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Divinus is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (aged 18 years and older). Divinus works by removing excess sugar from your body via your urine. Divinus is used if your diabetes cannot be controlled with other medicines for diabetes, diet and exercise. Your doctor may ask you to take Divinus on its own if you are intolerant to metformin or together with other medicines to treat diabetes. This may be another medicine taken by mouth and/or a medicine given by injection, such as insulin or a GLP‐1 receptor agonist. It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse. 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 Divinus If you are allergic to dapagliflozin or any of the other ingredients of this medicine Warnings and Precautions Talk to your doctor, pharmacist or nurse before taking Divinus, 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. 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 odour to your urine or sweat, contact a doctor or the nearest hospital straight away. If you have a kidney problem – your doctor may ask you to take a different medicine. If you have a liver problem – your doctor may start you on a lower dose. If you have a history of serious heart disease or if you have had a stroke. If you are on medicines to lower your blood pressure (anti‐hypertensives) and have a history of low blood pressure (hypotension). If you have very high levels of glucose in your blood which may make you dehydrated (lose too much body fluid). If you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink. If you are 75 years old or older, you should not start taking Divinus. If you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking Divinus. Side Effects Stop taking dapagliflozin and see a doctor as soon as possible if you notice any of the following serious side effects: Loss of too much fluid from your body (dehydration), seen uncommonly (may affect up to 1 in 100 people). Contact a doctor or the nearest hospital straight away if you have any of the following side effects: Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) Contact your doctor as soon as possible if you have any of the following side effects: Very common (may affect more than 1 in 10 people) Low blood sugar levels (hypo‐glycaemia) ‐ when taking this medicine with a sulphonylurea or insulin Other side effects when taking dapagliflozin: 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) Dizziness Rash Storage Information Do not store above 30°C. Store in the original package. Drug Interactions Especially tell your doctor: If you are taking a medicine used to remove water from the body (diuretic). Your doctor may ask you to stop taking Divinus. Possible signs of losing too much fluid from your body are listed at the top of section 4. 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 (hypo‐glycaemia). Ingredients The active substance is dapagliflozin.
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