Dapagliflozin 5 mg/10 mg Tablets

[PRODUCT NAME] contains 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. These are used to treat the following conditions: [PRODUCT NAME] is used in adult patients (aged 18 years and older) to treat:

• Type 2 diabetes - If your type 2 diabetes cannot be controlled with diet and exercise. - [PRODUCT NAME] can be used on its own or together with other medicines to treat diabetes. - [PRODUCT NAME] is used for prevention and treatment of heart failure (when the heart does not pump enough blood that the body needs).
• [PRODUCT NAME] is also used in patients with chronic kidney disease (reduced kidney function).

Do not take [PRODUCT NAME]:

• If you are allergic to dapagliflozin or any of the other ingredients of this medicine listed in section 6
• If you are pregnant plan to become pregnant. Talk with your doctor about the best way to control your blood sugar while you are pregnant.
• If you are breastfeeding, talk to your doctor if you would like to breastfeed your baby.
• If you have diabetes mellitus type 1 – the type that usually starts when you are young, and your body does not produce any insulin.
• If you have moderate or severe kidney disease or you are on dialysis.
• If you have a history of inflammation of the pancreas or pancreatic surgery.

Do not share medicines prescribed for you with any other person. Always take [PRODUCT NAME] exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose is one 10 mg tablet each day. If you have the impression that the effect of [PRODUCT NAME] 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. [PRODUCT NAME] can have side effects. Not all side effects reported for [PRODUCT NAME] are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking [PRODUCT NAME], please consult your doctor, pharmacist or other healthcare professional for advice.

Store at or below 25 °C. KEEP OUT OF THE REACH OF CHILDREN. Store in the original package / container. Keep the blisters in the carton until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the blister / label / carton bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).