Prospect: Information for the User

Valsartán Aurovitas 80 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to others even if they 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 prospect. See section 4.

1.What is Valsartán Aurovitas and what it is used for

2.What you need to know before starting to take Valsartán Aurovitas

3.How to take Valsartán Aurovitas

4.Possible adverse effects

5.Storage of Valsartán Aurovitas

6.Contents of the package and additional information

Valsartán Aurovitas contains the active ingredient: valsartán and belongs to a class of medications known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in an increase in blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Aurovitas 80 mg film-coated tablets can be used for three different conditions:

? to treat high blood pressure in adults and in children and adolescents aged 6 to less than 18 years. 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 12 hours and 10 days.

• ? to treat symptomatic heart failure in adult patients. Valsartán is used when it is not possible to use a group of medications called angiotensin-converting enzyme (ACE) inhibitors (a medication to treat heart failure), or it may be used added 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 difficulty breathing and swelling of the 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 Aurovitas

?if you areallergicto valsartán or to any of the other ingredients of this medicine (listed in section 6).

?if you havesevere liver disease.

?if you arepregnantmore than 3 months(it is also recommended to avoid Valsartán Aurovitas at the beginning of pregnancy - see the Pregnancy section).

?if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskirén.

If any of the above situations affect you,inform your doctor and do not take valsartán.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartán Aurovitas.

?if you have liver disease.

?if you have severe kidney disease or are undergoing dialysis.

?if you have a narrowing of the kidney artery.

?if you have recently undergone a kidney transplant (you received a new kidney).

?if you have a severe heart disease other than heart failure or heart attack.

?inform your doctor if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking other medications (including ACE inhibitors). If these symptoms appear while taking valsartán, stop taking the medicine immediately and do not take it again. See also the section 4 “Possible side effects”.

?if you are using medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to regularly control the amount of potassium in the blood.

?if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take valsartán.

?if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine elimination).

?if you are taking any of the following medications used to treat high blood pressure:

-an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril),especially if you have kidney problems related to diabetes.

-aliskirén.

?if you are being treated with an ACE inhibitor along with other medications specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Your doctor may need to regularly control your kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood.

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

You should inform your doctor if you think you are (or may be) pregnant. Valsartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see the Pregnancy section).

Other medicines and Valsartán Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

?other blood pressure-lowering medications, especiallydiuretics(medications to increase urine elimination), ACE inhibitors(such as enalapril, lisinopril, etc.) or aliskirén (see also the information under the headings “Do not take Valsartán Aurovitas” and “Warnings and precautions”).

?medications that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.

?certain pain medicationscalled nonsteroidal anti-inflammatory drugs (NSAIDs).

?some antibiotics (from the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of valsartán.

?lithium, a medication used to treat certain types of psychiatric diseases.

Additionally:

?ifyou are beingtreated after a heart attack,it is not recommended to combine withACE inhibitors(a medication for treating a heart attack).

?if you are being treated forheart failure,it is not recommended to take a triple combination withACE inhibitors and other medications specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers(such as metoprolol).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

?You should inform your doctor if you are pregnant (or if you suspect you may be).Your doctor will usually recommend that you stop taking valsartán before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of valsartán.

Valsartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period.

?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 want to breastfeed, especially if your baby is newborn or premature.

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 how valsartán affects you. Like many other medications used to treat high blood pressure, valsartán may cause dizziness and affect concentration.

Valsartán Aurovitas containslactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Valsartán Aurovitas containssodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.

To get the best results and reduce the risk of adverse effects, follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. 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 recommended dose is 80 mg per day. In some cases, your doctor may prescribe higher doses (e.g. 160 mg or 320 mg). You may also combine valsartan with another medication (e.g. a diuretic).

Children and adolescents (6 years old or less than 18 years of age) with high blood pressure

In patients weighing less than35kg, the recommended starting dose is 40 mg of valsartan once a day.

In patients weighing35kg or more, the recommended starting 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).

In children who have difficulty swallowing the tablets, oral solution administration is recommended.

Adult patients after a recent heart attack

After a heart attack, treatment usually starts at 12 hours, typically with 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 Aurovitas with or without food. Swallow the tablet with a glass of water. Take the medication approximately at the same time every day.

If you take more Valsartan Aurovitas than you should

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

If you forget to take Valsartan Aurovitas

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 compensate for the missed dose.

If you interrupt treatment with Valsartan Aurovitas

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 can cause side effects, although not everyone will experience them.

Some side effects may be serious and may 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 breathing or swallowing

?hives, itching

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

Other side effects include:

Frequent(may affect up to 1 in 10 people):

?dizziness

?low blood pressure with or without 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 spinning (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

Unknown frequency(cannot be estimated from available data):

?skin blisters (sign of bullous dermatitis)

?allergic reactions with skin rash, itching, and hives; symptoms of serum sickness, such as fever, swelling, and pain in the joints, muscle pain, swelling of the lymph nodes, and/or symptoms similar to the flu

?red purpura spots, fever, itching (signs of vasculitis, also known as inflammation of the blood vessels)

?excessive bleeding or petechiae (signs of thrombocytopenia)

?muscle pain (myalgia)

?fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia)

?reduction in hemoglobin levels and reduction in the percentage of red blood cells in the blood (which, in severe cases, can cause anemia)

?increase in potassium levels in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm)

?elevation of liver function values (which can indicate liver damage), including an increase in bilirubin levels in the blood (which, in severe cases, can cause the skin and eyes to turn yellow)

?increase in urea nitrogen levels in the blood and increase in serum creatinine levels (which can indicate renal anomalies)

?low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle fasciculations, and/or convulsions)

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

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

Reporting of 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 the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on 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 box after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

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

Composition of Valsartán Aurovitas

-The active ingredient is valsartán. Each film-coated tablet contains 80 mg of valsartán.

-The other components are:

Core of the tablet:microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, crospovidone (type B), hypromellose, sodium lauryl sulfate, talc, magnesium stearate.

Coating of the tablet:hypromellose, titanium dioxide (E171), macrogol 8000, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the package

Film-coated tablets of a light red color, round, bisected, biconvex, with the mark “I” on one face and “74” on the other, with a groove separating the numbers 7 and 4.

The tablet can be divided into equal doses.

Valsartán Aurovitas film-coated tablets are available in blister packs.

Package sizes:14, 28, and 56 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Last review date of this leaflet: April 2021

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