Leaflet: information for the user

valsartán cinfa 80 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to 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. 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 cinfacan be used to treat three different conditions:

• For treating high blood pressure in adults and in children and adolescents aged6 toless than 18years 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 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.
• 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 (ACE inhibitors) (a medication for treating heart failure), or it can be used in addition to ACE inhibitors when other medications for treating heart failure cannot be used.

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 cinfa

• if you areallergicto valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe liver disease.
• if you are more than 3 months pregnant (it is best to avoid valsartan during the first months of pregnancy - see the Pregnancy section).

• if you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take valsartan cinfa

• if you have liver disease
• if you have a 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.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (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 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 have aldosteronism, a condition 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 (medicines that increase urine production).

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

• a medicine that blocks the conversion of angiotensin (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren

• if you are being treated with an ACE inhibitor along with other medicines 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 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 cinfa”.

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

Other medicines and valsartan cinfa

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

The effect of valsartan treatment 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, stop treatment with one of the medicines. This applies to both prescription and non-prescription medicines, especially:

-Other medicines that lower blood pressure,especially diuretics (medicines that increase urine production), ACE inhibitors (such as enalapril, lisinopril, etc…), or aliskiren (see also the information under the headings “Do not take valsartan cinfa” and “Warnings and precautions”).

-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.

-Certain pain medicinescalled nonsteroidal anti-inflammatory drugs (NSAIDs)(AINEs)

-Some antibiotics (in the rifampicin group), a medicine used to protect against rejection in a transplant (ciclosporina) or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of valsartan.

-Lithium,a medicine used to treat certain types of psychiatric disorders.

Additionally:

• if you are beingtreatedafter a heart attack,it is not recommended to combine withACE inhibitors(a medication for treating a heart attack).
• if you are beingtreatedfor heart failure,it is not recommended to take the triple combination withACE inhibitorsandother medicines specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs)(such as spironolactone, eplerenone)or beta-blockers(such as metoprolol).

Taking valsartan cinfa with food and drinks

You can take valsartan with or without food.

Pregnancy and breastfeeding

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

You should inform your doctor if you arepregnantor if you suspect you may bepregnant. Your doctor will usually recommend that you stop taking valsartan before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine instead of valsartan. Valsartan is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant as it could cause serious harm to your baby, if taken during this period (see the Pregnancy section).

Inform your doctor if you are breastfeeding or plan to start breastfeeding.Valsartan is not recommended during breastfeeding, and your doctor will 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 how valsartan affects you. Like many other medicines used to treat high blood pressure, valsartan may cause, in rare cases, dizziness and affect concentration.

Valsartan cinfa contains lactose.

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

Valsartan cinfa contains sorbitol

This medicine contains 9.25 mg of sorbitol in each tablet.

Valsartan cinfa contains sodium

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

Follow exactly the administration instructions of this medication as 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 to less than18years of age) with high blood pressure

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

In patients weighing 35kg or more, the recommended starting dose is 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 a 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 takenwithother 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 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 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 the missed doses.

If you interrupt treatment with valsartan cinfa

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 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 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 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. By doing so, you will help protect the environment.

Composition of valsartan cinfa

• The active ingredient is valsartan. Each tablet contains 80 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.

Covering:Opadry OY-L-28900 (lactose monohydrate, hypromellose (E-464), titanium dioxide (E-171) and macrogol)and red iron oxide (E-172).

Appearance of the product and contents of the packaging

valsartan cinfa 80 mg are film-coated, cylindrical, pink, scored tablets marked with the code “V1”.

PVC/PVDC-Aluminum blisters 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 Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) Spain

Last review date of this leaflet:February 2025

Detailed information about this medicine 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 medicine 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/70324/P_70324.html

QR code to:https://cima.aemps.es/cima/dochtml/p/70324/P_70324.html