Package Leaflet: Information for the User

valsartán cinfa 320 mg film-coated tablets

Read this leaflet carefully before you start to take 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 their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

valsartán cinfa contains the active ingredient: valsartán and belongs to a class of medicines 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 an increase in blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a consequence, blood vessels relax and blood pressure decreases.

valsartán cinfacan be usedto treat high blood pressure in adults and in children and adolescents from 6 to less than 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.

Do not take valsartán cinfa

• if you are allergic to valsartán 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 better to avoid valsartán during the first months of pregnancy; see the pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine 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 doctoror pharmacist before starting to take valsartán cinfa

• 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 (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 valsartán, stop taking valsartán 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 checked regularly,
• 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 taking any of the following medicines used to treat high blood pressure:
• • a medicine that blocks the enzyme that converts angiotensin (ACE inhibitor) (such as enalapril, lisinopril, etc.), particularly if you have kidney problems related to diabetes.
  • aliskirén

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 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 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 taken during this period (see the pregnancy section).

Other medicines and valsartán cinfa

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 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, especiallydiuretics(medicines 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”)
• medicines that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin,
• certain pain medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• 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 valsartán.
• litium, a medicine used to treat certain types of psychiatric diseases.

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 must 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 will recommend that you take another medicine instead of valsartán. Valsartán is not recommended at the beginning of pregnancy, and it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.

• Inform your doctor if you are breastfeeding or are about 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 machines

Before driving a vehicle, using tools, or operating machines, or performing other activities that require concentration, make sure you know how valsartán affects you. Like many other medicines used to treat high blood pressure, valsartánmay 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 them before taking this medicine.

valsartán cinfa contains sorbitol

This medicine contains 37.0 mg of sorbitol in each tablet.

valsartán cinfa contains sodium.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. 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 valsartán with another medication (e.g. a diuretic).

Use in children and adolescents (6 to less than 18 years of age) with high blood pressure

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

In patients weighing 35 kg or more, the recommended starting dose is 80 mg of valsartán 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).

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

The tablet can be split into equal doses.

If you take more valsartán 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take valsartán 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 make up for the missed doses.

If you interrupt treatment with valsartán cinfa

If you stop taking valsartán, 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 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 pointof 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 film-coated tablet contains 320 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, laurilsulfate of sodium and crospovidone.

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

Appearance of the product and contents of the packaging

valsartan cinfa 320 mg are film-coated tablets, oblong, biconvex, violet-gray in color, scored and marked with the code “V3”.

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

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

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/73290/P_73290.html

QR code to:https://cima.aemps.es/cima/dochtml/p/73290/P_73290.html