MEGAGLIPTIN MF TABLET (10 TAB) by ARISTO PHARMACEUTICALS PRIVATE LIMITED

MEGAGLIPTIN MF TABLET is an antidiabetic medication manufactured by Aristo Pharmaceuticals Private Limited, used to manage Type 2 Diabetes Mellitus.

Composition Each uncoated bi-layered tablet contains:

• Teneligliptin Hydrobromide Hydrate equivalent to Teneligliptin 20 mg
• Metformin Hydrochloride IP 500 mg (as extended release)

Uses MEGAGLIPTIN MF TABLET is prescribed for adults with Type 2 Diabetes Mellitus to help control high blood sugar levels. It is particularly useful when diet and exercise alone are not sufficient, or when patients have not responded adequately to Metformin alone. This medication works by decreasing glucose production in the liver, reducing intestinal glucose absorption, and increasing insulin levels in the body while lowering glucagon levels. Effective management of blood sugar can help prevent serious complications such as kidney damage, blindness, heart attack, or stroke.

Dosage and Administration The tablet should be swallowed whole with a glass of water, typically once daily or as advised by a physician. It can be taken with or without food, but taking it with food may help reduce stomach upset. Do not crush, chew, or break the tablet. The dosage may vary based on the individual's condition and response to treatment.

Side Effects Common side effects may include:

• Nausea, vomiting, diarrhea
• Headache
• Stomach ache, abdominal pain, upset stomach
• Hypoglycemia (low blood sugar level), especially if used with insulin or sulfonylurea
• Respiratory infection, nasopharyngitis
• Weight gain, sweating
• Flatulence, constipation, loss of appetite

Serious but rare side effects include lactic acidosis, a life-threatening condition. Symptoms include deep or rapid breathing, persistent nausea, vomiting, unusual muscle pain, and stomach pain.

Precautions

• Allergies: Do not take if allergic to Metformin, Teneligliptin, or any other components.
• Kidney/Liver Problems: Use with caution and dose adjustment may be required in patients with kidney disease. It is contraindicated in severe renal or hepatic impairment.
• Pregnancy and Breastfeeding: Not recommended during pregnancy or breastfeeding; consult a doctor for alternatives.
• Alcohol: Avoid alcohol consumption as it increases the risk of lactic acidosis.
• Other Conditions: Inform your doctor if you have heart problems, severe infection, severe trauma, or are undergoing surgery.
• Vitamin B12 Deficiency: Long-term use may lead to Vitamin B12 deficiency.
• Interactions: Inform your doctor about all other medications you are taking, including other antidiabetic agents, corticosteroids, diuretics, and certain blood pressure medications, to avoid potential interactions.

Storage Store in a cool and dry place, away from direct sunlight and moisture. Keep it out of the sight and reach of children. The ideal storage temperature should be below 30°C.

MEGAGLIPTIN MF TABLET is a medication primarily used in the management of Type 2 Diabetes Mellitus. It is a combination of two active ingredients: Teneligliptin and Metformin hydrochloride.

Here are some frequently asked questions about MEGAGLIPTIN MF TABLET:

What is MEGAGLIPTIN MF TABLET used for?

MEGAGLIPTIN MF TABLET is prescribed to treat Type 2 Diabetes Mellitus in adults, particularly when diet and exercise alone, or metformin therapy alone, are insufficient to control blood sugar levels. It helps improve overall glycemic control by lowering both fasting and post-meal blood glucose.

How does MEGAGLIPTIN MF TABLET work?

This medicine combines two anti-diabetic agents:

• Teneligliptin: This is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by increasing the levels of certain natural substances called incretin hormones (like GLP-1) in the body. These hormones increase insulin release from the pancreas and decrease glucagon levels, particularly after meals, thereby helping to lower blood sugar.
• Metformin: This belongs to the biguanide class. It works by reducing the amount of glucose produced by the liver, decreasing the absorption of glucose from the intestines, and improving the body's sensitivity to insulin, allowing cells to take up more glucose from the blood. Together, these mechanisms lead to better control of blood sugar levels.

What is the usual dosage for MEGAGLIPTIN MF TABLET?

The usual adult starting dosage is typically 20 mg Teneligliptin and 500 mg Metformin extended release, administered orally once daily. If the initial dose is not sufficient, your doctor may increase it up to 40 mg Teneligliptin and 2000 mg Metformin once daily, while closely monitoring your condition. The tablet should be swallowed whole with a glass of water, usually with food to reduce stomach upset, and should not be broken, chewed, or crushed.

What are the possible side effects of MEGAGLIPTIN MF TABLET?

Common side effects may include nausea, vomiting, diarrhea, abdominal pain, bloating, constipation, loss of appetite, headache, respiratory infection, fatigue, and dizziness. More serious, but rare, side effects can occur. These include lactic acidosis (a build-up of lactic acid in the blood), which is a medical emergency characterized by deep or rapid breathing, severe fatigue, muscle cramps, and persistent stomach pain or vomiting. Hypoglycemia (low blood sugar) can also occur, especially if taken with other antidiabetic medications or insulin. Long-term use of metformin may also lead to Vitamin B12 deficiency. If you experience any persistent or severe side effects, consult your doctor.

Is MEGAGLIPTIN MF TABLET safe during pregnancy or breastfeeding?

• Pregnancy: Metformin is generally considered safe during pregnancy, but there is not enough well-established data on the safety of teneligliptin during pregnancy. The medication should only be used if the potential benefit outweighs the potential risk to the developing fetus, and poorly controlled diabetes itself can increase pregnancy complications.
• Breastfeeding: Metformin passes into breast milk in small amounts and is typically considered safe for breastfed infants. However, teneligliptin should be avoided by breastfeeding mothers as its transfer into milk has been reported in animal studies. Always consult your doctor before using this medicine if you are pregnant or breastfeeding.

Can MEGAGLIPTIN MF TABLET be taken with other medications?

MEGAGLIPTIN MF TABLET can interact with various medications. Inform your doctor about all medicines you are taking, including over-the-counter drugs and herbal supplements.

• Increased risk of hypoglycemia: If taken with other antidiabetic medications like sulfonylureas or insulin.
• Increased risk of lactic acidosis: With alcohol, carbonic anhydrase inhibitors (e.g., topiramate), and certain cationic drugs (e.g., digoxin, ranitidine, vancomycin).
• May affect blood sugar control: Diuretics, corticosteroids, thyroid hormones, estrogens, oral contraceptives, certain antibiotics (e.g., rifampicin, clarithromycin), and anti-fungals (e.g., fluconazole, ketoconazole). Your doctor will evaluate potential drug interactions and adjust your treatment if necessary.

What precautions should be taken while taking MEGAGLIPTIN MF TABLET?

Do not take this medicine if you are allergic to Teneligliptin, Metformin, or any of its ingredients. It is contraindicated in patients with Type 1 diabetes, severe kidney or liver problems, heart failure, bladder cancer, diabetic ketoacidosis, severe infection, severe trauma, or alcoholism. Your doctor may regularly monitor your kidney function, especially if you are elderly, and your Vitamin B12 levels during long-term treatment. Avoid excessive alcohol consumption as it increases the risk of lactic acidosis.

What happens if a dose of MEGAGLIPTIN MF TABLET is missed?

If you miss a dose, take it as soon as you remember. However, 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.

How should MEGAGLIPTIN MF TABLET be stored?

Store MEGAGLIPTIN MF TABLET in a cool, dry place, protected from direct sunlight, moisture, and heat. Keep it in the container it came in, tightly closed, and out of the sight and reach of children and pets.