Valsartan Pensa 160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valsartan Pensa 160 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this 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 consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Valsartan Pensa is and what it is used for
2. What you need to know before taking Valsartan Pensa
3. How to take Valsartan Pensa
4. Possible side effects
5. How to store Valsartan Pensa
6. Further information

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

Valsartán Pensa belongs to a class of medicines 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 narrow, resulting in increased blood pressure.

Valsartán Pensa works 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 for three different conditions:

• to treat high blood pressure in adults and in children and adolescents aged 6 to 18 years. High blood pressure increases the workload of the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart, and kidneys, and may lead to 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 within 12 hours to 10 days,
• to treat symptomatic heart failure in adult patients. Valsartán Pensa can be used for the treatment of symptomatic heart failure in adult patients. Valsartán Pensa is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication used to treat heart failure) cannot be used, or may be used in addition to ACE inhibitors when other heart failure treatments are not suitable.

Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This is caused by the heart muscle being unable to pump blood strongly enough to supply the body's needs.

2. Before taking Valsartán Pensa

Do not take Valsartán Pensa

• if you are allergic (hypersensitive) to valsartan or to any of the other ingredients of Valsartán Pensa listed at the end of this leaflet.
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is also advisable to avoid Valsartán Pensa during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Take special care with Valsartán Pensa

• if you have liver disease,

• if you have severe kidney disease or are undergoing dialysis,

• if you have narrowing of the artery to the kidney (renal artery stenosis),

• if you have recently undergone a kidney transplant (received a new kidney),

• if you are being treated for heart attack or heart failure, your doctor may check your kidney function,

• if you have a serious heart condition other than heart failure or heart attack,

• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin. Regular monitoring of blood potassium levels may be necessary,

• if you are under 18 years of age and take Valsartán Pensa together with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may periodically monitor your kidney function and blood potassium levels,

• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, taking Valsartán Pensa is not recommended,

• if you have lost a large amount of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretics (medicines that increase urine output),

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

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,

• aliskiren.

  • if you are being treated with an ACE inhibitor together with other specific medicines for heart failure treatment, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 should inform your doctor if you are pregnant (or suspect you might be). Use of Valsartán Pensa is not recommended during early pregnancy, and it must not be used after the third month of pregnancy, as it may cause serious harm to your baby from that stage onwards (see Pregnancy section).

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

Use of other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

The effect of treatment with Valsartán Pensa may be altered if taken together with certain medicines. Your doctor may need to adjust your dose and/or take other precautions or, in some cases, discontinue treatment with one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• other medicines that lower blood pressure, particularly diuretics (medicines that increase urine output), ACE inhibitors, or aliskiren (see also the information under the headings “Do not take Valsartán Pensa” and “Take special care with Valsartán Pensa”).

• medicines that increase potassium levels in blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin,

• certain medicines for pain known as non-steroidal anti-inflammatory drugs (NSAIDs),

• lithium, a medicine used to treat certain psychiatric conditions.

In addition:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medication used to treat heart attack) is not recommended,
• if you are being treated for heart failure, the triple combination with ACE inhibitors and other specific medicines for heart failure treatment, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol) is not recommended.

Taking Valsartán Pensa with food and drinks

You may take Valsartán Pensa with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

• Pregnancy

You must inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Valsartán Pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Valsartán Pensa. Use of Valsartán Pensa is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby from that stage.

• Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Valsartán Pensa is not recommended during breastfeeding. Your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving, operating tools or machinery, or performing other activities requiring concentration, make sure you know how Valsartán Pensa affects you. Like many other medicines used to treat high blood pressure, Valsartán Pensa may rarely cause dizziness and affect your ability to concentrate.

Important information about some of the ingredients of Valsartán Pensa

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

3. How to take Valsartán Pensa

To achieve the best results and reduce the risk of adverse effects, always take Valsartán Pensa exactly as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts. People with high blood pressure often do not experience any symptoms and may feel completely normal. Therefore, it is very important to keep your medical appointments, even if you feel well.

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

Children and adolescents (6 to 18 years of age) with high blood pressure

In patients weighing less than 35 kg, the usual dose is 40 mg of valsartan once daily.

In patients weighing 35 kg or more, the usual 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: Treatment is usually started within 12 hours after the heart attack, typically with a low starting 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 up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

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

Adult patients with heart failure: Treatment is usually started at 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan Pensa may be administered together with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

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

Take Valsartan Pensa at approximately the same time each day.

If you take more Valsartan 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 may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication 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 discontinue treatment with Valsartan Pensa, your condition may worsen. Do not stop taking the medicine unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, Valsartán Pensa may cause adverse effects, although not everyone experiences them.

These adverse effects may occur with certain frequencies, defined as follows:

• 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 of the face, lips, tongue, or throat,
• difficulty breathing or swallowing,
• hives, itching.

If you experience any of these symptoms, consult a doctor immediately.

Adverse effects include:

Common

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

Uncommon

• angioedema (see section “Some symptoms require immediate medical attention”),
• sudden loss of consciousness (syncope),
• sensation of spinning (vertigo),
• marked reduction in kidney function (signs of acute renal failure),
• muscle cramps, irregular heartbeat (signs of hyperkalaemia),
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhoea,
• fatigue,
• weakness.

Very rare:

• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

Frequency not known

• allergic reactions such as skin rash, itching, and hives; symptoms of fever, swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness),
• purplish red spots, fever, itching (signs of blood vessel inflammation, also called vasculitis),
• bleeding or bruising more easily 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 haemoglobin levels and reduction in the proportion of red blood cells in the blood (which, in severe cases, may lead to anaemia),
• increased blood potassium levels (which, in severe cases, may cause muscle cramps and irregular heartbeat),
• elevation of liver function test values (which may indicate liver injury), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes),
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate kidney function abnormalities).

The frequency of certain adverse effects may vary depending on your condition. For example, certain adverse 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.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán Pensa

• Store below 30°C. Keep in the original packaging to protect from moisture.

  • Keep out of the reach and sight of children.
  • Do not use Valsartán Pensa after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

• Do not use Valsartán 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. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Additional Information

Composition of Valsartán Pensa

• The active substance 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 corn starch (corn starch), povidone (E-1201), sodium stearyl fumarate, sodium lauryl sulfate, and crospovidone.

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

Valsartán Pensa 160 mg contains yellow/brown iron oxide (E-172).

Appearance of the product and contents of the package

Valsartán Pensa 160 mg are cylindrical, coated tablets, ocher in color, scored, and marked with the code “V2”.

The tablets are packaged in blister packs containing 28 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 most recent review of this leaflet: January 2025

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