Entresto® 50 mg/100 mg/200 mg Film-Coated Tablets

The active ingredient of ENTRESTO 50 mg film-coated tablets is 24 mg sacubitril and 26 mg valsartan. The active ingredient of ENTRESTO 100 mg film-coated tablets is 49 mg sacubitril and 51 mg valsartan. The active ingredient of ENTRESTO 200 mg film-coated tablets is 97 mg sacubitril and 103 mg valsartan.

ENTRESTO is an angiotensin receptor and neprilysin inhibitor (ARNI), which contains sacubitril (a neprilysin inhibitor), and valsartan (an angiotensin receptor blocker (ARB)). They both help to treat heart failure. ENTRESTO is used to treat heart failure in adults when other therapies are insufficient. Follow all the doctor’s instructions carefully. The instructions may differ from the general information contained in this leaflet.

Do not take ENTRESTO:

• If you have ever had an unusual or allergic reaction to sacubitril or valsartan or any other ingredients of ENTRESTO. If you think you may be allergic, ask your doctor for advice
• If you are taking medicines for treatment of your high blood pressure or heart failure called Angiotensin Converting Enzyme (ACE) Inhibitors or ARB’s. Do not start ENTRESTO until 36 hours after taking the last dose of these group of medicines (see “Taking other medicines”)
• If you 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 ARB
• If you are being treated with a medicine called aliskiren to lower your blood pressure (see “Taking other medicines”)
• If you are pregnant or planning to become pregnant.
• If you have a single kidney and have narrowing or constriction of the renal artery
• If you have too low a level of potassium or sodium in your blood, or if you have too high a level of calcium in your blood despite treatment.
• If you have porphyria (a group of rare disorders that result from a buildup of natural chemicals called porphyrins in the body).
• If you have a heart condition where you have abnormal narrowing of the aortic valve or a heart condition called “hypertrophic obstructive cardiomyopathy” (a heart condition due to the thickening of the wall [septum] between the left ventricle and right ventricle reducing the blood flow from the left ventricle to the body when the heart pumps).
• If you have a history of any type of angioedema
• If you use lithium (tablet used to treat mental disorders)
• If you have severe abnormal kidney functions
• If you use potassium sparing diuretics such as spironolactone, triamterene, amiloride (Water pills)
• If you are already taking any medicines to treat your high blood pressure or heart failure known as an ACE-inhibitor, ARB, or aliskiren.
• if you have serious kidney impairment and are elderly, do not take ENTRESTO with fluoroquinolones (a type of antibiotic)

If any of these apply to you, do not take ENTRESTO and tell your doctor.

Warnings and precautions

Take special care with ENTRESTO

If any of the following apply to you, tell your doctor or pharmacist or healthcare provider before taking ENTRESTO:

• If you have severe kidney disease.
• If you ever had a reaction called angioedema (swelling of the face, lips, tongue, and/or throat, difficulties in breathing).

Always take ENTRESTO exactly as your doctor has told you. Check with your doctor or pharmacist or healthcare provider if you are not sure. Do not exceed the recommended dose prescribed by your doctor. ENTRESTO is for oral use only. Do not share medicines prescribed for you with any other person.

How much ENTRESTO to take

The usual recommended target dose is 200 mg twice a day (one tablet in the morning and one tablet in the evening). You will usually start by taking 50 mg or 100 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.

If you were taking ACE inhibitors, or ARB’s previously, do not take ENTRESTO until 36 hours after your last dose of the ACE inhibitor or ARB’s.

When to take ENTRESTO

Taking ENTRESTO at the same time each day will help you to remember when to take your medicine.

How to take ENTRESTO

Take ENTRESTO tablets by mouth. The coated tablet should not be broken or divided into parts.

How long to take ENTRESTO

Continue taking ENTRESTO every day for as long as your doctor tells you. If you have questions about how long to take ENTRESTO, talk to your doctor or your pharmacist or healthcare provider.

Older people (aged 65 years age or above) Patients over the age of 65 years may have kidney problems, therefore a lower starting dose is recommended.

Children and adolescents (below 18 years) ENTRESTO is not to be used in children or adolescents (below 18 years).

If you take more ENTRESTO than you should If you have accidentally taken too many tablets, talk to your doctor. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take ENTRESTO If you forget to take a dose, take it as soon as you remember, and then take the next tablet at the usual time. If it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to make up for the forgotten tablet.

If you stop taking ENTRESTO Stopping your treatment with ENTRESTO may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to. If treatment with ENTRESTO is stopped and you are prescribed an ACE-inhibitor, do not start taking the ACE inhibitor until 36 hours after your last dose of ENTRESTO.

ENTRESTO may have side effects. Not all side effects reported for ENTRESTO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ENTRESTO, please consult your doctor, pharmacist or other healthcare professional. Some symptoms need immediate medical attention. Stop taking ENTRESTO and tell your doctor immediately if you experience any of the following symptoms which may be signs of an allergic reaction called “angioedema”:

• swollen face, tongue or throat;
• difficulty in swallowing;
• hives and difficulties in breathing.

Frequent:

• Anaemia
• Hypersensitivity
• Low blood pressure
• Kidney disorder (signs of renal impairment)
• High level of potassium in the blood as shown in a blood test.
• Hypoglycaemia (low blood sugar)
• Cough
• Dizziness
• Severe kidney disorder (severe renal failure)
• Low level of potassium in the blood (shown in a blood test)
• Diarrhoea
• Tiredness (Fatigue)
• Headache
• Sudden loss of consciousness (fainting)
• Feeling sick (nausea)
• Gastritis
• Pruritus (itchiness)
• Rash
• Weakness
• Dizziness and low blood pressure when switching from sitting or lying down to a standing position
• Spinning sensation (vertigo)
• Dizziness when switching from sitting to standing position (or vice versa).

Less frequent:

• Swelling of the face and throat (angioedema). If you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Store at or below 30 °C, protect from moisture. Store in the original package.

KEEP OUT OF REACH AND SIGHT OF CHILDREN