GLYXAMBI 25/5 MG TABLETS

GLYXAMBI 25/5 MG TABLETS

Description:

GLYXAMBI 25/5 mg tablets is a prescription oral antidiabetic medicine used in adults with type 2 diabetes mellitus. It combines two active ingredients, empagliflozin (an SGLT2 inhibitor) and linagliptin (a DPP-4 inhibitor), in one film‑coated tablet to help improve blood sugar control as an adjunct to diet and exercise. This fixed-dose combination is intended for patients in whom treatment with both empagliflozin and linagliptin is appropriate, helping to reduce fasting and post‑prandial blood glucose while offering the convenience of once‑daily dosing.

Indications:

• 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.
• Helps lower elevated fasting and post‑meal blood glucose levels in type 2 diabetes.
• May be used in patients insufficiently controlled on either empagliflozin alone, linagliptin alone, or other antidiabetic agents, when a combination of SGLT2 inhibitor and DPP‑4 inhibitor is considered suitable by the treating physician.
• Part of long‑term diabetes management to help reduce the risk of diabetes‑related complications when combined with lifestyle modification and other medications as prescribed.

Active Ingredients / Key Components:

• Empagliflozin – 25 mg per tablet (sodium-glucose co‑transporter 2 (SGLT2) inhibitor).
• Linagliptin – 5 mg per tablet (dipeptidyl peptidase‑4 (DPP‑4) inhibitor).
• Inactive ingredients (excipients): Full excipient list and concentrations , please check the product leaflet or the manufacturer’s official website; refer to the official package leaflet for complete details.

Dosage & Administration / How to Use:

• Usual starting dose (for this combination therapy class): 10 mg/5 mg orally once daily in the morning, with or without food, as directed by the physician.
• Based on glycemic response and tolerability, the dose may be increased to 25 mg/5 mg once daily. GLYXAMBI 25/5 mg tablets correspond to this higher strength.
• Take the tablet whole with a glass of water; do not crush, chew, or split unless advised by your healthcare provider.
• Take at the same time each day to maintain consistent blood levels and better 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.
• Use only under medical supervision. Dosage adjustments may be required in patients with renal impairment, elderly patients, or those on concomitant medications; follow your doctor’s instructions.

Clinical Benefits:

• Improves overall glycemic control in adults with type 2 diabetes when diet and exercise alone are insufficient.
• Combines two complementary mechanisms: empagliflozin promotes urinary glucose excretion, while linagliptin enhances incretin activity to increase insulin release and decrease glucagon secretion in a glucose‑dependent manner.
• Helps reduce both fasting plasma glucose and post‑prandial (after‑meal) blood sugar levels.
• Once‑daily fixed‑dose combination simplifies treatment regimen and may improve adherence compared with taking two separate tablets.
• Empagliflozin component may contribute to modest weight reduction and blood pressure lowering in some patients, as observed with SGLT2 inhibitors (individual results vary).
• Supports long‑term diabetes management as part of a comprehensive plan including diet, physical activity, and regular blood glucose monitoring.

Warnings & Contraindications:

• For adults with type 2 diabetes only; not indicated for type 1 diabetes or for the treatment of diabetic ketoacidosis.
• Contraindicated in patients with known hypersensitivity to empagliflozin, linagliptin, or any of the excipients.
• Use with caution in patients with renal impairment, volume depletion, hypotension, or those on diuretics, as SGLT2 inhibitors may increase the risk of dehydration and low blood pressure.
• Risk of ketoacidosis (including euglycemic diabetic ketoacidosis) has been reported with SGLT2 inhibitors; seek medical attention if you experience nausea, vomiting, abdominal pain, excessive thirst, difficulty breathing, confusion, or unusual fatigue.
• May increase risk of genital mycotic infections and urinary tract infections; maintain good personal hygiene and report symptoms such as burning, pain, unusual discharge, or fever.
• Use with caution in patients with a history of pancreatitis; DPP‑4 inhibitors have been associated rarely with pancreatitis. Report severe, persistent abdominal pain with or without vomiting.
• Monitor renal function periodically, especially in elderly patients or those with pre‑existing kidney disease.
• Consult your doctor before use if pregnant, planning pregnancy, or breastfeeding. Adequate data in pregnancy and lactation are limited; alternative treatments may be preferred.
• Inform your doctor about all medications you are taking, including insulin or sulfonylureas, as combination therapy may increase the risk of hypoglycemia and may require dose adjustment.
• Not intended to diagnose, treat, cure, or prevent any disease without proper medical supervision; it is a prescription medicine that must be used according to a doctor’s directions.
• Keep out of reach of children.

Side Effects:

• Common side effects may include increased urination, thirst, genital fungal infections (such as vulvovaginal candidiasis or balanitis), urinary tract infections, nasal congestion, cough, or mild gastrointestinal discomfort.
• Hypoglycemia (low blood sugar) is more likely when GLYXAMBI is used together with insulin or insulin secretagogues (e.g., sulfonylureas); symptoms include sweating, shakiness, dizziness, hunger, palpitations, or confusion.
• Less common but serious side effects may include ketoacidosis, severe urinary tract infections (e.g., pyelonephritis, urosepsis), dehydration, hypotension, acute kidney injury, or pancreatitis.
• Allergic reactions, including rash, itching, hives, or swelling of the face, lips, tongue, or throat, can occur; discontinue and seek immediate medical attention if signs of hypersensitivity appear.
• If you experience severe or persistent side effects, signs of infection, severe abdominal pain, difficulty breathing, or any unusual symptoms, contact your doctor or seek emergency medical care promptly.

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 tablet.
• Pack size: 30 film‑coated tablets per pack (30 f.c. tabs).
• Route of administration: Oral.

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.