Patient Information Leaflet: Information for the Patient

VALSARTÁN SUN 80 mg FILM-COATED TABLETS

valsartán

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Valsartán SUN

3. How to take Valsartán SUN

4. Possible side effects

5. Storage of Valsartán SUN

6. Contents of the pack and additional information

Valsartán SUN contains the active ingredient: valsartan 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 increased blood pressure. Valsartan acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán 80 mg film-coated tabletscan be used to treat 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.Valsartan 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 difficulty breathing 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 valsartan:

• if you areallergicto valsartan or to any of the other ingredients of this medication (listed in section 6).

• if you have aserious liver disease,

• if you aremore than 3 months pregnant(it is better to avoid valsartan during the first months of pregnancy – see Pregnancy section).

•if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén

If any of the above situations apply to you, inform your doctor and do not takevalsartan.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take valsartan:

• if you have a liver disease.

• if you have a serious kidney disease or if you 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 are being treated for a heart attack or heart failure, your doctor may

check your kidney function.

• if you have a serious heart disease other than heart failure or heart attack.

•if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking valsartan, stop taking valsartan immediately and never take it again. See also section 4 “Possible side effects”.

• if you are using medications that increase the amount of potassium in the blood. Among them are potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to control your potassium levels in the blood regularly.

• if you are under 18 years of age and take valsartan with other medications that inhibit the renin-angiotensin-aldosterone system (medications that lower blood pressure), your doctor

may check your kidney 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, it is not recommended to take valsartan.

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

• inform your doctor if you are pregnant (or if you suspect you may be). Valsartan is not recommended

to be used at the beginning of pregnancy, and in no case should it be administered if you are more than three months pregnant, as it may cause serious damage to your baby when administered from that moment on (see Pregnancy section).

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

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskirén

• if you are being treated with an ACE inhibitor along with other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone) or beta-blockers (for example, metoprolol).

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

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

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

If any of these situations apply to you, inform your doctor before takingvalsartan.

Taking valsartan with other medications

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

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

•other medications that lower blood pressure,especiallydiuretics(medications to increase urine production).

•medications that increase the amount of potassiumin the blood. Among them are potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.

•certain medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs).

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

•lithium,a medication used to treat certain types of psychiatric disorders.

•if you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Valsartan” and “Warnings and precautions”)

• If you are being treated for heart failure, it is not recommended to take the triple combination of ACE inhibitors and other medications specifically for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone) or beta-blockers (for example, metoprolol).”

Additionally:

• if you are being treated aftera heart attack,it is not recommended to combine withACE inhibitors(a medication to treat a heart attack),

Taking valsartan with food and drinks

You can take valsartan with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

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 valsartan before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of valsartan. Valsartan is not recommended to be used at the beginning of pregnancy, and in no case should it be administered from the third month of pregnancy as it may cause serious damage to your baby when administered from that moment on.

Inform your doctor if you are breastfeeding or plan to start breastfeeding.Valsartan is not recommended

to be used during breastfeeding, and your doctor will 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 machines, or engaging in other activities that require concentration, make sure you know how valsartan affects you. Like many other medications used to treat high blood pressure, valsartan may cause, in rare cases, dizziness and affect concentration.

To achieve 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.

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 appointments with the doctor, 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) with high blood pressure

In patients weighing less than35 kgthe recommended starting dose is 40 mg of valsartan once a day.

In patients weighing35 kgor 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 tablets, it is recommended to administer valsartan oral solution.

Adult patients after a recent heart attack:After a heart attack, treatment is usually initiated at 12 hours, normally, 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 increase this dose gradually over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

Valsartan may be administered in combination with other treatments for heart attack, and your doctor will decide what treatment is suitable for you.

Adult patients with heart failure:Treatment is usually initiated with 40 mg twice a day. Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

Valsartan may be administered in combination 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 SUN 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeValsartan SUN

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 doses.

If you interrupt treatment withValsartan SUN

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 medications, valsartan may cause side effects, although not everyone will experience them.

Some side effects can be severe 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

• urticaria, itching

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

Other side effects include:

Frequent (may affect up to 1 in 10 patients)

• dizziness

• low blood pressure with or without symptoms such as dizziness and fainting when standing up

• reduced kidney function (signs of renal deterioration)

Rare (may affect up to 1 in 100 patients)

• 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 patients)

Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency unknown (cannot be estimated from available data)

•blistering on the skin (sign of dermatitis bullosa)

• may occur allergic reactions with skin rash, itching, and urticaria; symptoms of fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to the flu (signs of serum sickness)

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

• more frequent bleeding or bruising than usual (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, may cause anemia)

• increase in potassium level in the blood (which, in severe cases, may 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, may cause the skin and eyes to turn yellow)

• increase in urea nitrogen level in the blood and increase in serum creatinine level (which may indicate renal anomalies).

• reduction in sodium level in the blood (which, may cause fatigue, confusion, muscle cramps, and/or seizures in severe cases).

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduced 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 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:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

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

This medication does not require special conditions for conservation.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you do not need. In this way, you will help protect the environment.

Composition of Valsartán SUN

The active ingredient is valsartan.

A film-coated tablet contains 80 mg of valsartan.

The other components are: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, pregelatinized cornstarch, talc.

The coating of the tablet contains hypromellose, titanium dioxide (E171), macrogol 400, macrogol 4000, talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the package

The film-coated tablets of Valsartán SUN 80 mg are orange in color, oval, scored on one face with the mark “V” on one side of the score and “2” on the other side of the score, and scored on the other.

The score serves to break and facilitate swallowing but not to divide into equal doses.

Valsartán SUN 80 mg is available in packages containing 14, 28, 30, 56, 84, 90, or 98 film-coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Responsible for Manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH, Hoofddorp

or

TERAPIA S.A.

124 Fabricii Street, 400 632 Cluj Napoca

Romania

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona.

Spain

Tel.: +34 93 342 78 90

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

Germany: VALSARTAN BASICS 80 mg/160 mg Filmtabletten

Italy: Valsartan SUN 80 mg/160 mg compresse rivestite con film

Spain: Valsartán SUN 80 mg/160 mg comprimidos recubiertos con película EFG

For more information about this product, please contact the holder of the marketing authorization.

Last review date of this leaflet: January 2025

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