Mellitofix Met 12.5/500 Mg 30 Tablets

Mellitofix Met 12.5/500 Mg 30 Tablets

Description:

Mellitofix Met 12.5/500 mg is a prescription oral antidiabetic medicine containing empagliflozin and metformin, developed by EVA Pharma for the management of type 2 diabetes mellitus in adults. It is used along with diet and exercise to help lower high blood sugar levels and to reduce the risk of cardiovascular death in adults with type 2 diabetes who have established cardiovascular disease. Mellitofix Met combines the benefits of an SGLT2 inhibitor (empagliflozin) and biguanide (metformin) to improve blood glucose control and support long-term cardiovascular protection.

Indications:

• Management of blood glucose levels in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise.
• May be used alone or in combination with other antidiabetic medicines (such as insulin, sulfonylureas, DPP-4 inhibitors) when additional glycemic control is needed.
• Reduction of the risk of cardiovascular death in adults with type 2 diabetes mellitus and known cardiovascular disease.
• Helps improve fasting and postprandial (after-meal) blood sugar levels.
• Not indicated for type 1 diabetes.
• Not indicated for the treatment of diabetic ketoacidosis.

Active Ingredients / Key Components:

• Empagliflozin – 12.5 mg per film-coated tablet (sodium-glucose cotransporter-2 (sglt2) inhibitor).
• Metformin hydrochloride – 500 mg per film-coated tablet (biguanide class oral hypoglycemic agent).
• Other excipients: film-coating agents, fillers, binders, and stabilizers (exact excipient list and concentrations , please check the product leaflet or the manufacturer’s official website; please refer to the official package leaflet for full details).

Dosage & Administration / How to Use:

• Use only as prescribed by your physician based on your individual medical condition, kidney function, and current antidiabetic therapy.
• Typical adult dosing: the dose and frequency are individualized; Mellitofix Met 12.5/500 mg is usually taken once or twice daily, but the exact regimen must be determined by the treating doctor.
• Take the tablets with meals to reduce the risk of gastrointestinal side effects related to metformin (such as nausea or stomach upset).
• Swallow the tablet whole with a glass of water. Do not crush, chew, or break the film-coated tablet unless advised by your doctor.
• If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a missed one.
• Continue to follow your prescribed diet plan and exercise program while taking this medicine.
• Regular monitoring of blood glucose, kidney function, and, when appropriate, cardiovascular status is recommended during treatment.
• Do not stop taking Mellitofix Met without consulting your doctor, as this may worsen your blood sugar control.

Clinical Benefits:

• Helps lower elevated blood sugar levels in adults with type 2 diabetes by two complementary mechanisms (increased urinary glucose excretion and reduced hepatic glucose production).
• Supports reduction in the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
• May contribute to modest weight reduction and blood pressure improvement due to the osmotic diuretic effect of empagliflozin (individual results may vary).
• Improves overall glycemic control (fasting and post-meal glucose) when used with diet, exercise, and, if needed, other antidiabetic medicines.

Warnings & Contraindications:

• Prescription-only medicine. Use under medical supervision only.
• Contraindicated in patients with type 1 diabetes mellitus.
• Contraindicated in patients with diabetic ketoacidosis (increased ketones in blood or urine), with or without high blood sugar.
• Do not use if you have severe kidney problems or are on dialysis. Kidney function must be assessed before and during treatment.
• Not recommended for children and adolescents under 18 years of age due to insufficient safety and efficacy data.
• Should not be used during pregnancy or breast-feeding. If you become pregnant or plan to become pregnant, contact your doctor immediately to switch to an appropriate alternative.
• Metformin is associated with a rare but serious condition called lactic acidosis, especially in patients with significant kidney impairment, severe infection, dehydration, heart failure, liver disease, or excessive alcohol intake.
• Empagliflozin may increase the risk of genital mycotic infections, urinary tract infections, and volume depletion (low blood pressure, dizziness), particularly in elderly patients or those on diuretics.
• Use with caution in patients with a history of cardiovascular disease, hypotension, or those taking antihypertensive medicines, as additional blood pressure lowering can occur.
• Inform your doctor if you have liver disease, recurrent urinary tract infections, genital infections, or conditions that may predispose to dehydration (vomiting, diarrhea, fever, or reduced fluid intake).
• Before surgery or imaging procedures requiring iodinated contrast agents, your doctor may advise temporarily stopping metformin to reduce the risk of lactic acidosis.
• Avoid excessive alcohol intake while using this medicine, as it increases the risk of lactic acidosis.
• Consult your doctor before use if pregnant, nursing, taking other medications, or if you have medical conditions such as kidney disease, liver disease, heart failure, or hypotension.
• Keep out of reach of children.

Side Effects:

• Common side effects: nausea, vomiting, diarrhea, abdominal pain, loss of appetite (mainly due to metformin), increased urination, thirst, and mild dehydration.
• Genital infections (such as yeast infections) and urinary tract infections may occur more frequently with empagliflozin; symptoms include itching, burning, unusual discharge, pain or burning during urination, or frequent urination.
• Dizziness or low blood pressure, especially in patients taking diuretics or those who are dehydrated.
• Changes in kidney function tests may occur; your doctor will monitor kidney function regularly.
• Rare but serious: lactic acidosis with metformin (symptoms include rapid breathing, severe tiredness, muscle pain, stomach discomfort, feeling cold, dizziness, or slow/irregular heartbeat). This is a medical emergency; stop the medicine and seek immediate medical attention if suspected.
• Very rare but serious: severe infections or diabetic ketoacidosis (even with moderately elevated blood sugar) have been reported with SGLT2 inhibitors; symptoms include nausea, vomiting, abdominal pain, excessive thirst, difficulty breathing, confusion, or unusual fatigue. Seek urgent medical care if these occur.
• If you experience any severe, persistent, or unusual symptoms, stop taking the medicine and contact your doctor or pharmacist immediately.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children.

Specifications:

• Product type: Prescription oral antidiabetic medicine.
• Strength: 12.5 mg empagliflozin + 500 mg metformin hydrochloride per film-coated tablet.
• Form: Film-coated tablets.
• Pack size: 30 tablets per pack.
• Intended use: Adult patients with type 2 diabetes mellitus, as directed by a healthcare professional.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.