Tapleo Tablets

TAPLEO 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.

• TAPLEO is used if your type 2 diabetes cannot be controlled, diet and exercise. Your doctor may ask you to take TAPLEO alone or with another diabetes medicine. It is important to keep following the advice about diet and exercise given to you by your doctor, nurse or pharmacist.
• TAPLEO is used for prevention and treatment of heart failure (when the heart does not pump enough blood that the body needs).
• TAPLEO is also used in patients with chronic kidney disease (reduced kidney function).
• TAPLEO is not recommended for children and young people under 18 years.

Do not take TAPLEO:

• if you are allergic (hypersensitive) to dapagliflozin or any of the other ingredients of TAPLEO (listed in “What TAPLEO contains”). If you are not sure, talk to your doctor or pharmacist before taking this medicine.
• 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.
• if you have a history of inflammation of the pancreas or pancreatic surgery.

Warnings and precautions:

Take special care with TAPLEO:

• 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, tiredness, difficulty breathing, increased levels of “ketone bodies” in your urine or blood. 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 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. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking TAPLEO.

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

How much to take:

• 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 TAPLEO will last.
• Do not stop treatment early.
• If you have the impression that the effect of TAPLEO is too strong or too weak for you, tell your doctor or pharmacist.

Taking this medicine:

• 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 TAPLEO together with other medicines to lower the amount of sugar in your blood.

Use in children:

TAPLEO 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 TAPLEO.

If you take more TAPLEO 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 TAPLEO:

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 TAPLEO:

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

Diabetic ketoacidosis (diabetic coma) and similar side effects may occur. Symptoms are nausea, vomiting, abdominal pain, fatigue, thirst, passing of large volumes of urine, shortness of breath and mental confusion. Urgent medical attention is required. TAPLEO can have side effects. Not all side effects reported for TAPLEO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TAPLEO, please consult your health care provider for advice. If you have a hypersensitivity (allergic) reaction, stop taking TAPLEO and tell your doctor immediately or go to the casualty department at your nearest hospital. 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 heart beat

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

• fever or chills
• burning sensation when passing water (urinating)
• pain in your back or side
• blood in your urine, although uncommon

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:

• low blood sugar levels (hypoglycaemia) - when taking this medicine with other medication or insulin to treat your diabetes. These are signs of low blood sugar (hypoglycaemia):
• shaking, sweating, feeling very anxious, fast heart beat
• feeling hungry, headache, change in vision
• a change in your mood or feeling confused
• Your doctor will tell you how to treat low blood sugar and what to do if you get any of the signs above.
• yeast infection (thrush) of your penis or vagina
• back pain
• passing more water (urine) than usual or needing to pass water more often
• high sugar levels (glucose) in urine (shown in tests).
• changes in the amount of cholesterol or fats in your blood (shown in tests)
• changes in the amount of red blood cells in your blood (shown in tests)
• infection of the bladder
• rash

Less frequent side effects:

• awakening from sleep at night to pass urine
• change in amount of urea in blood (shown in tests)
• increase thirst and dry feeling of the mouth
• constipation
• itching of the genitals
• increase sweating
• 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 or, pharmacist or nurse. You can also report side effects to SAHPRA 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 TAPLEO.

Store all medicines out of reach of children. Store at or below 30 °C. Store in the original package. Do not use TAPLEO after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).