VALSARTAN PENSA 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan Pensa 40 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the pack

1. What is Valsartan Pensa and what is it used for
2. Before you take Valsartan Pensa
3. How to take Valsartan Pensa
4. Possible side effects
5. Storage of Valsartan Pensa
6. Further information

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

Valsartan Pensa 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 Pensa works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartan Pensa 40 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in children and adolescents from6 to18years 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 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 Pensa can be used to treat symptomatic heart failure in adult patients. Valsartan Pensa is used when it is not possible to use a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure), or it can be used in addition to ACE 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 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. Before you take Valsartan Pensa

Do not take Valsartan Pensa

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of Valsartan Pensa, listed at the end of this leaflet.
• if you have severe liver disease.
• if you are pregnant for more than 3 months.(it is also better to avoid Valsartan Pensa 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 containing aliskiren.

If any of these situations apply to you, do not take Valsartan Pensa.

Be particularly careful with Valsartan Pensa

• if you have liver disease,
• if you have severe kidney disease or are undergoing dialysis,
• if you have narrowing of the kidney artery,
• if you have recently undergone a kidney transplant (received a new kidney),
• if you are being treated for a heart attack or heart failure, your doctor may check your kidney function,
• if you have severe heart disease other than heart failure or heart attack,
• if you are taking 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 are under 18 years of age and take Valsartan Pensa with other medications that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may periodically check your kidney function and blood potassium levels,
• 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 Pensa,
• 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 medications used to treat high blood pressure:

• a blood pressure-lowering medicine called an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren
  • if you are being treated with an ACE inhibitor along with other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.

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

See also the information under the heading "Do not take Valsartan Pensa."

You must inform your doctor if you are pregnant (or if you think you might be). It is not recommended to use Valsartan Pensa at the start of pregnancy, and in no case should it be administered if you are pregnant for more than three months, as it may cause serious harm to your baby when administered from that time on (see section Pregnancy).

If any of these situations apply to you, inform your doctor before taking Valsartan Pensa.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

The effect of treatment with Valsartan Pensa 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, interrupt treatment with one of the medications. This applies to both prescription and non-prescription medications, especially:

• other blood pressure-lowering medicines, especially diuretics(medicines to increase urine production), ACE inhibitors, or aliskiren(see also the information under the headings "Do not take Valsartan Pensa" and "Be particularly careful with Valsartan Pensa").
• 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),
• lithium, a medicine used to treat certain types of psychiatric disorders.

Additionally:

• if you are being treated after a heart attack, it is not recommended to combine with ACE inhibitors(a medication for treating a heart attack),
• if you are being treated for heart failure, it is not recommended to combine with ACE inhibitorsand other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs)(e.g., spironolactone, eplerenone) or beta-blockers(e.g., metoprolol).

Taking Valsartan Pensa with food and drinks

You can take Valsartan Pensa with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

• Pregnancy

You must inform your doctor if you are pregnant (or if you think you might be).Your doctor will normally advise you to stop taking Valsartan Pensa before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Valsartan Pensa. It is not recommended to use Valsartan Pensa at the start of pregnancy and in no case should it be administered if you are pregnant for more than three months, as it may cause serious harm to your baby when administered from that time on.

• Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. It is not recommended to use Valsartan Pensa 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 using machines

Before driving a vehicle, using tools, or operating machinery, or performing other activities that require concentration, make sure you know how Valsartan Pensa affects you. Like many other medicines used to treat high blood pressure, Valsartan Pensa can cause, in rare cases, dizziness and affect your ability to concentrate.

Important information about some of the ingredients of Valsartan Pensa

This medicine contains lactose and sorbitol. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Valsartan Pensa

To get the best results and reduce the risk of side effects, always take Valsartan Pensa exactly as your doctor tells you. 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.

Children and adolescents (6 to18years of age) with high blood pressure

In patients who weigh less than 35 kg, the usual dose is 40 mg of valsartan once a day.

In patients who weigh 35 kg or more, the usual starting dose is 80 mg of valsartan 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).

Adult patients after a recent heart attack:after a heart attack, treatment usually starts within 12 hours, normally with a low dose of 20 mg given twice a day. 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 a day. The final dose will depend on your particular tolerance.

Valsartan Pensa can be given with other treatments for heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure:treatment usually starts with 40 mg twice 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 particular tolerance.

V

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

Take Valsartan Pensa approximately at the same time each day.

If you take more Valsartan Pensa than you should

If you notice a strong 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan Pensa

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Valsartan Pensa

If you stop your treatment with Valsartan Pensa, your condition may worsen. Do not stop taking the medicine unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, Valsartan Pensa can cause side effects, although not everybody gets them.

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

• very common: may affect more than 1 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,
• frequency not known: 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
• hives, 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,
• reduced kidney function (signs of kidney impairment).

Uncommon

• angioedema (see section "Some symptoms require 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.

Very rare:

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

Frequency not known

• 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),
• purplish red spots, fever, itching (signs of vasculitis, also known as inflammation of blood vessels),
• 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 known as neutropenia),
• reduction in hemoglobin levels 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 urea nitrogen and creatinine serum levels (which may indicate kidney function abnormalities).

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 side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through 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 Pensa

• Store below 30°C. Store in the original packaging to protect from moisture.
• Keep out of the reach and sight of children.
• Do not use Valsartan Pensa after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

• Do not use Valsartan Pensa if you notice that the packaging is damaged or shows signs of tampering.
  • Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Additional Information

Composition of Valsartán Pensa

• The active ingredient is valsartan.
• Each tablet contains 40 mg of valsartan.
• The other components are:

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

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

Appearance of the Product and Packaging Contents

Valsartán Pensa 40 mg film-coated tablets are film-coated, cylindrical, yellow, scored, and marked with the code "V".

The tablets are presented in blister packs of 14 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 – Polígono Areta

31620 Huarte-Pamplona (Navarra)

Spain

Date of the Last Revision of this Leaflet:January 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/