Zomelis Dm 500 Mg Tablet (10 Tab)

ZOMELIS DM 500 MG TABLET

ZOMELIS DM 500 MG TABLET is an antidiabetic medication manufactured by Eris Lifesciences Limited.

Composition Each tablet of ZOMELIS DM 500 MG contains a combination of three active ingredients:

• Dapagliflozin 10 mg
• Metformin Hydrochloride 500 mg (often in sustained-release form)
• Vildagliptin 100 mg (often in sustained-release form)

These components work synergistically to lower blood sugar levels. Dapagliflozin aids in removing excess sugar from the body via urine, Vildagliptin increases insulin release, and Metformin reduces glucose production in the liver and improves insulin sensitivity.

Uses ZOMELIS DM 500 MG TABLET is primarily prescribed for the management of Type 2 Diabetes Mellitus in adults. It is used as an adjunct to diet and exercise to:

• Control high blood sugar levels.
• Improve overall glycemic control.
• Reduce the risk of long-term complications associated with diabetes, such as kidney damage, eye damage, nerve problems, and cardiovascular issues.
• Offer cardiovascular and renal protection by lowering blood pressure and improving vascular function.

Dosage and Administration The tablet is for oral consumption and should be taken as prescribed by a healthcare professional.

• Typically, the starting dose for adults is one tablet once or twice daily, taken with meals to minimize gastrointestinal side effects.
• The tablet should be swallowed whole with a full glass of water and not crushed, chewed, or broken.
• Consistency in taking the medication at the same time each day is important for maintaining stable blood glucose levels.
• Dosage adjustments may be made by the doctor based on blood glucose levels and kidney function.

Side Effects Common side effects may include:

• Nausea, vomiting, diarrhea, abdominal pain, loss of appetite, metallic taste.
• Headache.
• Frequent or painful urination, increased thirst.
• Vaginal yeast infection or inflammation of the penis (in men).
• Hypoglycemia (low blood sugar), especially when used with other antidiabetic medicines or alcohol, or with skipped meals.

Serious side effects, though less common, can include lactic acidosis (symptoms like rapid breathing, muscle cramps, abdominal pain) and liver problems (yellowing of skin/eyes, dark urine). Allergic reactions (rash, itching, swelling) can also occur. Consult a doctor immediately if severe or persistent side effects are experienced.

Precautions

• Pregnancy and Breastfeeding: ZOMELIS DM 500 MG TABLET is generally not recommended for use during pregnancy and breastfeeding. Consult a doctor.
• Alcohol: Avoid alcohol consumption as it increases the risk of hypoglycemia and lactic acidosis.
• Kidney and Liver Impairment: Use with caution in patients with kidney problems, and it is generally avoided in severe liver dysfunction due to increased risk of lactic acidosis. Regular monitoring of kidney function is essential.
• Children and Elderly: Not recommended for use in children below 18 years of age. Elderly patients may require dosage adjustments due to increased sensitivity to side effects.
• Other Conditions: Inform your doctor if you have Type 1 diabetes, diabetic ketoacidosis, severe dehydration, heart problems, or any known allergies to the components of the medicine.
• Drug Interactions: Inform your doctor about all medications, including herbal supplements, to avoid potential drug-drug interactions, particularly with cationic medications, iodinated contrast agents, and CYP3A4 inducers.

Storage Store ZOMELIS DM 500 MG TABLET in a cool and dry place, protected from direct sunlight and moisture. Keep it out of the sight and reach of children. The recommended storage temperature is below 25°C or 30°C.

What is ZOMELIS DM 500 MG TABLET used for?

ZOMELIS DM 500 MG TABLET is an antidiabetic medicine primarily used to treat Type 2 Diabetes Mellitus in adults. It helps control high blood sugar levels, improves glycemic control, and can reduce the risk of associated complications like kidney damage, eye damage, nerve problems, and cardiovascular diseases. It is used as an adjunct to diet and exercise.

How does ZOMELIS DM 500 MG TABLET work?

ZOMELIS DM 500 MG TABLET is a combination of three active ingredients: Dapagliflozin, Vildagliptin, and Metformin.

• Dapagliflozin works by inhibiting sodium-glucose co-transporter 2 (SGLT2) in the kidneys, leading to increased excretion of glucose through urine, thereby lowering blood sugar levels.
• Vildagliptin enhances glucose-mediated insulin secretion from the pancreas and reduces glucose production by the liver.
• Metformin reduces glucose production in the liver, decreases the absorption of sugar from the intestines, and improves the body's sensitivity to insulin.

What is the usual dosage of ZOMELIS DM 500 MG TABLET?

Generally, the starting dose for adults is one tablet (500mg) once or twice daily, taken with meals to minimize gastrointestinal side effects. Your doctor will determine and adjust the dosage based on your blood glucose levels and individual condition. It's crucial not to exceed the recommended dose.

What are the possible side effects of ZOMELIS DM 500 MG TABLET?

Common side effects may include vomiting, nausea, abdominal pain, headache, frequent urination, diarrhea, loss of appetite, metallic taste, and allergic reactions. Low blood sugar (hypoglycemia) is also a possible side effect, especially if taken with other antidiabetic medicines. Less common but potentially serious side effects include lactic acidosis. If side effects persist or worsen, consult your doctor.

Is ZOMELIS DM 500 MG TABLET safe during pregnancy or breastfeeding?

ZOMELIS DM 500 MG TABLET is not recommended for use during pregnancy or while breastfeeding. It is important to inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding before taking this medication.

Can ZOMELIS DM 500 MG TABLET be taken with other medications?

This medicine can interact with several other medications. Inform your doctor about all medicines, including herbal products and supplements, you are currently taking. Interactions can occur with other diabetic medications (e.g., insulin, glyburide), water pills (diuretics), birth control pills, thyroid medicines, corticosteroids, and certain cardiovascular agents. Using it with iodinated contrast agents may increase the risk of acute kidney failure and lactic acidosis.

What precautions should be taken while taking ZOMELIS DM 500 MG TABLET?

• Alcohol Consumption: Avoid drinking alcohol as it can increase the risk of hypoglycemia and lactic acidosis.
• Kidney and Liver Conditions: Use with caution if you have kidney or liver problems, as the risk of lactic acidosis is increased. Your doctor may adjust the dose or prescribe an alternative.
• Allergies: Do not take this medicine if you are allergic to dapagliflozin, vildagliptin, metformin, or any of its components.
• Children: It is not recommended for use in children below 18 years of age.
• Medical History: Inform your doctor about your complete medical history, especially if you have heart problems, before starting the treatment.
• Driving: Exercise caution while driving or operating machinery, as the medication may cause dizziness.
• Do not stop abruptly: Do not discontinue the medication without consulting your doctor, as this can lead to uncontrolled blood sugar levels.

What happens if a dose of ZOMELIS DM 500 MG TABLET is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should ZOMELIS DM 500 MG TABLET be stored?

Store ZOMELIS DM 500 MG TABLET in a cool, dry place, ideally below 25°C. Keep it away from direct sunlight and moisture, and ensure it is out of the sight and reach of children. Do not use the medication beyond its expiration date.