Valsacor 160 mg tabletki povlekane

Package Leaflet: Information for the Patient

Valsacor 160 mg Film-Coated Tablets

valsartan

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

• You should keep this leaflet, so you can read it again later.
• 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, tell your doctor or pharmacist. See section 4.

Contents of the Package 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 in the body that causes blood vessels to narrow, leading to an increase in blood pressure. Valsacor blocks the action of angiotensin II, which leads to the relaxation of blood vessels and a decrease in blood pressure.
Valsacor 160 mg film-coated tablets may be used to treat three different conditions:

• Treatment of high blood pressure in adults and in children and adolescents from 6 to less than 18 years of age.High blood pressure increases the workload on the heart and arteries. If not treated, it may lead to damage to the blood vessels in the brain, heart, and kidneys, and may result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of these disorders.
• Treatment of adult patients after a recent heart attack."Recent" means 12 hours to 10 days.
• Treatment of symptomatic heart failure in adult patients.Valsacor is used when a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (medicines used to treat heart failure) cannot be used or may be used in combination with ACE inhibitors, when other medicines used to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and ankles due to fluid accumulation. They occur when the heart muscle is not able to pump blood in sufficient quantities to supply the entire body.

2. Important information before taking Valsacor

When not to take Valsacor

• if you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6);
• in cases of severe liver disease;
• in pregnancy over 3 months(you should also avoid Valsacor in early pregnancy - see section "Pregnancy and breastfeeding");
• 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.

• if you have liver disease;
• if you have severe kidney disease or are undergoing dialysis;
• in patients with narrowing of the kidney arteries;
• in patients who have recently had a kidney transplant (received a new kidney);
• in patients with severe heart disease, other than heart failure or heart attack;
• if you are taking another medicine (angiotensin-converting enzyme inhibitors, including ACE inhibitors) and have ever had swelling of the face and tongue due to an allergic reaction called angioedema, you should tell your doctor. If such symptoms occur while you are taking Valsacor, stop taking the medicine and do not take it again. See also section 4 "Possible side effects".
• in patients taking medicines that increase potassium levels in the blood, such as potassium supplements or potassium-sparing diuretics and heparin. There may be a need for periodic blood tests to check potassium levels;
• in patients with aldosteronism. This is a disease where the adrenal glands produce too much of a hormone called aldosterone. It is not recommended to take Valsacor in patients with aldosteronism;
• in patients who 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 used to treat high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren;
• if you are being treated with an ACE inhibitor in combination with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

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.
Tell your doctor if you are pregnant or think you may be pregnant (or plan to become pregnant). It is not recommended to take Valsacor in early pregnancy and you should not take it after the 3rd month of pregnancy, as it may seriously harm your baby (see "Pregnancy").

• 3. 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 should not take Valsacor after the 3rd month of pregnancy, as it may seriously harm your baby.

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

Valsacor and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might 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 potassium-sparing diuretics and heparin.
• certain painkillerscalled non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (such as rifampicin), a medicine used to prevent transplant rejection (cyclosporin) or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsacor.
• lithium, a medicine used to treat certain mental illnesses.

In addition:

• in patients treated after a heart attack, it is not recommended to combine with ACE inhibitors(medicines used to treat heart attack);
• in patients treated for heart failure, it is not recommended to take Valsacor with ACE inhibitors and other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) and beta-blockers (such as metoprolol).

Taking Valsacor with food and drink

Valsacor can be taken with or without food.

Pregnancy and breastfeeding

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 tell your doctor if you are pregnant or think you may be pregnant. Your doctor will normally advise you to stop taking Valsacor before you become pregnant or as soon as you know you are pregnant, and will prescribe another medicine for you. It is not recommended to take Valsacor in early pregnancy. You should not take Valsacor after the 3rd month of pregnancy, as it may seriously harm your baby.
• You must tell your doctor if you are breast-feeding or plan to breast-feed. It is not recommended to take Valsacor while breast-feeding. Your doctor may choose another medicine for you if you want to breast-feed, especially if you are breast-feeding a newborn or premature baby.

Driving and using machines

Before driving, using machines, 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 may 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 means it is essentially "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. In case of doubt, consult your doctor or pharmacist again. Patients with high blood pressure often do not notice any symptoms, and many of them feel quite well. Therefore, it is very important to visit your doctor regularly, 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). Your doctor may also prescribe Valsacor in combination with another medicine (e.g., a diuretic).

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

in patients with a body weight below 35 kg, the dose of valsartan is usually 40 mg once daily. In 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).
Adult patients after a recent heart attack:treatment usually starts 12 hours after the heart attack, usually with a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing a 40 mg tablet. Your doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on your tolerance to the medicine.
Valsacor can be taken with other medicines used to treat patients after a heart attack. Your doctor will decide on the choice of treatment.
Heart failure in adult patients:treatment usually starts with a dose of 40 mg twice daily. Then, your doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on your tolerance to the medicine.
Valsacor can be taken with other medicines used to treat heart failure. Your doctor will decide on the choice of treatment.
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 every day.

Taking a higher dose of Valsacor than prescribed

In case of severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have taken 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 on the use of 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,
• difficulty breathing or swallowing,
• 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, difficulty breathing when lying down, swelling of the feet or ankles (symptoms of heart failure)
• headache
• cough
• abdominal 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 abdominal pain, nausea, vomiting, and diarrhea.

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

• blistering of the skin (symptoms of blistering skin disease)
• allergic reactions with rash, itching, and hives; symptoms may include: fever, swelling of the joints and 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 due to infection (symptoms of a low white blood cell count, known as neutropenia)
• decreased hemoglobin and red blood cell count (which in severe cases may lead to anemia)
• increased potassium levels in the blood (which in severe cases may cause muscle cramps and irregular heartbeat)
• low sodium levels in the blood (which in severe cases may cause fatigue, confusion, tremors, and/or convulsions)
• increased liver enzyme activity (which may indicate liver damage), including increased bilirubin levels in the blood (which in severe cases may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and serum creatinine levels (which 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 are less common 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 in adult patients.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the 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
You can also report side effects 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 package 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 160 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

Yellow-brown, oval, biconvex film-coated tablets with a score line on one side.
The tablet can be divided into equal doses.
Pack sizes: 28, 30, 50, 60, 84, 90, or 120 film-coated tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer/Importer

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