Product Information

Patient Information leaflet

Composition:

Each film coated tablet contains :
Dapagliflozin Propanediol Monohydrate
equivalent to Dapagliflozin .................................... 5 mg
Metformin Hydrochloride IP............................. 1000 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:

8901148255654

Manufacturing License Number:

M.L. G/25/2011

Overview

click to open accordion Signs/Symptoms

Signs/Symptoms of Daplo-MF/5 Tablets may include:

Common Side Effects:

  • Gastrointestinal issues: Nausea, diarrhea, abdominal discomfort, or bloating.
  • Headache or dizziness.
  • Fatigue or weakness.

Serious but Rare Side Effects:

  • Lactic acidosis: Symptoms may include muscle pain, breathing difficulty, dizziness, or extreme fatigue.
  • Pancreatitis: Severe abdominal pain, nausea, or vomiting.
  • Kidney issues: Swelling, changes in urination, or signs of kidney problems.
  • Hypoglycemia (low blood sugar): If taken with other diabetes medications like insulin or sulfonylureas.

Contact your doctor if you experience any unusual or severe symptoms. Always follow your healthcare provider's instructions for managing side effects.

click to open accordion Dosage and Administration

Dosage and Administration of Daplo-MF/5 Tablets:

  • Recommended Dose: The typical dose is one tablet taken once or twice daily with meals, as prescribed by your doctor.
  • How to Take: Swallow the tablet whole with a glass of water. Do not chew or crush the tablet.
  • Adjustments: Your doctor may adjust the dosage based on your blood sugar levels, kidney function, and overall response to the medication.
  • Consistency: It is essential to take the medication at the same time each day to help remember.
  • Do Not Overdose: Do not exceed the prescribed dose. If you miss a dose, take it as soon as possible unless it's almost time for the next dose.

Always follow your healthcare provider's instructions for the best results and management of your condition.

click to open accordion Side effects

Side Effects of Daplo-MF/5 Tablets may include:

Common Side Effects:

  • Gastrointestinal issues: Nausea, vomiting, diarrhea, or abdominal discomfort.
  • Headache or dizziness.
  • Fatigue or weakness.

Serious Side Effects (Rare but require immediate medical attention):

  • Lactic acidosis: Symptoms include muscle pain, difficulty breathing, extreme fatigue, or dizziness.
  • Pancreatitis: Severe abdominal pain, nausea, or vomiting.
  • Kidney issues: Swelling in legs or ankles, or changes in urination.
  • Hypoglycemia (low blood sugar): If taken with other diabetes medications like insulin, symptoms may include shakiness, sweating, or confusion.

If you experience any unusual or severe side effects, contact your healthcare provider immediately.

click to open accordion Precautions

Precautions of Daplo-MF/5 Tablets:

  1. Kidney or Liver Problems: If you have kidney or liver issues, inform your doctor. They may need to adjust the dose or monitor you more closely.

  2. Lactic Acidosis Risk: This medication can cause a rare but serious condition called lactic acidosis. Symptoms include muscle pain, difficulty breathing, and extreme fatigue. Seek immediate medical attention if you experience any of these signs.

  3. Pancreatitis: If you have a history of pancreatitis, inform your doctor as this medication may increase the risk of developing it.

  4. Alcohol: Limit alcohol consumption while taking this medication, as alcohol may increase the risk of lactic acidosis and affect blood sugar control.

  5. Monitor Blood Sugar: Regularly check your blood sugar levels, especially if taking Daplo-MF/5 with other diabetes medications like insulin.

  6. Pregnancy & Breastfeeding: Consult your doctor before using this medication if you are pregnant, planning to become pregnant, or breastfeeding.

  7. Hypoglycemia Risk: Be aware of the risk of low blood sugar (hypoglycemia) if you are using Daplo-MF/5 along with other diabetes medications like insulin or sulfonylureas.

  8. Surgery or Medical Procedures: If you’re scheduled for surgery or a procedure that requires contrast dye, let your doctor know as you may need to temporarily stop the medication.

  9. Avoid Dehydration: Stay well-hydrated to avoid dehydration, which can increase the risk of side effects.

Always follow your healthcare provider's advice to ensure safe and effective use of Daplo-MF/5 Tablets.

Manage your health

Here’s the rewritten version:

  1. Follow Your Doctor's Advice: Always take your medication as prescribed. Never adjust the dose or stop taking it without consulting your healthcare provider.

  2. Stay Hydrated: Ensure you drink plenty of water throughout the day to stay hydrated, particularly if the medication increases urination.

  3. Monitor Your Health: Regularly track your blood pressure, blood sugar levels, and kidney and liver function as advised by your doctor.

  4. Limit Alcohol: Minimize or avoid alcohol, as it may interact with your medication and increase the risk of side effects.

  5. Be Aware of Side Effects: Understand potential side effects and inform your healthcare provider if you experience any unusual or severe symptoms.

  6. Inform Your Doctor: Share any other medications, supplements, or herbal products you are taking to avoid potential interactions.

  7. Maintain a Healthy Lifestyle: Follow a balanced diet, engage in regular exercise, and ensure adequate sleep to improve your overall health and the medication's effectiveness.

  8. Limit High-Salt Foods: Reduce your intake of high-salt foods, as they may interfere with the medication's effectiveness in lowering blood pressure.

  9. Take with Food (If Applicable): Follow your doctor's instructions on whether to take your medication with food to minimize stomach discomfort.

  10. Store Safely: Keep your medication out of reach of children and pets, and store it according to the recommended temperature and conditions.

Frequently asked questions

What if I miss a dose?

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

How should I store Daplo-MF/5?

Store the tablets in a cool, dry place away from moisture and direct sunlight. Keep out of reach of children.

How long does it take to see results?

It may take a few weeks to notice improvements in blood sugar levels. Regular monitoring and follow-up with your doctor are essential.

What should I do if I experience unusual symptoms?

If you experience severe abdominal pain, unexplained tiredness, or signs of low blood sugar, contact your doctor immediately.