Product Information
Patient Information leafletComposition:
Dapagliflozin Propanediol Monohydrate
equivalent to Dapagliflozin…......................... 10 mg
Metformin Hydrochloride IP
(As extended release) ...................................500 mg
Sitagliptin Phosphate Monohydrate IP
equivalent to Sitagliptin………......................100 mg
Excipients……...............................................………q.s.
Colours: Ferric oxide Red USP-NF, Ferric oxide
yellow USP-NF & Titanium Dioxide IP.
Storage:
Store below 30°C. Protect from light and moistureUnique Identification Code:
8901148260313Manufacturing License Number:
M.L. G/25/2011Overview
The signs and symptoms associated with Daplo-SM 500 Tablets (Metformin and Sitagliptin) are usually related to their side effects. Common side effects include:
- Gastrointestinal issues: Nausea, diarrhea, stomach upset, or indigestion.
- Headache or dizziness.
- Fatigue or weakness.
- Low blood sugar (hypoglycemia), especially when used with other diabetic medications.
Serious side effects, though rare, may include:
- Lactic acidosis (symptoms include muscle pain, difficulty breathing, and fatigue).
- Pancreatitis (severe abdominal pain, nausea, vomiting).
- Kidney problems (changes in urination, swelling in the legs/ankles).
If any serious symptoms occur, it is important to seek medical attention immediately.
The dosage and administration of Daplo-SM 500 Tablets (containing Metformin 500 mg and Sitagliptin) should be determined by a healthcare provider based on individual needs. A general guideline includes:
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Starting Dose: Typically, one tablet (500 mg Metformin and Sitagliptin) once or twice daily, depending on the doctor’s recommendation.
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Maintenance Dose: The dose may be adjusted based on blood sugar levels, but the usual daily dose does not exceed 2 tablets per day (1 tablet twice daily).
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Administration: The tablets should be taken with food to reduce the risk of gastrointestinal discomfort. Swallow the tablet whole with a glass of water.
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Missed Dose: If a dose is missed, take it as soon as you remember unless it is almost time for the next dose. In this case, skip the missed dose—do not double the dose.
Important: Always follow the healthcare provider’s instructions and regularly monitor blood sugar levels as needed.
The common side effects of Daplo-SM 500 Tablets (Metformin and Sitagliptin) may include:
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Gastrointestinal issues:
- Nausea
- Diarrhea
- Stomach upset or indigestion
- Abdominal discomfort
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Headache or dizziness
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Fatigue or weakness
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Low blood sugar (hypoglycemia), especially if used with other diabetic medications
Serious but rare side effects may include:
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Lactic acidosis (a rare but serious condition caused by a buildup of lactic acid in the blood), with symptoms like:
- Muscle pain or cramping
- Difficulty breathing
- Fatigue or weakness
- Dizziness or lightheadedness
-
Pancreatitis (inflammation of the pancreas), with symptoms such as:
- Severe abdominal pain
- Nausea and vomiting
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Kidney problems, indicated by symptoms such as:
- Changes in urine output
- Swelling in the legs or ankles
If any serious side effects occur, it’s important to seek immediate medical attention. Always inform your healthcare provider if you experience any unusual or severe symptoms.
When using Daplo-SM 500 Tablets (Metformin and Sitagliptin), consider the following precautions:
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Kidney or Liver Issues: Caution is required if you have kidney or liver problems. Metformin can cause complications in individuals with kidney issues, and Sitagliptin may affect kidney function. Your doctor may adjust your dosage or recommend additional monitoring.
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Lactic Acidosis Risk: Lactic acidosis is a rare but serious side effect of Metformin. Symptoms include muscle pain, difficulty breathing, dizziness, and extreme fatigue. Seek medical help immediately if you experience these symptoms.
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Pancreatitis: Sitagliptin can increase the risk of pancreatitis (inflammation of the pancreas). Inform your doctor if you have a history of pancreatitis, gallstones, or alcohol use, as these factors can increase your risk.
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Hypoglycemia: While Sitagliptin alone typically does not cause low blood sugar, it may occur when combined with other diabetes medications like insulin or sulfonylureas. Monitor your blood sugar levels regularly.
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Heart Disease: If you have a history of heart disease, discuss this with your healthcare provider, as some conditions may require special attention when taking this medication.
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Alcohol Consumption: Limit alcohol intake, as it can increase the risk of lactic acidosis and may affect blood sugar control.
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Surgery or Medical Procedures: If you’re undergoing surgery or have any medical procedures requiring contrast dye, your doctor may temporarily stop the medication to avoid complications related to kidney function.
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Pregnancy and Breastfeeding: Consult your healthcare provider before using Daplo-SM 500 Tablets if you are pregnant or breastfeeding, as the medication's effects on pregnancy are not fully established.
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Other Medications: Inform your doctor about any other medications, supplements, or herbal products you are taking to avoid potential interactions that may affect the drug's efficacy or increase side effects.
Manage health Section
- Follow Your Doctor's Instructions: Take your medication exactly as prescribed. Do not adjust the dosage or stop taking it without consulting your doctor.
- Stay Hydrated: Drink plenty of water throughout the day, especially if the medication increases urination.
- Monitor Your Health: Regularly check your blood pressure, blood sugar, and kidney and liver function as advised by your doctor.
- Avoid Alcohol: Limit or avoid alcohol, as it may interact with your medication and heighten the risk of side effects.
- Be Aware of Side Effects: Familiarize yourself with potential side effects and report any unusual or severe symptoms to your healthcare provider immediately.
- Inform Your Doctor: Inform your doctor about any other medications, supplements, or herbal products you're using to avoid interactions.
- Maintain a Healthy Lifestyle: Eat a balanced diet, exercise regularly, and get enough sleep to support your overall health and medication effectiveness.
- Avoid High-Salt Foods: Limit high-salt foods, as they can reduce the medication's blood pressure-lowering effects.
- Take with Food (if applicable): Some medications should be taken with food to avoid stomach upset. Follow your doctor’s instructions regarding food.
- Keep Medication Safe: Store your medication in a secure place, out of reach of 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 almost time for your next dose. In that case, skip the missed dose—do not double the dose.
Is Daplo-SM 500 Tablets safe during pregnancy or breastfeeding?
If you are pregnant, planning to become pregnant, or breastfeeding, talk to your doctor before using this medication. The safety of this medication during pregnancy and breastfeeding has not been fully established.
How long will I need to take Daplo-SM 500 Tablets?
The duration of treatment depends on your individual response to the medication and your healthcare provider's advice. You may need to take it long-term as part of your diabetes management plan, in conjunction with diet and exercise.
How will Daplo-SM 500 Tablets affect my blood sugar?
Daplo-SM 500 Tablets help lower blood sugar by improving insulin sensitivity and reducing glucose production. It's important to monitor your blood sugar levels regularly to ensure the medication is working effectively.