Empozin-M Tablets 12.5/500mg Tablets

Empagliflozin and metformin are combined in one tablet to treat type 2 diabetes in adults and children aged 10 and over, together with diet and exercise.

• Empagliflozin (an SGLT2 inhibitor) makes the kidneys remove extra sugar in the urine.
• Metformin mainly reduces the amount of sugar the liver makes.

Because they work in different ways, they are combined when metformin alone, or with other diabetes medicines, does not control blood sugar well enough. The tablet can also replace taking the two medicines separately. Empagliflozin can also help protect the heart.

Take it exactly as your doctor or pharmacist tells you.

• Swallow the tablet whole with water.
• Take it with meals to lower the chance of an upset stomach.
• Do not also take separate empagliflozin or metformin tablets.
• If you miss a dose, take it when you remember. If it is nearly time for the next dose, skip the missed one. Never take a double dose.
• Do not stop taking it without talking to your doctor, as your blood sugar may rise.
• Keep to your diet and exercise plan and check your feet regularly.

Common side effects include:

• feeling or being sick, diarrhoea, stomach ache or loss of appetite
• genital thrush, and passing more urine than usual
• urine infection (burning when passing urine, cloudy urine)
• thirst, itching, rash, constipation or taste changes
• low blood sugar (shaking, sweating, hunger, fast heartbeat) if used with insulin or a sulfonylurea

Stop taking it and get medical help straight away if you have:

• signs of lactic acidosis: vomiting, stomach ache, muscle cramps, severe tiredness, difficulty breathing, feeling cold
• signs of ketoacidosis: fast deep breathing, confusion, unusual sleepiness, sweet-smelling breath, rapid weight loss, feeling sick (this can happen even with normal sugar levels)
• pain, redness or swelling of the genitals or the area behind them with fever (Fournier's gangrene)
• swelling of the face, lips, tongue or throat

Do not take it, and tell your doctor, if you have serious kidney or liver problems, type 1 diabetes, a severe infection, dehydration, or recent heart attack or severe heart or breathing problems, or if you drink a lot of alcohol.

Check with your doctor or pharmacist before taking it if you:

• are 75 or older, or take water tablets (diuretics) or blood pressure medicines
• take insulin or a sulfonylurea, steroids, painkillers like ibuprofen, or lithium
• are due to have major surgery or an X-ray or scan with iodine contrast dye (you may need to stop it for a while)
• have a mitochondrial disease

Your doctor will check your kidney function at least once a year.

No special storage conditions are needed. Keep out of the sight and reach of children.

Sick days: stop taking it for a short time and talk to your doctor if you are being sick, have diarrhoea or fever, are very hot, or cannot eat or drink normally, as you may become dehydrated.

Alcohol: avoid drinking a lot of alcohol, as it raises the risk of lactic acidosis.

Pregnancy and breastfeeding: do not take it if you are pregnant or breastfeeding.

Driving: do not drive if you feel dizzy or have signs of low blood sugar.

Your urine will test positive for sugar while you take it.