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Forxiga 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 Forxiga is used for Forxiga 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. Forxiga can be used on its own or 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. Heart failure in adults (aged 18 years and older) when the heart does not pump blood as well as it should. Chronic kidney disease In adults with reduced kidney function. How to use How much to take The recommended dose is one 10 mg tablet each day. Your doctor may start you on a 5 mg dose if you have a liver problem. Your doctor will prescribe the strength that is right for you. Taking this medicine 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. Warnings and precautions Do not take Forxiga If you are allergic to dapagliflozin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Contact a doctor or the nearest hospital straight away Diabetic ketoacidosis: 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 Forxiga, diabetic ketoacidosis can occur even if your blood sugar is normal. If you suspect you have diabetic ketoacidosis, contact a doctor or the nearest hospital straight away and do not take this medicine. Side Effects Stop taking Forxiga and see a doctor as soon as possible if you notice any of the following serious side effects: Urinary tract infection, seen commonly (may affect up to 1 in 10 people). 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. Although uncommon, if you see blood in your urine, tell your doctor immediately. Other side effects when taking Forxiga: Common 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 Storage Information Store below 30°C. Drug Interactions Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Especially tell your doctor: If you are taking a medicine used to remove water from the body (diuretic). If you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine. Your doctor may want to lower the dose of these other medicines, to prevent you from getting low blood sugar levels (hypoglycaemia). Ingredients Each Forxiga 5 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin. Specifications Forxiga 5 mg film-coated tablets are yellow and round with diameter of 0.7 cm. They have “5” on one side and “1427” on the other side.
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