Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - entresto

Document Subject

Generated Narrative: MedicinalProductDefinition mpa75d7e9d67efdcc2afd6268e67a7d0cd

identifier: http://ema.europa.eu/identifier/EU/1/15/1058/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Entresto 24 mg/26 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a75d7e9d67efdcc2afd6268e67a7d0cd

identifier: http://ema.europa.eu/identifier/EU/1/15/1058/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - entresto

Attesters

What is in this leaflet

1. What Entresto is and what it is used for
2. What you need to know before you take Entresto
3. How to take Entresto
4. Possible side effects
5. How to store Entresto
6. Contents of the pack and other information

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.

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 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 .

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.

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).

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

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

What Entresto contains

• The active substances are sacubitril and valsartan. * Each 24 mg/26 mg film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex). * Each 49 mg/51 mg film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex). * Each 97 mg/103 mg film-coated tablet contains 97.2 mg sacubitril and 102.8 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 24 mg/26 mg and the 97 mg/103 mg tablet coatings contain hypromellose, titanium dioxide (E171), Macrogol (4000), talc, iron oxide red (E172) and iron oxide black (E172).
• 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 24 mg/26 mg film-coated tablets are violet-white oval tablets with NVR on one side and LZ on the other side. Approximate tablet dimensions 13.1 mm x 5.2 mm. 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 Entresto 97 mg/103 mg film-coated tablets are light pink oval tablets with NVR on one side and L11 on the other side. Approximate tablet dimensions 15.1 mm x 6.0 mm.

The tablets are supplied in packs containing 14, 20, 28, 56, 168 or 196 tablets and in multipacks comprising 7 cartons, each containing 28 tablets. The 49 mg/51 mg and 97 mg/103 mg tablets are also supplied in multipacks comprising 3 cartons, each containing 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Novartis Pharmaceutical Manufacturing LLC Verovskova Ulica 1000 Ljubljana Slovenia

Novartis Farma S.p.A Via Provinciale Schito 80058 Torre Annunziata (NA) Italy

Novartis Pharma GmbH Roonstrasse 90429 Nuremberg Germany

LEK farmacevtska dru ba d. d., Poslovna enota PROIZVODNJA LENDAVA Trimlini 2D Lendava, 9Slovenia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD : +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: