Diabetes

Daplo-m10 Tablet Rx

Treatment of Diabetes

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DaploM10PS1 DaploM10PS3
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Patient Information leaflet

Composition:

Each film coated tablet contains :
Dapagliflozin Propanediol Monohydrate
equivalent to Dapagliflozin .................................. 10 mg
Metformin Hydrochloride IP............................. 500 mg
(as extended release form)
Excipients .................................................................. Q.S.
Colours: Titanium Dioxide IP & Ferric Oxide Yellow USP-NF

Storage:

Store below 30°C.

Unique Identification Code:

8901148255661

Manufacturing License Number:

M.L. G/25/2011

Overview

click to open accordion Signs/Symptoms

Signs/Symptoms of Daplo-M10 Tablets may include:

  1. Common side effects:

    • Nausea
    • Diarrhea
    • Stomach discomfort
    • Headache
    • Fatigue

  2. Serious but rare side effects:

    • Lactic acidosis (muscle pain, breathing difficulties, extreme fatigue)
    • Pancreatitis (severe abdominal pain, nausea, vomiting)
    • Kidney problems (swelling, changes in urination)
    • Low blood sugar (hypoglycemia), especially when used with other diabetes medications

If you experience any serious side effects, seek medical attention immediately.

click to open accordion Dosage and Administration

  • Dosage and Administration of Daplo-M10 Tablets:

  • Initial Dose: Typically, one tablet (Metformin 1000 mg + Vildagliptin 50 mg) once or twice a day, as directed by your doctor.

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

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

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

  • Always follow your doctor's instructions and monitor your blood sugar levels regularly while taking Daplo-M10 Tablets.

click to open accordion Side effects

Side effects of Daplo-M10 Tablets (Metformin and Vildagliptin) may include:

Common Side Effects:

  • Gastrointestinal issues: Nausea, diarrhea, stomach discomfort, or indigestion.
  • Headache.
  • Fatigue or weakness.

Serious but Rare Side Effects:

  • Lactic acidosis: Symptoms include muscle pain, difficulty breathing, dizziness, or extreme fatigue. This is a rare but serious side effect of Metformin.
  • Pancreatitis: Severe abdominal pain, nausea, or vomiting.
  • Kidney problems: Swelling, changes in urination, or signs of kidney issues.
  • Low blood sugar (hypoglycemia), especially if used with other diabetes medications like insulin or sulfonylureas.

If you experience any of these serious symptoms, seek medical attention immediately. Always consult your healthcare provider for advice on managing side effects.

click to open accordion Precautions

Precautions for Daplo-M10 Tablets (Metformin and Vildagliptin):

  1. Kidney Function: Use with caution if you have kidney problems. Your doctor may monitor kidney function regularly, as Metformin can affect kidney function.

  2. Lactic Acidosis: Although rare, lactic acidosis is a serious condition associated with Metformin. Symptoms include muscle pain, difficulty breathing, or extreme fatigue. Seek immediate medical attention if you experience these symptoms.

  3. Pancreatitis: Vildagliptin may increase the risk of pancreatitis. Contact your doctor if you experience severe abdominal pain, nausea, or vomiting.

  4. Low Blood Sugar: While Daplo-M10 is less likely to cause low blood sugar on its own, it may occur when combined with other diabetes medications, such as insulin or sulfonylureas. Monitor your blood sugar levels regularly.

  5. Pregnancy and Breastfeeding: Daplo-M10 is not recommended during pregnancy or breastfeeding. Consult your doctor before using it in these situations.

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

  7. Liver Issues: Use with caution if you have liver disease or a history of liver problems. Your doctor may monitor your liver function during treatment.

  8. Surgery and Imaging: If you're planning surgery or imaging procedures with contrast dyes, inform your healthcare provider, as Metformin may need to be temporarily discontinued.

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

Always follow your doctor’s advice and schedule regular check-ups to monitor your health while taking Daplo-M10 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 causes increased urination.
  3. Monitor Your Health: Regularly check your blood pressure, blood sugar, kidney function, and liver function as advised by your doctor.
  4. Avoid Alcohol: Limit or avoid alcohol, as it may interact with your medication and increase the risk of side effects.
  5. Be Aware of Side Effects: Familiarize yourself with potential side effects and inform your doctor if you experience any unusual or severe symptoms.
  6. Inform Your Doctor: Always disclose any other medications, supplements, or herbal products you are taking to avoid interactions.
  7. Maintain a Healthy Lifestyle: Eat a balanced diet, exercise regularly, and ensure sufficient rest to support your overall health and the effectiveness of the medication.
  8. Avoid High-Salt Foods: Limit salt intake to avoid affecting the medication's blood pressure-lowering effects.
  9. Take with Food (if applicable): Follow your doctor’s advice on whether to take your medication with food to prevent stomach discomfort.
  10. Keep Medication Out of Reach: Store your medication safely, away from children and pets, and at the recommended temperature.

Frequently asked questions

Can Daplo-M10 be taken with other diabetes medications?

Yes, but always inform your doctor about all other medications you're using. Daplo-M10 may interact with insulin or other oral diabetes drugs, which could affect your blood sugar levels.

Can I take Daplo-M10 if I have kidney or liver problems?

If you have kidney or liver issues, tell your doctor first. They may need to adjust your dosage or monitor you more closely while you're on this medication.

Can Daplo-M10 cause low blood sugar?

Low blood sugar (hypoglycemia) is rare with Daplo-M10 alone, but if you’re taking it alongside other diabetes medications, you may be at risk. Be sure to monitor your blood sugar levels regularly.

How should I store Daplo-M10 Tablets?

Store the tablets in a cool, dry place away from direct sunlight and out of reach of children or pets. Always check the expiration date and dispose of any expired tablets properly.