Sacubitril and valsartan Alter

Patient Information Leaflet

Sacubitril and Valsartan Alter 24 mg/26 mg film-coated tablets, 49 mg/51 mg film-coated tablets, 97 mg/103 mg film-coated tablets

sacubitril/valsartan
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sacubitril and Valsartan Alter is and what it is used for

Sacubitril and Valsartan Alter is a heart medication containing a neprilysin inhibitor and an angiotensin receptor blocker. It releases two active substances, sacubitril and valsartan.
Sacubitril and Valsartan Alter is used to treat a type of chronic heart failure in adults, children, and adolescents (from one year of age).
This type of heart failure occurs when the heart is weakened and cannot pump enough blood to the lungs and the rest of the body. The most common symptoms of heart failure are shortness of breath, weakness, fatigue, and swelling of the ankles.

2. What you need to know before taking Sacubitril and Valsartan Alter

Do not take Sacubitril and Valsartan Alter

• 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 are taking an ACE inhibitor, wait 36 hours after taking the last dose before starting Sacubitril and Valsartan Alter (see "Other medicines and Sacubitril and Valsartan Alter").
• 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 swelling of the throat blocks the airways) while taking an ACE inhibitor or an angiotensin receptor blocker (ARB) (such as valsartan, telmisartan, or irbesartan).
• if you have a history of angioedema that is hereditary or of unknown cause (idiopathic).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren (see "Other medicines and Sacubitril and Valsartan Alter").
• if you have severe liver disease.
• if you are more than 3 months pregnant (see "Pregnancy and breastfeeding"). If any of these apply to you, do not take Sacubitril and Valsartan Alter and consult your doctor.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before or when taking Sacubitril and Valsartan Alter

• if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren (see "Do not take Sacubitril and Valsartan Alter").
• if you have ever had angioedema (see "Do not take Sacubitril and Valsartan Alter" and section 4 "Possible side effects").
• if you have low blood pressure or are taking any other medicine to lower blood pressure (e.g., a medicine that increases urine production (diuretic)) or if you have vomiting or diarrhoea, especially if you are 65 years of age or older or have kidney disease and low blood pressure.
• if you have kidney disease.
• if you are dehydrated.
• if you have narrowing of a renal artery.
• if you have liver disease.
• if you experience hallucinations, paranoia, or changes in your sleep pattern while taking Sacubitril and Valsartan Alter.
• 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 out any physical activity without discomfort and may experience symptoms even at rest).

If any of these apply to you, inform your doctor, pharmacist, or nurse before taking Sacubitril and Valsartan Alter.
Your doctor may check your blood potassium and sodium levels regularly during treatment with Sacubitril and Valsartan Alter. In addition, your doctor may monitor your blood pressure at the start of treatment and when doses are increased.

Children and adolescents
Do not give this medicine to children under 1 year of age, as it has not been studied in this age group. For children aged 1 year and older with body weight below 40 kg, this medicine will be given as granules (instead of tablets).

Other medicines and Sacubitril and Valsartan Alter
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. It may be necessary to adjust the dose, take additional precautions, or even discontinue one of these medicines. This is particularly important for the following medicines:

• ACE inhibitors. Do not take Sacubitril and Valsartan Alter with ACE inhibitors. If you are being treated with an ACE inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting Sacubitril and Valsartan Alter (see "Do not take Sacubitril and Valsartan Alter"). If you stop taking Sacubitril and Valsartan Alter, wait 36 hours after taking the last dose 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 Sacubitril and Valsartan Alter").
• certain medicines known as statins, used to lower high cholesterol levels (e.g., atorvastatin).
• sildenafil, tadalafil, vardenafil, or avanafil, medicines used to treat erectile dysfunction or pulmonary hypertension.
• medicines that increase potassium levels in the blood. These include potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• painkillers of the type known as non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. If you are taking any of these, your doctor may want to monitor your kidney function when starting or adjusting treatment (see "Warnings and precautions").
• lithium, a medicine used to treat certain psychiatric conditions.
• furosemide, a medicine belonging to the diuretic class used to increase urine production.
• nitroglycerin, a medicine used to treat angina pectoris.
• certain types of antibiotics (rifamycin group), cyclosporine (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 these apply to you, inform your doctor or pharmacist before taking Sacubitril and Valsartan Alter.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Sacubitril and Valsartan Alter. This medicine is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.

Breastfeeding
Sacubitril and Valsartan Alter is not recommended for breastfeeding mothers. Inform your doctor if you are breastfeeding or planning to breastfeed.

Driving and using machines
Before driving a vehicle, operating tools or machinery, or performing other activities requiring concentration, you should be aware of how you react to Sacubitril and Valsartan Alter. If you experience dizziness or feel very tired while taking this medicine, do not drive, ride a bicycle, or operate tools or machinery.

Sacubitril and Valsartan Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 97 mg/103 mg dose, i.e., essentially "sodium-free".

3. How to take Sacubitril and Valsartan Alter

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.

Adults
You will usually start with 24 mg/26 mg or 49 mg/51 mg tablets twice daily (one tablet in the morning and one tablet in the evening). Your doctor will decide the exact starting dose based on the medicines you were previously taking and your blood pressure. Your doctor will then adjust your dose every 2–4 weeks, depending on your response to treatment, until the most suitable dose for you is found.
The usual recommended maintenance dose is 97 mg/103 mg twice daily (one tablet in the morning and one tablet in the evening).

Children and adolescents (from 1 year of age)
Your doctor (or your child’s doctor) will determine the starting dose based on body weight and other factors, including previously taken medicines. Your doctor will adjust the dose every 2–4 weeks until the optimal dose has been identified.
Sacubitril and Valsartan Alter should be administered twice daily (one tablet in the morning and one tablet in the evening).
Sacubitril and Valsartan Alter film-coated tablets are not intended for use in children weighing less than 40 kg. For these patients, sacubitril/valsartan granules are available.

Patients treated with Sacubitril and Valsartan Alter may develop low blood pressure (dizziness, feeling of emptiness in the head), high potassium levels in the blood (detected during blood tests performed by your doctor), or reduced kidney function. If this occurs, your doctor may reduce the dose of any concomitant medication, temporarily reduce the dose of Sacubitril and Valsartan Alter, or completely discontinue treatment with Sacubitril and Valsartan Alter.

Swallow the tablets with a glass of water. You may take Sacubitril and Valsartan Alter with or without food. Splitting or crushing the tablets is not recommended.

If you take more Sacubitril and Valsartan Alter than you should
If you have accidentally taken too many Sacubitril and Valsartan Alter tablets, or if someone else has taken your tablets, contact your doctor immediately. If you experience severe dizziness and/or fainting, inform your doctor as soon as possible and lie down.

If you forget to take Sacubitril and Valsartan Alter
It is recommended to take the medicine at the same time each day. However, if you forget to take a dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

If you stop taking Sacubitril and Valsartan Alter
Stopping treatment with Sacubitril and Valsartan Alter may cause your condition to worsen. Do not stop taking this medicine unless instructed by your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious.

• Stop taking Sacubitril and Valsartan Alter and seek immediate medical help if you notice any swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing. These may be signs of angioedema (an uncommon side effect that may affect up to 1 in 100 people).

Other possible side effects:
If any of the side effects listed below worsen, inform your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)

• low blood pressure which may cause symptoms of dizziness and lightheadedness (hypotension)
• high levels of potassium in the blood, detected by a blood test (hyperkalaemia)
• reduced kidney function (renal impairment)

Common (may affect up to 1 in 10 people)

• cough
• dizziness
• diarrhoea
• low levels of red blood cells in the blood, detected by a blood test (anaemia)
• tiredness (fatigue)
• sudden inability of the kidney to function properly (renal failure)
• low levels of potassium in the blood, detected by a blood test (hypokalaemia)
• headache
• fainting (syncope)
• weakness (asthenia)
• feeling unwell (nausea)
• low blood pressure (dizziness, lightheadedness) when moving from a sitting or lying position to a standing position
• gastritis (stomach pain, nausea)
• sensation of dizziness (vertigo)
• low levels of sugar in the blood, detected by a blood test (hypoglycaemia)

Uncommon (may affect up to 1 in 100 people)

• allergic reaction with skin rash and itching (hypersensitivity)
• dizziness when moving from a sitting to a standing position (postural dizziness)
• low levels of sodium in the blood, detected by a blood test (hyponatraemia)

Rare (may affect up to 1 in 1,000 people)

• seeing, hearing or sensing things that are not there (hallucinations)
• changes in the way of sleeping (sleep disorders)

Very rare (may affect up to 1 in 10,000 people)

• paranoia

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sacubitril and Valsartan Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 storage temperature conditions.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sacubitril and Valsartan Alter contains

• The active substances are sacubitril and valsartan.
  o Each film-coated tablet of 24 mg/26 mg contains 24.3 mg of sacubitril and 25.7 mg of valsartan.
  o Each film-coated tablet of 49 mg/51 mg contains 48.6 mg of sacubitril and 51.4 mg of valsartan.
  o Each film-coated tablet of 97 mg/103 mg contains 97.2 mg of sacubitril and 102.8 mg of valsartan.
• The other components of the tablet core are microcrystalline cellulose, hydroxypropylcellulose, crospovidone, anhydrous colloidal silica, talc, and magnesium stearate (see end of section 2 under “Sacubitril and Valsartan Alter contains sodium”).
• The tablet coatings contain hypromellose, titanium dioxide (E171), and triacetin.

Description of the appearance of Sacubitril and Valsartan Alter and pack sizes
Sacubitril and Valsartan Alter 24 mg/26 mg film-coated tablets are white, elongated, biconvex, film-coated tablets with a break line on one side. Approximate tablet dimensions: 8 mm x 4 mm.
Sacubitril and Valsartan Alter 49 mg/51 mg film-coated tablets are white, elongated, biconvex, film-coated tablets without a break line. Approximate tablet dimensions: 13 mm x 5.3 mm.
Sacubitril and Valsartan Alter 97 mg/103 mg film-coated tablets are white, elongated, biconvex, film-coated tablets with a break line on one side. Approximate tablet dimensions: 15.5 mm x 7 mm.
The 24 mg/26 mg and 49 mg/51 mg tablets are supplied in packs containing 28 tablets.
The 49 mg/51 mg and 97 mg/103 mg tablets are supplied in packs containing 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan
Italy

Manufacturer
Laboratorios Alter S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain