Product Details

What you need to know before you take Entresto

Do not take Entresto • if you are allergic to sacubitril, valsartan or any of the other ingredients of this medicine (listed in section 6). • if you are taking another type of medicine called an angiotensin converting enzyme (ACE) inhibitor (for example enalapril, lisinopril or ramipril). ACE inhibitors are used to treat high blood pressure or heart failure. If you have been taking an ACE inhibitor, wait for 36 hours after taking the last dose before you start to take Entresto (see “Other medicines and Entresto”). • if you or a member of your family have ever had a reaction called angioedema (swelling of the face, lips, tongue and/or throat, difficulties in breathing) when taking an ACE inhibitor or an angiotensin receptor blocker (ARB) (such as valsartan, telmisartan or irbesartan). • if you have diabetes or impaired kidney function and you are being treated with a blood pressure lowering medicine containing aliskiren (see “Other medicines and Entresto”). • if you have severe liver disease. • if you are more than 3 months pregnant (it is also better to avoid this medicine in early pregnancy, see “Pregnancy and breast-feeding”). If any of the above applies to you, do not take Entresto and talk to your doctor. 2 Warnings and precautions Talk to your doctor, pharmacist or nurse before or when taking Entresto: • if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren (see “Do not take Entresto”). • if you have ever had angioedema (see “Do not take Entresto” and section 4 “Possible side effects”). • if you have low blood pressure or are taking any other medicines that reduce your blood pressure (for example, a diuretic) or are suffering from vomiting or diarrhoea, especially if you are aged 65 years or more, or if you have kidney disease and low blood pressure. • if you have severe kidney disease. • if you are suffering from dehydration. • if your kidney artery has narrowed. • if you have liver disease. • if you experience hallucinations, paranoia or changes in sleeping pattern. Your doctor may check the amount of potassium in your blood at regular intervals during Entresto treatment. If any of the above applies to you, tell your doctor, pharmacist or nurse before you take Entresto. Children and adolescents Do not give this medicine to children (aged below 18 years) because it has not been studied in this age group. Other medicines and Entresto Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. It may be necessary to change the dose, to take other precautions, or even to stop taking one of the medicines. This is particularly important for the following medicines: • ACE inhibitors. Do not take Entresto with ACE inhibitors. If you have been taking an ACE inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting to take Entresto (see “Do not take Entresto”). If you stop taking Entresto, wait 36 hours after taking your last dose of Entresto before starting an ACE inhibitor. • other medicines used to treat heart failure or lower blood pressure, such as angiotensin receptor blockers or aliskiren (see “Do not take Entresto”). • some medicines known as statins that are used to lower high cholesterol levels (for example atorvastatin). • sildenafil, a medicine used to treat erectile dysfunction or lung hypertension. • medicines that increase the amount of potassium in the blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing medicines and heparin. • painkillers of the type called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 (Cox-2) inhibitors. If you are taking one of these, your doctor may want to check your kidney function when starting or adjusting treatment (see “Warnings and precautions”). • lithium, a medicine used to treat some types of psychiatric illness. • furosemide, a medicine belonging to the type known as diuretics, which are used to increase the amount of urine you produce. • nitroglycerine, a medicine used to treat angina pectoris. • some types of antibiotics (rifamycin group), ciclosporin (used to prevent rejection of transplanted organs) or antivirals such as ritonavir (used to treat HIV/AIDS). • metformin, a medicine used to treat diabetes. If any of the above applies to you, tell your doctor or pharmacist before you take Entresto. 3 Pregnancy and breastfeeding Pregnancy You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Entresto. This medicine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy. Breast-feeding Entresto is not recommended for mothers who are breast-feeding. Tell your doctor if you are breastfeeding or about to start breast-feeding. Driving and using machines Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Entresto affects you. If you feel dizzy or very tired while taking this medicine, do not drive a vehicle, cycle or use any tools or machines.