Empacoza Plus 10/5

Empacoza Plus 10/5

Description:

Empacoza Plus 10/5 mg film-coated tablets is an oral prescription anti-diabetic medicine combining two modern agents: empagliflozin (a sodium-glucose co-transporter 2 – SGLT2 – inhibitor) and linagliptin (a dipeptidyl peptidase-4 – DPP-4 – inhibitor). It is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate. By targeting complementary pathways, Empacoza Plus 10/5 helps lower blood glucose, supports long-term diabetes management, and may assist in reducing diabetes-related complications when used as directed under medical supervision.

Indications:

• Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• For patients insufficiently controlled on empagliflozin or linagliptin alone or already receiving both agents as separate tablets.
• Helps reduce elevated fasting and postprandial blood glucose levels.
• May be considered in adults with type 2 diabetes who require combination therapy to reach individualized HbA1c targets, as assessed by their physician.
• Not indicated for type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Active Ingredients / Key Components:

• Empagliflozin – 10 mg per film-coated tablet (SGLT2 inhibitor that increases urinary glucose excretion).
• Linagliptin – 5 mg per film-coated tablet (DPP-4 inhibitor that enhances incretin activity and increases insulin secretion in a glucose-dependent manner).
• Other inactive ingredients (excipients) are present to form the film-coated tablet; detailed excipient list and exact concentrations , please check the product leaflet or the manufacturer’s official website. Refer to the official package leaflet for full composition.

Dosage & Administration / How to Use:

• Standard adult dose: 1 tablet of Empacoza Plus 10/5 mg taken orally once daily in the morning.
• Tablets may be taken with or without food, swallowed whole with a sufficient amount of water. Do not crush or chew unless advised by your doctor.
• If additional glycemic control is needed and the medicine is well tolerated, the dose may be increased (according to the prescriber) to a higher empagliflozin strength combination such as 25 mg / 5 mg once daily, as clinically appropriate.
• Use exactly as prescribed by your physician; do not change the dose or stop treatment without medical advice.
• If you miss a dose, take it as soon as you remember on the same day. If it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed tablet.
• Suitable only for adults with type 2 diabetes; not recommended for children or adolescents unless specifically prescribed by a specialist.
• Patients with kidney or liver impairment, elderly patients, or those on diuretics or other anti-diabetic medications may require special monitoring and possible dose adjustments as determined by their doctor.

Clinical Benefits:

• Provides dual mechanism of action by combining an SGLT2 inhibitor (empagliflozin) and a DPP-4 inhibitor (linagliptin) for enhanced blood glucose control.
• Helps reduce fasting and post-meal blood glucose levels, supporting achievement of individualized HbA1c targets in type 2 diabetes.
• Once-daily oral tablet improves treatment convenience and may enhance adherence compared to taking the two components separately.
• Empagliflozin promotes urinary glucose excretion, which may contribute to modest weight reduction and slight blood pressure lowering in some patients (as observed with SGLT2 inhibitors in general).
• Linagliptin works in a glucose-dependent manner, which is associated with a relatively low risk of hypoglycemia when used without sulfonylureas or insulin.
• Supports long-term diabetes management and may help reduce the risk of microvascular and macrovascular complications when combined with comprehensive lifestyle modifications and regular medical follow-up.

Warnings & Contraindications:

• Contraindicated in patients with known hypersensitivity to empagliflozin, linagliptin, or any of the excipients in the formulation.
• Not for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis (DKA); SGLT2 inhibitors may increase the risk of ketoacidosis, sometimes with only moderately elevated blood glucose.
• Use with caution in patients with renal impairment; efficacy may be reduced and risk of adverse effects (such as volume depletion) may increase. Renal function should be assessed before initiation and periodically during treatment.
• Use with caution in patients with hepatic impairment, elderly patients, those with low blood pressure, or those on diuretics or medications that may affect kidney function.
• Risk of volume depletion, hypotension, and dehydration, especially in patients with impaired renal function, elderly patients, or those on diuretics. Ensure adequate fluid intake and monitor for signs of dizziness, fainting, or weakness.
• SGLT2 inhibitors have been associated with increased risk of genital mycotic infections and urinary tract infections; advise patients on genital hygiene and to seek medical attention if symptoms occur.
• Pancreatitis has been reported with DPP-4 inhibitors; discontinue and seek urgent medical care if severe, persistent abdominal pain occurs.
• Monitor blood glucose regularly; dose adjustments of concomitant insulin or sulfonylureas may be needed to reduce risk of hypoglycemia.
• Consult your doctor before use if pregnant, planning pregnancy, or breastfeeding. Use during pregnancy or lactation is generally not recommended unless clearly needed and prescribed by a specialist.
• Consult your doctor before use if you have kidney disease, liver disease, recurrent urinary tract or genital infections, history of pancreatitis, cardiovascular disease, low blood pressure, are on diuretics, or taking other anti-diabetic medications.
• Not intended to diagnose, treat, cure, or prevent any disease without proper medical supervision.
• Keep out of reach of children.

Side Effects:

• Common side effects (usually mild to moderate): increased urination, thirst, genital fungal infections (such as vulvovaginal candidiasis or balanitis), urinary tract infections, nasal congestion, cough, headache, or gastrointestinal discomfort.
• Less common but potentially serious side effects: dehydration and low blood pressure (dizziness, fainting), ketoacidosis (nausea, vomiting, abdominal pain, difficulty breathing, confusion, unusual fatigue), severe urinary tract infection, or signs of acute kidney injury (reduced urine output, swelling, sudden weight gain).
• Pancreatitis: severe, persistent abdominal pain (possibly radiating to the back), sometimes with nausea and vomiting; stop the medicine and seek urgent medical attention.
• Allergic reactions: rash, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing; discontinue immediately and seek emergency medical help.
• Hypoglycemia (low blood sugar) is more likely when used with insulin or sulfonylureas; symptoms include sweating, tremor, hunger, palpitations, confusion, or headache. Follow your doctor’s plan for managing low blood sugar.
• If you experience any unusual, severe, or persistent side effects, stop taking the medicine and contact your doctor or pharmacist promptly.

Storage Instructions:

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

Specifications:

• Form: Film-coated tablets for oral use.
• Strength per tablet: empagliflozin 10 mg + linagliptin 5 mg.
• Pack size: 30 film-coated tablets (sufficient for approximately 1 month of once-daily therapy, depending on prescribed regimen).
• Intended user group: 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.