Sartan ta

Package leaflet: Information for the patient

Sartesta, 24 mg + 26 mg, film-coated tablets
Sartesta, 49 mg + 51 mg, film-coated tablets
Sartesta, 97 mg +103 mg, film-coated tablets
Sacubitrilum + Valsartanum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Sartesta is and what it is used for

Sartesta is a heart medication containing an angiotensin receptor antagonist and a neprilysin inhibitor.
It provides two active substances to the body: sacubitril and valsartan.
Sartesta is used in the treatment of a certain type of chronic heart failure in adults.
This type of heart failure occurs when the heart is too weak to pump sufficient blood to the lungs and other parts of the body. The most common symptoms of heart failure are: shortness of breath, feeling tired, fatigue, and swelling around the ankles.

2. Important information before taking Sartesta

When not to use Sartesta

• if the patient is allergic to sacubitril, valsartan, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking another medicine called an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril or ramipril), which is used to treat high blood pressure or heart failure. If the patient has been taking an ACE inhibitor, they should wait 36 hours after taking the last dose of the ACE inhibitor before starting treatment with Sartesta (see section "Sartesta with other medicines");
• if the patient has ever had a reaction called angioedema (rapid swelling of the subcutaneous tissues in areas such as the face, throat, arms and legs, which may be life-threatening if swelling of the throat causes airway obstruction) after

taking an ACE inhibitor or an angiotensin receptor blocker (ARB) (e.g. valsartan,
telmisartan or irbesartan);

• if the patient has previously experienced angioedema that is hereditary or of unknown cause (idiopathic angioedema);
• if the patient has diabetes or kidney function disorders and is currently being treated with a blood pressure-lowering medicine containing aliskiren (see section "Sartesta with other medicines");
• if the patient has severe liver disease;
• if the patient is more than 3 months pregnant (see section "Pregnancy and breastfeeding").

If any of these situations apply to the patient, Sartesta must not be taken
and the patient should speak to their doctor.
Warnings and precautions
Before starting and while taking Sartesta, discuss the following with your doctor, pharmacist or
nurse:

• if the patient is currently being treated with an angiotensin receptor blocker (ARB) or aliskiren (see section "When not to use Sartesta");
• if the patient has ever experienced angioedema (see section "When not to use Sartesta" and section 4 "Possible side effects");
• if the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Sartesta, this should be discussed with the doctor. The doctor will decide whether treatment should continue. Do not make decisions about stopping Sartesta on your own;
• if the patient has low blood pressure or is taking any other medicines that lower blood pressure (e.g. a medicine that increases urine production (a diuretic)), or if the patient has vomiting or diarrhoea, especially if the patient is 65 years of age or older, or if the patient has kidney disease and low blood pressure;
• if the patient has kidney disease;
• if the patient is dehydrated;
• if there is renal artery stenosis;
• if the patient has liver disease;
• if the patient experiences hallucinations, paranoia or changes in sleep patterns while taking Sartesta;
• if the patient has hyperkalaemia (high potassium levels in the blood);
• if the patient has heart failure classified as NYHA class IV (inability to carry out any physical activity without discomfort and possible occurrence of symptoms even at rest).

If any of these situations apply to the patient, speak to your doctor,
pharmacist or nurse before taking Sartesta.
While being treated with Sartesta, your doctor may regularly check the levels of potassium and sodium in your blood.
Additionally, your doctor may monitor your blood pressure at the start of treatment and when increasing doses.
Children and adolescents
Sartesta is not indicated for use in children and adolescents. Other medicines containing sacubitril + valsartan should be used in children and adolescents.
Sartesta with other medicines
Tell your doctor, pharmacist or nurse about all medicines you are currently taking, have recently taken or plan to take. 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 Sartesta with ACE inhibitors. If the patient is taking an ACE inhibitor, they must wait 36 hours after taking the last dose of the ACE inhibitor before starting treatment with Sartesta (see section "When not to use Sartesta"). If treatment with Sartesta is discontinued, wait 36 hours after taking the last dose of Sartesta before starting treatment with an ACE inhibitor;
• other medicines used to treat heart failure or lower blood pressure, such as angiotensin receptor blockers or aliskiren (see "When not to use Sartesta");
• certain medicines called 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 belonging to a group called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. If the patient is taking one of these medicines, the doctor may order kidney function tests at the start of treatment or when changing doses (see "Warnings and precautions");
• lithium, a medicine used to treat certain types of mental illness;
• furosemide, a medicine belonging to a group called diuretics, used to increase urine production;
• nitroglycerin, a medicine used to treat angina;
• certain antibiotics (such as rifampicin), cyclosporine (used to prevent rejection of transplanted organs), or antiviral medicines such as ritonavir (used to treat HIV/AIDS infection);
• metformin, a medicine used to treat diabetes.

If any of the above apply to the patient, inform your doctor or
pharmacist before taking Sartesta.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
If the patient thinks she is (or suspects she might be) pregnant, she must inform her doctor.
Doctors usually advise women to stop taking this medicine before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe an alternative medicine to replace Sartesta.
This medicine is not recommended during early pregnancy and must not be taken after 3
months of pregnancy, as it may seriously harm the unborn child if used after the third month
of pregnancy.
Breastfeeding
Sartesta is not recommended for use in breastfeeding mothers. Inform your doctor if
the patient is breastfeeding or intends to start breastfeeding.
Driving and operating machinery
Before the patient starts driving, operating tools or machinery, or performing any activity
requiring concentration, they should ensure they know how Sartesta affects them. If the patient experiences
dizziness or fatigue while taking this medicine, they should not drive, ride a bicycle, or use tools or machinery.
Sartesta contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Sartesta

Sartesta must always be taken exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
Treatment usually starts with one 49 mg + 51 mg tablet taken twice daily (one tablet in the morning and one tablet in the evening).
Your doctor will determine the exact starting dose based on your previous medications and blood pressure. If your doctor recommends a starting dose different from 49 mg + 51 mg, a different product containing sacubitril + valsartan should be used. Your doctor will then adjust the dose every 2–4 weeks, depending on your response to treatment, until the optimal dose for you is established.
The usual recommended target 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)
Other medications containing sacubitril + valsartan should be used for children and adolescents.
Patients taking Sartesta may experience low blood pressure (dizziness, feeling faint), high potassium levels in the blood (detected through blood tests ordered by your doctor), or worsening kidney function. If this occurs, your doctor may reduce the dose of one of your other medications, temporarily reduce the dose of Sartesta, or permanently discontinue Sartesta.
Tablets should be swallowed with a glass of water. Sartesta can be taken with or without food. Do not split or crush the tablets.
If you take more Sartesta than prescribed
If you accidentally take too many Sartesta tablets, or if someone else takes them, contact your doctor immediately. If severe dizziness and/or fainting occur, contact your doctor without delay and the patient should lie down.
If you forget to take Sartesta
It is recommended to take the medicine at the same time each day. However, if you forget a dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping Sartesta
Stopping treatment with Sartesta may lead to worsening of your condition. Do not discontinue taking this medicine unless instructed to do so by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Some adverse reactions may be serious.

• Discontinue taking Sartesta and seek medical help immediately if the patient experiences any swelling of the face, lips, tongue, and (or) throat, which may cause difficulty in breathing or swallowing. These may be symptoms of angioedema (an uncommon adverse reaction, occurring in up to 1 in 100 people).

Other possible adverse reactions:
If any of the symptoms listed below become severe, inform your doctor or
pharmacist.
Very common (may occur in more than 1 in 10 people)

• low blood pressure, which may cause symptoms such as dizziness and lightheadedness (hypotension)
• high potassium levels in the blood, detected in blood tests (hyperkalaemia)
• reduced kidney function (renal function disorders)

Common (may occur in up to 1 in 10 people)

• cough
• dizziness
• diarrhoea
• low number of red blood cells, detected in blood tests (anaemia)
• fatigue
• (acute) inability of the kidneys to function properly (renal failure)
• low potassium levels in the blood, detected in blood tests (hypokalaemia)
• headache
• fainting
• weakness
• nausea
• low blood pressure (dizziness, lightheadedness) upon changing position from sitting or lying to standing
• gastric inflammation (abdominal pain, nausea)
• sensation of spinning (dizziness)
• low blood sugar levels, detected in blood tests (hypoglycaemia)

Uncommon (may occur in up to 1 in 100 people)

• allergic reaction with rash and itching (hypersensitivity)
• dizziness upon changing position from sitting to standing (orthostatic dizziness)
• low sodium levels in the blood, detected in blood tests (hyponatraemia)

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

• seeing, hearing, or feeling things that are not real (hallucinations)
• changes in sleep cycle (sleep disturbances)

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

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

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

• sudden, involuntary, jerking muscle contractions (myoclonus).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Sartesta

Keep this medicine out of the sight and reach of children.
There are no special temperature requirements for storage of this medicine. Store in the original
packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the pack after: EXP. The expiry date
refers to the last day of the stated month.
The marking on the pack after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Sartesta contains

• The active substances in this medicine are sacubitril and valsartan.
• Each 24 mg + 26 mg film-coated tablet contains sodium sacubitril and valsartan disodium equivalent to 24.3 mg of sacubitril and 25.7 mg of valsartan.
• Each 49 mg + 51 mg film-coated tablet contains sodium sacubitril and valsartan disodium equivalent to 48.6 mg of sacubitril and 51.4 mg of valsartan.
• Each 97 mg + 103 mg film-coated tablet contains sodium sacubitril and valsartan disodium equivalent to 97.2 mg of sacubitril and 102.8 mg of valsartan.
• Other ingredients are:
• Tablet core: microcrystalline cellulose (type 102), low-substituted hydroxypropyl cellulose, crospovidone type A and type B, talc, colloidal anhydrous silica, magnesium stearate.
• Coating: 24 mg + 26 mg: partially hydrolysed polyvinyl alcohol, titanium dioxide, macrogol 4000, talc.
  49 mg + 51 mg: partially hydrolysed polyvinyl alcohol, titanium dioxide, macrogol 4000, talc, iron oxide red (E 172), iron oxide yellow (E 172).
  97 mg + 103 mg: partially hydrolysed polyvinyl alcohol, titanium dioxide, macrogol 4000, talc, iron oxide red (E 172), iron oxide yellow (E 172).

What Sartesta looks like and contents of the pack

Sartesta 24 mg + 26 mg film-coated tablets are white, biconvex, oval tablets, embossed with the code "S7V" on one side and "L1" on the other side.
Approximate tablet dimensions are 13 mm x 5 mm.

Sartesta 49 mg + 51 mg film-coated tablets are pink, biconvex, oval tablets, embossed with the code "S7V" on one side and "M2" on the other side.
Approximate tablet dimensions are 12 mm x 5 mm.

Sartesta 97 mg + 103 mg film-coated tablets are pink, biconvex, oval tablets, embossed with the code "S7V" on one side and "H3" on the other side.
Approximate tablet dimensions are 16 mm x 6 mm.

Sartesta 24 mg + 26 mg is available in packs containing 14, 20, 28, 56 or 196 tablets, and in multipacks containing 196 tablets (7 packs of 28 tablets each).

Sartesta 49 mg + 51 mg and 97 mg + 103 mg are available in packs containing 14, 20, 28, 56, 168 or 196 tablets, and in multipacks containing 168 tablets (3 packs of 56) or 196 tablets (7 packs of 28).

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer/Importer
Synthon Hispania S.L.
Calle De Castello 1
Sant Boi De Llobregat
Barcelona 08830
Spain

Synthon B.V.
Microweg 22
Nijmegen
Gelderland
6545 CM
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands: Sartesta 24 mg/26 mg, filmomhulde tabletten, Sartesta 49 mg/51 mg, filmomhulde tabletten, Sartesta 97 mg/103 mg, filmomhulde tabletten