Mellitofix Met 12.5/1000 Mg 30 Tablets

Mellitofix Met 12.5/1000 Mg 30 Tablets

Description:

Mellitofix Met 12.5/1000 mg 30 tablets is a prescription oral antidiabetic medicine from Eva Pharma, combining empagliflozin and metformin to help control blood glucose levels in adults with type 2 diabetes mellitus. It is used alongside a proper diet, regular exercise, and lifestyle modification to improve glycemic control and to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Mellitofix Met belongs to the class of sodium-glucose cotransporter-2 (sglt2) inhibitors plus biguanide (metformin), offering dual action: increasing urinary glucose excretion and reducing hepatic glucose production and intestinal glucose absorption.

Indications:

• Management of blood glucose levels in adults with type 2 diabetes mellitus when diet and exercise alone are not sufficient.
• Can be used as monotherapy (when metformin is inappropriate) or in combination with other antidiabetic medicines (such as insulin, sulfonylureas, dpp-4 inhibitors, etc.) as prescribed by the physician.
• Reduction of the risk of cardiovascular death in adults with type 2 diabetes mellitus and known cardiovascular disease.
• Helps reduce elevated fasting and postprandial blood sugar levels and supports long-term glycemic control (hba1c reduction).
• Not indicated for type 1 diabetes or for the treatment of diabetic ketoacidosis.

Active Ingredients / Key Components:

• Empagliflozin – 12.5 mg per film-coated tablet (sglt2 inhibitor).
• Metformin hydrochloride – 1000 mg per film-coated tablet (biguanide class).
• Excipients: film-coating agents, fillers, binders, and other inactive ingredients (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:

• Mellitofix Met 12.5/1000 mg is for oral use only and must be taken exactly as prescribed by your doctor.
• Typical dosing: usually 1 tablet once or twice daily, depending on the individual’s current regimen and kidney function; the exact dose and frequency are determined by the treating physician. Do not change your dose without medical advice.
• Take the tablets with meals to reduce gastrointestinal side effects related to metformin (such as nausea or stomach upset). Swallow the tablet whole with a glass of water; do not crush or chew unless your doctor advises otherwise.
• 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 tablet.
• Continue following your prescribed diabetic diet, exercise plan, and regular blood glucose monitoring while using this medicine.
• Regular check-ups of kidney function, liver function, blood glucose, and hba1c are recommended during treatment.

Clinical Benefits:

• Improves glycemic control in adults with type 2 diabetes by combining two complementary mechanisms of action (sglt2 inhibition and metformin).
• Empagliflozin increases urinary glucose excretion by inhibiting sglt2 in the kidneys, helping lower blood sugar independently of insulin secretion.
• Metformin decreases hepatic glucose production, reduces intestinal absorption of glucose, and improves insulin sensitivity, contributing to better fasting and postprandial glucose levels.
• Helps reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, as demonstrated for empagliflozin-containing regimens.
• May support modest weight reduction and lower blood pressure in some patients due to increased urinary glucose and sodium excretion (effect varies between individuals).
• Convenient fixed-dose combination (12.5 mg empagliflozin/1000 mg metformin) reduces pill burden compared to taking both medicines separately.

Warnings & Contraindications:

• Do not use Mellitofix Met if you are allergic (hypersensitive) to empagliflozin, metformin, or any of the excipients.
• Contraindicated in patients with severe kidney impairment, end-stage renal disease, or those on dialysis. Kidney function must be assessed before starting and regularly during treatment.
• Do not use in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis or lactic acidosis, with or without coma.
• Not for use in people with type 1 diabetes or for the treatment of diabetic ketoacidosis (risk of ketoacidosis may be increased with sglt2 inhibitors).
• Not recommended for children and adolescents under 18 years of age due to insufficient data on safety and efficacy.
• Use is not recommended during pregnancy or breast-feeding. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor for an alternative treatment.
• Use with caution in elderly patients, those with reduced kidney function, liver impairment, dehydration, low blood pressure, or those taking diuretics or medications that may affect kidney function.
• Metformin is associated with a rare but serious risk of lactic acidosis, especially in patients with significant kidney impairment, severe infection, dehydration, heart failure, or in situations of hypoxia. Seek immediate medical attention if you develop unexplained muscle pain, severe weakness, abdominal pain, rapid breathing, or feeling very unwell.
• Sglt2 inhibitors, including empagliflozin, may increase the risk of genital infections, urinary tract infections, and in rare cases, diabetic ketoacidosis (even with moderately elevated blood glucose). Report symptoms such as nausea, vomiting, abdominal pain, excessive thirst, difficulty breathing, confusion, or unusual fatigue to your doctor immediately.
• Inform your doctor if you are scheduled for major surgery or imaging procedures using iodinated contrast agents, as metformin may need to be temporarily discontinued.
• 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, recurrent urinary tract infections, frequent genital infections, or dehydration.
• Keep out of reach of children.
• This product is a prescription medicine and should be used only under medical supervision.

Side Effects:

• Common side effects: genital yeast infections (vaginal candidiasis in women, balanitis in men), urinary tract infections, increased urination, nausea, vomiting, diarrhea, abdominal discomfort, loss of appetite, and mild dehydration.
• Metformin-related gastrointestinal symptoms (nausea, diarrhea, abdominal pain, metallic taste) are more likely at the start of therapy and often improve with time or dose adjustment.
• Less common side effects: dizziness, low blood pressure (especially in patients on diuretics or with low blood volume), rash, itching, or allergic reactions.
• Serious but rare side effects: lactic acidosis (associated with metformin) and diabetic ketoacidosis (associated with sglt2 inhibitors), severe urinary tract infections, or severe genital infections. Seek urgent medical attention if you experience severe weakness, difficulty breathing, abdominal pain, confusion, high fever, or signs of severe infection.
• If you notice any unusual or persistent side effects, stop taking the medicine and contact your doctor or pharmacist immediately.

Storage Instructions:

Store in a cool, dry place away from direct sunlight and moisture. Keep the blister pack in the original outer carton to protect from light. Do not store above the temperature specified on the outer packaging (exact temperature range is not available in the provided information; refer to the official pack). Keep container tightly closed and keep out of reach of children.

Specifications:

• Product type: Prescription antidiabetic medicine (oral).
• Form: Film-coated tablet.
• Strength per tablet: Empagliflozin 12.5 mg + metformin hydrochloride 1000 mg.
• Pack size: 30 film-coated tablets.
• Intended users: Adults with type 2 diabetes mellitus, as prescribed 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.