Sacubitril and valsartan Pensa

Package leaflet: Information for the patient

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

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Sacubitril and Valsartan Pensa is a heart medication containing a neprilysin inhibitor and an angiotensin receptor blocker. It releases two active substances, sacubitril and valsartan.
Sacubitril and Valsartan Pensa is used for the treatment of a type of long-term heart failure in adults, children and adolescents (aged 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 shortness of breath, lack of energy, fatigue, and swelling of the ankles.

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

Do not take Sacubitril and Valsartan Pensa

• 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 Pensa (see "Other medicines and Sacubitril and Valsartan Pensa").
• 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 Pensa").
• 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 Pensa and consult your doctor.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before or while taking Sacubitril and Valsartan Pensa:

• if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren (see "Do not take Sacubitril and Valsartan Pensa").
• if you have ever had angioedema (see "Do not take Sacubitril and Valsartan Pensa" and section 4 "Possible side effects").
• if, after taking Sacubitril and Valsartan Pensa, you experience abdominal pain, nausea, vomiting, or diarrhea. Your doctor will decide whether treatment should continue. Do not stop taking Sacubitril and Valsartan Pensa on your own.
• if you have low blood pressure or are taking any other medicines to lower blood pressure (for example, a medicine that increases urine production (diuretic)) or if you have vomiting or diarrhea, 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 Pensa.
• if you have hyperkalemia (high levels of potassium in the blood).
• if you suffer from heart failure classified as NYHA class IV (inability to carry out any physical activity without discomfort and may have symptoms even at rest).

If any of these apply to you, inform your doctor, pharmacist, or nurse before taking
Sacubitril and Valsartan Pensa.
Your doctor may check your blood potassium and sodium levels at regular intervals during treatment with Sacubitril and Valsartan Pensa. 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 Pensa
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 Pensa 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 Pensa (see "Do not take Sacubitril and Valsartan Pensa"). If you stop taking Sacubitril and Valsartan Pensa, wait 36 hours after 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 Pensa").
• 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 one of these, your doctor may wish to monitor your kidney function when starting or adjusting treatment (see "Warnings and precautions").
• lithium, a medicine used to treat certain psychiatric disorders.
• 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 Pensa.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you are 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 find out you are pregnant, and will recommend an alternative medicine instead of Sacubitril and Valsartan Pensa.
This medicine is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month of pregnancy.
Breastfeeding
Sacubitril and Valsartan Pensa is not recommended for breastfeeding mothers. Inform your doctor if you are breastfeeding or planning to breastfeed.
Driving and using machines
Before driving, operating tools or machinery, or performing other activities requiring concentration, you should be aware of how you react to Sacubitril and Valsartan Pensa. If you feel dizzy or very tired while taking this medicine, do not drive, ride a bicycle, or use tools or machinery.
Sacubitril and Valsartan Pensa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Sacubitril and Valsartan Pensa

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
You will usually start by taking either 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 the dose every 2–4 weeks depending on your response to treatment, until the most suitable dose for you is found.
The usual recommended optimal dose is 97 mg/103 mg twice daily (one tablet in the morning and one tablet in the evening).
Children and adolescents (from one 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 Pensa should be given twice daily (one tablet in the morning and one tablet in the evening).
Sacubitril and Valsartan Pensa film-coated tablets are not intended for use in children weighing less than 40 kg. For these patients, sacubitril/valsartan granules are available.
Patients receiving treatment with Sacubitril and Valsartan Pensa may develop low blood pressure (dizziness, feeling of emptiness in the head), high levels of potassium in the blood (detected when your doctor performs a blood test), or reduced kidney function. If this occurs, your doctor may reduce the dose of any medicine you are taking, temporarily reduce the dose of Sacubitril and Valsartan Pensa, or completely discontinue treatment with Sacubitril and Valsartan Pensa.
Swallow the tablets with a glass of water. You may take Sacubitril and Valsartan Pensa with or without food. Splitting or crushing the tablets is not recommended.
If you take more Sacubitril and Valsartan Pensa than you should
If you have accidentally taken too many Sacubitril and Valsartan Pensa 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 Pensa
It is recommended to take the medicine at the same time every 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 Pensa
Stopping treatment with Sacubitril and Valsartan Pensa may cause your condition to worsen. Do not stop taking this medicine unless instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Some side effects may be serious.

• Stop taking sacubitril/valsartan 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 which 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, shown 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, shown by a blood test (anaemia)
• tiredness (fatigue)
• sudden inability of the kidney to function properly (renal failure)
• low levels of potassium in the blood, shown 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 blood sugar levels, shown 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, shown 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 sleep patterns (sleep disorders)

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

• paranoia
• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea

Not known (frequency cannot be estimated from the available data)

• sudden involuntary muscle twitch (myoclonus)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to 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 Pensa

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.
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. Contents of the pack and other information

What Sacubitril and Valsartan Pensa contains
The active substances are sacubitril and valsartan.
Sacubitril and Valsartan Pensa 24 mg/26 mg tablets: each film-coated tablet contains sodium sacubitril equivalent to 24.3 mg of sacubitril and valsartan disodium equivalent to 25.7 mg of valsartan.
Sacubitril and Valsartan Pensa 49 mg/51 mg tablets: each film-coated tablet contains sodium sacubitril equivalent to 48.6 mg of sacubitril and valsartan disodium equivalent to 51.4 mg of valsartan.
Sacubitril and Valsartan Pensa 97 mg/103 mg tablets: each film-coated tablet contains sodium sacubitril equivalent to 97.2 mg of sacubitril and valsartan disodium equivalent to 102.8 mg of valsartan.

The other components in the tablet core are mannitol (E421), low-substituted hydroxypropylcellulose (E463), microcrystalline cellulose (102) (E460), crospovidone (type A) (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b), talc (E553b).

The coating of the 24 mg/26 mg tablet contains hypromellose type 2910 (50 mPas) (E464), titanium dioxide (E171), macrogol (3350) (E1521), red iron oxide (E172) and black iron oxide (E172).

The coating of the 49 mg/51 mg tablet contains hypromellose type 2910 (50 mPas) (E464), titanium dioxide (E171), macrogol (3350) (E1521), red iron oxide (E172) and yellow iron oxide (E172).

The coating of the 97 mg/103 mg tablet contains hypromellose type 2910 (3 mPas) (E464), titanium dioxide (E171), talc (E553b), macrogol (4000) (E1521), red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of Sacubitril and Valsartan Pensa and contents of the pack
Film-coated tablets. (tablet)
Sacubitril and Valsartan Pensa 24 mg/26 mg film-coated tablets: film-coated, white-violet coloured, oval, biconvex tablets, marked 'C 50' on the upper side and smooth on the lower side, with approximate dimensions of 7.8 x 4.0 mm.
Sacubitril and Valsartan Pensa 49 mg/51 mg film-coated tablets: film-coated, pale yellow coloured, oval, biconvex tablets, marked 'C 100' on the upper side and smooth on the lower side, with approximate dimensions of 12.0 x 5.0 mm.
Sacubitril and Valsartan Pensa 97 mg/103 mg film-coated tablets: film-coated, light pink coloured, ovaloid, biconvex tablets, marked 'C 200' on the upper side and smooth on the lower side, with approximate dimensions of 15.1 x 6.0 mm.

Pack sizes: 28, 30, 56, 60, 196 film-coated tablets.
Blister OPA-Al-PVC/Al in cardboard packaging.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milano – Italy

Manufacturer
Delorbis Pharmaceuticals Limited
17 Athinon Str, Ergates Industrial Area
2643 Lefkosia – Cyprus
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park, Paola
PLA 3000 – Malta

This medicinal product is authorised in the European Economic Area countries under the
following names:
Netherlands: Sacubitril/Valsartan AET
Spain: SACUBITRILO/VALSARTÁN PENSA
Italy: Sacubitril e Valsartan Pensa

This leaflet was last reviewed on