Zavamet Sr 500mg Tablet

ZAVAMET SR 500MG TABLET by INTAS PHARMACEUTICALS LTD.

Name

Brand Name: ZAVAMET SR 500MG TABLET Common Name: Metformin Hydrochloride and Vildagliptin (Extended Release)

Composition

Each sustained-release tablet contains:

• Metformin Hydrochloride: 500 mg
• Vildagliptin: 50 mg

Uses

ZAVAMET SR 500MG TABLET is prescribed for the management of Type 2 Diabetes Mellitus in adults. It is used when diet and exercise alone, or other antidiabetic medicines, are insufficient to control blood sugar levels. It works by enhancing insulin production, improving the body's use of insulin, and reducing glucose production by the liver. This helps to control blood sugar levels, especially after meals, and reduces the risk of serious long-term complications such as kidney damage, eyesight loss (retinopathy), nerve damage (neuropathy), diabetic foot ulcers, heart disease, and stroke.

Dosage and Administration

ZAVAMET SR 500MG TABLET should be taken orally as directed by a healthcare professional. It is typically advised to be taken with food to minimize stomach upset, often twice daily. The tablet should be swallowed whole with a glass of water and should not be crushed, chewed, or broken. Consistent daily administration at the same time is recommended for optimal benefits. Patients should not discontinue the medication abruptly without consulting their doctor.

Side Effects

Common Side Effects:

• Hypoglycemia (low blood glucose levels), characterized by dizziness, sweating, hunger pangs, palpitations, dry mouth, and skin (especially when used with insulin or sulfonylureas)
• Nausea, vomiting, diarrhea
• Stomach pain/upset, loss of appetite, metallic taste
• Headache, dizziness
• Changes in taste
• Upper respiratory tract infections, nasal congestion, sore throat
• Joint pain, tiredness, constipation, swollen hands, ankles, or feet (oedema)

Serious Side Effects (Seek immediate medical attention if experienced):

• Lactic acidosis: A rare but serious condition with symptoms such as muscle pain or weakness, dizziness, severe tiredness, difficulty breathing, feeling cold in arms and legs, nausea, vomiting, stomach pain, or slow heart rate.
• Signs of an inflamed pancreas (pancreatitis): Severe and persistent pain in the abdomen, with or without nausea or vomiting.
• Serious skin reactions like bullous pemphigoid.

Precautions

• Allergies: Do not use if allergic to Metformin, Vildagliptin, or any other ingredients of the tablet.
• Medical Conditions: Inform your doctor if you have a history of pancreatitis, severe kidney or liver disease, heart problems (like congestive heart failure or irregular heartbeat), or low vitamin B12 levels.
• Diabetes Type: Not recommended for Type 1 Diabetes Mellitus or diabetic ketoacidosis.
• Alcohol Consumption: Avoid alcohol consumption during treatment as it can increase the risk of lactic acidosis and interfere with blood sugar control.
• Pregnancy and Breastfeeding: Not recommended during pregnancy or breastfeeding unless specifically advised by a doctor.
• Pediatric Use: Not suitable for children and adolescents under 18 years of age.
• Drug Interactions: Inform your doctor about all other medications, supplements, or herbal products you are taking, as they may interact with ZAVAMET SR 500MG TABLET (e.g., insulin, sulfonylureas, certain cationic medications like amiloride, digoxin, trimethoprim, iodinated contrast agents, and CYP3A4 inducers like rifampicin).
• Surgery: Inform your doctor about your diabetes treatment if you are scheduled for surgery under general anesthetic.
• Monitoring: Regular monitoring of blood sugar levels, kidney function, and liver enzymes is essential. Prolonged use may require annual thyroid-stimulating hormone (TSH) check-ups.
• Driving: Exercise caution while driving or operating machinery as your ability may be affected by very low or high blood sugar levels.

Storage

Store ZAVAMET SR 500MG TABLET in a cool and dry place, protected from direct sunlight. Keep it in its original container, tightly closed, and out of the sight and reach of children. The recommended storage temperature is below 25°C or below 30°C.

Here are frequently asked questions about ZAVAMET SR 500MG TABLET:

What is ZAVAMET SR 500MG TABLET used for?

ZAVAMET SR 500MG TABLET is a combination medication primarily used to manage type 2 diabetes mellitus in adults. It is prescribed when diet and exercise alone, or with other single diabetes medications, are insufficient to control blood sugar levels. It helps to regulate blood sugar and can reduce the risk of serious diabetes-related complications such as kidney damage, eye problems, nerve damage, and cardiovascular issues.

How does ZAVAMET SR 500MG TABLET work?

This medicine contains two active ingredients: Metformin and Vildagliptin. Metformin works by decreasing the amount of glucose produced by the liver, delaying glucose absorption from the intestines, and increasing the body's sensitivity to insulin. Vildagliptin, a DPP-4 inhibitor, increases the release of insulin from the pancreas and reduces the production of glucagon, a hormone that raises blood sugar. Together, these actions help to control both fasting and post-meal blood sugar levels.

What is the usual dosage for ZAVAMET SR 500MG TABLET?

ZAVAMET SR 500MG TABLET should be taken exactly as prescribed by your doctor. Typically, the tablet should be swallowed whole with water, preferably after a meal to help minimize stomach upset. It can be taken once or twice daily, depending on your doctor's instructions regarding dosage and duration. Do not crush, chew, or break the tablet.

What are the possible side effects of ZAVAMET SR 500MG TABLET?

Common side effects may include nausea, vomiting, diarrhea, stomach pain, headache, loss of appetite, and a metallic taste. Low blood sugar (hypoglycemia) can occur, especially if taken with other diabetes medicines like insulin or sulfonylureas. Other reported side effects include joint pain, tiredness, constipation, and swollen hands, ankles, or feet (oedema). Rarely, serious conditions like lactic acidosis or an inflamed pancreas (pancreatitis) may occur. If you experience severe or persistent side effects, contact your doctor.

Is ZAVAMET SR 500MG TABLET safe during pregnancy or breastfeeding?

ZAVAMET SR 500MG TABLET is generally not recommended during pregnancy and is contraindicated for use by breastfeeding women. If you are pregnant or planning to become pregnant, you should consult your doctor, who will assess the potential benefits against any risks.

Can ZAVAMET SR 500MG TABLET be taken with other medications?

It is important to inform your doctor about all medicines, supplements, or herbal products you are currently taking, as ZAVAMET SR 500MG TABLET can interact with certain drugs. These include glucocorticoids, beta-2 agonists, diuretics, NSAIDs, Angiotensin-converting enzyme (ACE) inhibitors, and cationic medications. The use of iodinated contrast agents with ZAVAMET SR 500MG TABLET may also increase the risk of acute kidney failure and lactic acidosis.

What precautions should be taken while using ZAVAMET SR 500MG TABLET?

Avoid consuming alcohol while taking this medicine as it can increase the risk of lactic acidosis. This medication is not suitable for individuals with type 1 diabetes, severe kidney or liver disease, or diabetic ketoacidosis. Use with caution if you have heart problems, such as congestive heart failure. Your kidney and liver function should be monitored by your doctor before and during treatment. If you experience dizziness, avoid driving or operating machinery. It is also crucial to adhere to a healthy diet and exercise program.

What happens if a dose of ZAVAMET SR 500MG TABLET is missed?

If you miss a dose of ZAVAMET SR 500MG 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 a missed one.

How should ZAVAMET SR 500MG TABLET be stored?

Store ZAVAMET SR 500MG TABLET in a cool and dry place, away from direct sunlight, moisture, and heat. Keep it out of the sight and reach of children. The medication should be stored below 30°C.