Valsacor 80 mg tabletki povlekane

Leaflet accompanying the packaging: patient information

Valsacor 80 mg film-coated tablets

valsartan

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 packaging 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 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 dilation of blood vessels and a decrease in blood pressure.
Valsacor 80 mg film-coated tablets can be used to treat three different diseases:

• 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 burden on the heart and arteries. If left untreated, it can cause damage to blood vessels in the brain, heart, and kidneys, and lead to 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.
• Treatment of adult patients after a recent heart attack."Recent" means a period from 12 hours to 10 days.
• Treatment of symptomatic heart failure in adult patients.Valsacor is used when a group of medicines known as 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 heart failure medicines 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 unable to pump enough blood to supply the entire body.

2. Important information before taking Valsacor

When not to take Valsacor

• if the patient is allergicto valsartan or any of the other ingredients of this medicine (listed in section 6);
• in case of severe liver disease;
• in pregnancy over 3 months(Valsacor should also be avoided in early pregnancy - see section "Pregnancy and breastfeeding");
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, they should not take Valsacor.

Warnings and precautions

Before starting treatment with Valsacor, the patient should discuss it with their doctor.

• if the patient has liver disease;
• if the patient has severe kidney disease or is undergoing dialysis;
• in patients with narrowing of the renal 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 the patient taking another medicine (angiotensin-converting enzyme inhibitors, including ACE inhibitors) has ever experienced swelling of the tongue and face due to an allergic reaction called angioedema, they should inform their doctor. If such symptoms occur while taking Valsacor, the patient should stop taking the medicine immediately and 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-containing salt substitutes, potassium-sparing medicines, and heparin. It may be necessary to periodically check potassium levels in the blood;
• in patients with aldosteronism. This is a disease in which the adrenal glands produce too much of a hormone called aldosterone. Valsacor is not recommended for patients with aldosteronism;
• in patients who have lost a lot of fluid (dehydrated) due to diarrhea, vomiting, or high doses of diuretics;
• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren;
• if the patient is being treated with an ACE inhibitor in combination with other heart failure medicines known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

The doctor may monitor kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Valsacor".
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Valsacor, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Valsacor on their own.
The patient should tell their doctor if they suspect they are pregnant (or plan to become pregnant). Valsacor should not be taken in early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby if taken at this stage (see "Pregnancy").

Valsacor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 over-the-counter medicines, in particular:

• other blood pressure-lowering medicines, especially diuretics, angiotensin-converting enzyme inhibitors (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-containing salt substitutes, potassium-sparing medicines, and heparin.
• certain painkillerscalled non-steroidal anti-inflammatory drugs ( NSAIDs).
• some 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 heart failure medicines, 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

• The patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy.The doctor will usually recommend stopping Valsacor before becoming pregnant or as soon as pregnancy is confirmed and will prescribe another medicine. Valsacor should not be taken in early pregnancy. Valsacor should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby at this stage.
• The patient should inform their doctor about breastfeeding or intending to breastfeed.Valsacor should not be taken while breastfeeding. The doctor may choose another medicine if the patient intends to breastfeed, especially if breastfeeding a newborn or premature baby.

Driving and using machines

Before driving, using tools, or operating machinery, or performing other activities that require concentration, the patient should make sure what effect Valsacor has on them. Like many other blood pressure-lowering medicines, Valsacor may cause dizziness and affect the ability to concentrate.

Valsacor contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Valsacor

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. If in doubt, the patient should contact their 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 the doctor even if the patient feels well.
Adult patients with high blood pressure:the usual dose is 80 mg once a day.
In some cases, the doctor may prescribe higher doses (e.g., 160 mg or 320 mg). The doctor may also prescribe Valsacor in combination with another medicine (e.g., a diuretic).

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

in patients weighing less than 35 kg, the dose of valsartan is usually 40 mg once a day. In patients weighing 35 kg or more, the initial dose is usually 80 mg of valsartan once a day.
In some cases, the doctor may prescribe higher doses (the dose of the medicine can be increased to 160 mg, and up to 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 a day. The 20 mg dose is obtained by dividing a 40 mg tablet. The doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice a day. The final dose depends on the patient's tolerance to the medicine.
Valsacor can be taken with other medicines used to treat patients after a heart attack. The doctor will decide on the choice of treatment.
Heart failure in adult patients:treatment usually starts with a dose of 40 mg twice a day. Then, the doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice a day. The final dose depends on the patient's tolerance to the medicine.
Valsacor can be taken with other medicines used to treat heart failure. The 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 recommended

In case of severe dizziness and/or fainting, the patient should contact their doctor immediately and lie down. In case of accidental ingestion of too many tablets, the patient should contact their doctor, pharmacist, or hospital.

Missing a dose of Valsacor

The patient should not take a double dose to make up for a missed dose.
If a dose of the medicine is missed, it should be taken as soon as the patient remembers. If it is close to the time for the next dose, the missed dose should be skipped.

Stopping treatment with Valsacor

Stopping treatment may worsen the disease being treated. The patient should not stop taking Valsacor unless their doctor advises them to do so.
If the patient has any further doubts about taking this medicine, they should consult their 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:

Angioedema (a specific allergic reaction) may occur, with symptoms such as:

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

If the patient experiences any of these symptoms, they should stop taking Valsacor and contact their doctor immediately (see section 2 "Warnings and precautions").

Other side effects:

Common side effects (may occur in less than 1 in 10 people):

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

Uncommon side effects (may occur in less than 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 function impairment (symptoms of severe kidney failure)
• muscle cramps, heart rhythm disturbances (symptoms of hyperkalemia)
• shortness of breath, breathing difficulties when lying down, swelling of the feet or ankles (symptoms of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• fatigue
• weakness.

Very rare side effects (may occur in less than 1 in 10,000 people):

• angioedema of the intestine: intestinal swelling 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 bullous dermatitis)
• allergic reactions with rash, itching, and hives; symptoms such as fever, joint swelling, and joint pain, muscle pain, lymph node swelling, and/or flu-like symptoms (symptoms of serous illness)
• 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 low white blood cell count, known as neutropenia)
• decreased hemoglobin levels and decreased red blood cell percentage 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 heart rhythm disturbances)
• low sodium levels in the blood (which in severe cases can cause fatigue, confusion, muscle twitching, and/or seizures)
• 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 function disorders).

The frequency of some side effects may vary depending on the disease. For example, side effects such as dizziness or kidney function impairment 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.
Side effects observed in children and adolescents are similar to those in adult patients.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Valsacor

The medicine should be stored out of 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 stated.
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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Valsacor contains

• The active substance of the medicine is valsartan. Each film-coated tablet contains 80 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, 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

Pink, round, biconvex film-coated tablets with a score line on one side.
The tablet can be divided into equal doses.
Packaging: 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