Empacoza Plus 5/25

Empacoza Plus 5/25

Description:

Empacoza Plus 25/5 mg film-coated tablets is an oral antidiabetic prescription medicine combining empagliflozin (an sglt2 inhibitor) and linagliptin (a 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 two different pathways involved in blood glucose regulation, Empacoza Plus helps lower fasting and postprandial blood sugar levels and supports long-term diabetes management. This product belongs to the Health & Wellness / Diabetes Care / Insulin and Diabetic Medicines segment.

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 being treated with empagliflozin and linagliptin as separate tablets.
• Helps reduce elevated fasting and postprandial blood glucose levels.
• May be used in patients who require combination oral therapy before or in addition to insulin, as directed by a physician.

Active Ingredients / Key Components:

• Empagliflozin – 25 mg per film-coated tablet (sglt2 inhibitor).
• Linagliptin – 5 mg per film-coated tablet (dpp-4 inhibitor).
• Other excipients: full list of inactive ingredients is not available in the provided information; please refer to the official package insert for complete excipient details.

Dosage & Administration / How to Use:

• Standard adult dose: 10 mg empagliflozin / 5 mg linagliptin orally once daily in the morning, with or without food, as initial combination therapy or when switching from individual components (according to physician’s judgment).
• For patients requiring additional glycemic control and who tolerate therapy, the dose may be increased to 25 mg empagliflozin / 5 mg linagliptin once daily. Empacoza Plus 25/5 mg tablets correspond to this higher strength.
• Swallow the tablet whole with a glass of water; do not crush, break, or chew unless advised by your doctor.
• Take at the same time each day to maintain consistent blood levels and optimal glycemic control.
• If a dose is missed, 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 resume your regular schedule. Do not double the dose.
• Dosage adjustments may be required in patients with renal impairment, elderly patients, or those on concomitant medications that can affect kidney function or blood glucose; follow physician instructions strictly.
• Use only under medical supervision as part of a comprehensive diabetes management plan including diet, exercise, and regular blood glucose monitoring.

Clinical Benefits:

• Dual mechanism of action: combines sglt2 inhibition (empagliflozin) with dpp-4 inhibition (linagliptin) for enhanced glycemic control in type 2 diabetes.
• Helps lower fasting and post-meal blood glucose levels, supporting achievement of individualized HbA1c targets.
• Empagliflozin promotes urinary glucose excretion, which may contribute to modest weight reduction and a decrease in blood pressure in some patients.
• Linagliptin enhances incretin activity, increasing insulin secretion and reducing glucagon levels in a glucose-dependent manner, with a low intrinsic risk of hypoglycemia when not combined with agents that cause hypoglycemia.

Warnings & Contraindications:

• Contraindicated in patients with known hypersensitivity to empagliflozin, linagliptin, or any of the excipients.
• Not indicated for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
• Use with caution in patients with renal impairment; empagliflozin efficacy is reduced in moderate to severe renal dysfunction and the risk of adverse effects may increase. Dose adjustment or discontinuation may be required based on kidney function and medical advice.
• Risk of volume depletion and hypotension, particularly in elderly patients, those on diuretics, or with low blood pressure; monitor for signs of dizziness, fainting, or dehydration.
• Empagliflozin may increase the risk of genital mycotic infections and urinary tract infections; advise patients on genital hygiene and to report symptoms such as burning, itching, or unusual discharge.
• Cases of pancreatitis have been reported with dpp-4 inhibitors (including linagliptin); discontinue and seek medical attention if severe, persistent abdominal pain occurs.
• Monitor renal function periodically, especially in patients with pre-existing kidney disease, cardiovascular disease, or those taking nephrotoxic drugs.
• Hypoglycemia risk increases when used with insulin or insulin secretagogues (e.g., sulfonylureas); dose adjustment of these agents may be necessary.
• Consult your doctor before use if pregnant, planning pregnancy, or breastfeeding; safety in pregnancy and lactation is not well established.
• Consult your doctor before use if you have liver disease, kidney disease, recurrent urinary or genital infections, low blood pressure, cardiovascular disease, or are taking diuretics or other antidiabetic medications.
• Not intended to diagnose, treat, cure, or prevent any disease without a physician’s prescription and supervision.
• Keep out of reach of children.

Side Effects:

• Common side effects: increased urination, thirst, genital fungal infections (such as vulvovaginal candidiasis or balanitis), urinary tract infections, nasal congestion, cough, or mild gastrointestinal discomfort.
• Less common but important: hypotension (low blood pressure), dehydration, elevated blood lipids, joint pain, or rash.
• Serious side effects (seek immediate medical attention): signs of severe allergic reaction (swelling of face, lips, tongue, or throat; difficulty breathing; severe rash), symptoms of pancreatitis (severe, persistent abdominal pain, possibly radiating to the back), signs of ketoacidosis (nausea, vomiting, abdominal pain, difficulty breathing, confusion, unusual fatigue), or severe urinary or genital infections.
• This is not a complete list of side effects. Patients should consult their doctor or pharmacist for full safety information and report any unexpected or persistent symptoms.

Storage Instructions:

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

Specifications:

• Strength: 25 mg empagliflozin / 5 mg linagliptin per film-coated tablet.
• Form: film-coated oral tablets.
• Pack size: 30 film-coated tablets per pack (sufficient for approximately 1 month of once-daily therapy at the 25/5 mg dose, as directed by a physician).

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.