VALSARTAN CINFA 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

valsartan cinfa 160 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is valsartan cinfa and what is it used for
2. What you need to know before you take valsartan cinfa
3. How to take valsartan cinfa
4. Possible side effects

5 Conservation of valsartan cinfa

1. Contents of the pack and further information

1. What is valsartan cinfa and what is it used for

valsartan cinfa contains the active substance: valsartan and belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

valsartan cinfa can be used for three different conditions:

• To treat high blood pressure in adults and in children and adolescents from6 toless than 18years of age.

High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels in the brain, heart, and kidneys, and can lead to a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels 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 medicines called angiotensin-converting enzyme inhibitors (ACEIs) (a medication to treat heart failure), or it can be used in addition 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 the feet and legs due to fluid retention. This is because the heart muscle cannot pump blood with enough force to provide all the blood needed for the body.

2. What you need to know before you take valsartan cinfa

Do not take valsartan cinfa

• if you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe liver disease.
• if you are pregnant more than 3 months(it is also better to avoid valsartan during the first months of pregnancy - see section Pregnancy).
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If any of the above applies to you, tell 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 severe kidney disease or are undergoing dialysis.
• if you have a narrowing of the kidney artery.
• if you have recently undergone a kidney transplant (received a new kidney),
• if you have 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 medications (including ACEIs), inform your doctor. If you have these symptoms when taking valsartan, stop treatment with 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. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. It may be necessary to regularly check 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 valsartan.
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine elimination).
• if you are taking any of the following medications used to treat high blood pressure:

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

• if you are being treated with an ACEI along with other specific medications for the treatment of 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) in the blood at regular intervals.

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

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

Other medicines and valsartan cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of treatment with valsartan may be affected if taken with certain medicines. Your doctor may need to change 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 to increase urine elimination), ACEIs (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 potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (cyclosporine), 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 illnesses.

In addition:

• if you are being treated after a heart attack,it is not recommended to combine with ACEIs(a medication to treat a heart attack).
• if you are being treated for heart failure,it is not recommended to combine with ACEIs and other specific medications for the treatment of 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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You must tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of valsartan. It is not recommended to take valsartan during the first few months of pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby.
• Tell your doctor if you are breast-feeding or about to start breast-feeding. Valsartan is not recommended during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, especially if your baby is newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how valsartan affects you. Like many other medicines used to treat high blood pressure, valsartan can cause, in rare cases,

dizziness and affect your ability to concentrate.

valsartan cinfa contains lactose.

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

valsartan cinfa contains sorbitol.

This medicine contains 18.5 mg of sorbitol in each tablet.

valsartan cinfa contains sodium.

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

3. How to take valsartan cinfa

Follow exactly the instructions of administration of this medicine 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 appointments with the doctor, even if you feel well.

Adult patients with high blood pressure: The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Valsartan can also be combined with another medicine (e.g., a diuretic).

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

In patients who weigh less than 35 kg, the recommended dose is 40 mg of valsartan once daily.

In patients who weigh 35 kg or more, the recommended starting dose is 80 mg of valsartan once daily.

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).

Adult patients after a recent heart attack:after a heart attack, treatment is usually started at 12 hours, normally with a low dose of 20 mg, given twice daily. 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 daily. The final dose will depend on your individual tolerance. Valsartan can be given 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 started with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan can be given 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 at approximately the same time each day.

The tablet can be divided into equal doses.

If you take more valsartan cinfa than you should

If you notice a strong 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, telephone 91 562 04 20, indicating the medicine 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 make up for missed doses.

If you stop taking valsartan cinfa

If you stop your treatment with valsartan, your disease may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and may need 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 valsartan and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects include:

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

• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing up.
• reduced kidney function (signs of kidney impairment).

Uncommon(may affect up to 1 in 100 people):

• angioedema (see section “Some symptoms need immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of spinning (vertigo)
• marked reduction in kidney function (signs of acute kidney failure)
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• fatigue
• weakness

Rare(may affect up to 1 in 10,000 people):

• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• blistering of the skin (sign of bullous dermatitis)
• allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and joint pain, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness)
• red purple spots, fever, itching (signs of vasculitis)
• bleeding or bruising more often than usual (signs of thrombocytopenia),
• muscle pain (myalgia)
• fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also called neutropenia)
• reduction in hemoglobin 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 an abnormal heart rhythm)
• elevation of liver function values (which may 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 blood urea nitrogen and increase in serum creatinine levels (which may indicate kidney function abnormalities)
• low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle twitching, and/or convulsions)

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 with high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan Cinfa

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any unused medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of cartons and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valsartan Cinfa

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

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

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

Appearance of the Product and Package Contents

Valsartan Cinfa 160 mg are film-coated tablets, cylindrical, ochre in color, scored, and marked with the code “V2”.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi 10. Polígono Industrial Areta

31620 Huarte (Navarra) Spain

Date of Last Revision of this Leaflet:February 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (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 carton with your mobile phone (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