COMPOSITION

Each film-coated tablet contains:

• Empagliflozin 10 mg
• Empagliflozin 25 mg

DESCRIPTION

Empazin (Empagliflozin) is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors. SGLT2 is located in the proximal renal tubules and is responsible for the reabsorption of filtered glucose from the tubular lumen. Through SGLT2 inhibition, Empazin reduces renal absorption of glucose and sodium and increases urinary excretion of glucose, so the blood glucose levels will be reduced and thus used to treat type 2 diabetes.

INDICATIONS

Empazin is used to:

• Treat type 2 diabetes in adult patients (aged 18 years and older) that cannot be controlled by diet and exercise alone.
• Reduce risk of cardiovascular death and hospitalization due to heart failure in adult patients with type 2 diabetes and established cardiovascular disease.

DOSAGE & ADMINISTRATION

• The starting dose of Empazin is 10 mg once daily in the morning with or without food, may be increased to 25 mg as needed.
• Assessment of renal function is recommended prior to initiation of Empazin and periodically thereafter.

Treatment of patients with type 2 diabetes:

• Empazin should not be initiated in patients with an eGFR less than 30 mL/min/1.73 m².
• No dose adjustment is needed in patients with an eGFR greater than or equal to 30 mL/min/1.73 m².

Treatment of heart failure (with or without diabetes mellitus):

• In patients with an eGFR greater than or equal to 20 mL/min/1.73 m², no dose adjustment is needed.
• In patients with an eGFR less than or equal to 20 mL/min/1.73 m², Empazin should not be recommended.
• Empazin should not be used in patients with end stage of renal disease or patients on dialysis.
• No dose adjustment required for patients with hepatic impairment.

RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to Empagliflozin.

Precautions

If you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away. These symptoms could be a sign of diabetic ketoacidosis: a rare, but serious, sometimes life-threatening problem.

• Empazin can cause some people to become dehydrated and may cause patient to feel dizzy, faint or weak, especially when standing up. There have been reports of sudden worsening of kidney function.
• Empazin should not be taken to treat type 1 diabetes.
• The caution should be taken in patients with serious liver problems, have kidney problems, 75 years of age or older.
• Kidneys should be checked before you start taking and whilst using this medicine.
• Because of how this medicine works, urine will test positive for sugar while you are taking this medicine.
• If patient has a serious infection of the kidney or the urinary tract with fever, stop taking Empazin until patient have recovered.
• If you are 85 years old or older, you should not start taking Empazin.
• If you are being sick, have diarrhoea or fever, or if you are not able to eat or drink. These conditions can cause dehydration. Your doctor may ask you to stop taking Empazin until you recover to prevent loss of too much body fluid.
• Like for all diabetic patients, it is important to check your feet regularly and adhere to any other advice regarding foot care given by your health care professional.

Effect on the ability of driving vehicles and use machines

Empazin has minor influence on the ability to drive and use machines. Especially if taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low. Do not drive or use any tools or machines, if patient feel dizzy while taking Empazin.

Use in pregnancy and lactation

Empazin should not be used during the second and third trimesters of pregnancy or during lactation.

DRUG INTERACTIONS

The caution should be taken when coadministration of Empazin with the following drugs:

• Diuretics: resulted in increased urine volume.
• Insulin or insulin secretagogues: increases the risk for hypoglycemia.

ADVERSE EFFECTS

• Rare side effects: diabetic ketoacidosis (rapid weight loss, feel sick, stomach pain, excessive thirst, fast and deep breathing, confusion).
• Common side effects: Low blood sugar, genital yeast infection (thrush), thirst, passing more urine than usual or needing to pass urine more often, itching, rash or red skin, blood tests may show an increase in blood fat (cholesterol), constipation, urinary tract infection.
• Very common side effects: low blood sugar.
• Uncommon side effects: Hives, straining or pain when emptying the bladder.

STORAGE INSTRUCTIONS

Store below 30°C, in a dry place.

PRESENTATIONS

Empazin 10, 25 mg tablets: pack of different sizes.

012.06-217 [68/23] | Mid. By. | Primary / Secondary