Neparvis 97 mg/103 mg comprimidos recubiertos con pelicula

Package Insert: Information for the Patient

Neparvis 24 mg/26 mg Film-Coated Tablets

Neparvis 49 mg/51 mg Film-Coated Tablets

Neparvis 97 mg/103 mg Film-Coated Tablets

sacubitrilo/valsartán

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Neparvis is a heart medication that contains a neprilisina inhibitor and an angiotensin receptor inhibitor. It provides two active principles, sacubitrilo and valsartán.

Neparvis is used for the treatment of a type of heart failure in adults, children, and adolescents (from one year of age).

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 difficulty breathing, fatigue, tiredness, and swelling of the ankles.

Do not takeNeparvis

• if you are allergic to sacubitril, valsartan, or any of the other ingredients in this medication (listed in section6).
• if you are taking another type of medication called angiotensin-converting enzyme (ACE) inhibitors (such as enalapril, lisinopril, or ramipril), which are used to treat high blood pressure or heart failure. If you have been taking ACE inhibitors, wait 36hours after taking your last dose before starting to takeNeparvis(see “Other medications andNeparvis”).
• if you have ever had a reaction called angioedema (rapid swelling under the skin in areas such as the face, throat, arms, and legs that can put your life at risk if the swelling of the throat blocks the passage of air) when taking an ACE inhibitor or angiotensin receptor antagonist (ARA) (such as valsartan, telmisartan, or irbesartan).
• if you have hereditary or idiopathic angioedema.
• if you have diabetes or kidney damage and are being treated with a medication to lower blood pressure that contains aliskiren (see “Other medications andNeparvis”).
• if you have severe liver disease.
• if you are more than 3months pregnant (see “Pregnancy and breastfeeding”).

If you are in one of these cases, do not takeNeparvisand talk to your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take or while takingNeparvis:

• if you are being treated with an angiotensin receptor antagonist (ARA) or aliskiren (see “Do not takeNeparvis”).
• if you have ever had angioedema (see “Do not takeNeparvis” and section4 “Possible side effects”).
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Neparvis. Your doctor will decide whether to continue treatment. Do not stop taking Neparvis on your own.
• if you have low blood pressure or are taking any other medication that lowers your blood pressure (such as a diuretic) or have vomiting or diarrhea, especially if you are over 65years old, or if you have liver disease and low blood pressure.
• if you have kidney disease.
• if you have dehydration
• if your kidney arteries have narrowed.
• if you have kidney disease.
• if you experience hallucinations, paranoia, or changes in sleep patterns while taking Neparvis.
• if you have hyperkalemia (high levels of potassium in the blood).
• if you have heart failure classified as NYHA IV (inability to perform any physical activity without discomfort and may have symptoms even at rest).

If you are in one of these cases, talk to your doctor, pharmacist, or nurse before taking Neparvis.

Your doctor may check the amount of potassium and sodium in your blood at regular intervals during treatment with Neparvis. Additionally, your doctor may check your blood pressure at the start of treatment and when increasing doses.

Children and adolescents

Do not give this medication to children under 1year as it has not been studied in this age group. For children 1 year and older with a body weight below40kg, this medication will be administered in granules (instead of tablets).

TakingNeparviswith other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication. It may be necessary to change doses, take other precautions, or even stop taking one of the medications. This is especially important for the following medications:

• ACE inhibitors. Do not take Neparvis with ACE inhibitors. If you have been taking an ACE inhibitor, wait 36hours after taking your last dose of the ACE inhibitor before starting to take Neparvis (see “Do not takeNeparvis”). If you stop taking Neparvis, wait 36hours after taking your last dose of Neparvis before starting to take an ACE inhibitor.
• other medications used to treat heart failure or lower blood pressure, such as angiotensin receptor antagonists or aliskiren.
• some medications known as statins that are used to lower high cholesterol levels (such as atorvastatin).
• sildenafil, tadalafil, vardenafil, or avanafil, which are medications used to treat erectile dysfunction or pulmonary hypertension.
• medications that increase the amount of potassium in the blood. This includes potassium supplements, salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• types of pain relievers called nonsteroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. If you are taking one of these medications, your doctor may want to check your kidney function when you start or adjust treatment (see “Warnings and precautions”).
• lithium, a medication used to treat certain types of psychiatric disorders.
• furosemide, which belongs to a type of medication known as diuretics, used to increase the amount of urine you produce.
• nitroglycerin, a medication used to treat angina.
• some types of antibiotics (rifamycin group), cyclosporine (used to prevent organ rejection after transplantation), or antivirals such as ritonavir (used to treat HIV/AIDS).
• metformin, a medication used to treat diabetes.

If you are in one of these cases, talk to your doctor or pharmacist before taking Neparvis.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Inform your doctor if you think you are (or may become) pregnant. Your doctor will usually advise you to stop taking this medication before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead ofNeparvis.

This medication is not recommended in early pregnancy, and should not be taken when more than 3months pregnant, as it could cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Neparvis is not recommended for mothers who are breastfeeding. Inform your doctor if you are breastfeeding or plan to start breastfeeding.

Driving and operating machinery

Before driving a vehicle, using tools, or operating machinery, or engaging in other activities that require concentration, make sure you know howNeparvisaffects you. If you feel dizzy or very tired while taking this medication, do not drive a vehicle, ride a bike, or use machinery.

Neparvis contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose of 97mg/103mg; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

You will usually start taking one tablet of24 mg/26 mg or 49 mg/51 mg twice a day (one tablet in the morning and one tablet at night). Your doctor will decide your exact initial dose based on the medication 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 finding the best dose for you.

The recommended target dose is 97 mg/103 mg twice a day (one tablet in the morning and one tablet at night).

Children and adolescents (one year and older)

Your doctor (or your child's doctor) will decide the initial dose based on your child's body weight and other factors including the medications taken previously. The doctor will adjust the dose every2-4weeksuntil finding the best dose.

Neparvis should be taken twice a day (one tablet in the morning and one tablet at night)

Neparvis film-coated tablets should not be used in children with a weight less than 40kg. For these patients, Neparvis granules are available.

Patients taking Neparvis may develop low blood pressure (dizziness, feeling of faintness), high potassium levels in the blood (which may be detected when your doctor performs a blood test) or decreased kidney function. If this occurs, your doctor may reduce the dose of one of the other medications you are taking, temporarily reduce the dose of Neparvis, or completely discontinue Neparvis treatment.

Swallow the tablets with a glass of water. You can take Neparvis with or without food. Do not recommend dividing or crushing the tablets.

If you take more Neparvis than you should

If you accidentally take too many Neparvis tablets, or if someone has taken your tablets, contact your doctor immediately. If you experience severe dizziness and/or fatigue, inform your doctor as soon as possible and lie down.

If you forget to take Neparvis

It is recommended to take your medication at the same time every day. However, if you forget to take Neparvis, simply take the next dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt Neparvis treatment

If you stop taking Neparvis, your condition may worsen. Do not stop taking your medication unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious

• Stop taking Neparvis and seek immediate medical attention if you notice swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing. These could be signs of angioedema (a rare side effect that can affect up to 1 in 100 people).

Other possible side effects:

If any of the side effects listed below become severe, inform your doctor or pharmacist.

Very common(can affect more than 1 in 10 people)

• Low blood pressure, which can cause symptoms such as dizziness and feeling faint (hypotension)
• High levels of potassium in the blood, detected by blood test (hyperkalemia)
• Decreased kidney function (renal insufficiency).

Common(can affect up to 1 in 10people)

• Cough
• Dizziness
• Diarrhea
• Low red blood cell count, detected by blood test (anemia)
• Fatigue (tiredness)
• Acute kidney failure (renal failure)
• Low potassium levels in the blood, detected by blood test (hypokalemia)
• Headache
• Fainting (syncope)
• Weakness (asthenia)
• Feeling que you are spinning (nausea)
• Low blood pressure (dizziness, feeling faint) when standing up from sitting or lying down
• Gastritis (stomach pain, nausea)
• Sensation of spinning (vertigo)
• Low blood sugar, detected by blood test (hypoglycemia)

Rare(can affect up to 1 in 100people)

• Allergic reaction with rash and itching (hypersensitivity)
• Dizziness when changing from sitting to standing (postural dizziness)
• Low sodium levels in the blood, detected by blood test (hyponatremia)

Very rare(can affect up to1 in 10000people)

• Seeing, hearing, or feeling things that are not there (hallucinations)
• Changes in sleep pattern (sleep disorder)

Very rare(can affect up to1 in 10000people)

• Paranoia
• Intestinal angioedema: swelling in the intestine that causes symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of handling.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Neparvis

• The active principles are sacubitril and valsartan.

• Each film-coated tablet of 24 mg/26 mg contains 24.3 mg of sacubitril and 25.7 mg of valsartan (as a complex salt of sacubitril, valsartan and sodium).
• Each film-coated tablet of 49 mg/51 mg contains 48.6 mg of sacubitril and 51.4 mg of valsartan (as a complex salt of sacubitril, valsartan and sodium).
• Each film-coated tablet of 97 mg/103 mg contains 97.2 mg of sacubitril and 102.8 mg of valsartan (as a complex salt of sacubitril, valsartan and sodium).

• The other components in the tablet core are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate, talc and colloidal silicon dioxide (see section 2 ‘Neparvis contains sodium’).(see section 2 ‘Neparvis contains sodium’).
• The coatings of the 24 mg/26 mg and 97 mg/103 mg tablets contain hypromellose, titanium dioxide (E171), Macrogol (4000), talc, iron oxide red (E172) and iron oxide black (E172).
• The coating of the 49 mg/51 mg tablets contains hypromellose, titanium dioxide (E171), Macrogol (4000), talc, iron oxide red (E172) and iron oxide yellow (E172).

Appearance of the product and contents of the pack

Neparvis 24 mg/26 mg film-coated tablets are white-pinkish, oval-shaped tablets with the inscription “NVR” on one face and “LZ” on the other. Approximate dimensions of the tablets are 13.1 mm x 5.2 mm.

Neparvis 49 mg/51 mg film-coated tablets are pale yellow, oval-shaped tablets with the inscription “NVR” on one face and “L1” on the other. Approximate dimensions of the tablets are 13.1 mm x 5.2 mm.

Neparvis 97 mg/103 mg film-coated tablets are pale pink, oval-shaped tablets with the inscription “NVR” on one face and “L11” on the other. Approximate dimensions of the tablets are 15.1 mm x 6.0 mm.

The tablets are presented in packs containing 14, 20, 28 or 56 tablets and in multiple packs which include 7 packs, each containing 28 tablets. The 49 mg/51 mg and 97 mg/103 mg tablets are also presented in multiple packs which include 3 packs, each containing 56 tablets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Novartis Pharmaceutical Manufacturing LLC

Verovskova Ulica 57

1000 Ljubljana

Slovenia

Novartis Farma S.p.A

Via Provinciale Schito 131

80058 Torre Annunziata (NA)

Italy

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

LEK farmacevtska družba d.d., Production unit Lendava

Trimlini 2D

Lendava 9220

Slovenia

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.