Leaflet: information for the user

Valsartan pensa 160 mg film-coated tablets

Read this leaflet carefully before you start taking the medicine.

• 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, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist. See section 4.

1. What Valsartan Pensa is and what it is used for

2. What you need to know before you start taking Valsartan Pensa

3. How to take Valsartan Pensa

4. Possible side effects

5. Storage of Valsartan Pensa

6. Additional information

Valsartán Pensa belongs to a class of medications 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 Pensa acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Pensa 160 mg film-coated tablets can be used to treat three different conditions:

• to treat high blood pressure in adults and in children and adolescents aged 6 to 18 years old. The 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. Valsartán Pensa can be used to treat symptomatic heart failure in adult patients. Valsartán Pensa is used when it is not possible to use a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication to treat heart failure), or it can be used added to angiotensin-converting enzyme 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 Valsartán Pensa

• if you areallergic(hypersensitive) to valsartán or to any of the other components of Valsartán Pensa, listed at the end of this prospectus.
• if you have asevere liver disease.
• if you arepregnant more than 3 months(it is better to avoid Valsartán Pensa also during the first months of pregnancy - see Pregnancy section).
• if you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskirén

If any of these situations affect you, do not take Valsartán Pensa.

Be especially careful with Valsartán Pensa

• if you have liver disease,
• if you have a severe 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 renal function,
• if you have a severe heart disease other than heart failure or heart attack,
• 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 regularly control the amount of potassium in the blood,
• if you are under 18years of age and take Valsartán Pensaalong with other medications that inhibit the renin-angiotensin-aldosterone system (medications that lower blood pressure), your doctor may periodically check your renal function and the amount of potassium in your blood,
• if you have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Valsartán Pensa 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 elimination),
• if you are taking any of the following medications used to treat high blood pressure:

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

- aliskirén.

• 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) (for example, spironolactone, eplerenone) or beta-blockers (for example, metoprolol).

Your doctor may periodically check your renal function, blood pressure, and electrolyte levels (such as potassium) in the blood.

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

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

You must inform your doctor if you are pregnant (or if you suspect you may be).Valsartán Pensa is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point on (see Pregnancy section).

If any of these situations affect you, inform your doctor before taking Valsartán Pensa.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

The effect of treatment with Valsartán Pensa may be altered if taken with certain medications. Your doctor may need to modify your dose and/or take other precautions or, in some cases, discontinue 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 elimination),ACEIsoraliskirén(see also the information under the headings “Do not take Valsartán Pensa” and “Be especially careful with Valsartán Pensa”).

• 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,
• certainmedications for pain reliefcalled nonsteroidal anti-inflammatory drugs (NSAIDs)(AINEs),
• litium,a medication used to treat certain types of psychiatric disorders.

Additionally:

• if you are beingtreatedafter a heart attack,the combination withACEIs(a medication for treating a heart attack) is not recommended,
• if you are beingtreatedfor heart failure,the triple combination withACEIsand other specific medications for the treatment of your heart failure,known as mineralocorticoid receptor antagonists (MRAs)(for example, spironolactone, eplerenone) orbeta-blockers(for example, metoprolol) is not recommended.

Taking Valsartán Pensa with food and drinks

You can take Valsartán Pensawith or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

• Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be).Your doctor will generally recommend that you stop taking Valsartán Pensa before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Valsartán Pensa. Valsartán Pensa is not recommended for use at the beginning of pregnancy and 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.

• Breastfeeding

Inform your doctor if you are breastfeeding or plan to start.Valsartán Pensa is not recommended for use 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 engaging in other activities that require concentration, make sure you know how Valsartán Pensa affects you. Like many other medicationsused to treat high blood pressure, Valsartán Pensamay cause, in rare cases, dizziness and affect concentration.

Important information about some of the components of Valsartán Pensa

This medication contains lactose and sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

To get the best results and reduce the risk of side effects, take Valsartán Pensa exactly as your doctor tells you to. Consult your doctor or pharmacist if you have any doubts. 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 your doctor, even if you feel well.

Adult patients with high blood pressure:The usual dose is 80mg per day. In some cases, your doctor may prescribe higher doses (e.g. 160mg or 320mg). You may also combine Valsartán Pensa with another medication (e.g. a diuretic).

Children and adolescents (6 to18years old) with high blood pressure

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

In patients weighing 35kg or more, the usual starting dose is 80mg of valsartán once a day.

In some cases, your doctor may prescribe higher doses (the dose may be increased to160mg and up to a maximum of 320mg).

Adult patients after a recent heart attack:After a heart attack, treatment usually starts at 12hours, usually 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.

ValsartánPensamay 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 starts with 40mgtwice a day. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

ValsartánPensamay be taken with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You can take Valsartán Pensa with or without food. Swallow Valsartán Pensa with a glass of water.

Take Valsartán Pensa approximately at the same time every day.

If you take more Valsartán Pensa 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. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartán Pensa

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 Pensa

If you stop taking Valsartán Pensayour 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 product, ask your doctor or pharmacist.

Like all medicines, Valsartán Pensamay cause side effects, although not everyone will experience them.

These side effects may occur with certain frequencies, which are defined below:

• Very common: may affect more than one in 10 people,
• Common: may affect up to 1 in 10 people,
• Uncommon: may affect up to 1 in 100 people,
• Rare: may affect up to 1 in 1,000 people,
• Very rare: may affect up to 1 in 10,000 people,
• Unknown frequency: the frequency cannot be estimated from the available data.

Some symptoms 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, consult a doctor immediately.

The side effects include:

Common

• Dizziness,
• Low blood pressure with or without symptoms such as dizziness and fainting when standing up,
• Reduction in kidney function (signs of renal deterioration).

Uncommon

• 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:

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

Unknown frequency

• 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),
• Reddish-purple spots, fever, itching (signs of inflammation of blood vessels, also called vasculitis),
• Bleeding or bruising more frequently 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 called neutropenia),
• Reduction in hemoglobin level and reduction in percentage of red blood cells in the blood (which, in severe cases, may cause anemia),
• Increased 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),
• Increased urea nitrogen level in the blood and increased serum creatinine level (which may indicate renal anomalies).

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and kidney function reduction 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.

The 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, pharmacist, or nurse, 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.

-Conserve below30°C.Conserve in the original packaging to protect it from humidity.

• Maintain out of reach and sight of children.
• Do not use Valsartán Pensa after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

-Do not use Valsartán Pensa if you observe that the packaging is damaged or shows signs of manipulation

• Medicines should not be thrown down the drains or in the trash. Deposit the packaging and medicines that you do not need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help to protect the environment.

Composition of Valsartán Pensa

• 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 (cornstarch), povidone (E-1201), stearate of fumaric acid and sodium, lauryl sulfate of sodium, and crospovidone.

Coating: Opadry OY-L-28900 (monohydrate lactose (lactose), hypromellose (E-464), titanium dioxide (E-171), and macrogol).

Valsartán Pensa160mg contains iron oxide yellow/brown (E-172).

Appearance of the product and contents of the package

Valsartán Pensa 160 mg are coated, cylindrical, ochre-colored, scored, and marked with the code “V2” tablets.

The tablets are presented in blister packs with 28 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 – Areta Industrial Estate

31620 Huarte-Pamplona (Navarra)

Spain

Last review date of this leaflet:January 2025

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