Sacubitril/Valsartan 49 mg/51 mg film-coated tablets What is Sacubitril/Valsartan and what is used for: This medicine contains an angiotensin receptor neprilysin inhibitor. It delivers two active substances, Sacubitril and Valsartan. It is used to treat a type of long-term heart failure in adults. This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body. The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling. If you have any questions about how Sacubitril/Valsartan works or why this medicine has been prescribed for you, ask your doctor. Do not take Sacubitril/Valsartan: if you are allergic to sacubitril, valsartan or any of the other ingredients of this medicine 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 this medicine. 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 Sacubitril/Valsartan”). 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) Warnings & Precautions: Talk to your doctor or pharmacist before taking Sacubitril/Valsartan: if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren. if you have ever had angioedema (swelling of the face, lips, tongue and/or throat, which may cause difficulties in breathing or swallowing). 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. Possible Side Effects: Stop taking Sacubitril/Valsartan and seek immediate medical attention if you notice any swelling of the face, lips, tongue and/or throat, which may cause difficulties in breathing or swallowing. These may be signs of angioedema Other medicines and Sacubitril/Valsartan: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is particularly important that you mention any of the following medicines containing any of the following active substances, as your doctor may need to adjust the Sacubitril/Valsartan dose for you. ACE inhibitors. Do not take Sacubitril/Valsartan 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 Sacubitril/Valsartan. If you stop taking Sacubitril/Valsartan, wait 36 hours after taking your last dose of Sacubitril/Valsartan before starting an ACE inhibitor. other medicines used to treat heart failure or lower blood pressure, such as angiotensin receptor blockers or aliskiren. 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. 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. How to take Sacubitril/Valsartan: You will usually start by taking 24 mg/26 mg or 49 mg/51 mg twice a day (one tablet in the morning and one tablet in the evening). Your doctor will decide your exact starting dose based on which medicines you have been taking previously. Your doctor will then adjust the dose depending on how you respond to the treatment until the best dose for you is found. The usual recommended target dose is 97 mg/103 mg twice a day (one tablet in the morning and one tablet in the evening). Patients taking Sacubitril/Valsartan can develop low blood pressure (dizziness, light-headedness), a high level of potassium in the blood (which would be detected when your doctor performed a blood test) or decreased kidney function. If this happens, your doctor may reduce the dose of any other medicine you are taking, temporarily reduce your Sacubitril/Valsartan dose, or stop your Sacubitril/Valsartan treatment completely. Swallow the tablets with a glass of water. You can take Sacubitril/Valsartan with or without food. How to store Sacubitril/Valsartan: 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 carton and blister after EXP. The expiry date refers to the last day of that month. This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. A valid prescription should be available upon delivery

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