Valzek

Leaflet accompanying the packaging: information for the user

VALZEK, 80 mg, tablets

VALZEK, 160 mg, tablets

Valsartan

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Table of contents of the leaflet

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

1. What is VALZEK and what is it used for

VALZEK belongs to a group of medicines called angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance produced in the human body that causes blood vessels to constrict, thereby increasing blood pressure. VALZEK works by blocking the action of angiotensin II. As a result, blood vessels dilate, and blood pressure decreases.
VALZEK can be used to treat three different diseases:

• to treat high blood pressure in adult patients and in children and adolescents from 6 to 18 years of age. High blood pressure increases the burden on the heart and blood vessels. If left untreated, it can lead to damage to blood vessels in the brain, heart, and kidneys, which can result in stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal values allows reducing the risk of these disorders.
• to treat adult patients after a recent heart attack(myocardial infarction). "Recent" means a period from 12 hours to 10 days.
• to treat symptomatic heart failure in adult patients. VALZEK is used if angiotensin-converting enzyme (ACE) inhibitors (drugs used to treat heart failure) cannot be used or as additional treatment along with ACE inhibitors, if beta-blockers (other drugs used to treat heart failure) cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. They are caused by the fact that the heart muscle is not able to pump blood with sufficient force to meet the body's needs.

2. Important information before taking VALZEK

When not to take VALZEK

• if the patient is allergicto valsartan or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver disease;
• if the patient is pregnant over 3 months(it is also not recommended to take VALZEK 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 conditions apply to the patient, they must not take VALZEK.

Warnings and precautions

Before starting to take VALZEK, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver disease;
• if they have severe kidney disease or are undergoing dialysis;
• in case of narrowing of the renal artery;
• if the patient has recently had a kidney transplant (the patient has received a new kidney);
• in patients after a heart attack or with heart failure, the doctor may monitor kidney function;
• if the patient has severe heart disease, other than heart failure or heart attack;
• if the patient has ever had swelling of the tongue and face caused by an allergic reaction, called angioedema, after taking another medicine (including an ACE inhibitor), they should tell their doctor. If such symptoms occur while taking VALZEK, the patient should stop taking it immediately and never take it again - see also section 4;
• if the patient is taking medicines that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparins. Regular monitoring of potassium levels in the blood may be necessary;
• if the patient is under 18 years of age and is taking VALZEK in combination with other medicines that block the renin-angiotensin-aldosterone system (medicines that lower blood pressure), the doctor will regularly monitor kidney function and potassium levels in the blood;
• if the patient has hyperaldosteronism (a disease in which the adrenal glands produce too much of a hormone called aldosterone) - in this case, VALZEK should not be taken;
• in case of significant fluid loss (dehydration) due to diarrhea, vomiting, or the use of high doses of diuretics;
• the patient should tell their doctor about pregnancy, suspected pregnancy, or planning pregnancy - it is not recommended to take VALZEK in early pregnancy and it must not be taken after 3 months of pregnancy, as it may be very harmful to the baby if taken after the third month of pregnancy.
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if the patient has kidney problems due to diabetes,
• aliskiren;
• if the patient is taking an ACE inhibitor in combination with other medicines used to treat heart failure, called mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol);
• if the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking VALZEK, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking VALZEK on their own. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium).

If any of the above conditions apply to the patient, they should inform their doctor before taking VALZEK.

VALZEK 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 VALZEK may be altered if it is taken with certain other medicines.
A dose change, other precautions, or in some cases, discontinuation of one of the medicines may be necessary. This applies to both prescription and non-prescription medicines, in particular:

• other blood pressure-lowering medicines, especially diuretics;
• medicines that increase potassium levels in the blood, including potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparins;
• certain painkillers, called non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (from the rifamycin group), a medicine used to prevent the rejection of a transplanted organ (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir) - these medicines may enhance the effect of VALZEK;
• lithium (a medicine used to treat certain mental illnesses).

In addition:

• in the case of treatment after a heart attack, it is not recommended to take ACE inhibitors (medicines used to treat heart attacks) in combination;
• in the case of treatment for heart failure, it is not recommended to take a triple combination of ACE inhibitors and beta-blockers (medicines used to treat heart failure).

The doctor may recommend a dose change and/or other precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also "When not to take VALZEK" and "Warnings and precautions");
• if the patient is taking an ACE inhibitor in combination with other medicines used to treat heart failure, called mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

VALZEK with food and drink

VALZEK 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 should tell their doctor about pregnancy, suspected pregnancy, or planning pregnancy. Usually, the doctor will recommend stopping VALZEK before planned pregnancy or as soon as pregnancy is confirmed and will advise taking another medicine instead of VALZEK. It is not recommended to take VALZEK in early pregnancy and it must not be taken after 3 months of pregnancy, as it may be very harmful to the baby if taken after the third month of pregnancy.
• The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take VALZEK in breastfeeding women - the doctor may recommend another medicine if the patient plans to breastfeed, especially a newborn or premature baby.

Driving and using machines

Before driving, using tools, operating machines, or performing other activities that require attention, each patient should find out how VALZEK affects them. Like many other medicines used to treat high blood pressure, VALZEK may rarely cause dizziness and affect concentration.

3. How to take VALZEK

VALZEK should always be taken as directed by the doctor to achieve the best results and minimize the risk of side effects. In case of doubts, the patient should consult their doctor or pharmacist.
People with high blood pressure often do not notice any symptoms associated with it.
Many of them feel quite well. Therefore, it is particularly important to attend doctor's appointments, even if they feel well.
Use in adult patients

High blood pressure

The usual dose is 80 mg once a day. In some cases, the doctor may recommend a higher dose (e.g., 160 mg or 320 mg). They may also prescribe VALZEK along with an additional medicine (e.g., a diuretic).

Condition after a recent heart attack

Treatment usually starts 12 hours after the heart attack, usually with a small dose of 20 mg twice a day. Doses of 20 mg cannot be obtained with VALZEK tablets. Other medicines containing 20 mg of valsartan should be used. The doctor will gradually increase this 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.
VALZEK can be given with other medicines used to treat heart attacks, and the doctor will decide which treatment is suitable for the patient.

Heart failure

The usual initial dose is 40 mg twice a day. The patient receives a dose of 40 mg, obtained by dividing an 80 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.
VALZEK can be given with other medicines used to treat heart failure, and the doctor will decide which treatment is suitable for the patient.
Use in children and adolescents

Children and adolescents (from 6 to 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 a day. The patient receives a dose of 40 mg, obtained by dividing an 80 mg tablet. In patients with a body weight of 35 kg or more, the initial dose is usually 80 mg of valsartan (1 VALZEK tablet, 80 mg) once a day. In some cases, the doctor may recommend a higher dose (the dose of the medicine can be increased to 160 mg, and up to 320 mg).
VALZEK can be taken with or without food. VALZEK should be swallowed with a glass of water.
VALZEK should be taken every day, approximately at the same time.

Taking a higher dose of VALZEK 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 or go to the hospital.

Missing a dose of VALZEK

In case of a missed dose, the patient should take it as soon as possible. However, if the next dose is near, they should skip the missed dose.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with VALZEK

Stopping treatment with VALZEK may worsen the disease. The patient should not stop taking the medicine unless their doctor recommends it.
In case of any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, VALZEK can cause side effects, although not everybody gets them.
Side effects may occur with a certain frequency, defined as follows:

• very common: occur in more than 1 in 10 patients,
• common: occur in 1 to 10 patients in 100;
• uncommon: occur in 1 to 10 patients in 1000;
• rare: occur in 1 to 10 patients in 10,000;
• very rare: occur in less than 1 in 10,000 patients;
• unknown: frequency cannot be estimated from the available data.

Some symptoms that require immediate medical attention:

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

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

If any of these symptoms occur, the patient should stop taking VALZEK and contact their doctor (see also section 2 "Warnings and precautions").

Side effects:

Common

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

Uncommon

• angioedema (see above "Some symptoms that require immediate medical attention"),
• sudden loss of consciousness (fainting),
• feeling of spinning (dizziness of labyrinthine origin),
• severe kidney function disorders (symptoms of acute kidney failure),
• muscle cramps, heart rhythm disturbances (symptoms of hyperkalemia),
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (symptoms of heart failure),
• headache,
• cough,
• stomach pain,
• nausea,
• diarrhea,
• feeling of tiredness,
• weakness.

Very rare

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

Unknown

• formation of blisters on the skin (bullous dermatitis),
• allergic reactions with rash, itching, and hives; symptoms such as fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or flu-like symptoms (symptoms of serous disease),
• purple-red spots, fever, itching (symptoms of vasculitis),
• unusual bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain,
• fever, sore throat, or mouth ulcers due to infection (symptoms of neutropenia),
• decreased hemoglobin and hematocrit values (percentage of red blood cells in the blood), which can lead to anemia in severe cases,
• increased potassium levels in the blood (which can cause muscle cramps and heart rhythm disturbances in severe cases),
• increased liver function test values (which may indicate liver damage), including increased bilirubin levels in the blood (which can cause a yellow discoloration of the skin and eyes in severe cases),
• increased urea and creatinine levels in the blood (which may indicate kidney function disorders),
• low sodium levels in the blood (which can cause fatigue, disorientation, muscle tremors, and/or seizures in severe cases).

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

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient 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, tel.: +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 VALZEK

Store at a temperature below 30°C, in the original packaging.
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.
The expiry date refers to the last day of the given month.
Do not use VALZEK if the packaging is damaged or shows signs of attempted opening.
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 VALZEK contains

The active substance of the medicine is valsartan.
Each tablet contains 80 mg or 160 mg of valsartan.
The other ingredients are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, crospovidone, colloidal anhydrous silica, magnesium stearate.

What VALZEK looks like and contents of the pack

White, round, biconvex tablets with a score line on one side.
The tablet can be divided into equal doses.

VALZEK, 80 mg and VALZEK, 160 mg

28 tablets in an HDPE container with a screw cap containing a desiccant, with a tamper-evident ring and a child-resistant closure, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Celon Pharma S.A
ul. Ogrodowa 2A, Kiełpin
05-092 Łomianki

Manufacturer:

Celon Pharma S.A
ul. Marymoncka 15
05-152 Kazuń Nowy
To obtain additional information, the patient should contact the representative of the marketing authorization holder:
Celon Pharma S.A.
tel.: +48 22 751 59 33
e-mail: [email protected]

Date of last revision of the leaflet: 12.2024

To protect the medicine from unauthorized access and children, the bottle cap is equipped with a seal and a locking mechanism.
The patient should follow the instructions below to properly open the packaging:
 PRESS THE CAP
TURN BY HALF A TURN
 PRESS THE CAP STRONGLY