Valsacor 320 mg tabletki povlekane

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Valsacor 320 mg, film-coated tablets

Valsartan

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 relaxation of blood vessels and a decrease in blood pressure.
Valsacor 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 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.

2. Important information before taking Valsacor

When not to take Valsacor:

• if the patient is allergic(hypersensitive) to 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 to take Valsacor, the patient should discuss it with their doctor or pharmacist:

• 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 has ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors). The doctor should be informed about this. If the patient experiences such symptoms, they should stop taking Valsacor and contact their doctor immediately. The patient should never take Valsacor 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 used to treat high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.

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".
The patient should tell their doctor if they are pregnant (or plan to become pregnant). Valsacor should not be taken during pregnancy, especially after the third month, as it may seriously harm the baby (see section "Pregnancy").

If any of the above situations apply to the patient, they should inform their doctor before starting to take Valsacor.

Children and adolescents

If the patient is under 18 years of age and is taking Valsacor in combination with other medicines that affect the renin-angiotensin-aldosterone system (blood pressure-lowering medicines), the doctor will regularly check their kidney function and potassium levels in the blood.

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 Valsacor may change if it 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, 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-containing salt substitutes, potassium-sparing medicines, and heparin;

Some painkillers called 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 enhance 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 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 advise stopping Valsacor before becoming pregnant or as soon as pregnancy is confirmed and prescribe another medicine. Valsacor should not be taken during early pregnancy. Valsacor should not be taken after the third month of pregnancy, as it may seriously harm the baby.
• The patient should inform their doctor about breastfeeding or intending to breastfeed.Valsacor is not recommended during 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 they know how Valsacor affects 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 an intolerance to some sugars, they should contact their doctor before taking Valsacor.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Valsacor

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted. Patients with high blood pressure often do not notice any symptoms of the disease. Many of them may feel perfectly well. Therefore, it is essential to attend doctor's appointments, even if the patient feels well.

Adults with high blood pressure

The usual dose is 80 mg once daily. In some cases, the doctor may prescribe higher doses (e.g., 160 mg or 320 mg). The doctor may also prescribe an additional 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 of less than 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, the 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 approximately 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. If the patient has accidentally taken too many tablets, they 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 Valsacor is missed, it should be taken as soon as possible. If it is almost time for the next dose, the missed dose should be skipped.

Stopping Valsacor

Stopping treatment may worsen the treated disease. 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;
• weak kidney function (symptoms of kidney problems).

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 weak kidney function (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.

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 such as fever, joint swelling, and joint pain, muscle pain, lymph node swelling, 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 low white blood cell count, called 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 heart rhythm disturbances);
• 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 weak kidney function 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 observed in children and adolescents are similar to those seen in adult patients.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health,
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 (22) 49 21 301,
fax: +48 (22) 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Valsacor

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 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 Valsacor is valsartan. Each film-coated tablet contains 320 mg of valsartan.
• The other ingredients of Valsacor are: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, silicon dioxide, 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 or 30 film-coated tablets in blisters, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 58/078/10-C

Parallel import authorization number: 266/21

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

Date of leaflet approval: 10.05.2022
[Information about the trademark]