Empatrol M 12.5/500mg Tab

EMPATROL M 12.5/500MG TAB by ARISTO PHARMA

• Name: Empatrol-M 12.5/500 Tablet. The manufacturer is Aristo Pharmaceuticals Pvt Ltd.

• Composition: Each tablet contains Empagliflozin 12.5 mg and Metformin 500 mg.

• Uses: Empatrol-M 12.5/500 Tablet is primarily used to treat Type 2 Diabetes Mellitus in adults, in conjunction with diet and exercise. It works by helping to lower high blood glucose (sugar) levels and improve glycemic control. Empagliflozin aids in removing excess sugar from the body through urine, while Metformin reduces glucose production in the liver, delays intestinal glucose absorption, and increases the body's sensitivity to insulin. This combination also offers cardiovascular benefits, reducing the risk of heart attacks, strokes, and other cardiovascular events in patients with Type 2 diabetes and existing cardiovascular disease.

• Dosage and Administration: Take Empatrol-M 12.5/500 Tablet orally as a whole with sufficient water, exactly as prescribed by your doctor. It is typically taken once daily, preferably at the same time each day, and can be taken with or without food, though taking it with food may help reduce stomach upset. Do not chew, crush, or break the tablet. Do not exceed the prescribed dose or discontinue the medicine without consulting your doctor, as abrupt cessation can elevate blood sugar levels.

• Side Effects: Common side effects may include frequent urination, mild skin rash or itchy skin, nausea, vomiting, diarrhea, stomach ache, loss of appetite, general weakness, gas, constipation, urinary tract infections (UTIs), and genital fungal infections. More serious, but less common, side effects can include lactic acidosis (symptoms like trouble breathing, unusual muscle pain, irregular heartbeats), severe dehydration, and hypoglycemia (low blood sugar), especially when used with other antidiabetic medicines or alcohol.

• Precautions: Consult your doctor if you are pregnant or breastfeeding, as this medication is generally not recommended during these periods. Do not take Empatrol-M if you have Type 1 Diabetes Mellitus, severe kidney or liver disease, or a history of metabolic acidosis. Inform your doctor about all current medications and medical conditions to avoid potential interactions. Avoid excessive alcohol consumption, as it can increase the risk of lactic acidosis and hypoglycemia. This medicine is not recommended for individuals under 18 or over 85 years of age. It may cause dizziness or blurred vision, so exercise caution when driving or operating machinery. Regular monitoring of blood sugar levels is crucial.

• Storage: Store Empatrol-M 12.5/500 Tablet in a cool and dry place, away from direct sunlight, ideally between 10°C to 25°C or below 30°C. Keep it out of reach of children and pets.

What is EMPATROL M 12.5/500MG TAB used for?

EMPATROL M 12.5/500MG Tablet is primarily used to manage type 2 diabetes mellitus in adults, in conjunction with diet and exercise. It is prescribed when diabetes is not adequately controlled by metformin alone or other diabetes medications. Additionally, this medication helps lower the risk of cardiovascular death in patients with type 2 diabetes and existing heart or blood vessel disease. It also helps reduce the risk of worsening kidney disease, end-stage kidney disease, and hospitalization in patients with chronic kidney disease.

How does EMPATROL M 12.5/500MG TAB work?

EMPATROL M 12.5/500MG Tablet contains two active ingredients: Empagliflozin and Metformin.

• Empagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor. It works by blocking the SGLT2 protein in the kidneys, which reduces the reabsorption of glucose (sugar) back into the bloodstream and increases its excretion through urine. This mechanism works independently of insulin.
• Metformin is a biguanide that reduces blood sugar levels by decreasing glucose production in the liver, delaying glucose absorption from the intestines, and improving the body's sensitivity to insulin, thus enhancing glucose uptake and utilization by cells. Together, these two components provide a more effective reduction in blood glucose levels.

What is the usual dosage for EMPATROL M 12.5/500MG TAB?

You should always take EMPATROL M 12.5/500MG Tablet exactly as prescribed by your doctor. It is typically recommended to take this medicine at the same time every day, preferably with meals, for optimal benefits. Do not cut, break, or chew the tablet, and do not exceed the prescribed dose. Your doctor will determine the appropriate dosage based on your medical condition and how you respond to the treatment, but the daily dose usually does not exceed 25 mg of empagliflozin and 2000 mg of metformin.

What are the possible side effects of EMPATROL M 12.5/500MG TAB?

Common side effects may include frequent urination, mild skin rash or itchy skin, nausea, vomiting, diarrhea, stomach ache, loss of appetite, joint pain, urinary tract infections (UTIs), genital yeast infections, taste changes, general weakness, gas, and constipation. More serious, but rare, side effects can include lactic acidosis, with symptoms such as vomiting, stomach pain, muscle cramps, a general feeling of unwellness, tiredness, difficulty breathing, and reduced body temperature. Hypoglycemia (low blood sugar) is uncommon when this medicine is taken alone, but the risk increases if taken with other diabetes medications or alcohol, or if meals are missed. Staying well-hydrated is important to prevent dehydration, which can be a side effect.

Is EMPATROL M 12.5/500MG TAB safe during pregnancy or breastfeeding?

Pregnancy: There is limited information on the effects of EMPATROL M Tablet during pregnancy. It should only be taken if prescribed by your doctor, who will carefully assess the benefits against the potential risks. Empagliflozin is generally not recommended during pregnancy, and animal studies have indicated harmful effects on the developing fetus. Metformin can also affect the menstrual cycle, potentially increasing the risk of pregnancy, so it is advisable to discuss birth control with your doctor.

Breastfeeding: EMPATROL M Tablet is generally not recommended during breastfeeding as it may pass into human breast milk. While metformin passes into breast milk in small amounts, it is unknown if empagliflozin does.

Can EMPATROL M 12.5/500MG TAB be taken with other medications?

It is crucial to inform your doctor about all other medications, supplements, and herbal products you are currently taking or plan to take, to avoid potential drug interactions. EMPATROL M Tablet may reduce the levels of lithium in the blood. Concurrent use with diuretics (water pills) can increase the risk of dehydration and lower blood pressure. The risk of low blood sugar (hypoglycemia) can increase if this medicine is taken with other diabetes medications, such as insulin or glipizide. Certain drugs, like carbonic anhydrase inhibitors (e.g., topiramate), may increase the risk of lactic acidosis when taken with EMPATROL M Tablet.

What precautions should be taken while using EMPATROL M 12.5/500MG TAB?

Do not take EMPATROL M Tablet if you are allergic to empagliflozin, metformin, or any of its other ingredients. It should also be avoided if you have metabolic acidosis (such as lactic acidosis or diabetic ketoacidosis), kidney failure, liver problems, or a diabetic pre-coma. Inform your doctor if you have a kidney or liver disorder, uncontrolled diabetes, a serious infection, are fasting for extended periods, consume alcohol, are dehydrated, have a condition causing reduced oxygen supply to a body part, have type 1 diabetes, are over 75 years old, have a urinary tract infection with fever, or require an examination with iodination contrast agents. Avoid alcohol consumption as it can increase the risk of lactic acidosis. Maintain good genital hygiene to prevent fungal infections and drink plenty of fluids to avoid dehydration. Monitor your blood sugar levels regularly and carry sugary food or fruit juice to treat any sudden hypoglycemia symptoms. This medication is not recommended for individuals under 18 years of age. Discontinue use and consult your doctor if kidney function worsens.

What happens if a dose of EMPATROL M 12.5/500MG TAB is missed?

If you miss a dose of EMPATROL M Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one. Missing doses frequently can lead to increased blood sugar levels and may raise the risk of diabetes-related complications. If you miss more than one dose or experience symptoms of high blood sugar, contact your doctor.

How should EMPATROL M 12.5/500MG TAB be stored?

EMPATROL M 12.5/500MG Tablet should be stored in a cool and dry place, away from direct sunlight. Keep it out of reach of children and pets. The recommended storage temperature is below 30°C.