Dapagliflozin 5 mg Film-Coated Tablets

Dapagliflozin Adco contains the active substance dapagliflozin. It belongs to a group of medicines called “sodium glucose co-transporter-2 (SGLT2) inhibitors”. They work by blocking the SGLT2 protein in your kidney. By blocking this protein, blood sugar (glucose), salt (sodium) and water are removed from your body via the urine.

What Dapagliflozin Adco is used for

Dapagliflozin Adco is used in adult patients aged 18 years and older to treat:

• Type 2 diabetes
  • together with diet and exercise.
  • Dapagliflozin Adco can be used together with other medicines to treat diabetes.
  • It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.
  • Dapagliflozin Adco can be used to reduce the risk of developing new or worsening existing heart failure if you already have established disease of the heart and blood vessels.
• Heart failure
  • in patients with symptoms due to a weak pump function of the heart.

Do not take Dapagliflozin Adco:

• if you are hypersensitive (allergic) to dapagliflozin or any of the other ingredients of Dapagliflozin Adco (listed in section 6).
• you have type 1 diabetes - the type that usually starts when you are young, and your body does not produce any insulin.
• you are pregnant.
• you are breastfeeding your baby.

Warnings and precautions

Contact a doctor or go to the nearest hospital straight away, if any of the following occurs:

1. Diabetic ketoacidosis:
   • If you develop symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness, you may have a condition called ketoacidosis.
   • This is a 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, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
2. Necrotising fasciitis of the perineum
   • This is a serious bacterial infection that destroys tissue under the skin. The condition spreads quickly. Symptoms include blisters, fever, fatigue, swelling, tenderness and pain worse than a person would expect based on the wound's appearance. This is a serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment.

Talk to your doctor, pharmacist or nurse before taking Dapagliflozin Adco:

• If your blood pressure is lower than normal
• if you have a liver problem.
• If you are on high blood pressure medication, have a history of low blood pressure, or are an elderly patient
• 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 Dapagliflozin Adco until you recover to prevent dehydration.
• if you often get infections of the urinary tract.
• elderly patients

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Dapagliflozin Adco.

Kidney function

Your doctor will determine your kidney function prior to treatment and will monitor it on an ongoing basis.

Diabetes and foot care

If you have diabetes, it is important to check your feet regularly and adhere to any other advice regarding foot care given by your healthcare professional.

Urine glucose

Because of how Dapagliflozin Adco works, your urine will test positive for sugar while you are on this medicine.

Children and adolescents

Dapagliflozin Adco is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.

Do not share medicines prescribed for you with any other person.

Always take Dapagliflozin Adco exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you are taking Dapagliflozin Adco for type 2 diabetes or for heart failure:

The recommended dose of Dapagliflozin Adco is 10 mg once daily. Your doctor will prescribe the strength that is right for you.

Taking Dapagliflozin Adco

Swallow the tablet whole with half a glass of 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 Dapagliflozin Adco together with other medicine(s) to lower the amount of sugar in your blood. Remember to take these other medicine(s) as your doctor has told you. This will help get the best results for your health.

Diet and exercise can help your body use its blood sugar better. It is important to stay on any diet and exercise program recommended by your doctor while taking Dapagliflozin Adco.

Your doctor will tell you how long your treatment with Dapagliflozin Adco will last. If you have the impression that the effect of Dapagliflozin Adco is too strong or too weak, tell your doctor or pharmacist.

If you take more Dapagliflozin Adco than you should

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

If you forget to take Dapagliflozin Adco

• Do not take a double dose to make up for forgotten individual doses.

If you stop taking Dapagliflozin Adco

Do not stop taking Dapagliflozin Adco without talking to your doctor first. Your blood sugar may increase without Dapagliflozin Adco.

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

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

These are signs of angioedema - swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing, - hives, rash or itching, - fainting.

These are the signs of diabetic ketoacidosis - nausea, vomiting, extreme weight loss, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness. This may occur regardless of blood sugar level. Your doctor may decide to temporarily or permanently stop your treatment with Dapagliflozin Adco.

• necrotising fasciitis of the perineum or Fournier’s gangrene This is a serious soft tissue infection of the genitals or the area between the genitals and the anus. These are all very serious side effects. If you have them, you may have had a serious reaction to Dapagliflozin Adco. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)
• urinary tract infections (UTI) characterised by back pain, strong, persistent urge to urinate, burning sensation when urinating, blood in the urine.
• low blood sugar ( confusion, heart palpitations, shakiness and anxiety are symptoms)
• dizziness
• rash
• excessive urination
• Positive test for glucose in the urine
• 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

Less frequent side - effects:

• Fungal infection, you may experience a red, itchy rash
• loss of too much fluid from your body (dehydration, signs may include very dry or sticky mouth, passing little or no water (urine) or fast heartbeat)
• thirst
• constipation
• dry mouth
• awakening from sleep at night to pass urine
• itchy genitals
• increases in creatinine (shown in laboratory blood tests) in the beginning of treatment
• increases in urea (shown in laboratory blood tests)

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 to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of Dapagliflozin Adco.

Store all medicines out of reach of children.

Store at or below 25 °C.

Store in the original packaging until required for use, in order to protect from light.

Do not use after the expiry date stated on the label, carton and bottle.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).