopenia with platelet count less than 10,000/μl and thrombocytopenic purpura have been reported in post-marketing experience (frequency not known).

Skin and subcutaneous tissue disorders; Alopecia (frequency not known)

  • General disorders: Occasionally, allergic or pseudoallergic reactions may occur, e.g. in the form of itching, urticaria or rashes. Such mild reactions may develop into serious reactions with dyspnoea and a fall in blood pressure, sometimes progressing to shock. Glimepiride,like all sulfonylureas , can cause weight gain (frequency not known).

For Metformin:

Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite (>10%) are very common: these occur most frequently during initiation of therapy and resolve spontaneously in most cases.

– Metallic taste (3%) is common.-Mild erythema has been reported in some hypersensitive individuals. The incidence of such effects is regarded as very rare (<0.01%).- A decrease of vitamin B12 absorption with decrease of serum levels has been observed in patients treated long-term with metformin and appears generally to be without clinical significance (<0.01%).-Lactic acidosis (0.03 cases/1000 patient-years) is very rare (see Warnings).- Hemolytic anemia (frequency unknown)

-Reduction of thyrotropin level in patients with hypothyroidism (frequency unknown)- Hypomagnesemia in the context of diarrhea (frequency unknown) – Encephalopathy (frequency unknown) – Photosensitivity (frequency unknown)

Do not take Metformin HCl & Glimepiride Tablets if you are:

  • if you are allergic to metformin hydrochloride & Glimepiride
  • if you have severely reduced kidney function or liver problems
  • If you have uncontrolled diabetes, with, for example, severe hyperglycemia, nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis or ketoacidosis.
  • if you lost too much water from your body, such as due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis
  • if you have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis
  • if you are treated for heart failure or have recently had a heart attack, have severe problems with your circulation or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis 
  • if you drink a lot of alcohol

If any of the above applies to you, talk to your doctor, before you start taking this medicine. Please note the following particular risk of lactic acidosis: Make sure you ask your doctor for advice, if

  • you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream
  • you need to have major surgery

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Metformin HCl & Glimepiride tablets.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Metformin HCl & Glimepiride tablets

  • If you are recovering from an injury, operation, infections with fever, or from other forms of stress, inform your doctor as temporary change of treatment may be necessary
  • If you have severe liver or kidney disorder
  • Lowering of the hemoglobin level and breakdown of red blood cells (hemolytic anemia) can occur in patients missing the enzyme glucose-6-phoshate dehydrogenase.

Following factors could increase the risk of you getting hypoglycemia:

Undernourishment, irregular meal time, missed or delayed meal or period of fasting or Changes to your diet; Taking more tablets than needed; Having kidneys that do not work properly or Having severe liver disease; If you suffer from particular hormone-induced disorders; Drinking alcohol (especially when you skip a meal); If you increase the amount of exercise you do and you don’t eat enough food or eat food containing less carbohydrate than usual.

Risk of lactic acidosis: Metformin HCl & Glimepride Tablets may cause a very rare, & serious side effect called lactic acidosis. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration, liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen.

If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Medicines and contact a doctor or the nearest hospital immediately if you have symptoms of lactic acidosis, as this condition may lead to coma.

Metformin HCl & Glimepride Tablets can cause hypoglycaemia, there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia, it usually helps to eat or drink something containing sugar.

Metformin HCl & Glimepiride Tablets with food drink and alcohol: Avoid alcohol intake while taking Metformin HCl & Glimepiride Tablets, since this may increase the risk of lactic acidosis.

Pregnancy, breast-feeding and fertility: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

During pregnancy, you need insulin to treat your diabetes.

Do not take this medicine if you are breast-feeding or if you are planning to breast-feed your baby.

Driving and using machines: Metformin HCl & Glimepiride Tablets itself and with other medicines to treat diabetes can cause hypoglycemia. Symptoms of hypoglycemia include weakness, dizziness, increased sweating, fast heart beat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms

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In Treatment of Type 2 diabetes mellitus

AROMET G is a combination medication that boosts insulin production in your pancreas. This increased insulin helps to decrease your blood sugar levels. Managing blood sugar is crucial for diabetes care, as it reduces the risk of severe complications like kidney and eye damage, nerve issues, and limb loss. Consistently taking this medicine, along with a balanced diet and regular exercise, can help you maintain a normal, healthy lifestyle.

Description

AROMET G belongs to a category of medicines known as anti-diabetic drugs. It is a combination of two medicines: Metformin Hydrochloride and Glimepiride which is used to treat type 2 diabetes mellitus in adults. Metformin belongs to a group of medicines called Biguanides & Glimepiride is a drug belongs to a blood sugar lowering group of medicines called Sulfonylureas.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Metformin HCl & Glimepiride Tablets cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and get some regular exercise.

If you take insulin too, your doctor will tell you how to start Metformin HCl & Glimepride Tablets.

Monitoring

  • Your doctor will perform regular blood glucose test and adapt your dose of Metformin hydrochloride tablets to your blood glucose levels. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are an older person
  • Your doctor will also check at least once a year how well your kidneys work. You may need more frequent checks if you are an older person or if your kidneys are not working normally How to take Metformin hydrochloride tablets Take the tablets with or after a meal. This will avoid you having side effects affecting your digestion.

Do not crush or chew the tablets. Swallow each tablet with a glass of water.

Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Metformin hydrochloride. It is especially important to mention the following:

Medicines which increase urine production, medicines used to treat pain and inflammation, certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists), beta-2 agonists such as salbutamol or terbutaline, corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma), other medicines used to treat diabetes.

Medicines can increase the blood sugar lowering effect of Glimepiride: Medicines to treat pain and inflammation, Other medicines to treat diabetes mellitus, Medicines supporting muscle build up, Medicines to inhibit blood clotting, Medicines used to reduce weight, Medicines called anti-arrhythmic agents used to control abnormal heart beat, Medicines lowering high cholesterol level, Medicines lowering high blood pressure (ACE inhibitors), Medicines to treat depression (MAO inhibitors), Medicines to treat gout, Medicines to treat cancer, Medicines to treat bacterial and fungal infections, Medicines to treat nasal allergies such as hay fever, Medicines to increase circulation when given in a high dose intravenous infusion, Medicines to treat urinary infections (such as some long acting sulfonamides), Medicines used for male sex hormone replacement therapy, Medicines called sympatholytic to treat high blood pressure, heart failure, or prostate symptoms

Medicines may decrease the blood sugar lowering effect of Glimepiride: Medicines containing female sex hormones, Medicines to treat high blood pressure called thiazide diuretics, Medicines used to stimulate the thyroid gland, Medicines to treat allergies and inflammation, Medicines to treat severe mental disorders, Medicines used to raise heart beat, to treat asthma or nasal congestion, coughs and colds, used to reduce weight, or used in life-threatening emergencies (adrenaline and sympathomimetics), Medicines to treat high cholesterol level (nicotinic acid), Medicines to treat constipation when they are used long term (laxatives), Medicines to treat fits (phenytoin), Medicines to treat high blood pressure or lowering blood sugar (diazoxide), Medicines to treat severe low blood sugar levels (glucagon), Medicines to treat nervousness and sleep problems, Medicines to treat infections, tuberculosis, Medicines to treat increased pressure in the eye.

If you need to have an injection of contrast containing iodine, you must stop taking medicines before or at the time of the injection. Your doctor will decide to restart your treatment with Metformin.

For Glimepiride and Metformin Tablets; The use of a combination of both compounds, either as a free combination or as a fixed combination, is associated with the same safety characteristics as the use of each compound

For Glimepiride:

Metabolism and nutrition disorders As a result of the blood-glucose-lowering action of glimepiride, hypoglycemia may occur, which may also be prolonged. Possible symptoms of hypoglycemia include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, impaired alertness and reactions, depression, confusion, speech disorders, aphasia, visual disorders, tremor, paresis, sensory disturbances, dizziness, helplessness, loss of self-control, delirium, cerebral convulsions, somnolence and loss of consciousness up to and including coma, shallow respiration and bradycardia.

In addition, signs of adrenergic counter-regulation may be present such as sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris, and cardiac arrhythmias.

The clinical picture of a severe hypoglycaemic attack may resemble that of a stroke. The symptoms nearly always subside when hypoglycaemia is corrected.

  • Eye disorders: Especially at the start of treatment, there may be temporary visual impairment due to the change in blood glucose levels. The cause is a temporary alteration in the turgidity and hence the refractive index of the lens, this being dependent on blood glucose level.
  • Gastrointestinal disorders: In isolated cases, there may be hepatitis, elevation of liver enzyme levels and/or cholestasis and jaundice, which may progress to life-threatening liver failure but can regress after withdrawal of glimepiride.
  • Blood and lymphatic system disorders: Changes in the blood picture may occur: Rarely, thrombocytopenia and, in isolated cases, leucopenia, hemolytic anemia, erythrocytopenia, granulocytopenia, agranulocytosis or pancytopenia may develop. Cases of severe thrombocytopenia with platelet count less than 10,000/μl and thrombocytopenic purpura have been reported in post-marketing experience (frequency not known).

Skin and subcutaneous tissue disorders; Alopecia (frequency not known)

  • General disorders: Occasionally, allergic or pseudoallergic reactions may occur, e.g. in the form of itching, urticaria or rashes. Such mild reactions may develop into serious reactions with dyspnoea and a fall in blood pressure, sometimes progressing to shock. Glimepiride,like all sulfonylureas , can cause weight gain (frequency not known).

For Metformin:

Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite (>10%) are very common: these occur most frequently during initiation of therapy and resolve spontaneously in most cases.

– Metallic taste (3%) is common.-Mild erythema has been reported in some hypersensitive individuals. The incidence of such effects is regarded as very rare (<0.01%).- A decrease of vitamin B12 absorption with decrease of serum levels has been observed in patients treated long-term with metformin and appears generally to be without clinical significance (<0.01%).-Lactic acidosis (0.03 cases/1000 patient-years) is very rare (see Warnings).- Hemolytic anemia (frequency unknown)

-Reduction of thyrotropin level in patients with hypothyroidism (frequency unknown)- Hypomagnesemia in the context of diarrhea (frequency unknown) – Encephalopathy (frequency unknown) – Photosensitivity (frequency unknown)

Do not take Metformin HCl & Glimepiride Tablets if you are:

  • if you are allergic to metformin hydrochloride & Glimepiride
  • if you have severely reduced kidney function or liver problems
  • If you have uncontrolled diabetes, with, for example, severe hyperglycemia, nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis or ketoacidosis.
  • if you lost too much water from your body, such as due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis
  • if you have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis
  • if you are treated for heart failure or have recently had a heart attack, have severe problems with your circulation or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis 
  • if you drink a lot of alcohol

If any of the above applies to you, talk to your doctor, before you start taking this medicine. Please note the following particular risk of lactic acidosis: Make sure you ask your doctor for advice, if

  • you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream
  • you need to have major surgery

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Metformin HCl & Glimepiride tablets.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Metformin HCl & Glimepiride tablets

  • If you are recovering from an injury, operation, infections with fever, or from other forms of stress, inform your doctor as temporary change of treatment may be necessary
  • If you have severe liver or kidney disorder
  • Lowering of the hemoglobin level and breakdown of red blood cells (hemolytic anemia) can occur in patients missing the enzyme glucose-6-phoshate dehydrogenase.

Following factors could increase the risk of you getting hypoglycemia:

Undernourishment, irregular meal time, missed or delayed meal or period of fasting or Changes to your diet; Taking more tablets than needed; Having kidneys that do not work properly or Having severe liver disease; If you suffer from particular hormone-induced disorders; Drinking alcohol (especially when you skip a meal); If you increase the amount of exercise you do and you don’t eat enough food or eat food containing less carbohydrate than usual.

Risk of lactic acidosis: Metformin HCl & Glimepride Tablets may cause a very rare, & serious side effect called lactic acidosis. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration, liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen.

If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Medicines and contact a doctor or the nearest hospital immediately if you have symptoms of lactic acidosis, as this condition may lead to coma.

Metformin HCl & Glimepride Tablets can cause hypoglycaemia, there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia, it usually helps to eat or drink something containing sugar.

Metformin HCl & Glimepiride Tablets with food drink and alcohol: Avoid alcohol intake while taking Metformin HCl & Glimepiride Tablets, since this may increase the risk of lactic acidosis.

Pregnancy, breast-feeding and fertility: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

During pregnancy, you need insulin to treat your diabetes.

Do not take this medicine if you are breast-feeding or if you are planning to breast-feed your baby.

Driving and using machines: Metformin HCl & Glimepiride Tablets itself and with other medicines to treat diabetes can cause hypoglycemia. Symptoms of hypoglycemia include weakness, dizziness, increased sweating, fast heart beat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms

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