Empaglimax 10 mg

Empaglimax 10 mg

Description:

Empaglimax 10 mg is a prescription oral antidiabetic medicine containing empagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, manufactured by Hikma Pharma. It is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus and to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Empaglimax 10 mg works by increasing the amount of glucose excreted in the urine, thereby lowering blood glucose levels and supporting long-term diabetes management and heart protection.

Indications:

• Type 2 diabetes mellitus in adults, as an adjunct to diet and exercise to improve glycemic control.
• May be used as monotherapy when metformin is not tolerated or contraindicated, or in combination with other antidiabetic agents (such as metformin, sulfonylureas, insulin, DPP-4 inhibitors), as prescribed by the physician.
• Reduction of the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
• Helps reduce elevated fasting and postprandial blood glucose levels and associated symptoms such as excessive thirst, frequent urination, and fatigue when part of a comprehensive diabetes management plan.
• Not indicated for type 1 diabetes or for the treatment of diabetic ketoacidosis.

Active Ingredients / Key Components:

• Empagliflozin – 10 mg per film-coated tablet.
• Other inactive ingredients/excipients: full excipient list is not available in the provided information; please refer to the official package leaflet for complete details.

Dosage & Administration / How to Use:

• Recommended dose for adults: 10 mg empagliflozin once daily, as prescribed by your doctor. The dose may be increased to 25 mg once daily based on individual response and tolerability, according to physician judgment.
• Route of administration: oral. Swallow the film-coated tablet whole with water; do not crush or chew.
• Can be taken with or without food, preferably at the same time each day to help maintain consistent blood levels.
• Use in combination therapy: when used with insulin or insulin secretagogues (e.g., sulfonylureas), your doctor may need to adjust the dose of those medicines to reduce the risk of hypoglycemia.
• Renal function considerations: do not use if you have severe kidney problems or are on dialysis. Dose adjustments or discontinuation may be required in patients with impaired kidney function; follow physician guidance.
• Missed dose: if you miss a dose, take it as soon as you remember on the same day. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not take a double dose to make up for a missed tablet.
• Duration of use: long-term treatment as directed by your healthcare provider as part of a comprehensive diabetes and cardiovascular risk management plan.
• Always follow your doctor’s instructions and the patient information leaflet. Do not change the dose or stop taking the medicine without medical advice.

Clinical Benefits:

• Helps lower blood sugar levels in adults with type 2 diabetes by promoting urinary glucose excretion via SGLT2 inhibition in the kidneys.
• Contributes to a reduction in the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease when used as prescribed.
• May support modest weight reduction and decrease in blood pressure in many patients, as a result of increased glucose and osmotic diuresis (fluid loss), when combined with diet and exercise.
• Improves overall glycemic control (HbA1c, fasting plasma glucose, and postprandial glucose) as part of a comprehensive diabetes management program.

Warnings & Contraindications:

• Contraindicated in patients with known hypersensitivity to empagliflozin or any of the excipients.
• Do not use in patients with type 1 diabetes mellitus.
• Do not use in patients with diabetic ketoacidosis (DKA) or a history of DKA; this medicine is not suitable for treating DKA.
• Do not take this medicine if you have severe kidney problems or are on dialysis. Renal function should be assessed before starting and periodically 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 and breast-feeding. If you become pregnant or plan to become pregnant, inform your doctor immediately to switch to a more appropriate therapy.
• May increase the risk of volume depletion (dehydration), especially in elderly patients, those on diuretics, or with low blood pressure. Symptoms include dizziness, lightheadedness, or fainting; ensure adequate fluid intake.
• May increase the risk of genital mycotic (fungal) infections and urinary tract infections. Maintain good personal hygiene and seek medical advice if symptoms occur.
• Rare but serious cases of diabetic ketoacidosis (including euglycemic DKA) have been reported with SGLT2 inhibitors. Seek urgent medical attention if you develop nausea, vomiting, abdominal pain, excessive thirst, difficulty breathing, confusion, or unusual fatigue.
• Use with caution in patients with cardiovascular disease, hypotension, or those taking antihypertensive medications, as further blood pressure reduction may occur.
• Consult your doctor before use if you have liver disease, kidney disease, recurrent urinary tract infections, history of genital infections, or are taking diuretics, blood pressure medicines, or other antidiabetic drugs.
• Consult your doctor before use if pregnant, nursing, taking medications, or have medical conditions such as kidney disease, liver disease, cardiovascular disease, or hypotension.
• Keep out of reach of children.

Side Effects:

• Common side effects may include increased urination, thirst, genital fungal infections (such as vulvovaginal candidiasis in women and balanitis in men), urinary tract infections, and mild dehydration symptoms.
• Other possible side effects include dizziness, especially when standing up (orthostatic hypotension), increased cholesterol levels, and mild reductions in kidney function, usually reversible after discontinuation.
• Serious but less common side effects may include diabetic ketoacidosis (even with moderately elevated blood sugar), severe urinary tract infections (such as pyelonephritis or urosepsis), and severe allergic reactions (rash, itching, swelling of face/lips/tongue, difficulty breathing).
• Stop taking the medicine and seek immediate medical attention if you experience symptoms of severe allergic reaction, signs of ketoacidosis (nausea, vomiting, abdominal pain, difficulty breathing, confusion, unusual fatigue), or severe infection with fever and pain.
• This is not a complete list of side effects. For full safety information, read the patient leaflet and consult your healthcare provider.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children. Do not use after the expiry date printed on the pack. Store at or below the temperature specified on the package insert (exact storage temperature is not available in the provided information; refer to the official leaflet).

Specifications:

• Product form: film-coated tablets.
• Strength: empagliflozin 10 mg per tablet.
• Pack size: 30 film-coated tablets per pack (30 f.c. tabs.).
• Intended use: prescription medicine for adults with type 2 diabetes.

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.