Package Insert: Information for the Patient

Valsartan Sandoz 40 mg Film-Coated Tablets

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

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

6.Contents of the pack and additional information

Valsartán Sandoz belongs to a class of medications known as angiotensin II receptor antagonists that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in increased blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Sandoz 40 mg film-coated tabletscan be used to treat three different conditions:

• to treat high blood pressure in children and adolescents aged6 to18 years old.High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, and may cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders,
• to treat adult patients after a recent heart attack (myocardial infarction).“Recent” means here between 12hours and 10days,
• totreatsymptomatic heart failure in adult patients.Valsartán is used when it is not possible to use a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure), or it may be used in addition to ACE inhibitors when it is not possible to use other medications for the treatment of heart failure.

Among the symptoms of heart failure are shortness of breath and swelling of feet and legs due to fluid retention. This is because the heart muscle is not able to pump blood with sufficient force to provide all the blood needed by the body.

Do not take Valsartán Sandoz:

• if you areallergicto valsartán or to any of the other ingredients of this medicine (listed in section6),
• if you havesevere liver disease,
• if you arepregnantover 3 months(in any case, it is better to avoid taking valsartán at the beginning of your pregnancy - see section Pregnancy),
• if you have diabetes or kidney failure and are being treated with a medicine to lower blood pressure that contains aliskirén.

If any of these situations apply to you, do not takeValsartán Sandoz.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeValsartán Sandoz:

• if you have liver disease,
• if you have severe kidney disease or are being treated with dialysis,
• if you have a narrowing of the kidney artery,
• if you have recently undergone a kidney transplant (received a new kidney),
• if you are being treated for a heart attack or heart failure, your doctor may check yourrenal function,
• if you have a severe heart disease other than heart failure or heart attack,
• if you have ever experienced swelling mainly of the face and tongue due to an allergic reaction while taking other medicines (including ACE inhibitors). If you have these symptoms, stop taking valsartán and contact your doctor immediately. Do not take valsartán again. See also section 4 “Possible side effects”,
• if you are using medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin. You may need to have your potassium levels in the blood checked regularly,
• if you are under 18 years of age and taking valsartán with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor maycheckyour renal function and potassium levels in the blood periodically,
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, valsartán is not recommended,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine production),
• if you are pregnant, think you may be pregnant (orif you plan to becomepregnant), you must inform yourdoctor. Valsartán is not recommended at the beginning of pregnancy and should not be administered after the third month of pregnancy because it can cause serious harm to your baby, (see section Pregnancy),
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• a renin-angiotensin-aldosterone system (RAAS) inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
• aliskirén.
• if you are being treated with an ACE inhibitor together with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

If any of these situations apply to you, inform your doctor before taking Valsartán Sandoz.

Your doctor may check your renal function, blood pressure, and electrolyte levels in the blood (such as potassium) at regular intervals.

See also the information under the heading “Do not take Valsartán Sandoz”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking valsartán. Your doctor will decide whether to continue treatment. Do not stop taking valsartán on your own.

Taking Valsartán Sandoz with other medicines

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medicine.

The effect of treatment with valsartán may be altered if taken with certain medicines. Your doctor may need to adjust your dose and/or take other precautions or, in some cases, discontinue one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure,especiallydiuretics(medicines to increase urine production)ACE inhibitors(such as enalapril, lisinopril, etc) oraliskirén(see also the information under the headings “Do not take Valsartán Sandoz” and “Warnings and precautions”),
• medicines that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin,
• some pain medicines called nonsteroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (rifampicin group), a medicine used to protect against rejection in a transplant (ciclosporina) or antiretroviral medicines used to treat HIV/AIDS (ritonavir). These medicines may increase the effect ofvalsartán,
• lithium,a medicine used to treat certain types of psychiatric disorders.

Additionally:

• if you are beingtreatedafter suffering a heart attack,it is not recommended to combine withACE inhibitors(a medicine to treat heart attack),
• if you are being treated with anACE inhibitortogether with other specific medicines for the treatment of yourheart failure, known asmineralocorticoid receptor antagonists(MRAs) (such as spironolactone, eplerenone) orbeta-blockers(such as metoprolol).

Taking Valsartán Sandoz with food and drinks

You can take valsartán with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant (orif you plan to becomepregnant), consult your doctor or pharmacist before using this medicine.

• You must inform your doctorif you are pregnant(or if you suspect that you may be). In general, your doctor will advise you to stop taking valsartánbefore becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medicine instead of valsartán. Valsartán is not recommended at the beginning of pregnancy and should not be administered after the third month of pregnancy because it can cause serious harm to your baby when administered from that time.

• Inform your doctor if you are breastfeeding or plan to start.Valsartán is not recommended during breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

Before driving a vehicle, using tools or operating machinery, or performing other activities that require concentration, make sure you know your reactions to the effects of valsartán. Like many other medicines used to treat high blood pressure, valsartán may cause, in rare cases, dizziness and affect concentration.

To get the best results and reduce the risk of adverse effects, take this medication exactly as your doctor tells you to. Consult your doctor or pharmacist if you have any doubts. People with high blood pressure often do not notice any signs of the disease. Many feel normal. This makes it very important to attend your doctor's appointments, even if you feel well.

Adult patients with high blood pressure

The usual dose is 80 mg per day. In some cases, your doctor may prescribe higher doses (for example, 160 mg or 320 mg). You may also combine valsartan with another medication (for example, a diuretic).

Children and adolescents (6 to 18 years old) with high blood pressure

In patients weighing less than 35 kg, the usual dose is 40 mg of valsartan once a day. In patients weighing 35 kg or more, the initial usual dose is 80 mg of valsartan once a day. In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

Adult patients after a recent heart attack

After a heart attack, treatment usually starts at 12 hours, typically at a low dose of 20 mg administered twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

Valsartan can be taken with other treatments for a heart attack, and your doctor will decide what treatment is suitable for you.

Adult patients with heart failure

Treatment usually starts with 40 mg twice a day. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

Valsartan can be taken with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You can take valsartan with or without food. Swallow valsartan with a glass of water.

Take valsartan approximately at the same time every day.

If you take more Valsartan Sandoz than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartan Sandoz

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Valsartan Sandoz

If you stop taking valsartan, your condition may worsen. Do not stop taking the 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 may cause side effects, although not everyone will experience them.

Some symptoms require immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as:

• swelling in the face, lips, tongue, or throat,
• difficulty swallowing,
• hives, itching.

If you experience any of these symptoms, stop taking Valsartán Sandoz and contact your doctor immediately (see also section 2 “Warnings and precautions”).

The side effects include:

Frequent(may affect up to 1 in 10 people)

• dizziness,
• low blood pressure with symptoms such as dizziness and fainting when standing up,
• reduction in kidney function (signs of renal deterioration).

Rare (may affect up to 1 in 100 people)

• angioedema (see section “Some symptoms require immediate medical attention”),
• sudden loss of consciousness (syncope),
• sensation of rotation (vertigo),
• marked reduction in kidney function (signs of acute renal insufficiency),
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia),
• shortness of breath, difficulty breathing while lying down, swelling of the feet or legs (signs of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhea,
• fatigue,
• weakness.

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

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

Unknown(the frequencycannot be estimated from available data)

• skin blisters (symptom of bullous dermatitis),
• skin rash, itching, along with some of the following signs or symptoms: fever, joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to the flu (signs of serum disease),
• red purpuric spots, fever, itching (signs of inflammation of blood vessels, also known as vasculitis),
• unusual bleeding or bruising (signs of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat, or ulcers in the mouth due to infections (symptoms of low white blood cell count, also known as neutropenia),
• reduction in hemoglobin level and reduction in percentage of red blood cells in the blood (which, in severe cases, can cause anemia),
• increase in potassium level in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm),
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, can cause yellowing of the skin and eyes),
• increase in urea nitrogen level in the blood and increase in serum creatinine level (which may indicate renal anomalies),
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle cramps, and/or seizures).

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and kidney function reduction were observed less frequently in patients treated for hypertension than in patients treated for heart failure or after a recent heart attack.

Side effects in children and adolescents are similar to those detected in adults.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

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

Do not store above 86°F (30°C).

Store in the original packaging to protect it from moisture.

Do not use Valsartán Sandoz if you observe that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed ofthrough the drains orin the trash.Deposit the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of thepackaging and unusedmedicines. By doing so, you will help protect the environment.

Composition of Valsartán Sandoz 40 mg

- The active ingredient is valsartán. Each tablet contains 40 mg of valsartán.

- The other components are:

Core: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), macrogol 8000, iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172).

Appearance of the product and contents of the package

The film-coated tablets of Valsartán Sandoz 40 mg are yellow, oval-shaped, film-coated tablets with beveled edges, slightly convex, scored on one side with a "D" and an "O" on the other side, and with "NVR" on the opposite side of the tablet. The tablets can be divided into equal doses.

The tablets are presented in blister packs with 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100, or 280 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Ott-von-Guericke-allee 1,

39179 Barleben,

Germany

Ó

S.C. Sandoz S.R.L.

Str. Livezeni nr. 7A,

540472 Targu-Mures

Romania

Ó

LEK S.A.

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

Ó

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana,

Slovenia

Ó

Lek Pharmaceuticals d.d.

Trimlini 2D9220 Lendava

Slovenia

Ó

LEK, S.A.

Ul Podlipie, 16

Strykow - PL95-010

Poland

Ó

Novartis Farmacéutica S.A.

Gran Vía de les Corts Catalanes,

764,

08013 Barcelona

Spain

Ó

Novartis Farma S.p.A

Via Provinciale Schito 131

80058 Torre Annunziata

Italy

This medicine is authorized in the member states of the European Economic Area with the following names:

Chipre: Valsartan Sandoz 40 mg

Slovenia: Valsartan Lek 40 mg filmsko obložene tablete

France: Valsartan Sandoz 40 mg, comprimé pelliculé sécable

Greece: Valsartan/Sandoz

Netherlands: Valsartan Sandoz 40 mg, filmomhulde tabletten

Hungary: Valsartan Sandoz 40 mg filmtabletta

Norway: Valsartan Sandoz 40 mg tabletter, filmdrasjerte

Portugal: Valsartan Sandoz

Sweden: Valsartan Sandoz 40 mg filmdragerade tabletter

Last review date of this leaflet: February 2025

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/