Diabetes

Daplo SM 1000 Tablet Rx

Treatment of Diabetes

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Product Information

Patient Information leaflet

Composition:

Each film coated tablet contains:
Sitagliptin Phosphate Monohydrate IP
equivalent to Sitagliptin…............................100 mg
Metformin Hydrochloride IP
(As extended release) .................................1000 mg
Dapagliflozin Propanediol Monohydrate
equivalent to Dapagliflozin…........................ 10 mg
Excipients……...............................................………q.s.
Colours: Indigo carmine aluminium lake &
Titanium Dioxide IP

Storage:

Store below 30°C. Protect from light and moisture

Unique Identification Code:

8901148260360

Manufacturing License Number:

M.L. G/25/2011

Overview

click to open accordion Signs/Symptoms

Common signs and symptoms associated with Daplo-SM 1000 Tablets (Metformin and Sitagliptin) may include:

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

Serious side effects, though rare, may include:

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

If any serious symptoms occur, seek medical attention immediately.

click to open accordion Dosage and Administration

The dosage and administration of Daplo-SM 1000 Tablets (Metformin 1000 mg and Sitagliptin) are typically as follows:

  1. Initial Dose: The usual starting dose is one tablet (1000 mg Metformin / Sitagliptin) once or twice daily, as prescribed by your healthcare provider.

  2. Maintenance Dose: Your doctor may adjust the dose based on your blood sugar levels, but typically the dose does not exceed two tablets per day (1 tablet in the morning and 1 tablet in the evening).

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

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

Important: Always follow your healthcare provider’s instructions for dosing. Regular monitoring of blood sugar is essential to ensure effective control of your condition.

click to open accordion Side effects

The side effects of Daplo-SM 1000 Tablets (Metformin and Sitagliptin) may include:

Common Side Effects:

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

Serious but Rare Side Effects:

  1. Lactic acidosis (symptoms like muscle pain, difficulty breathing, fatigue, dizziness).
  2. Pancreatitis (severe abdominal pain, nausea, vomiting).
  3. Kidney problems (e.g., changes in urination, swelling in the legs/ankles).

If you experience any severe or unusual symptoms, seek medical attention immediately. Always consult your healthcare provider for more detailed information.

click to open accordion Precautions

Precautions for Daplo-SM 1000 Tablets (Metformin and Sitagliptin):

  1. Kidney or Liver Issues: Use with caution in individuals with kidney or liver problems. Metformin can affect kidney function, and Sitagliptin may require dose adjustments.

  2. Lactic Acidosis: Lactic acidosis is a rare but serious side effect of Metformin. Seek immediate medical attention if you experience muscle pain, difficulty breathing, fatigue, or dizziness.

  3. Pancreatitis: Sitagliptin has been linked to pancreatitis (inflammation of the pancreas). Contact your doctor if you experience severe abdominal pain, nausea, or vomiting.

  4. Kidney Function Monitoring: Regular monitoring of kidney function is recommended, as Metformin can cause complications in individuals with reduced kidney function.

  5. Pregnancy and Breastfeeding: Daplo-SM 1000 Tablets should be avoided during pregnancy unless prescribed by a doctor. It is also not recommended during breastfeeding. Consult your doctor if pregnant or planning to become pregnant.

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

  7. Low Blood Sugar (Hypoglycemia): While Sitagliptin alone does not cause hypoglycemia, it may occur if combined with other diabetes medications like insulin or sulfonylureas. Monitor blood sugar levels closely.

  8. Other Medications: Inform your healthcare provider about all other medications you are taking to avoid potential drug interactions, especially with other diabetes medications, blood pressure drugs, or diuretics.

  9. Heart Disease: If you have a history of heart disease, discuss with your doctor, as this may require special monitoring during treatment.

Always follow your doctor’s recommendations for dosage and monitoring to ensure the safe use of Daplo-SM 1000 Tablets.

Manage your health

Here are some key guidelines to follow while taking your medication:

  1. Follow Your Doctor’s Instructions: Always take your medication as prescribed. Never alter the dosage or stop taking it without consulting your healthcare provider.

  2. Stay Hydrated: Drink plenty of water throughout the day to stay hydrated, 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 may interact with your medication and increase the risk of side effects.

  5. Be Aware of Side Effects: Be familiar with the potential side effects and inform your healthcare provider if you notice anything unusual or severe.

  6. Inform Your Doctor: Let your doctor know about any other medications, supplements, or herbal products you're using to prevent interactions.

  7. Maintain a Healthy Lifestyle: Follow a balanced diet, exercise regularly, and get sufficient rest to support your overall health and the effectiveness of your treatment.

  8. Limit High-Salt Foods: Try to avoid high-sodium foods, as they can reduce the effectiveness of the medication in lowering blood pressure.

  9. Take with Food (if needed): Some medications should be taken with food to prevent stomach upset. Follow your doctor’s guidance on whether to take your medication with or without food.

  10. Store Safely: Keep your medication in a safe place, out of reach of children and pets, and store it at the recommended temperature.

Frequently asked questions

How should I take Daplo-SM 1000 Tablets?

Take the tablet as prescribed by your doctor, usually once or twice daily with meals to reduce the risk of stomach upset. Swallow the tablet whole with a glass of water.

Can I drink alcohol while taking Daplo-SM 1000 Tablets?

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

Can I take Daplo-SM 1000 Tablets if I am pregnant or breastfeeding?

Daplo-SM 1000 Tablets should generally be avoided during pregnancy and breastfeeding. Talk to your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. If it’s too close to your next dose, skip the missed dose. Do not take two doses at once.