Valsartan Pensa 320 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valsartan Pensa 320 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 only; do 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. Before you take Valsartan Pensa
3. How to take Valsartan Pensa
4. Possible side effects
5. How to store Valsartan Pensa
6. Contents of the pack and other 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 320 mg film-coated tablets can be used

• to treat high blood pressure in adults and in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may damage the blood vessels of the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. Before taking Valsartán Pensa

Do not take Valsartán Pensa:

• if you are allergic (hypersensitive) to valsartan or to any of the other components of Valsartán Pensa listed at the end of this leaflet,
• if you have a severe liver disease,
• if you are more than 3 months pregnant (it is also better 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 a liver disease,

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

• if you have a narrowing of the renal 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 a serious heart disease other than heart failure or heart attack,

• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, 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 diarrhea, vomiting, or high doses of diuretics (medicines that increase urine output),

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

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

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

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 suspect you might be). Use of Valsartán Pensa is not recommended during early pregnancy, and it must not be administered after the third month of pregnancy, as it may cause serious harm to your baby when used from that point onward (see Pregnancy section).

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

Use of other medicines

Inform 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 Valsartán Pensa may be altered when 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 information under the headings “Do not take Valsartán Pensa” and “Take special care with Valsartán Pensa”),
• medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin,
• certain pain medicines known as non-steroidal anti-inflammatory drugs (NSAIDs),
• lithium, a medicine used to treat certain psychiatric disorders.

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 using any medicine.

• Pregnancy: 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 another medicine instead of Valsartán Pensa. Use of Valsartán Pensa is not recommended during early pregnancy, and it must not be administered after the third month of pregnancy, as it may cause serious harm to your baby from that stage onward.

• Breastfeeding

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

Driving and using machines

Before driving, operating tools, handling machinery, or engaging in 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 components of Valsartán Pensa

This medicine contains lactose and sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult with 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 perfectly well. This makes it very important to attend your medical appointments regularly, even if you feel fine.

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). Your doctor may also combine valsartan 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).

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

Take Valsartán Pensa at approximately the same time each 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 may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 your next dose, skip the missed dose.

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

If you stop taking Valsartán Pensa

If you stop treatment with Valsartán Pensa, your condition may worsen. Do not stop taking this 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 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: 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 kidney 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, abnormal heart rhythm (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 may occur with 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 inflammation of blood vessels, 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 percentage 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 abnormal heart rhythm),
• elevated liver function test values (which may indicate liver damage), 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 some 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 it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 packaging. The expiry date refers to the last day of the month indicated.
• Do not use Valsartán Pensa if the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Additional Information

Composition of Valsartán Pensa

• The active substance is valsartan.
• One film-coated tablet contains 320 mg of valsartan.
• The other components are 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.
• The tablet coating contains Opadry OY-L-28900 (lactose monohydrate (lactose), hypromellose (E-464), titanium dioxide (E-171), and macrogol), iron oxide red/brown (E-172), and indigo carmine blue lake.

Appearance of the medicinal product and contents of the container

Valsartán Pensa 320 mg film-coated tablets are oblong, violet-grey in color, and scored.

The tablets are presented 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 – Areta Industrial Park

31620 Huarte-Pamplona (Navarra)

Spain

Date of the most recent review of this leaflet: January 2025

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