Product Details

What you need to know before you take Rybelsus

Do not take Rybelsus® 2 • if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Rybelsus®. Traceability In order to improve the traceability of biological medicinal products, record the name and the lot number (included on the outer cartons and blister) of the medicine you are taking and provide this information when reporting any side effects. General: This medicine is not the same as insulin and you should not use it if: • you have type 1 diabetes (your body does not produce any insulin) • you develop diabetic ketoacidosis. This is a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth. Stomach and gut problems and dehydration During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns. Severe and on-going stomach pain which could be due to an inflamed pancreas If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis). Low blood sugar (hypoglycaemia) Taking a sulfonylurea medicine or insulin with Rybelsus® might increase the risk of getting low blood sugar (hypoglycaemia). See section 4 for the warning signs of low blood sugar levels. Your doctor may ask you to test your blood sugar levels. This will help to decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar. Diabetic eye disease (retinopathy) Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. If you have diabetic eye disease and get eye problems while taking this medicine, talk to your doctor. Treatment response If the treatment response with semaglutide is lower than expected, this may be due to low absorption caused by variability in absorption and low absolute bioavailability. You should follow the instructions given in section 3 for optimal effect of semaglutide. Children and adolescents This medicine is not recommended in children and adolescents aged under 18 years as the safety and efficacy in this age group have not been established. Other medicines and Rybelsus® Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following: • levothyroxine which is used for thyroid disease. This is because your doctor may need to check your thyroid levels if you are taking Rybelsus® together with levothyroxine. 3 • warfarin or similar medicines taken by mouth to reduce blood clotting (oral anti-coagulants). You may need frequent blood tests to check how quickly your blood clots. • If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to breakdown glucose because there is not enough insulin). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. This medicine should not be used during pregnancy, as it is not known if it affects your unborn baby. Therefore, use of contraception is recommended while taking this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, talk to your doctor straight away, as your treatment will need to be changed. Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk. Driving and using machines If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information. Rybelsus® contains sodium This medicine contains 23 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 1% of the recommended maximum daily dietary intake of sodium for an adult.