Tuerizin Film-Coated Tablets

• TUERIZIN is used to treat type 2 diabetes in adult patients to improve blood sugar (glucose) control together with diet and exercise.

• TUERIZIN can also be used with other medicines for the treatment of diabetes. These may be medicines taken by mouth or given by injection, such as insulin.

• TUERIZIN is also used in adults with type 2 diabetes if you have an increased cardiovascular risk (health problems due to your heart and blood vessels), to lower the risk of dying from a heart attack or other events related to your heart or blood vessels, or to reduce the risk of being admitted to hospital for heart failure. It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.

Do not take TUERIZIN:

• • if you are allergic to empagliflozin or any of the other ingredients of TUERIZIN (listed in section 6)
• • if you have type I diabetes (high sugar levels in your blood)
• • If you have increased levels of ketone bodies in your urine of blood (see Take special care with TUERIZIN)
• • if you have severe kidney problems, or have kidney failure and are on kidney dialysis
• • if you are pregnant or are breastfeeding your baby.

Warnings and precautions

Take special care with TUERIZIN

Talk to your doctor, pharmacist or nurse before taking TUERIZIN, and during treatment with TUERIZIN 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 your doctor or the nearest hospital immediately. These symptoms could be a sign of diabetic ketoacidosis – a rare, but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of ketone bodies in your urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness, or if you have or have had problems with your pancreas including pancreatitis or surgery on your pancreas. Ketoacidosis is a serious problem which is life-threatening and needs to be treated in a hospital. It has been reported in people taking TUERIZIN, regardless of blood sugar level. Stop taking TUERIZIN and contact your doctor or the nearest hospital immediately.
• • are taking or using any other medicines to lower your blood sugar, including other diabetic medicine known as a sulphonylurea, or if you are injecting insulin. Your doctor may want to reduce the dose of the sulphonylurea or insulin when you take it in combination with TUERIZIN in order to avoid low blood sugar (hypoglycaemia). Please refer to possible signs of low blood sugar listed in section 4.
• • have serious kidney problems – your doctor may prescribe you a different medicine. Your kidney function should be assessed before you start taking TUERIZIN, at least 6 monthly during treatment, and if you are taking TUERIZIN together with metformin (another medicine used to control your blood sugar).
• • have liver problems.
• • are 75 years old or older, or have problems with low blood pressure or if you are taking medicine to treat high blood pressure and/or diuretics (medicine used to remove water from the body also known as “water tablets”) as increased passing of urine due to the medicine may affect the fluid balance in your body and increase your risk of dehydration.
• • are sick or if you have diarrhoea or fever or if you are not able to eat or drink. These can cause dehydration (excessive loss of body fluid). To prevent the excessive loss of body fluid, your doctor may ask you to stop taking TUERIZIN until you have recovered.
• • are 85 years old or older as you should not start taking TUERIZIN
• • have a history of urinary tract infections or have a serious infection of the kidneys or urine. Your doctor may ask you to stop taking TUERIZIN until you have recovered.

Talk to your doctor immediately if you develop a combination of symptoms of pain, tenderness, redness or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell. These symptoms could be a sign of a rare but serious or even life-threatening infection, called necrotising fasciitis of the perineum or Fournier’s gangrene which destroys the tissue under the skin. Fournier’s gangrene has to be treated immediately.

Do not share medicines prescribed for you with any other medicine. Always take TUERIZIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The usual dose of TUERIZIN is one 10 mg film-coated tablet once a day. Your doctor will decide whether to increase your dose to 25 mg once a day.

• Your doctor will prescribe the strength that is right for you. Do not change your dose unless your doctor has told you to.

If you take more TUERIZIN than you should

In the event of overdosage, consult your doctor of pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take TUERIZIN

If you forget to take a dose of TUERIZIN, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. Never take two doses on the same day.

If you stop taking TUERIZIN

Do not stop taking TUERIZIN without first consulting your doctor. Your blood sugar levels may increase when you stop taking TUERIZIN. If you have any further questions on the use of TUERIZIN, ask your doctor, pharmacist or nurse.

TUERIZIN can have side effects. Not all side effects reported for TUERIZIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TUERIZIN, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop taking TUERIZIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• • swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• • rash or itching
• • fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to TUERIZIN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• • increased levels of ketone bodies in your urine or blood
• • 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.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequently occurring:

• • genital yeast infection (thrush)
• • low blood sugar (hypoglycaemia) with the following symptoms:
  • - shaking, sweating, feeling very anxious or confused, fast heartbeat
  • - excessive hunger, headache
• • urinary tract infection with the following symptoms:
  • - burning sensation when passing urine
  • - urine that appears cloudy
  • - pain in the pelvis, or mid-back pain (when kidneys are infected)
• • sugar (glucose) in the urine
• • an urge to pass urine or more frequent urination may be due to the way TUERIZIN works, but they can also be signs of urinary tract infection. If you note an increase in such symptoms, you should contact your doctor
• • thirst
• • increased blood fats (lipids)
• • blood tests may show an increase in cholesterol levels in your blood.

Less frequently occurring:

• • dehydration, including the following signs:
  • - unusual thirst
  • - light-headedness or dizziness upon standing (low blood pressure)
  • - fainting or loss of consciousness
• • hives
• • straining or pain when emptying the bladder
• • ‘ketones’ in the urine
• • blood tests may show a decrease in kidney function (creatinine or urea)
• • blood tests may show increases in the amount of red blood cells in your blood (haematocrit).

Frequency unknown:

• • necrotising fasciitis of the perineum or Fournier’s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of TUERIZIN.

• Store at or below 25 °C. Protect from moisture.

• Keep blister strip in outer carton until required for use.

• Keep bottle tightly closed.

• STORE ALL MEDICINE OUT OF REACH OF CHILDREN.