Patient leaflet - Entresto 49 mg / 51 mg film-coated tablets
1. What Entresto is and what it is used for
Entresto is a heart medicine containing an angiotensin receptor neprilysin inhibitor. It delivers two active substances, sacubitril and valsartan.
Entresto is used to treat a type of long-term heart failure in adults, children and adolescents (one year and older).
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.
2. 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), which is 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 have ever had a reaction called
angioedema (rapid swelling under the skin in areas such as the face, throat, arms and legs which can be life threatening if throat swelling blocks the airway) when taking an ACE inhibitor or an angiotensin receptor blocker (ARB) (such as valsartan, telmisartan or irbesartan).
if you have a history of angioedema which is
hereditary or for which the cause is unknown (idiopathic).
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 (see
“Pregnancy and breast-feeding”).
If any of the above applies to you, do not take Entresto and talk to your doctor.
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 experience abdominal pain, nausea,
vomiting or diarrhoea after taking Entresto. Your doctor will decide on further treatment. Do not stop taking Entresto on your own.
if you have low blood pressure or are taking
any other medicines that reduce your blood pressure (for example, a medicine that increases urine production (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 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 while taking Entresto.
if you have hyperkalaemia (high levels of
potassium in the blood).
if you suffer from heart failure classified
as NYHA class IV (unable to carry on any physical activity without discomfort and may have symptoms even when resting).
If any of the above applies to you, tell your doctor, pharmacist or nurse before you take Entresto.
Your doctor may check the amount of potassium and sodium in your blood at regular intervals during Entresto treatment. In addition, your doctor may check your blood pressure at start of treatment and when the doses are increased.
Children and adolescents
Do not give this medicine to children aged below 1 year because it has not been studied in this age group. For children one year and older with a body weight below 40 kg, this medicine will be given as granules (instead of tablets).
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, tadalafil, vardenafil or avanafil,
which are medicines 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.
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 or pharmacist for advice before taking this medicine.
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 breast-feeding 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.
Entresto contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 97 mg/103 mg dose, that is to say essentially ‘sodium free’.
3. How to take Entresto
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults
You will usually start by taking a 24 mg/26 mg or 49 mg/51 mg tablet 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 and your blood pressure. Your doctor will then adjust the dose every 2-4 weeks 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).
Children and adolescents (one year and older) Your (or your child’s) doctor will decide the starting dose based on body weight and other factors including previously taken medicines. The doctor will adjust the dose every 2-4 weeks until the best dose is found.
Entresto should be given twice a day (one tablet in the morning and one tablet in the evening).
Entresto film-coated tablets are not meant to be used in children who weigh less than 40 kg. For these patients, Entresto granules are available.
Patients taking Entresto 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 the Entresto dose, or stop Entresto treatment completely.
Swallow the tablets with a glass of water. You can take Entresto with or without food. Splitting or crushing of the tablets is not recommended.
If you take more Entresto than you should
If you have accidentally taken too many Entresto tablets, or if someone else has taken your tablets, contact your doctor immediately. If you experience severe dizziness and/or fainting, tell your doctor as quickly as possible and lie down.
If you forget to take Entresto
It is advisable to take your medicine at the same time each day. However, if you forget to take a dose, you should simply take the next one at the scheduled time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Entresto
Stopping your treatment with Entresto may cause your condition to get worse. Do not stop taking your medicine unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious.
Stop taking Entresto 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 (an uncommon side effect which may affect up to 1 in 100 people).
Intestinal angioedema: a swelling in the gut
presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea (a very rare side effect which may affect up to 1 in 10 000 people).
Other possible side effects:
If any of the side effects listed below becomes severe, tell your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)
low blood pressure, which can cause
symptoms of dizziness and light-headedness (hypotension)
high level of potassium in the blood, shown in
a blood test (hyperkalaemia)
- decreased kidney function (renal impairment)
Common (may affect up to 1 in 10 people)
- cough
- dizziness
- diarrhoea
low level of red blood cells, shown in a blood
test (anaemia)
- tiredness (fatigue)
(acute) inability of the kidney to work properly
(renal failure)
low level of potassium in the blood, shown in
a blood test (hypokalaemia)
- headache
- fainting (syncope)
- weakness (asthenia)
- feeling sick (nausea)
low blood pressure (dizziness, light-
headedness) when switching from sitting or lying to standing position
- gastritis (stomach pain, nausea)
- spinning sensation (vertigo)
low level of sugar in the blood, shown in a
blood test (hypoglycaemia)
Uncommon (may affect up to 1 in 100 people)
allergic reaction with rash and itching
(hypersensitivity)
dizziness when switching from sitting to
standing position (dizziness postural)
low level of sodium in the blood, shown in a
blood test (hyponatraemia)
Rare (may affect up to 1 in 1 000 people)
- seeing, hearing or feeling things that are not there (hallucinations)
- changes in sleeping pattern (sleep disorder)
Very rare (may affect up to 1 in 10 000 people)
- paranoia
Not known (frequency cannot be estimated from the available data)
sudden involuntary muscle twitching
(myoclonus)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Entresto
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.
Do not use this medicine if you notice that the pack is damaged or shows signs of tampering. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
If the medicine becomes discolored or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Entresto contains
The active substances are sacubitril and valsartan.
○ Each 49 mg/51 mg film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex).
- The other ingredients in the tablet core are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate, talc and silica colloidal anhydrous (see end of section 2 under ‘Entresto contains sodium’).
- The 49 mg/51 mg tablet coating contains hypromellose, titanium dioxide (E171), Macrogol (4000), talc, iron oxide red (E172) and iron oxide yellow (E172).
What Entresto looks like and contents of the pack
Entresto 49 mg/51 mg film-coated tablets are pale yellow oval tablets with “NVR” on one side and “L1” on the other side. Approximate tablet dimensions 13.1 mm x 5.2 mm.
The tablets are supplied in packs containing 56 tablets.
Manufacturer:
LEK farmacevtska družba d. d., Poslovna enota PROIZVODNJA LENDAVA
Trimlini 2D
Lendava 9220
Slovenia
Or
Novartis Pharmaceutical Manufacturing LLC Verovskova Ulica 57
1000 Ljubljana
Slovenia
Or
Novartis Farma S.p.A
Via Provinciale Schito 131
80058 Torre Annunziata (NA)
Italy
Or
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Procured from within the EU and repackaged for the PL Holder: Abacus Medicine Ltd., Abbey House, 282 Farnborough Road, Farnborough, GU14 7NA, United Kingdom
PL 45763/1091
PL 45763/1092
PL 45763/1093
PL 45763/1094
PL 45763/1095
PL 45763/1096
PL 45763/1097
PL 45763/1098
PL 45763/1099
POM
Entresto® is a registered trademark of Novartis AG
For any information about this medicine, please contact the local representative of the Product Licence Holder:
Abacus Medicine Ltd.
tel: +44(0)2036301244 email: MedInfo@abacusmedicine.co.uk or drugsafetyuk@abacusmedicine.co.uk
This leaflet was last revised on 07-11-2025
Blind or partially sighted? Is this leaflet hard to see or read? Call 02036301310 or write to info@abacusmedicine. com to obtain the leaflet in a format suitable for you.