Leaflet: information for the user

valsartán cinfa 160 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because 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 must 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 valsartán cinfa is and what it is used for

2.What you need to know before you start taking valsartán cinfa

3.How to take valsartán cinfa

4.Possible side effects

5Storage of valsartán cinfa

6.Contents of the pack and additional information

valsartán cinfa contains the active ingredient: valsartán and belongs to a class of medications known as angiotensin II receptor antagonists, which help control high blood pressure. The angiotensin II is a body substance 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 cinfa can be used to treat three different conditions:

• For treating high blood pressure in adults and in children and adolescents aged 6 years and under 18 years of age.

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 can 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.

• For treating adult patients after a recent heart attack (myocardial infarction). “Recent” means here between 12 hours and 10 days,
• For treating symptomatic heart failure in adult patients. Valsartán is used when it is not possible to use a group of medications called angiotensin-converting enzyme inhibitors ( ACEIs) s (a medication for treating heart failure), or it can be used added to ACEIs 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 valsartán cinfa

• if you areallergicto valsartán or to any of the other ingredients of this medicine (listed in section 6).
• if you have aserious liver disease.
• if you aremore than 3 months pregnant(it is better to avoid valsartán during the first months of pregnancy - see 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 apply to you, inform your doctor and do not take valsartán

Warnings and precautions

Consult your doctor or pharmacist before starting to take valsartán cinfa

• if you have 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 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 valsartán, stop taking valsartán 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. 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, valsartán is not recommended.
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medications to increase urine production).
• if you are taking any of the following medications used to treat high blood pressure:

• a medication that converts angiotensin to angiotensin II (ACE inhibitor) (such as enalapril, lisinopril, etc.), particularly 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).

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.

Your doctor may regularly check 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 cinfa”.

You should inform your doctor if you think you are (or could 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 could cause serious harm to your baby, if you take it during this period (see Pregnancy section).

Other medications and valsartán cinfa

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

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

• other medications that lower blood pressure,especiallydiuretics(medications to increase urine production), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskirén (see also the information under the headings “Do not take valsartán cinfa” 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 medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (in 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 disorders.

Additionally:

• if you are beingtreated after a heart attack,it is not recommended to combine withACE inhibitors(a medication to treat 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).

Taking valsartán cinfa 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, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• You must inform your doctorif you are pregnant(or if you suspect you may be). Your doctor will usually recommend that you stop taking valsartánbefore becoming pregnant or as soon as you know you are pregnant, and will recommend that you takeanother 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 could cause serious harm to your baby, if you take it during this period (see Pregnancy section).
• Inform your doctor if you are breastfeeding or plan to start.Valsartán is not recommended 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 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, in rare cases,

dizziness and affect concentration.

valsartán cinfa contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

valsartán cinfa contains sorbitol.

This medication contains 18.5 mg of sorbitol in each tablet.

valsartán cinfa contains sodium.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in 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 80mgper 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).

Use in children and adolescents (6 toless than18years of age) with high blood pressure

In patients weighing less than 35kg the recommended doseis 40mg of valsartan once a day.

In patients weighing 35kg or more the recommended starting doseis 80mg of valsartan once a day.

In some cases, your doctor may prescribe higher doses (the dose may be increased to160 mg and up to a maximum of 320 mg).

Adult patients after a recent heart attack:after a heart attack, treatment usually begins at 12hours, typically with a low dose of 20 mg, administered twice a day. The 20mgdose 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 heart attack, and your doctor will decide what treatment is suitable for you.

Adult patients with heart failure:treatment usually begins with 40mgtwice a day. Your doctor will gradually increase the dose over several weeks to a maximum of 160mg 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 foryou.

You can take valsartan with or without food. Swallow valsartan with a glass of water. Take Valsartan approximately at the same time every day.

The tablet can be split into equal doses.

If you take more valsartan cinfa than you should

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take valsartan cinfa

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 missed doses.

If you interrupt treatment with valsartan cinfa

If you stop taking your medication, your condition may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

Some side effects can be serious and may require immediate medical attention:

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

If you experience any of these symptoms, stop taking valsartan 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):

Rare(may affect up to 1 in 100 patients):

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

Frequency not known(cannot be estimated from available data):

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 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 Pharmacovigilance of Medicines for Human Use:http://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 store at a temperature above 30°C.

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

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of valsartan cinfa

• The active ingredient is valsartan. Each tablet contains 160 mg of valsartan.
• The other components are:

Tablet core: microcrystalline cellulose (E-460), anhydrous colloidal silica, sorbitol (E-420), magnesium carbonate (E-504), pregelatinized cornstarch, povidone (E-1201), stearate fumarate and sodium, lauryl sulfate of sodium, and crospovidone.

Coating: Opadry OY-L-28900 (lactose monohydrate, hypromellose (E-464), titanium dioxide (E-171), and macrogol) andyellow/brown iron oxide (E-172).

Appearance of the product and contents of the packaging

valsartan cinfa 160 mg are film-coated, cylindrical, ochre-colored, scored, and marked with the code “V2”.

PVC/PVDC-Aluminum blisters and are available in packaging with 28, 56, or 280 (clinical packaging) tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Cinfa, S.A. Laboratories

Carretera Olaz-Chipi 10. Industrial Park Areta

31620 Huarte (Navarra) Spain

Last review date of this leaflet:February 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/70323/P_70323.html

QR code to:https://cima.aemps.es/cima/dochtml/p/70323/P_70323.html