Valzek

Package leaflet: Information for the user

VALZEK, 80 mg, tablets
VALZEK, 160 mg, tablets
Valsartanum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist.

Contents of the leaflet

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

1. What VALZEK is and what it is 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 narrow, thereby increasing blood pressure. VALZEK works by blocking the action of angiotensin II. As a result, blood vessels relax and widen, and blood pressure is lowered.
VALZEK can be used to treat three different conditions:

• for the treatment of high blood pressure in adult patients and in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and blood vessels. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially resulting in stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels helps reduce the risk of these complications.
• for the treatment of adult patients following a recent heart attack (myocardial infarction). "Recent" refers to the period from 12 hours to 10 days after the event.
• for the treatment of symptomatic heart failure in adult patients. VALZEK is used either when angiotensin-converting enzyme (ACE) inhibitors (medicines used in the treatment of heart failure) cannot be administered, or as additional therapy to ACE inhibitors when β-adrenergic receptor blockers (other medicines used in heart failure treatment) cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. These symptoms occur because the heart muscle is unable to pump blood strongly enough to meet the body's needs.

2. Information before using VALZEK

When not to use VALZEK

• if the patient is allergic to 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 in pregnancy beyond the 3rd month (use of Valzek is also not recommended during early pregnancy – see section “Pregnancy and breastfeeding”);
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions applies to the patient, Valzek must not be used.

Warnings and precautions

Before starting treatment with Valzek, discuss the following with your doctor or pharmacist:

• if the patient has liver disease;
• if the patient has severe kidney disease or is undergoing dialysis;
• in case of renal artery stenosis;
• if the patient has recently received a kidney transplant;
• in patients after myocardial infarction or with heart failure, the doctor may monitor kidney function;
• if the patient has severe heart disease other than heart failure or myocardial infarction;
• if the patient has ever experienced swelling of the tongue and face due to an allergic reaction, called angioedema, after taking another medicine (including an ACE inhibitor), inform the doctor. If such symptoms occur while taking Valzek, treatment must be stopped immediately and the medicine must never be used again – see also section 4;
• if the patient is taking medicines that increase blood potassium levels, such as potassium supplements or potassium-containing salt substitutes, potassium-sparing agents, or heparins. Regular monitoring of blood potassium levels may be necessary;
• if the patient is under 18 years of age and is taking Valzek in combination with other medicines blocking the renin-angiotensin-aldosterone system (medicines lowering blood pressure), the doctor will regularly monitor kidney function and blood potassium levels;
• if the patient has been diagnosed with hyperaldosteronism (a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone) – in this case, Valzek must not be used;
• in case of significant fluid loss (dehydration) due to diarrhoea, vomiting, or use of high doses of diuretic medicines (diuretics);
• inform the doctor if the patient is pregnant, suspects pregnancy, or plans to become pregnant – use of Valzek is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used during this period (see section “Pregnancy and breastfeeding”);
• 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 certain 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 abdominal pain, nausea, vomiting, or diarrhoea after taking Valzek, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Valzek on your 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, inform the doctor before using Valzek.

VALZEK and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

The effect of Valzek may be altered when taken with certain other medicines. A dose adjustment, additional precautions, or in some cases discontinuation of one of the medicines may be necessary. This applies to both prescription and over-the-counter medicines, particularly:

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

Additionally:

• in the treatment after myocardial infarction, combination therapy with ACE inhibitors (medicines used to treat heart attack) is not recommended;
• in the treatment of heart failure, triple combination therapy with ACE inhibitors and beta-adrenergic receptor blockers (medicines used to treat heart failure) is not recommended.

Your doctor may recommend a dose adjustment and/or additional precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also “When not to use VALZEK” and “Warnings and precautions”);
• if the patient is taking an ACE inhibitor in combination with certain 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 independently of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

• Inform the doctor about pregnancy, suspected pregnancy, or plans for pregnancy. Usually, the doctor will advise stopping Valzek before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine instead of Valzek. Valzek is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may be highly harmful to the unborn child if used beyond the third month of pregnancy.
• Inform the doctor if the patient is breastfeeding or intends to breastfeed. Use of Valzek is not recommended in breastfeeding women – the doctor may recommend an alternative medicine if the patient intends to breastfeed, especially if the infant is a newborn or premature.

Driving and operating machinery

Before driving, using tools, operating machinery, or performing any other activity requiring concentration, each patient should assess how Valzek affects them. Like many other medicines used to treat high blood pressure, Valzek may rarely cause dizziness and affect the ability to concentrate.

3. How to use VALZEK

VALZEK should always be used exactly as directed by your doctor in order to achieve the best results and reduce the risk of side effects. If in doubt, consult your doctor or pharmacist.

People with high blood pressure often do not experience any symptoms related to it. Many of them feel quite well. Therefore, it is especially important to attend regular medical check-ups, even if you feel well.

Use in adult patients

High blood pressure
The usual dose is 80 mg once daily. In some cases, your doctor may prescribe a higher dose (e.g. 160 mg or 320 mg). Your doctor may also prescribe VALZEK together with another medicine (e.g. a diuretic).

After a recent heart attack
Treatment usually begins within 12 hours after the heart attack, typically starting with a low dose of 20 mg twice daily. The 20 mg dose cannot be obtained using VALZEK tablets. Other medicines containing 20 mg of valsartan should be used. Your doctor will gradually increase the dose over several weeks up to a maximum dose of 160 mg twice daily. The final dose depends on how well the patient tolerates the medicine.

VALZEK may be given together with other medicines used in the treatment of heart attack. Your doctor will decide which treatment is appropriate for the individual patient.

Heart failure
The usual starting dose is 40 mg twice daily. The 40 mg dose is obtained by splitting an 80 mg tablet. Your doctor will gradually increase the dose over several weeks up to a maximum dose of 160 mg twice daily. The final dose depends on how well the patient tolerates the medicine.

VALZEK may be given together with other medicines used in the treatment of heart failure. Your doctor will decide which treatment is appropriate for the individual patient.

Use in children and adolescents

Children and adolescents (aged 6 to 18 years) with high blood pressure
In patients with body weight less than 35 kg, the usual dose of valsartan is 40 mg once daily. The 40 mg dose is obtained by splitting an 80 mg tablet. In patients with body weight of 35 kg or more, the usual starting dose is 80 mg of valsartan (1 tablet of VALZEK 80 mg) once daily. In some cases, your doctor may prescribe a higher dose (the dose may be increased up to 160 mg, and a maximum of 320 mg).

VALZEK may be taken with or without food. Swallow the tablet with a glass of water.

VALZEK should be taken every day, approximately at the same time each day.

Taking more VALZEK than prescribed
If severe dizziness and/or fainting occur, contact your doctor immediately and lie down. In case of accidental overdose, contact your doctor or go to a hospital immediately.

If you miss a dose of VALZEK
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping VALZEK treatment
Stopping treatment with VALZEK may worsen your condition. Do not discontinue use unless instructed by your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions may occur with a certain frequency, defined as follows:

• very common: occurs in more than 1 in 10 patients,
• common: occurs in 1 to 10 in 100 patients,
• uncommon: occurs in 1 to 10 in 1,000 patients,
• rare: occurs in 1 to 10 in 10,000 patients,
• very rare: occurs in less than 1 in 10,000 patients,
• unknown: frequency cannot be estimated based on available data.

Symptoms requiring immediate medical attention:
Symptoms of angioedema (a specific allergic reaction) may occur, such as:

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

If any of these symptoms occur, stop taking Valzek immediately
and contact your doctor (see also section 2 "Warnings and precautions").
Adverse reactions:
Common

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

Uncommon

• angioedema (see above "Symptoms requiring immediate medical attention"),
• sudden loss of consciousness (fainting),
• sensation of spinning (peripheral dizziness),
• severe renal function disorders (symptoms of acute kidney failure),
• muscle cramps, cardiac arrhythmias (symptoms of hyperkalemia),
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (symptoms of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhoea,
• feeling of fatigue,
• weakness.

Very rare

• Intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Unknown

• blistering of the skin (bullous dermatitis),
• allergic reactions with rash, itching and hives; symptoms such as fever, swelling and joint pain, muscle pain, swollen lymph nodes and (or) flu-like symptoms (symptoms of serum sickness) may occur,
• 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 low white blood cell count, so-called neutropenia),
• decreased haemoglobin concentration and haematocrit values (percentage of red blood cells in blood), which may lead to anaemia in severe cases,
• increased potassium levels in blood (which may cause muscle cramps and cardiac arrhythmias in severe cases),
• increased liver function parameters (which may indicate liver damage), including increased blood bilirubin concentration (which may cause yellowing of the skin and eyes in severe cases),
• increased blood urea nitrogen and serum creatinine levels (which may indicate kidney function disorders),
• low sodium levels in blood (which may cause fatigue, disorientation, muscle tremors and (or) seizures in severe cases).

The frequency of some adverse reactions may vary depending on the patient's condition.
For example, adverse reactions such as dizziness and renal function disorders have been 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.
Adverse reactions observed in children and adolescents are similar to those occurring in adult patients.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store VALZEK

Store below 30°C, in the original packaging.
Keep the medicine 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 stated month.
Do not use Valzek if the packaging is damaged or shows any signs of tampering.
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 package and other information

What Valzek contains
The active substance is valsartan.
Each tablet contains 80 mg or 160 mg of valsartan.
Excipients: 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 cap containing a desiccant, a tamper-evident ring, and child-resistant closure, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Celon Pharma S.A
ul. Ogrodowa 2A, Kiełpin
05-092 Łomianki

Manufacturer:
Celon Pharma S.A
ul. Marymoncka 15
05-152 Kazuń Nowy

For additional information, please contact the Marketing Authorisation Holder:
Celon Pharma S.A.
tel.: +48 22 751 59 33
e-mail: [email protected]

To protect the medicine from unauthorized access and children, the container cap is equipped with a seal and a child-resistant locking mechanism.
Please follow the instructions in the figures below to correctly open the package:
 PRESS DOWN FIRMLY  WHILE PRESSING,
TURN THE CAP HALF A TURN