Dapagliflozin Film-Coated Tablets

DAPAGLIFLOZIN SANDOZ contains the active substance dapagliflozin. It belongs to a group of medicines called “oral anti-diabetics”. These are medicines taken by mouth for diabetes.

• DAPAGLIFLOZIN SANDOZ 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 DAPAGLIFLOZIN SANDOZ alone or with another diabetes medicines.
• DAPAGLIFLOZIN SANDOZ is also used for prevention and treatment of heart failure (when the heart does not pump enough blood that the body needs).
• DAPAGLIFLOZIN SANDOZ 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 DAPAGLIFLOZIN SANDOZ:

• if you are allergic (hypersensitive) to dapagliflozin or any of the other ingredients of DAPAGLIFLOZIN SANDOZ (listed in “What DAPAGLIFLOZIN SANDOZ contains”). If you are not sure, talk to your doctor or pharmacist before taking this medicine.
• 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 or plan to become pregnant. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
• if you are breast-feeding. Talk to your doctor if you would like to breast-feed your baby.
• If you have a history of problems with your pancreas or had surgery on your pancreas.

Warnings and precautions

Take special care with DAPAGLIFLOZIN SANDOZ:

• if you are going to have surgery.
• if you are eating less due to illness or surgery, or you are dieting.
• if you have or have had problems with your pancreas.
• if you drink large amounts of alcohol, either every day or only from time to time.
• if you develop any of the following symptoms, which may be signs of ketoacidosis: nausea, vomiting, stomach-area(abdominal) pain, difficulty breathing, increased levels of “ketone bodies” in your urine or blood, excessive thirst, confusion and tiredness. If this happens to you contact a doctor or the nearest hospital immediately.
• if you have mild kidney disease your doctor will want to monitor your kidney function on an ongoing basis.
• If you have liver problems.
• If your blood sugar levels are very high, as this may cause your body to dehydrate (lose too much water and salts).
• if you often get infections of the urinary tract.
• if you are allergic to any other medicine used to lower the amount of sugar in your blood.

Tell your doctor or pharmacist immediately if you develop a combination of pain, tenderness, redness or swelling in your genital area or the area between the genitals and anus, with fever or a general unwell feeling. These symptoms could be a sign of a rare but serious infection called necrotising fasciitis of the perineum, or Fournier’s gangrene.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking DAPAGLIFLOZIN SANDOZ.

Do not share medicines prescribed for you with any other person. Always take DAPAGLIFLOZIN SANDOZ 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 DAPAGLIFLOZIN SANDOZ will last.
• Your doctor may prescribe you DAPAGLIFLOZIN SANDOZ together with other medicines to lower your blood sugar levels.
• Your doctor will tell you how long your treatment with DAPAGLIFLOZIN SANDOZ will last.
• Do not stop treatment early.
• If you have the impression that the effect of DAPAGLIFLOZIN SANDOZ 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.

If you take more DAPAGLIFLOZIN SANDOZ than you should

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

If you forget to take DAPAGLIFLOZIN SANDOZ

Take your missed dose as soon as you remember, if within a few hours after missing a dose. However, 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 DAPAGLIFLOZIN SANDOZ

Do not stop taking DAPAGLIFLOZIN SANDOZ without talking to your doctor first. If you have any further questions on the use of DAPAGLIFLOZIN SANDOZ, ask your doctor or pharmacist.

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

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

• swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing
• rash
• diabetic ketoacidosis (diabetic coma) (causing nausea (feeling sick), vomiting (being sick), pain in the stomach area, tiredness, thirst, passing of large volumes of urine, shortness of breath and confusion)
• necrotising fasciitis of the perineum (causing pain, tenderness, redness and swelling of the genital area or area between the genitals and anus, along with fever and a general unwell feeling)

These are all very serious side effects. If you have them, you may have had a serious reaction to DAPAGLIFLOZIN SANDOZ. 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:

• Very dry or sticky mouth, feeling very thirsty
• Feeling very sleepy or tired
• Passing little or no water (urine)
• Fast heartbeat

These are signs of losing too much fluid from body (volume depletion or dehydration)

Fever or chills

Burning sensation when passing water (urinating)

Pain in your back or side

Blood in your urine

These are signs of a severe infection of the urinary tract.

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

Tell your doctor if you notice any of the following:

• Frequent side effects:
• urinary tract infection (causing fever and/or chills, a burning sensation while urinating, an urge to frequently urinate, pain in your back or side and sometimes blood in your urine)
• low blood sugar levels, especially when taking DAPAGLIFLOZIN SANDOZ with insulin or a sulphonylurea (causing shaking, sweating, fast heartbeat, headache, changes in vision, a change in your mood and confusion)
• changes in test results when testing the amount of red blood cells in your blood
• changes in test results when testing the amount of cholesterol (fat) in your blood
• changes in test results when testing your kidney function,
• genital infections, including vaginal and penile thrush (causing irritation and itching in the area, discomfort while urinating and an increased amount of discharge) and inflammation of the penis glans (head) (causing tightness and redness of the skin, itching, irritation, an unpleasant smell and painful urination)
• high glucose (sugar) levels in the urine when tested
• painful or difficult urination, urinating more or more frequently than usual
• infection of the bladder
• dizziness
• rash
• back pain

Less frequent side effects:

• changes in test results when testing your blood creatinine or urea levels
• decreased blood pressure
• urinating more frequently during the night
• genital itching
• thirst or a dry mouth
• constipation
• excessive sweating
• decreased weight
• tight foreskin which may cause difficulty urinating or inflammation of glans or foreskin (phimosis)

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 SANDOZ.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not store above 25 °C.
• Do not use after the expiry date stated on the carton / blister.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).