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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the package 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 to 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 conditions:

• 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 a 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 treatments for 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 you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver disease;
• if you are more than 3 months pregnant(it is also better to avoid taking Vanatex during early pregnancy - see the section on pregnancy and breastfeeding);
• if you have diabetes or kidney problems and are treated with aliskiren(a medicine used to treat high blood pressure).

If any of the above conditions apply to you, do not take Vanatex.

Warnings and precautions

Before taking Vanatex, tell your doctor or pharmacist:

• if you have liver disease;
• if you have severe kidney disease or are undergoing dialysis;
• if you have narrowing of the renal arteries;
• if you have recently had a kidney transplant (received a new kidney);
• if you are being treated for heart attack or heart failure, your doctor may check your kidney function;
• if you have severe heart disease other than heart failure or heart attack;
• if you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics, and heparin. Regular monitoring of potassium levels in your blood may be necessary.
• if you are under 18 years of age and are taking Vanatex in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor will regularly check your kidney function and potassium levels in your blood;
• if you have aldosteronism; this is a disease where the adrenal glands produce too much of a hormone called aldosterone. If you have this condition, taking Vanatex is not recommended.
• if you have had a significant loss of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (water pills);
• if you have ever had swelling of the tongue and face due to an allergic reaction called angioedema when taking other medicines (including ACE inhibitors). Tell your doctor if this happens to you. If such symptoms occur while taking Vanatex, stop taking the medicine and never take it again. See also section 4 "Possible side effects".
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
• aliskiren;
• if you are being treated with 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).

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the information under the heading "When not to take Vanatex". If you are pregnant or think you might be pregnant, tell your doctor. Vanatex is not recommended during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm your baby if taken at this stage (see the section on pregnancy and breastfeeding).

• 3. If you are pregnant or think you might be pregnant, tell your doctor.

If any of the above conditions apply to you, tell your doctor before taking Vanatex.

Vanatex and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription. Taking Vanatex with certain other medicines may affect your treatment. Your doctor may need to change your 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 the amount of potassium in your blood; these include potassium supplements or salt substitutes containing potassium, potassium-sparing diuretics, and heparin;
• certain types of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs);
• lithium(a medicine used to treat certain types of mental illness).

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.

Your doctor may need to change your dose and/or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also the information under the headings "When not to take Vanatex" and "Warnings and precautions");
• if you are 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 you are pregnant or think you might be pregnant, or if you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Vanatex should not be taken during pregnancy.Your doctor will normally advise you to stop taking Vanatex before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Vanatex. Vanatex is not recommended during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm your baby if taken after the 3rd month of pregnancy.

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

Vanatex is not recommended for mothers who are breastfeeding.Your doctor may choose a different treatment for you if you are planning to breastfeed, especially if you have 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 establish how Vanatex affects them. Like many other medicines used to treat high blood pressure, Vanatex can cause dizziness and affect your ability to concentrate.

Vanatex contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Vanatex

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Patients with high blood pressure often do not feel unwell. Many feel fine. This is why it is so important to keep your appointments with your doctor, even if you are feeling well.

High blood pressure in adult patients:

The usual dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Your 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 starting dose is usually 80 mg of valsartan once daily. In some cases, your doctor may prescribe higher doses (the dose 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 a heart attack, with a low dose of 20 mg twice daily. You will receive a dose of 20 mg, achieved by dividing a 40 mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on how well you tolerate the medicine. Vanatex can be given with other medicines used to treat heart attack, and your doctor will decide which treatment is suitable for you.

Heart failure in adult patients:

Treatment usually starts with a dose of 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on how well you tolerate the medicine. Vanatex can be given in combination with other medicines used to treat heart failure, and your doctor will decide which treatment is suitable for you. 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 more Vanatex than prescribed:

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken 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 almost 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 your condition. Do not change your treatment without consulting your doctor. If you have any further questions on the use of this product, 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 require immediate medical attention:

May occur 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 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 occur symptoms such as fever, swelling, and joint or muscle pain, swelling of lymph nodes, and/or flu-like symptoms (symptoms of serum sickness),
• purple or red spots, fever, itching (symptoms of inflammation of blood vessels, also known as vasculitis),
• unusual 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 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 those not listed in this leaflet, please inform 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 this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month. The packaging is labeled with the batch number after LOT/LOT. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 package leaflet: