Glyxambi 10 mg/5 mg 30 tablets

Glyxambi 10 mg/5 mg 30 tablets

Composition:
Each tablet contains:
- Empagliflozin - 10 mg
- Linagliptin - 5 mg
Excipients:
Lactose monohydrate, corn starch, crospovidone, povidone, magnesium stearate, hypromellose, titanium dioxide, etc.
Description:
Glyxambi is a fixed-dose oral combination of empagliflozin (SGLT2 inhibitor) and linagliptin (DPP-4 inhibitor) used to improve glycemic control in adults with type 2 diabetes.
Empagliflozin increases urinary glucose excretion, while linagliptin enhances incretin activity, promotes insulin secretion, and reduces hepatic glucose production.
The medication also reduces cardiovascular mortality in adults with type 2 diabetes and established cardiovascular disease.
Indications for Use:
- Type 2 diabetes mellitus in adults when diet and exercise alone are insufficient.
- Reduction of cardiovascular mortality in adults with type 2 diabetes and established cardiovascular disease (empagliflozin-related benefit).
Not indicated for type 1 diabetes.
Dosage and Method of Administration:
- Recommended dose: 1 tablet (10 mg/5 mg) once daily, in the morning, with or without food.
- Swallow tablets whole.
- Do not discontinue therapy without consulting a healthcare provider.
Contraindications:
- Dialysis.
- Hypersensitivity to empagliflozin, linagliptin or excipients.
- Severe renal impairment (lack of efficacy).
- Type 1 diabetes or diabetic ketoacidosis.
Precautions:
Inform your healthcare provider if you have:
- Pancreatitis or pancreatic surgery;
- Frequent urinary infections;
- Genital infections;
- Dehydration, vomiting, diarrhea;
- Low-carbohydrate or ketogenic diet;
- Alcohol abuse;
- Renal or hepatic impairment;
- Heart failure;
- Upcoming surgery (treatment may need to be paused).
Side Effects:
Very Common:
- Elevated triglyceride levels
- Increased total cholesterol (including LDL cholesterol)
- Decreased hemoglobin
- Decreased HDL cholesterol
- Dizziness
- Somnolence
- Dry mouth
- Headache
- Extrapyramidal symptoms.
Common:
- Vomiting
- Urinary tract infections
- Upper respiratory tract infections
- Hypoglycemia (when used with insulin or sulfonylureas)
- Increased red blood cell count
- Dyspepsia
- Constipation
Seek immediate help if:
- Severe abdominal pain;
- Nausea/vomiting;
- Fruity breath odor, difficulty breathing;
- Swelling of face or throat;
- Redness or swelling in the genital/perineal area.
Pregnancy and Breastfeeding:
- Not recommended during pregnancy.
- Breastfeeding should be discontinued during treatment.
Storage Conditions:
Store below 30°C.
Protect from moisture and light.
Keep out of reach of children.
Packaging:
Carton containing 30 film-coated tablets.