Valsacor 320 mg tabletki povlekane

Leaflet accompanying the packaging: patient information

Valsacor 320 mg film-coated tablets

Valsartan

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

• 1. What is Valsacor and what is it used for
• 2. Important information before taking Valsacor
• 3. How to take Valsacor
• 4. Possible side effects
• 5. How to store Valsacor
• 6. Contents of the pack and other information

1. What is Valsacor and what is it used for

Valsacor belongs to a group of medicines called angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance present in the body that causes blood vessels to narrow, resulting in increased blood pressure. Valsacor blocks the action of angiotensin II, leading to the relaxation of blood vessels and a decrease in blood pressure.
Valsacor 320 mg film-coated tablets may be used

• to treat high blood pressure in adults and in children and adolescents from 6 to less than 18 years of age.High blood pressure increases the strain on the heart and arteries. If left untreated, it can lead to damage to the blood vessels in the brain, heart, and kidneys, and can result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal values reduces the risk of these disorders.

2. Important information before taking Valsacor

When not to take Valsacor

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of this medicine (listed in section 6);
• in cases of severe liver disease;
• in pregnancy after the third month(you should also avoid Valsacor in early pregnancy - see section "Pregnancy and breast-feeding");
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above applies to you, do not take Valsacor

Warnings and precautions

Before taking Valsacor, discuss it with your doctor or pharmacist:

• if you have liver disease;
• if you have severe kidney disease or are undergoing dialysis;
• in patients with narrowing of the kidney artery;
• in patients who have recently undergone kidney transplantation (received a new kidney);
• in patients with severe heart disease, other than heart failure or heart attack;
• if you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors). You should inform your doctor. If you experience such symptoms, stop taking Valsacor and contact your doctor immediately. You should never take Valsacor again. See also section 4 "Possible side effects";
• if you are taking medicines that increase potassium levels in the blood, such as potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin. It may be necessary to periodically check potassium levels in the blood;
• if you have aldosteronism. This is a disease where the adrenal glands produce too much of a hormone called aldosterone. Valsacor is not recommended for patients with aldosteronism;
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics;
• if you are taking any of the following medicines for high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Valsacor".
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Valsacor, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Valsacor on your own.
If you are pregnant or think you may be pregnant, or if you are planning to become pregnant, inform your doctor. Valsacor should not be used in early pregnancy and should not be used after the third month of pregnancy, as it may seriously harm the baby (see section "Pregnancy").

If any of the above applies to you, inform your doctor before taking Valsacor.

Children and adolescents

If you are under 18 years old and taking Valsacor in combination with other medicines that affect the renin-angiotensin-aldosterone system (blood pressure-lowering medicines), your doctor will regularly check your kidney function and potassium levels in your blood.

Valsacor with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
The effect of the medicine may change if Valsacor is taken with certain other medicines. It may be necessary to change the dose, take other precautions, or, in some cases, stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other blood pressure-lowering medicines, especially diuretics, ACE inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also the information under the heading "When not to take Valsacor" and "Warnings and precautions").
• medicines that increase potassium levels in the blood, such as potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• certain painkillerscalled non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (rifampicin), a medicine used to prevent organ rejection (cyclosporin), or antiretroviral medicines used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsacor.
• lithium, a medicine used to treat certain mental illnesses.

Taking Valsacor with food and drink

Valsacor can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You must inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.Your doctor will usually advise you to stop taking Valsacor before you become pregnant or as soon as you find out you are pregnant, and will prescribe another medicine. Valsacor should not be used in early pregnancy. You should not take Valsacor after the third month of pregnancy, as it may seriously harm the baby.
• You must inform your doctor if you are breast-feeding or plan to breast-feed.Valsacor is not recommended during breast-feeding. Your doctor may choose another medicine if you are going to breast-feed, especially if you are breast-feeding a newborn or premature baby.

Driving and using machines

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

Valsacor contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be "sodium-free".

3. How to take Valsacor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Patients with high blood pressure often do not feel any symptoms. Many of them may feel perfectly well. Therefore, it is important to see your doctor regularly, even if you feel fine.

Adults 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 prescribe another medicine (e.g., a diuretic).

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

For patients with a body weight of less than 35 kg, the dose of valsartan is usually 40 mg once daily. For patients with a body weight of 35 kg or more, the initial dose is usually 80 mg of valsartan once daily. In some cases, your doctor may prescribe higher doses (the dose of the medicine can be increased to 160 mg, and up to a maximum of 320 mg).
It is not possible to obtain a dose of Valsacor 320 mg that is less than 160 mg.
Valsacor can be taken with or without food. Valsacor should be swallowed with a glass of water. The medicine should be taken at about the same time each day.

Taking a higher dose of Valsacor than recommended

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you accidentally take too many tablets, contact your doctor, pharmacist, or hospital.

Missing a dose of Valsacor

Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.

Stopping treatment with Valsacor

Stopping treatment may worsen the disease being treated. Do not stop taking Valsacor unless your doctor tells you to.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects may be serious and require immediate medical attention:

There may be symptoms of angioedema (a specific allergic reaction), such as:

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

If you experience any of these symptoms, stop taking Valsacor and contact your doctor immediately (see section 2 "Warnings and precautions").

Other side effects:

Common side effects (may affect up to 1 in 10 people):

• dizziness
• low blood pressure with symptoms such as dizziness and fainting when standing up, or without these symptoms
• kidney problems (symptoms of kidney dysfunction).

Uncommon side effects (may affect up to 1 in 100 people):

• angioedema (see "Some side effects may be serious and require immediate medical attention")
• sudden loss of consciousness (fainting)
• feeling of spinning (vertigo)
• severe kidney problems (symptoms of severe kidney failure)
• muscle cramps, irregular heartbeat (symptoms of hyperkalemia)
• shortness of breath, breathing difficulties when lying down, swelling of the feet or ankles (symptoms of heart failure)
• headache
• cough
• stomach pain
• nausea
• diarrhea
• fatigue
• weakness.

Rare side effects (may affect up to 1 in 10,000 people):

• angioedema of the intestine: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• blisters on the skin (symptoms of bullous dermatitis)
• allergic reactions with rash, itching, and hives; may include symptoms such as fever, joint swelling, and joint pain, muscle pain, swelling of the lymph nodes, and (or) flu-like symptoms (symptoms of serum sickness)
• purple-red spots, fever, itching (symptoms of vasculitis)
• abnormal bleeding or bruising (symptoms of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat, or mouth ulcers caused by infection (symptoms of neutropenia)
• decreased hemoglobin levels and decreased red blood cell count in the blood (which in severe cases can lead to anemia)
• increased potassium levels in the blood (which in severe cases can cause muscle cramps and irregular heartbeat)
• low sodium levels in the blood (which in severe cases can cause fatigue, confusion, muscle twitching, and (or) convulsions)
• increased liver enzyme activity (may indicate liver damage), including increased bilirubin levels in the blood (in severe cases can cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (may indicate kidney problems).

The frequency of some side effects may vary depending on the disease. For example, side effects such as dizziness or kidney problems were less common in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

Additional side effects in children and adolescents

The side effects seen in children and adolescents are similar to those seen in adult patients.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsacor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Valsacor contains

• The active substance is valsartan. Each film-coated tablet contains 320 mg of valsartan.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172), and red iron oxide (E 172) in the tablet coating.
• See section 2 "Valsacor contains lactose and sodium".

What Valsacor looks like and contents of the pack

Light brown, capsule-shaped, biconvex film-coated tablets with a score line on one side. The tablet can be divided into equal doses.
Packaging:28 film-coated tablets in blisters, in a cardboard box.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:24.04.2025