Empanorm M 12.5/500mg Tab

EMPANORM M 12.5/500MG Tablet

EMPANORM M 12.5/500MG Tablet, manufactured by ALKEM LAB-DIABETOLOGY DIVISION, is a combination medication prescribed for the management of Type 2 Diabetes Mellitus.

Composition

EMPANORM M 12.5/500MG Tablet contains two active ingredients:

• Empagliflozin: 12.5mg
• Metformin: 500mg

Empagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor, which helps the kidneys remove excess glucose from the body through urine. Metformin belongs to the biguanide class, reducing glucose production in the liver, delaying glucose absorption from the intestines, and increasing the body's sensitivity to insulin.

Uses

EMPANORM M 12.5/500MG Tablet is primarily used for:

• Management of Type 2 Diabetes Mellitus: It helps lower blood sugar levels and improve glycemic control in adults when diet and exercise alone are insufficient or when metformin alone is not enough.
• Cardiovascular Benefits: It reduces the risk of heart attacks, strokes, and other cardiovascular events in patients with Type 2 diabetes and existing heart disease.
• Complication Prevention: Helps prevent serious diabetes complications such as kidney damage (diabetic nephropathy), blindness (diabetic retinopathy), and nerve damage (diabetic neuropathy).
• Weight Management: May aid in weight loss by causing the body to excrete excess glucose.

Dosage and Administration

This medication should be taken orally, usually once daily, with or without food. It is often recommended to take it with meals to minimize stomach upset. For optimal benefits, it should be taken at the same time each day. The dosage is determined by a healthcare professional based on medical condition and response to treatment. Do not exceed the prescribed dose.

Side Effects

Common side effects may include:

• Frequent urination
• Mild skin rash or itchy skin
• Nausea, vomiting, diarrhea, stomach ache, loss of appetite
• Headache, dizziness
• Genital yeast infections
• Metallic taste in the mouth

Serious side effects, though less common, require immediate medical attention:

• Lactic Acidosis: Symptoms include trouble breathing, unusual muscle pain, weakness, irregular heartbeats, rapid weight loss, excessive thirst, fast and deep breathing, confusion, sweet smell to breath, metallic taste in the mouth, or a different odor to urine or sweat.
• Ketoacidosis: Similar symptoms to lactic acidosis.
• Hypoglycemia (Low Blood Sugar): Especially when used with other diabetes medications. Symptoms include shaking, sweating, feeling very anxious or confused, fast heartbeat, and excessive hunger.

Precautions

• Contraindications: Do not take if allergic to empagliflozin or metformin, if you have Type 1 diabetes, severe kidney or liver disease, metabolic acidosis (like lactic acidosis or diabetic ketoacidosis), diabetic pre-coma, or conditions affecting kidney function such as severe infection or dehydration.
• Pregnancy and Breastfeeding: Generally not recommended during pregnancy or breastfeeding; consult a doctor.
• Alcohol Consumption: Avoid excessive alcohol as it increases the risk of lactic acidosis.
• Drug Interactions: Inform your doctor about all other medications, supplements, or herbal products being taken to avoid potential interactions.
• Monitoring: Regular monitoring of kidney function is crucial, especially for older adults.
• Do not stop the medication abruptly without consulting a doctor, as this can lead to increased blood sugar levels.

Storage

Store EMPANORM M 12.5/500MG Tablet in a cool and dry place, away from direct sunlight, at temperatures between 10ºC to 25ºC or below 30ºC. Keep out of reach of children and pets.

Here are the most frequently asked questions about EMPANORM M 12.5/500MG TAB, along with concise answers:

1. What is EMPANORM M 12.5/500MG TAB used for?

EMPANORM M 12.5/500MG TAB is a combination medicine used with a proper diet and exercise program to treat high blood sugar levels in adults with type 2 diabetes mellitus. It also helps reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and lowers the risk of cardiovascular death and hospitalization for heart failure. Additionally, it can reduce the risk of worsening kidney disease, end-stage kidney disease, and hospitalization in adults with chronic kidney disease.

2. How does EMPANORM M 12.5/500MG TAB work?

This medicine contains two active ingredients: Empagliflozin and Metformin. Empagliflozin works by blocking a protein in the kidneys called SGLT2 (sodium-glucose co-transporter 2). This prevents the kidneys from reabsorbing glucose back into the bloodstream, leading to increased glucose excretion in the urine, thus lowering blood sugar. Metformin works by reducing the amount of sugar produced by the liver, decreasing the absorption of sugar from the intestines, and improving your body's sensitivity to insulin, allowing your cells to use sugar more effectively.

3. What is the usual dosage of EMPANORM M 12.5/500MG TAB?

The usual dosage of EMPANORM M 12.5/500MG TAB is typically one tablet, taken twice a day with meals. Taking it with food helps reduce stomach upset. Your doctor will determine the exact dose and frequency based on your condition and how you respond to the medication. It's important to swallow the tablet whole and not to crush, break, or chew it.

4. What are the common side effects of EMPANORM M 12.5/500MG TAB?

Common side effects may include frequent urination, thirst, nausea, vomiting, diarrhea, abdominal pain, gas, headache, and weakness. Empagliflozin can also increase the risk of genital yeast infections in both men and women, and urinary tract infections (UTIs). If these side effects persist or worsen, contact your doctor.

5. Are there any serious side effects to be aware of?

Serious but less common side effects include lactic acidosis (a rare but severe buildup of lactic acid, primarily associated with metformin, especially in individuals with kidney or liver problems, heart failure, or excessive alcohol use) and ketoacidosis (high levels of ketones in the blood). Other serious concerns include dehydration (especially if experiencing severe vomiting or diarrhea), low blood pressure, severe urinary tract infections, and, rarely, a serious genital infection called Fournier's gangrene. Low blood sugar (hypoglycemia) can occur, especially when taken with other diabetes medications. Contact your doctor immediately if you experience symptoms of any serious side effect.

6. Is EMPANORM M 12.5/500MG TAB safe during pregnancy or breastfeeding?

There is limited information on the use of EMPANORM M during pregnancy, and it may cause harm to an unborn baby. It is generally not recommended during pregnancy and should only be used if specifically prescribed by your doctor after carefully weighing the benefits and risks. Regarding breastfeeding, the medicine may pass into human breast milk, so it is generally advised not to use it while breastfeeding. Consult your doctor for advice if you are pregnant, planning to become pregnant, or breastfeeding.

7. Can EMPANORM M 12.5/500MG TAB be taken with other medications?

Yes, it can be taken with other medications, but you should inform your doctor about all prescription, over-the-counter, herbal, and vitamin supplements you are taking. Taking EMPANORM M with insulin or certain other diabetes medications (like sulfonylureas) can increase the risk of low blood sugar, and dose adjustments of those medications may be necessary. Caution is also advised with diuretics due to increased urine output and potential for dehydration. Certain medications and medical procedures involving iodinated contrast agents can increase the risk of lactic acidosis with metformin, so your doctor may advise temporarily stopping EMPANORM M.

8. What precautions should I take while using EMPANORM M 12.5/500MG TAB?

You should not take this medicine if you have type 1 diabetes or diabetic ketoacidosis. It's crucial to monitor your kidney function before and during treatment, as it should be avoided in severe kidney or liver disease. Avoid excessive alcohol consumption, as it can increase the risk of lactic acidosis. Stay well-hydrated, especially during exercise, hot weather, or if you experience vomiting or diarrhea, to prevent dehydration. Inform your doctor if you have upcoming surgery or radiological procedures requiring iodinated contrast. Regular blood sugar monitoring and adherence to your doctor's prescribed diet and exercise plan are essential.

9. What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember, provided it is several hours before your next scheduled dose (e.g., more than 12 hours). If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one, as this can increase the risk of side effects.

10. How should EMPANORM M 12.5/500MG TAB be stored?

Store the medicine at room temperature in a dry place, away from excess heat and moisture. Keep it in the container it came in, tightly closed, and out of the reach of children and pets. Do not store it in the bathroom. Dispose of any unused or expired medication properly, preferably through a medicine take-back program, rather than flushing it down the toilet.