Leaflet: information for the user

Valsartán pensa 320mg film-coated tablets EFG

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 doubts, consult 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 that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

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

2. Before taking Valsartán Pensa

3. How to take Valsartán Pensa

4. Possible side effects

5. Storage of Valsartán Pensa

6. Contents of the pack and additional information

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

Valsartán Pensa 320mg film-coated tabletsmay be used

• to treat high blood pressure in adults and 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 cause a stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

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 arepregnantover 3 months(it is better to avoid Valsartán Pensa 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 takeValsartán 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 renal 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 check the amount of potassium in your blood,
• if you are under 18 years 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, it is not recommended to take Valsartán Pensa,
• 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), particularly if you have kidney problems related to diabetes.

- aliskirén.

Your doctor may regularly 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).No Valsartán Pensa is recommended to be used at the beginning of pregnancy, and in no case should it be administered if you are pregnant over three months, as it may cause serious damage to your baby when administered from that moment 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 acquired 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,
• certain medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• litium,a medication used to treat certain types of psychiatric diseases.

Taking Valsartán Pensa with food and beverages

You can take Valsartán with 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 takingValsartán Pensabefore becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead ofValsartán Pensa. No Valsartán Pensa is recommended to be used at the beginning of pregnancy, and in no case should it be administered from the third month of pregnancy as it may cause serious damage to your baby when administered from that moment on.

• Breastfeeding

Inform your doctor if you are in the breastfeeding period or are about to start it. No Valsartán Pensa is recommended to be used 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 performing other activities that require concentration, make sure you know how Valsartán Pensa affects you. Like many other medications used to treat high blood pressure, Valsartán Pensa may cause, in rare cases, dizziness and affect concentration.

Important information about some of the components of Valsartán Pensa

This medication contains lactoseandsorbitol. 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 adverse 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 symptoms of the disease; many feel normal. This makes it very important to attend your doctor's appointments, 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 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 initial usual dose is 80mg of valsartán once a day.

In some cases, your doctor may prescribe higher doses (the dose may be increased to 160mg and up to a maximum of 320mg).

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

TakeValsartán Pensa approximately at thesame hour 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 alsocall the Toxicological 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 withValsartán Pensa

If you stop taking Valsartán Pensa, your condition may worsen. Do not stop taking the medication unless your doctor tells you to.

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

Like all medicines, Valsartán Pensa may 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 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,
• 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,
• 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,
• 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 hives; symptoms of serum sickness, such as fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to the flu,
• 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 reduction in 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.

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 the Vigilance of Medicinal Products for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Store below30°C. Store in the original packaging to protect it from humidity.
• Keep out of the 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 handling.
• Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition ofValsartan Pensa

• The active ingredient is valsartan.
• A film-coated tablet contains 320 mg of valsartan.
• The other components aremicrocrystalline 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, laurilsulfate of sodium and crospovidone
• The tablet coating containsOpadry OY-L-28900 (lactose monohydrate (lactose), hypromellose (E-464), titanium dioxide (E-171) and macrogol), iron oxide red/brown (E-172) and indigo carmine lacquer.

Appearance of the product and contents of the package

The film-coated valsartan Pensa 320 mg tablets areoblong, violet-gray in color, and scored.

The tablets are presented in blister packs with 28 tablets

Holder of the marketing authorization

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