Dapagliflozin/metformin 5 mg/1000 mg film-coated tablets What dapagliflozin/metformin is used for: It is used for a type of diabetes called “type 2 diabetes” in adult patients (aged 18 years and older) and usually occurs when you are older. Do not use dapagliflozin/metformin: if you are allergic to dapagliflozin, metformin or any of the other ingredients of this medicine if you have ever had a diabetic coma if you have uncontrolled diabetes, with, for example severe hyperglycemia, nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis or ketoacidosis if you have severely reduced kidney function if you have a severe infection if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhea, or if you have vomited several times in a row if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing if you have problems with your liver if you drink large amounts of alcohol, either every day or only from time to time Warnings and precautions: Talk to your doctor, pharmacist or nurse before taking dapagliflozin/metformin, and during treatment: if you have “type 1 diabetes” – the type that usually starts when you are young, and your body does not produce any insulin. It should not be used to treat this condition if you experience rapid weight loss, 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 odor to your urine or sweat, contact a doctor or the nearest hospital straight away if you have problems with your kidneys. Your doctor will check your kidney function. if you have very high levels of glucose in your blood which may make you dehydrated (lose too much body fluid). Tell your doctor before you start taking this medicine if you have any of these signs. if you are taking medicines to lower blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension) if you often get infections of the urinary tract. This medicine may cause urinary tract infections and your doctor may want to monitor you more closely Possible side effects: Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing. Stop using the product if you develop hives or itching of the face or body. Other medicines and dapagliflozin/metformin: Tell your doctor if you are taking, have recently taken or might take any other medicines: if you are taking medicines which increase urine production (diuretics). Your doctor may ask you to stop taking this medicine 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 blood sugar levels that are too low (hypoglycemia) if you are taking cimetidine, a medicine used to treat stomach problems if you are using bronchodilators (beta-2 agonists) which are used to treat asthma if you are using corticosteroids that are given by mouth, as an injection, or inhaled if you are using medicines used to treat pain and inflammation if you are using certain medicines for the treatment of high blood pressure How to use dapagliflozin/metformin: How much to take: The amount of this medicine that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of dapagliflozin and metformin. Your doctor will tell you exactly which strength of this medicine to take The recommended dose is one tablet twice a day Taking this medicine Swallow the tablet whole with half a glass of water Take your tablet with food. This is to reduce the risk of side effects in the stomach Take your tablet twice daily, once in the morning (breakfast) and once in the evening (dinner) How to store dapagliflozin/metformin: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister or carton after ‘EXP’. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. A valid prescription should be available upon delivery