Dapalex SM 10/100/500 Tablet (10 Tab)

Dapalex SM 10/100/500 Tablet Overview:

Dapalex SM 10/100/500 Tablet is an oral anti diabetic medication used for adults with type 2 diabetes mellitus.

It is recommended when dietary changes, physical activity, and previous single or dual oral therapy fail to maintain adequate blood glucose levels.

Dapalex SM 10/100/500 Tablet works by improving the body’s response to insulin and stimulating insulin production, helping prevent severe symptoms linked to uncontrolled diabetes.

Dapalex SM 10/100/500 Tablet supports glycemic control through multiple mechanisms of action, which helps lower the chances of diabetes-related complications such as heart disease, nerve damage, and kidney problems.

It should be noted that this medication is not intended for type 1 diabetes management and is not considered a first-line treatment.

Composition:

Each film coated bilayered tablet contains- Dapagliflozin propanediol monohydrate equivalent to Dapagliflozin: 10 mg, Sitagliptin Phosphate Monohydrate equivalent to Sitagliptin: 100 mg, Metformin Hydrochloride (As Extended Release form): 500 mg,  and Excipients q.s.

Colour: Sunset Yellow (In Sitagliptin & Dapagliflozin Layer).

Uses & Benefits of Dapalex SM 10/100/500 Tablet:

Dapalex SM 10/100/500 Tablet is primarily used for the treatment of Type 2 diabetes mellitus or non-insulin-dependent diabetes mellitus (NIDDM).

How Dapalex SM 10/100/500 Tablet Works:

This medication uses three complementary mechanisms to control blood sugar.

Dapagliflozin works in the kidneys by blocking a protein called SGLT2, which normally reabsorbs glucose back into the blood. By blocking this protein, excess sugar is removed from the body through urine. Sitagliptin increases natural substances in the body called incretins, which help the pancreas release more insulin when blood sugar rises and signal the liver to stop making excess sugar.

Metformin decreases the amount of glucose your liver produces, reduces the amount of sugar absorbed from food in your intestines, and improves your body's sensitivity to insulin. Together, these three medicines provide comprehensive blood sugar control through multiple pathways, making the treatment more effective than using any single medicine alone.

Dosage of Dapalex SM 10/100/500 Tablet:

• Usage Directions

Take Dapalex SM 10/100/500 Tablet exactly as prescribed by your doctor. Taking it with food helps reduce stomach upset that can occur with metformin. Swallow the tablet whole preferably with a food without crushing, breaking, or chewing it. Your doctor may have started you on different doses of the individual components before prescribing this combination tablet. Do not change your dose or stop taking this medicine without consulting your doctor, even if you feel well. Continue following your prescribed diet and exercise program while taking this medication, as these are important parts of diabetes management.

• Missed Dose

If you miss a dose, take the tablet as soon as you remember on the same day. However, if it is nearly time for your next scheduled dose, skip the missed one and continue with your regular dosing routine. Do not take two tablets together to make up for a missed dose, as this may increase the risk of side effects, including excessively low blood sugar or other complications. If you frequently miss doses, set a daily reminder or take your medicine at the same time each day with your evening meal to help you remember. Contact your doctor if you are having trouble remembering to take your medicine regularly.

• Overdose

In case of overdose with Dapalex SM 10/100/500 Tablet, seek immediate medical attention or contact your local poison control center. Overdose symptoms may include severe nausea, vomiting, stomach pain, extreme tiredness, difficulty breathing, dizziness, unusual muscle pain, feeling very cold especially in hands or feet, irregular heartbeat, or signs of very low blood sugar such as shakiness, confusion, or loss of consciousness. Metformin overdose can lead to a serious condition called lactic acidosis, which requires emergency treatment in a hospital setting. Do not delay seeking help if you suspect an overdose.

Contraindications of Dapalex SM 10/100/500 Tablet:

Do not take Dapalex SM 10/100/500 Tablet if you are allergic to allergic to Dapagliflozin, metformin, sitagliptin, or any of the ingredients of this medicine, including symptoms like difficulty breathing, swelling of face or throat, or severe skin reactions. Dapalex SM 10/100/500 Tablet should not be used if you have severe kidney problems or have end-stage kidney disease, type 1 diabetes mellitus, acute or chronic metabolic acidosis, including diabetic ketoacidosis. The medication is not recommended for people with severe liver disease, those who consume excessive alcohol regularly, or individuals with conditions that cause low oxygen levels, such as severe heart failure or a recent heart attack.

Precautions & Warnings of Dapalex SM 10/100/500 Tablet:

Inform your doctor if you notice reduced urination, swelling, or unusual tiredness. Kidney function (eGFR) should be checked before starting and monitored regularly, as dose changes may be needed. Stay well-hydrated, especially if you are elderly or taking diuretics. Stop the medicine temporarily before surgeries or contrast X-ray tests and restart only after kidney function is stable. Watch for symptoms of lactic acidosis such as severe weakness, muscle pain, breathing difficulty, dizziness, or feeling cold. Women may have a higher risk of urinary or genital infections. Elderly patients can use this medicine but need closer medical monitoring.

Side Effects of Dapalex SM 10/100/500 Tablet:

Common side effects may include urinary tract infections, genital yeast infections in men and women, frequent urination, and stomach problems such as nausea, diarrhea, gas, or stomach discomfort.

Serious but less common side effects can occur. These include symptoms of ketoacidosis (nausea, vomiting, stomach pain, extreme tiredness, or breathing difficulty), severe allergic reactions (rash, hives, swelling), signs of lactic acidosis, pain or blood while passing urine, or unusual pain, swelling, or tenderness in the genital area.

Seek medical attention immediately if you notice any serious or unusual symptoms.

Safety Related Concerns of Dapalex SM 10/100/500 Tablet:

• Pregnancy

If you are pregnant or planning to become pregnant, talk to your doctor to determine if Dapalex SM 10/100/500 Tablet is safe for you. Animal studies have shown that dapagliflozin may affect kidney development in unborn babies during the later stages of pregnancy. Your doctor will need to switch you to a different diabetes treatment during pregnancy to ensure safe blood sugar control for both you and your baby. If you discover you are pregnant while taking this medication, contact your doctor right away to discuss safer alternatives for managing your diabetes during pregnancy. Well-controlled blood sugar is important during pregnancy, but this particular combination should be avoided.

• Breastfeeding

This medication is not recommended while breastfeeding. Metformin passes into breast milk in small amounts, and it is not known whether dapagliflozin and sitagliptin pass into human breast milk. Since there is potential risk to nursing infants, you should not breastfeed while taking Dapalex SM 10/100/500 Tablet. Discuss with your doctor about alternative diabetes treatments if you are breastfeeding or planning to breastfeed. If diabetes management is essential and Dapalex SM 10/100/500 Tablet is needed, you may need to decide whether to stop breastfeeding or use a different medication. Never make this decision on your own; always consult your healthcare provider to determine the best approach for both you and your baby.

• Alcohol

Limit or avoid alcohol consumption while taking Dapalex SM 10/100/500 Tablet. Drinking alcohol, especially excessive amounts, significantly increases your risk of developing lactic acidosis, a serious and potentially fatal condition associated with metformin. Alcohol can also affect blood sugar control, potentially causing either low or high blood sugar levels. If you choose to drink alcohol, do so in moderation, never on an empty stomach, and monitor your blood sugar more frequently.

• Using Machinery & Driving

This medicine may cause dizziness or affect your alertness, especially if your blood sugar levels become too low or too high. Do not drive, operate machinery, or perform activities requiring full alertness until you know how this medication affects you. Always check your blood sugar before driving, especially during the first few weeks of treatment or after dose changes.

• Food Interactions

There are no specific foods that you must avoid, but maintaining a consistent, healthy, diabetes-friendly diet is essential for optimal blood sugar control. Some patients find that taking the medicine with a larger meal helps minimize gastrointestinal side effects. Stay well-hydrated by drinking adequate water throughout the day, as the dapagliflozin component increases urination. Avoid excessive sugary foods and drinks, as these can counteract the medication's effects and make blood sugar control more difficult.

• Drug Interactions

This combination can be used with other diabetes medications, but dose adjustments may be necessary. When combined with insulin or medicines that increase insulin secretion, like sulfonylureas, your doses may need to be lowered to prevent low blood sugar. Certain medicines can interact with these components, including water pills, blood pressure medications, steroids, thyroid medicines, birth control pills, heart medications like digoxin, and medicines that affect kidney function. Some antibiotics, anti-seizure medications, and medicines for mental health conditions may also interact.

Inform your doctor about all medications you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Storage Instructions:

Store below 30°C. Protect from light and moisture. Keep the medicine out of reach of children. Do not use the medicine past its expiration date printed on the packaging. Dispose of expired or unused medication properly according to local guidelines or by returning it to a pharmacy take-back program.

Additional Notes:

• Regular monitoring of blood sugar levels at home, or as directed by your doctor.

• Maintain all scheduled appointments for blood tests and check-ups to monitor kidney function, liver function, and other parameters.

• Maintain a healthy lifestyle, including a balanced diet, regular physical activity, weight management, and stress reduction.

• Do not share your medicine with other persons, even if they also have similar symptoms.

• Carry quick sugar sources in case of low blood sugar.

Related Blood Glucose Monitors:

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Frequently Asked Questions (FAQs):

Q1. Who should take Dapalex SM 10/100/500 Tablet?

A: This medication is prescribed for adults with type 2 diabetes whose blood sugar levels are not adequately controlled with lifestyle modifications and other diabetes medicines. It is particularly suitable for patients who need triple therapy but want the convenience of a single tablet. The medicine requires a prescription and should only be taken under medical supervision.

This medicine is not intended for people with type 1 diabetes or for treating diabetic ketoacidosis, a serious condition that requires immediate medical treatment.

Q2. Dapalex SM 10/100/500 Tablet cause low blood sugar?

A: When used alone, this combination typically does not cause severe low blood sugar. However, hypoglycemia can occur when combined with insulin or other diabetes medicines that increase insulin release, when meals are skipped or delayed, during excessive exercise, or with alcohol consumption. Signs of low blood sugar include shakiness, sweating, rapid heartbeat, hunger, confusion, and irritability. Keep a quick sugar source like glucose tablets or juice available.

Q3. Is Dapalex SM 10/100/500 Tablet safe for long-term use?

A: This medicine can be used long-term under medical supervision with regular monitoring of kidney function, vitamin B12 levels, and overall health.

Q4. Does Dapalex SM 10/100/500 Tablet help in weight loss?

A: Dapalex SM 10/100/500 Tablet is not meant for weight loss, but some people may notice mild weight reduction due to glucose being removed through urine. Any weight change should be monitored by your doctor. Check your blood sugar regularly as advised, and attend routine tests such as HbA1c, kidney, and liver function. Inform your doctor about any unusual symptoms.

Q5. Can I stop taking Dapalex SM 10/100/500 Tablet if my blood sugar is under control?

A: No, you should never stop taking this medication without consulting your doctor, even if your blood sugar levels are well-controlled. The medicine is keeping your blood sugar in the target range, and stopping suddenly can cause your blood sugar to rise again quickly. Diabetes is a chronic condition requiring ongoing management. If you experience side effects or have concerns about the medication, discuss them with your doctor who may adjust your treatment plan rather than simply stopping the medicine.

Q6: What should I do if I experience frequent urination after starting Dapalex SM 10/100/500 Tablet?

A: Increased urination is a common and expected effect of the dapagliflozin component, which works by removing excess sugar through urine. This typically improves after the first few weeks as your body adjusts. Stay well-hydrated by drinking adequate fluids throughout the day, and be mindful of bathroom access when planning activities. The increased urination usually occurs during daytime hours when you are more active. If the frequent urination becomes bothersome, interferes significantly with your daily activities, or is accompanied by burning or pain, contact your doctor.

Q7: Will Dapalex SM 10/100/500 Tablet affect my vitamin B12 levels?

A: The metformin component in this medication can reduce vitamin B12 absorption over time. Your doctor should monitor your vitamin B12 levels periodically, especially if you have been on metformin-containing medications for several years or if you develop symptoms of deficiency such as unusual tiredness, pale skin, shortness of breath, tingling in hands or feet, or difficulty concentrating. If deficiency occurs, your doctor may recommend vitamin B12 supplementation. This is a manageable side effect that can be easily addressed through monitoring and supplementation when needed.

References:

1. GLUCRETA SM. Dapagliflozin, Sitagliptin and Metformin Hydrochloride Extended Release Tablets. Torrentpharma. Last Revised: JUN 2024. Accessed on: 21st July 2026. Click Here

2. SITACIP DM Tablets. Sitagliptin dapagliflozin and metformin hydrochloride. Prescribing information. Cipla. Last Revised: February 2022. Accessed on: 21st July 2026. Click Here