Product Information

Patient Information leaflet

Composition:

Each film coated tablet contains :
Dapagliflozin Propanediol Monohydrate equivalent to Dapagliflozin .................................... 5 mg
Metformin Hydrochloride IP............................. 500 mg
(as extended release form)
Excipients .................................................................. Q.S.
Colours: Titanium Dioxide IP & Ferric Oxide Red USP-NF

Storage:

Store below 30°C.

Unique Identification Code:

8901148255562

Manufacturing License Number:

M.L. G/25/2011

Overview

click to open accordion Signs/Symptoms

Common signs and symptoms of Daplo-M5 Tablets (Metformin and Vildagliptin) may include:

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

Serious but rare side effects include:

  1. Lactic acidosis: Symptoms like muscle pain, difficulty breathing, or extreme fatigue.
  2. Pancreatitis: Severe abdominal pain, nausea, or vomiting.
  3. Kidney problems: Changes in urination or swelling in the legs and ankles.

If any of these serious symptoms occur, seek medical attention immediately.

click to open accordion Dosage and Administration

The dosage and administration of Daplo-M5 Tablets (Metformin and Vildagliptin) are typically as follows:

  1. Initial Dose: The usual starting dose is one tablet (Metformin 500 mg + Vildagliptin 50 mg) once or twice daily with meals, as directed by your doctor.

  2. Maintenance Dose: Your doctor may adjust the dose based on your blood sugar levels, typically up to two tablets per day (one tablet in the morning and one in the evening).

  3. Administration: Take the tablet(s) with food to minimize gastrointestinal side effects. Swallow the tablet whole with a glass of water.

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

Always follow your doctor's instructions for dosing and monitor your blood sugar levels regularly.

click to open accordion Side effects

Side effects of Daplo-M5 Tablets (Metformin and Vildagliptin) 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 if used 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 problems: Changes in urination, swelling, or signs of kidney issues.

Seek immediate medical attention if you experience any of these serious symptoms. Always consult your healthcare provider if you notice any unusual or severe side effects.

click to open accordion Precautions

Precautions for Daplo-M5 Tablets (Metformin and Vildagliptin):

  1. Kidney Function: Use with caution in patients with kidney problems, as Metformin can affect kidney function. Regular kidney function tests are recommended.

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

  3. Pancreatitis: Vildagliptin has been linked to an increased risk of pancreatitis. Contact your doctor if you experience severe abdominal pain, nausea, or vomiting.

  4. Low Blood Sugar: While Daplo-M5 is less likely to cause low blood sugar, it may increase the risk if taken with other blood sugar-lowering medications like insulin or sulfonylureas. Monitor your blood sugar regularly.

  5. Pregnancy and Breastfeeding: Daplo-M5 is generally not recommended during pregnancy and breastfeeding. Consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

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

  7. Liver Issues: If you have a history of liver disease or liver dysfunction, consult your doctor before taking this medication.

  8. Surgery or Imaging: If you are planning to have surgery or undergo medical imaging with contrast dye, inform your healthcare provider as Metformin may need to be temporarily stopped.

  9. Other Medications: Inform your doctor about all medications you are taking, including over-the-counter drugs and supplements, to avoid interactions.

Always follow your doctor's advice and schedule regular check-ups to monitor your health while taking Daplo-M5 Tablets.

Manage your health

  1. Follow Your Doctor's Instructions: Always take your medication exactly as prescribed. Do not adjust the dosage or stop without consulting your healthcare provider.
  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 doctor.
  4. Avoid Alcohol: Limit or avoid alcohol, as it can interact with your medication and raise the risk of side effects.
  5. Be Aware of Side Effects: Understand the potential side effects of your medication and inform your doctor if you experience any unusual or severe symptoms.
  6. Inform Your Doctor: Always update your doctor on 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 enough rest to support your overall health and treatment.
  8. Avoid High-Salt Foods: Limit your intake of salty foods, as they may reduce the effectiveness of the 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 avoid stomach discomfort.
  10. Keep Medication Out of Reach: Store your medication in a safe place, away from children and pets, and at the recommended temperature.

Frequently asked questions

What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember, unless it's time for your next dose. Do not take two doses at once.

Can Daplo-M5 Tablet cause low blood sugar?

Daplo-M5 Tablet is less likely to cause low blood sugar (hypoglycemia) on its own. However, if you're also taking other diabetes medications like insulin, you may need to monitor your blood sugar levels closely.

Can I drink alcohol while taking Daplo-M5 Tablet?

It is advisable to limit alcohol consumption, as it can increase the risk of lactic acidosis and interfere with blood sugar control.

How will my doctor monitor my treatment with Daplo-M5 Tablet?

Your doctor will likely monitor your blood sugar levels, kidney function, and overall health through regular check-ups and lab tests.