Empacoza 10 mg 30 tablets

Empacoza Empagliflozin 10 mg 30 Film coated tablets

Composition:

Empagliflozin 10 mg 30 Film coated tablets

Description:

Empacoza is indicated :

-to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.

-to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Indications:

Type 2 Diabetes Mellitus

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease

Indicated to reduce the risk of cardiovascular death plus hospitalization in adults with heart failure (HF).

Limitations of Use:

- Empacoza is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.

Precautions:

- Empacoza is Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73m.

Empacoza is likely to be ineffective in this setting based upon its mechanism of action.

Dosage and Administration:

Prior to Initiation of Empacoza

Assess renal function before initiating Empacoza and as clinically indicated

Recommended Dosage:

The recommended dose of Empacoza is 10 mg once daily in the morning, taken with or without food.

For additional glycemic control, the dose may be increased to 25 mg in patients tolerating Empacoza.

Contraindication:

Empacoza is contraindicated in patients on dialysis

Hypersensitivity to empaglinozin or any of the excipients in Empacoza, reactions such as angioedema have occurred.

Anaphylaxis to tablets or any of their components.

Acute nephropathy.

Caution and consult a doctor before use in cases of:

Impaired liver or kidney function.

Urinary tract infection.

Diseases of the pancreas.

Alcoholism.

Retention or difficulty urinating.

Heart failure.

Side Effects:

Taking Impacoza may cause some unwanted symptoms, including:

Fungal infections of the genitals.

Frequency of urination.

Joint pain.

Low blood sugar level.

Nausea or vomiting.

Stomach pain.

Dizziness or drowsiness.

Discontinue use of Empacoza and consult a physician as soon as possible if any severe or unknown side effects occur, or if signs of allergy to any of its components including swelling of the face or tongue, difficulty breathing and severe skin itching.

Storage:

Store at a temperature not exceeding 30 °C in a dry place.

Package:

A Carton Box containing 3 blisters of 10 tablets each.