FLEXIGLIM 1MG TABLET

Manufacturer : UNI-UNISEARCH
Composition : GLIMEPIRIDE-1MG
Dose Form : TABLET
Description : FLEXIGLIM 1MG TAB
Route Of Administration : ORAL
Pack : 10
₹45.20
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SKU
FLE0043

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Manufacturer : UNI-UNISEARCH
Composition : GLIMEPIRIDE-1MG
Dose Form : TABLET
Description : FLEXIGLIM 1MG TAB
Route Of Administration : ORAL
Pack : 10

Drug Ingredient Information

GLIMEPIRIDE-1MG

GLIMEPIRIDE

Information for patients
Drug Information Glimepiride is a medicine taken by mouth to help lower blood sugar. It belongs to a group of medicines called sulfonylureas. Glimepiride works by increasing the amount of insulin released from your pancreas. The insulin then lowers your blood sugar levels. What Glimepiride is used for: • Glimepiride is used to treat a certain form of diabetes (type 2 diabetes mellitus) when diet, physical exercise and weight reduction alone have not been able to control your blood sugar levels
Drug Alert
Alert You are allergic (hypersensitive) to: Glimepiride or other sulfonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or any of the other ingredients of Glimepiride (listed in Section 6 What Glimepiride contains) • You have insulin dependent diabetes (type 1 diabetes mellitus)
Before Consuming the Medicine
Avoid Drug You are allergic (hypersensitive) to: Glimepiride or other sulfonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or any of the other ingredients of Glimepiride (listed in Section 6 What Glimepiride contains) • You have insulin dependent diabetes (type 1 diabetes mellitus) • You have diabetic ketoacidosis (a complication of diabetes when your acid level is raised in your body and you may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness) • You are in a diabetic coma • You have severe kidney disease • You have a severe liver disease 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 Glimepiride
Drug Special Care Check with your doctor or pharmacist before taking your medicine 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 • You have a severe liver or kidney disorder If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Glimepiride. Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase. The information available on the use of Glimepiride in people under 18 years of age is limited. Therefore, its use in these patients is not recommende
Drug Drug Interactions Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may wish to change your dose of Glimepiride if you are taking other medicines, which may weaken or strengthen the effect of Glimepiride on the level of sugar in your blood. The following medicines can increase the blood sugar lowering effect of Glimepiride. This can lead to a risk of hypoglycaemia (low blood sugar): • Other medicines to treat diabetes mellitus (such as insulin or metformin) • Medicines to treat pain and inflammation (phenylbutazone, azopropazone, oxyphenbutazone, aspirin-like medicines) • Medicines to treat urinary infections (such as some long acting sulfonamides) • Medicines to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin) • Medicines to inhibit blood clotting (coumarin derivatives such as warfarin) • Medicines supporting muscle build up (anabolics) • Medicines used for male sex hormone replacement therapy • Medicines to treat depression (fluoxetine, MAO- inhibitors) • Medicines lowering high cholesterol level (fibrates) • Medicines lowering high blood pressure (ACE inhibitors) • Medicines called anti-arrhythmic agents used to control abnormal heart beat (disopyramide) • Medicines to treat gout (allopurinol, probenecid, sulfinpyrazone) • Medicines to treat cancer (cyclophosphamide, ifosfamide, trofosfamide) • Medicines used to reduce weight (fenfluramine) • Medicines to increase circulation when given in a high dose intravenous infusion (pentoxifylline) • Medicines to treat nasal allergies such as hay fever (tritoqualine) • Medicines called sympatholytics to treat high blood pressure, heart failure, or prostate symptoms The following medicines may decrease the blood sugar lowering effect of Glimepiride. This can lead to a risk of hyperglycaemia (high blood sugar level): • Medicines containing female sex hormones (oestrogens, progestogens) • Medicines to treat high blood pressure called thiazide diuretics (water tablets) • Medicines used to stimulate the thyroid gland (such as levothyroxine) • Medicines to treat allergies and inflammation (glucocorticoids) • Medicines to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives) • 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 nervousness and sleep problems (barbiturates) • Medicines to treat increased pressure in the eye (azetazolamide) • Medicines to treat high blood pressure or lowering blood sugar (diazoxide) • Medicines to treat infections, tuberculosis (rifampicine) • Medicines to treat severe low blood sugar levels (glucagon) The following medicines can increase or decrease the blood sugar lowering effect of Glimepiride: • Medicines to treat stomach ulcers (called H2 antagonists) • Medicines to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine and reserpine. These can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines Glimepiride may either increase or weaken the effects of the following medicines: • Medicines inhibiting blood clotting (coumarin derivatives such as warfarin)
Drug Pregnancy Interaction Glimepiride should not be taken during pregnancy. Tell your doctor if you are, you think you might be or are planning to become pregnant
Drug Breast feeding Interaction Glimepiride may pass into breast milk. Glimepiride should not be taken during breast feeeding. Ask your doctor or pharmacist for advice before taking any medicine
Drug Machinery Interaction your blood sugar is lowered (hypoglycaemia), or raised (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (e.g. when driving a car or using machines). Please ask your doctor whether you can drive a car if you: • have frequent episodes of hypoglycaemia, • have fewer or no warning signals of hypoglycaemia
Drug More Information Important information about hypoglycaemia (low blood sugar) When you take Glimepiride, you may get hypoglycaemia (low blood sugar). Please see below for additional information about hypoglycaemia, its signs and treatment. Following factors could increase the risk of you getting hypoglycaemia: • Undernourishment, irregular meal time, missed or delayed meal or period of fasting • Changes to your diet • Taking more Glimepiride than needed • Having kidneys that do not work properly • Having severe liver disease • If you suffer from particular hormone-induced disorders (disorders of the thyroid glands, of the pituitary gland or adrenal cortex) • Drinking alcohol (especially when you skip a meal) • Taking certain other medicines (See Taking other medicines below) • If you increase the amount of exercise you do and you don''t eat enough food or eat food containing less carbohydrate than usual. Signs of hypoglycaemia include: • Hunger pangs, headache, nausea, vomiting, sluggishness, sleepiness, problems sleeping, restlessness, aggression, problems with concentration, reduced alertness and reaction time, depression, confusion, problems with your speech and sight, slurred speech, shakiness, partial paralysis, dizziness, helplessness • The following signs may also occur: sweating, clammy skin, anxiety, fast or increased heart beat, high blood pressure, awareness of your heart beat, sudden strong pain in the breast that may radiate into neighbouring areas (angina pectoris and cardiac arrhythmias) If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop fits, lose self control, breathing may be shallow and your heart beat slowed down, you may fall into unconsciousness. The clinical picture of a severe reduced blood sugar level may resemble that of a stroke. Treating hypoglycaemia: In most cases the signs of reduced blood sugar vanish very quickly when you consume some form of sugar, e.g. sugar cubes, sweet juice, sweetened tea. You should therefore always take some form of sugar with you (e.g. sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or go to the hospital if taking sugar does not help or if the symptoms recur. Laboratory Tests The level of sugar in your blood or urine should be checked regularly. Your doctor may also take blood tests to monitor your blood cell levels and liver function.
How to take the Medicine
Consumption Info Glimepiride contains lactose. If you have been told by your doctor that you cannot tolerate some sugars, contact your doctor before taking this medicinal product. Alcohol intake may increase or decrease the blood sugar lowering action of Glimepiride in an unpredictable way.
Drug quanitty The dose of Glimepiride depends on your needs, condition and results of blood and urine sugar tests and is determined by your doctor. Do not take more tablets than your doctor has prescribed. • The usual starting dose is one Glimepiride 1 mg tablet once a day • If necessary, your doctor may increase the dose after each 1 - 2 weeks of treatment • The maximum recommended dose is 6 mg Glimepiride per day • A combination therapy of glimepiride plus metformin or of glimepiride plus insulin may be started. In such a case your doctor will determine the proper doses of glimepiride, metformin or insulin individually for you • Your dose of Glimepiride may need to be adjusted if you change weight, change your lifestyle, or if you are under a lot of stress. Please speak to your doctor if any of these situations apply to you • If you feel the effect of your medicine is too weak or too strong do not change the dose yourself, but ask your doctor
Drug Dose • Take this medicine by mouth, just before or with the first main meal of the day (usually breakfast). If you do not have breakfast you should take the product on schedule as prescribed by your doctor. It is important not to leave out any meal when you are on Glimepiride • Swallow the tablets whole with at least half glass of water. Do not crush or chew the tablets
Excess Drug Consumption If you happen to have taken too much Glimepiride or an additional dose there is a danger of hypoglycaemia (signs of hypoglycaemia see Section 2 - Take special care with Glimepiride) and therefore you should instantly consume enough sugar (e.g. a small bar of sugar cubes, sweet juice, sweetened tea) and inform a doctor immediately. When treating hypoglycaemia due to accidental intake in children, the quantity of sugar given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia. Persons in a state of unconsciousness must not be given food or drink. Since the state of hypoglycaemia may last for some time it is very important that the patient is carefully monitored until there is no more danger. Admission into hospital may be necessary, also as a measure of precaution. Show the doctor the package or remaining tablets, so the doctor knows what has been taken. Severe cases of hypoglycaemia accompanied by loss of consciousness and coma are cases of medical emergency requiring immediate medical treatment and admission into hospital. It may be helpful to tell your family and friends to call a doctor immediately if this happens to you
Forgot Drug Consumption If you forget to take a dose, do not take a double dose to make up for forgotten doses
Stop Drug Consumption If you interrupt or stop the treatment you should be aware that the desired blood sugar lowering effect is not achieved or that the disease will get worse again. Keep taking Glimepiride until your doctor tells you to stop.
Possible Side Effects
General Information • Allergic reactions (including inflammation of blood vessels, often with skin rash) which may develop into serious reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock • Abnormal liver function including yellowing of the skin and eyes (jaundice), problems with the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure • Allergy (hypersensitivity) of the skin such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions • Severe hypoglycaemia including loss of consciousness, seizures or coma Some patients experienced the following side effects whilst taking
Common Drug Side Effects • Allergy (hypersensitivity) of the skin may occur such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions with swallowing or breathing problems, swelling of your lips, throat or tongue. Therefore in the event of one of these side effects, tell your doctor immediately • Allergic reactions with sulfonylureas, sulfonamides, or related drugs may occur • Problems with your sight may occur when beginning treatment with Glimepiride. This is due to changes in blood sugar levels and should soon improve • Increased liver enzymes If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
Rare Drug Side Effects • Lower blood sugar than normal (hypoglycaemia) (See Section 2 - Take special care with Glimepiride) • Decrease in the number of blood cells: • Blood platelets (which increases risk of bleeding or bruising) • White blood cells (which makes infections more likely) • Red blood cells (which can make the skin pale and cause weakness or breathlessness) These problems generally get better after you stop taking Glimepiride
Very Rare Drug Side Effects • Allergic reactions (including inflammation of blood vessels, often with skin rash) which may develop into serious reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock. If you experience any of these symptoms, tell your doctor immediately • Abnormal liver function including yellowing of the skin and eyes (jaundice), impairment of the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure. If you experience any of these symptoms, tell your doctor immediately • Feeling or being sick, diarrhoea, feeling full or bloated, and abdominal pain • Decrease in the amount of sodium level in your blood (shown by blood tests)
Drug Side Effects Symptoms
How to Store the Medicine
How to Store the Medicine Keep out of the reach and sight of children. Do not use Glimepiride after the expiry date which is stated after ‘EXP’ on the blister and carton. The expiry date refers to the last day of that month. Glimepiride 1 mg, 2 mg, 3 mg, and 4 mg tablets: do not store above 30°C. Store in the original package in order to protect from moisture Do not use Glimepiride if you notice visible signs of deterioration. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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