Product Information

Patient Information leaflet

Composition:

Each bilayered tablet contains:
Dapagliflozin Propanediol Monohydrate
equivalent to Dapagliflozin .......... 10 mg
Vildagliptin
(As sustained release) IP...............100 mg
Excipients..............................................q.s.
Color: Ferric oxide yellow USP-NF.

Storage:

Store below 30°C.

Unique Identification Code:

8901148259102

Manufacturing License Number:

M.L. G/25/2011

Overview

click to open accordion Signs/Symptoms

 

Common signs and symptoms of Daplo V Tablet (Vildagliptin and Metformin) may include:

  1. Gastrointestinal issues: Nausea, diarrhea, abdominal discomfort, or indigestion.
  2. Headache or dizziness.
  3. Fatigue or weakness.
  4. Low blood sugar (hypoglycemia), particularly if taken with other diabetes medications.

Serious but less common side effects may include:

  1. Lactic acidosis (symptoms like muscle pain, difficulty breathing, or extreme fatigue).
  2. Pancreatitis (severe abdominal pain, nausea, vomiting).
  3. Kidney issues (e.g., changes in urination, swelling).

Seek medical attention if any severe or unusual symptoms occur.

click to open accordion Dosage and Administration

The dosage and administration of Daplo V Tablet (Vildagliptin and Metformin) are generally as follows:

  1. Initial Dose: Typically, one tablet (usually 50 mg Vildagliptin and 500 mg Metformin) once or twice a day, as prescribed by your doctor.

  2. Maintenance Dose: The dose may be adjusted by your healthcare provider based on your blood sugar levels, but typically, the maximum dose does not exceed two tablets per day (one in the morning and one in the evening).

  3. Administration: Take the tablet with meals to reduce gastrointestinal side effects. Swallow it whole with a glass of water.

  4. Missed Dose: If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose—do not take two doses at once.

Important: Always follow your doctor’s instructions for dosing, and make sure to monitor your blood sugar levels regularly.

click to open accordion Side effects

Side effects of Daplo V Tablet (Vildagliptin and Metformin) may include:

Common Side Effects:

  1. Gastrointestinal issues: Nausea, diarrhea, stomach pain, or indigestion.
  2. Headache or dizziness.
  3. Fatigue or weakness.
  4. Low blood sugar (hypoglycemia), especially when combined with other diabetes medications like insulin.

Serious but Rare Side Effects:

  1. Lactic acidosis: Symptoms include muscle pain, difficulty breathing, dizziness, or extreme fatigue. This is a rare but serious side effect of Metformin.
  2. Pancreatitis: Severe abdominal pain, nausea, or vomiting.
  3. Kidney issues: Changes in urination, swelling in the legs or ankles, or signs of kidney problems.

If any of these serious symptoms occur, seek medical attention immediately. Always consult your healthcare provider if you experience any unusual symptoms.

click to open accordion Precautions

Precautions for Daplo V Tablet (Vildagliptin and Metformin):

  1. Kidney Function: Use with caution if you have kidney problems, as Metformin can affect kidney function. Regular monitoring of kidney function is recommended.

  2. Lactic Acidosis: Lactic acidosis is a rare but serious condition that can occur with Metformin. Seek immediate medical help if you experience muscle pain, difficulty breathing, dizziness, or extreme fatigue.

  3. Pancreatitis: Vildagliptin has been linked to an increased risk of pancreatitis (inflammation of the pancreas). If you experience severe abdominal pain, nausea, or vomiting, contact your doctor immediately.

  4. Low Blood Sugar: Although Vildagliptin is less likely to cause low blood sugar on its own, it may increase the risk if used with other diabetes medications like insulin or sulfonylureas. Monitor your blood sugar regularly.

  5. Pregnancy and Breastfeeding: Daplo V Tablets should generally be avoided during pregnancy and breastfeeding. Consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

  6. Alcohol: Limit alcohol intake, as it can increase the risk of lactic acidosis and affect blood sugar levels.

  7. Liver Problems: If you have liver disease or any history of liver issues, consult your doctor before using Daplo V Tablets.

  8. Surgery: If you are scheduled for surgery or using contrast dye for medical imaging, inform your healthcare provider, as you may need to temporarily stop taking the medication.

  9. Other Medications: Inform your doctor of all medications, including over-the-counter drugs and supplements, as interactions with other drugs can affect your treatment.

Always follow your healthcare provider’s guidance to ensure safe and effective use of Daplo V Tablets.

Manage your health

  1. Follow Your Doctor's Instructions: Take your medication exactly as prescribed. Do not adjust the dose or stop without consulting your doctor.
  2. Stay Hydrated: Drink plenty of water throughout the day, especially if the medication increases urination.
  3. Monitor Your Health: Regularly check your blood pressure, blood sugar, kidney, and liver function as advised by your healthcare provider.
  4. Avoid Alcohol: Limit or avoid alcohol, as it can interact with the medication and increase the risk of side effects.
  5. Be Aware of Side Effects: Know the potential side effects and immediately report any unusual or severe symptoms to your healthcare provider.
  6. Inform Your Doctor: Inform your doctor about any other medications, supplements, or herbal products you're taking to avoid interactions.
  7. Maintain a Healthy Lifestyle: Eat a balanced diet, exercise regularly, and get adequate sleep to support your overall health and the effectiveness of the medication.
  8. Avoid High-Salt Foods: Limit your intake of high-salt foods, as they may reduce the effectiveness of your medication in lowering blood pressure.
  9. Take with Food (if applicable): Follow your doctor's instructions on whether to take your medication with or without food to reduce stomach upset.
  10. Store Medication Safely: Keep your medication out of reach of children and pets, and store it according to the recommended conditions.

Frequently asked questions

What is Daplo V Tablet used for?

Daplo V Tablet is used to help control blood sugar levels in individuals with type 2 diabetes. It combines Vildagliptin and Metformin to improve insulin sensitivity and reduce glucose production in the liver.

What should I do if I experience any unusual side effects?

If you notice any unusual or severe symptoms such as severe abdominal pain, dizziness, or difficulty breathing, contact your healthcare provider immediately.

Can I drink alcohol while taking Daplo V Tablet?

It's best to limit alcohol consumption, as drinking alcohol can increase the risk of lactic acidosis and affect blood sugar levels.

Can I take Daplo V Tablet if I am pregnant or breastfeeding?

Daplo V Tablet is generally not recommended during pregnancy or breastfeeding. Consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.