Avaxiga 5 mg/10 mg Film-Coated Tablets

AVAXIGA contains the active substance dapagliflozin. It belongs to a group of medicines called "oral anti-diabetics". These are medicines taken by mouth for diabetes. AVAXIGA is used if your type 2 diabetes cannot be controlled with different medicines for diabetes, diet and exercise. Your doctor may ask you to take AVAXIGA alone or with other diabetes medicines. AVAXIGA increases the amount of sugar excreted by your kidneys. AVAXIGA is not recommended for children and young people under 18 years. It is important to keep following the advice about diet and exercise given to you by your doctor, nurse or pharmacist.

Do not take AVAXIGA:

• if you are allergic (hypersensitive) to dapagliflozin or any of the other ingredients of AVAXIGA (listed in section 6).
• if you have moderate or severe kidney disease or you are on dialysis.
• if you have type 1 diabetes - the type that usually starts when you are young, and your body does not produce any insulin.
• if you are pregnant (see Pregnancy and Breastfeeding).
• if you are breast-feeding (see Pregnancy and Breastfeeding).

Warnings and precautions

Take special care with AVAXIGA:

• If you have diabetes and experience 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 or rapid weight loss. The above 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.
• When you are treated with AVAXIGA, diabetic ketoacidosis can occur even if your blood sugar is normal.
• 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.
• if you have a liver problem
• if you are on medicines to lower your blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension). See ‘Other medicines and AVAXIGA’.
• if you have very high levels of sugar in your blood which may make you dehydrated (lose too much body fluid). Tell your doctor before you start taking AVAXIGA if you have any of these signs.
• if you have or develop nausea (feeling sick), vomiting 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 AVAXIGA until you recover to prevent dehydration.
• if you often get infections of the urinary tract. Do not stop taking this medicine without speaking to your doctor.

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

• The usual dose is: one 10 mg tablet each day.
• Your doctor will prescribe the strength that is right for you.
• Your doctor will tell you how long your treatment with AVAXIGA will last.
• Do not stop treatment early.
• If you have the impression that the effect of AVAXIGA is too strong or too weak for you, tell your doctor or pharmacist.
• Swallow the tablet whole with some water.
• You can take your tablet with or without food.
• You can take the tablet at any time of the day. However, try to take it at the same time each day. This will help you to remember to take it.
• Your doctor may prescribe AVAXIGA together with other medicines to lower the amount of sugar in your blood.

Use in children:

AVAXIGA is not recommended for children or young people under 18 years old.

Diet and exercise:

To control your diabetes, you still need to diet and exercise, even when you are taking this medicine. So, it is important to keep following the advice about diet and exercise from your health care professional. In particular, if you are following a diabetic weight control diet, keep on with this while you are taking AVAXIGA.

If you take more AVAXIGA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take a dose of AVAXIGA: Try to take AVAXIGA as prescribed by your healthcare professional. However, if you miss a dose, take your missed dose as soon as you remember, if within a few hours after missing a dose. If it is nearly time for your next dose, skip the missed dose. Then take your next dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking AVAXIGA: Do not stop taking AVAXIGA without talking to your doctor first. If you have the impression that the effect of AVAXIGA is too strong or too weak, talk to your doctor or pharmacist.

AVAXIGA can have side effects. Not all side - effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

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

• If you have a hypersensitivity (allergic) reaction
• 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 very serious side effects. If you have them, you may have had a serious reaction to AVAXIGA. 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:

• Angioedema These are signs of angioedema:
• swelling of the face, tongue, or throat
• difficulties swallowing
• hives and breathing problems
• Diabetic ketoacidosis These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions):
• increased levels of “ketone bodies” in your urine or blood
• 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.
• rapid weight loss.
• 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, seen very rarely.
• urinary tract infection These are signs of a severe infection of the urinary tract:
• fever and/or chills
• burning sensation when passing water (urinating)
• pain in your back or side

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

Tell your doctor if you notice any of the following:

• Frequent:
• low blood sugar levels (hypoglycaemia) These are the signs of low blood sugar:
• shaking, sweating, feeling very anxious, fast heartbeat
• feeling hungry, headache, change in vision.
• a change in your mood or feeling confused.
• genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)
• back pain
• passing more water (urine) than usual or needing to pass water more often
• changes in the amount of cholesterol or fats in your blood (shown in tests)
• increases in the amount of red blood cells in your blood (shown in tests)
• decreases in creatinine renal clearance (shown in tests) in the beginning of treatment.
• dizziness
• rash

• loss of too much fluid from your body (dehydration, signs may include very dry or sticky mouth, passing little or no urine or fast heartbeat)
• thirst
• constipation
• awakening from sleep at night to pass urine.
• dry mouth
• weight decreased.
• increases in creatinine (shown in laboratory blood tests) in the beginning of treatment.
• increases in urea (shown in laboratory blood tests)
• excessive sweating

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

STORE ALL MEDICINE OUT OF REACH OF CHILDREN

Store AVAXIGA at or below 30 °C in an outer carton. Protect from light and moisture. Do not use this medicine after the expiry date shown on the pack. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or the sewerage system (e.g. toilets).