Vanatex

Package Leaflet: Information for the Patient

Vanatex, 80 mg, Film-Coated Tablets

Vanatex, 160 mg, Film-Coated Tablets

Valsartan

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

• Keep this leaflet, you may need to read it again.
• 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Vanatex and what is it used for

Vanatex belongs to a class of medicines known as 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. Vanatex works by blocking the action of angiotensin II. As a result, blood vessels widen and blood pressure decreases.

Vanatex 80 mg and 160 mg film-coated tablets can be used to treat three different diseases:

• to treat high blood pressure in adult patients and children and adolescents from 6 to 18 years of ageHigh blood pressure increases the strain on the heart and arteries. If left uncontrolled, it can lead to damage to the blood vessels in the brain, heart, and kidneys, which can result in stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of these disorders.
• to treat adult patients after a recent heart attack(myocardial infarction) "Recent" means 12 hours to 10 days.
• to treat symptomatic heart failure in adult patientsVanatex can be used in adult patients to treat symptomatic heart failure. Vanatex is used when a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) (medicines used to treat heart failure) cannot be used or Vanatex can 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 are caused by the heart muscle not being able to pump blood with sufficient force to supply the required amount of blood to the whole body.

the heart muscle is not able to pump blood with sufficient force to supply the required amount of blood to the whole body.

2. Important information before taking Vanatex

When not to take Vanatex:

• 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 more than 3 months pregnant(it is also recommended to avoid taking Vanatex in early pregnancy - see the section on pregnancy and breastfeeding);
• if the patient has diabetes or kidney problems and is being treated with aliskiren(a medicine used to treat high blood pressure).

If any of the above conditions are met, do not take Vanatex.

Warnings and precautions

Before taking Vanatex, discuss with your doctor or pharmacist:

• if the patient has liver disease;
• if the patient has severe kidney disease or is undergoing dialysis;
• if the patient has renal artery stenosis;
• if the patient has recently undergone kidney transplantation(received a new kidney);
• if the patient is being treated for heart attack or 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 is taking medicines that increase potassium levels in the blood. This includes potassium supplements or salt substitutes containing potassium, potassium-sparing diuretics, and heparin. Regular monitoring of potassium levels in the blood may be necessary.
• if the patient is under 18 years of age and is taking Vanatex in combination with other medicines that affect 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 aldosteronism, a disease in which the adrenal glands produce too much of a hormone called aldosterone. If this disease is present in the patient, taking Vanatex is not recommended.
• if the patient has experienced significant fluid loss(dehydration) due to diarrhea, vomiting, or taking high doses of diuretics (water pills);
• if the patient has ever experienced angioedema(a type of allergic reaction) when taking other medicines (including ACE inhibitors). If such symptoms occur while taking Vanatex, the medicine should be stopped immediately and never taken again. See also section 4 "Possible side effects".
• if the patient is taking any of the following medicines used to treat high blood pressure:
• ACE inhibitors(e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease;
• aliskiren;
• if the patient is being treated with an ACE inhibitor in combination with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Vanatex". If the patient is pregnant or thinks she may be pregnant, she should tell her doctor. Vanatex is not recommended in early pregnancy and should not be taken by pregnant women after the third month of pregnancy, as it may seriously harm the baby if taken at this stage (see the section on pregnancy and breastfeeding).

• 3. If any of the above conditions are met, the doctor should be informed before taking Vanatex.

Vanatex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Taking Vanatex with certain other medicines may affect your treatment. Your doctor may need to change the dose or take other precautions, or in some cases, stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure, especially diuretics(water pills) and a medicine called aliskiren;
• medicines that increase potassium levels in the blood; this includes potassium supplements or salt substitutes containing potassium, potassium-sparing diuretics, and heparin;
• certain types of painkillerscalled non-steroidal anti-inflammatory drugs (NSAIDs);
• lithium(a medicine used to treat certain mental illnesses).

In addition:

• in the case of treatment after a heart attack, combination with ACE inhibitors(medicines used to treat heart attack) is not recommended;
• in the case of treatment of heart failure, taking Vanatex in combination with ACE inhibitors and beta-blockers(medicines used to treat heart failure) is not recommended.

The doctor may need to change the dose and/or take other precautions:

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

Vanatex with food and drink

Vanatex can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Tell your doctor if you think you are pregnant (or might become pregnant).

If you are pregnant, your doctor will normally advise you to stop taking Vanatex before you become pregnant or as soon as you find out you are pregnant, and will advise you to take a different medicine instead of Vanatex. Vanatex is not recommended in early pregnancy and should not be taken by pregnant women after the third month of pregnancy, as it may seriously harm the baby if taken after the third month of pregnancy.

Tell your doctor if you are breastfeeding or plan to start breastfeeding.

Vanatex is not recommended for mothers who are breastfeeding; the doctor may choose a different treatment for a patient who is planning to breastfeed, especially a newborn or premature baby.

Driving and using machines

Before driving, using tools, or operating machinery, or performing other activities that require concentration, each patient should determine how Vanatex affects them. Like many other medicines used to treat high blood pressure, Vanatex can occasionally cause dizziness and affect concentration.

Vanatex contains lactose and sodium

If the patient has been diagnosed with an intolerance to some sugars, the patient 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 Vanatex

This medicine should always be taken exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist. Patients with high blood pressure often do not notice any symptoms. Many of them feel quite well. For this reason, it is especially important to visit your doctor regularly, even if you feel well.

High blood pressure in adult patients:

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 Vanatex in combination with another medicine (e.g., a diuretic).

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 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).

Condition after a recent heart attack in adult patients:

Treatment usually starts 12 hours after the heart attack, usually with a low dose of 20 mg twice daily. The patient receives a dose of 20 mg, obtained by dividing a 40 mg tablet. The doctor will gradually increase this dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on the patient's tolerance to the medicine. Vanatex can be given in combination with other medicines used to treat heart attack, and the doctor will decide which treatment is appropriate in each case.

Heart failure in adult patients:

Treatment usually starts with a dose of 40 mg twice daily. The doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on the patient's tolerance to the medicine. Vanatex can be given in combination with other medicines used to treat heart failure, and the doctor will decide which treatment is appropriate in each case. Vanatex can be taken with or without food. Vanatex should be swallowed with a glass of water. Vanatex should be taken every day at approximately the same time.

Taking a higher dose of Vanatex than recommended

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you accidentally take too many tablets, contact your doctor, pharmacist, or hospital.

Missing a dose of Vanatex

If you miss a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Vanatex

Stopping treatment with Vanatex may worsen the disease. Do not change your treatment without consulting your doctor first. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vanatex can cause side effects, although not everybody gets them. Side effects may occur with the following frequencies, defined as:

• very common: occurs in more than 1 in 10 patients,
• common: occurs in less than 1 in 10 patients;
• uncommon: occurs in less than 1 in 100 patients;
• rare: occurs in less than 1 in 1,000 patients;
• very rare: occurs in less than 1 in 10,000 patients;
• not known: frequency cannot be estimated from the available data.

Some symptoms that require immediate medical attention:

May include symptoms of angioedema, such as:

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

If you experience any of these symptoms, contact your doctor immediately.

Side effects:

Common:

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

Uncommon:

• angioedema (see "Some symptoms that require immediate medical attention"),
• sudden loss of consciousness (fainting),
• feeling of spinning (dizziness),
• severe kidney problems (symptoms of acute 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,
• feeling tired,
• weakness.

Not known:

• allergic reactions with rash, itching, and hives; may include symptoms such as fever, swelling, and joint or muscle pain, swollen lymph nodes, and/or flu-like symptoms (symptoms of serum sickness),
• purple-red spots, fever, itching (symptoms of vasculitis, also known as inflammation of the blood vessels),
• unusual bleeding or bruising (symptoms of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat, or mouth ulcers due to infection (symptoms of neutropenia),
• decreased hemoglobin and decreased red blood cell count in the blood (which can lead to anemia in severe cases),
• increased potassium levels in the blood (which can cause muscle cramps and irregular heartbeat in severe cases),
• decreased sodium levels in the blood (which can cause fatigue, disorientation, muscle tremors, and/or seizures in severe cases),
• increased liver enzyme values (which may indicate liver damage), including increased bilirubin levels in the blood (which can cause yellowing of the skin and eyes in severe cases),
• increased urea and creatinine levels in the blood (which may indicate kidney problems).

The frequency of some side effects may vary depending on the disease. For example, side effects such as dizziness and kidney problems are observed less frequently in patients treated for high blood pressure than in patients treated for heart failure or after a heart attack. Side effects observed in children and adolescents are similar to those observed in adult patients.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Vanatex

Vanatex 80 mg:Do not store above 25°C. Store in the original package to protect from light. Vanatex 160 mg:Do not store above 25°C. Keep the medicine out of the 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 month stated. The packaging is marked with the expiry date and batch number after the EXP and Lot/LOT abbreviations, respectively. 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 Vanatex contains

• The active substance is valsartan. Each tablet contains 80 mg or 160 mg of valsartan.
• The other ingredients are: Tablet core: lactose monohydrate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate. Tablet coating: hypromellose 6 cp, macrogol 400, titanium dioxide (E171), iron oxide red (E172); 160 mg tablets also contain iron oxide yellow (E172) and iron oxide black (E172).

What Vanatex looks like and contents of the pack

Vanatex 80 mg film-coated tablets are pink, round, biconvex tablets with a score line. Vanatex 160 mg film-coated tablets are light brown, oval, biconvex tablets with a score line. The tablets can be divided into equal doses. One pack contains 28 tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Date of last revision of the leaflet: