Vanatex

Package leaflet: Information for the patient

Vanatex, 80 mg, film-coated tablets
Vanatex, 160 mg, film-coated tablets
Valsartanum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Vanatex is and what it is 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 Vanatex is and what it is 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 narrow, thereby increasing blood pressure. Vanatex works by blocking the action of angiotensin II. As a result, blood vessels relax and widen, and blood pressure decreases.
Vanatex 80 mg and 160 mg film-coated tablets 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 attacks. Lowering blood pressure to normal levels helps reduce the risk of developing these complications.
• for the treatment of adult patients following a recent heart attack (myocardial infarction)
  "Recent" means within 12 hours to 10 days after the event.
• for the treatment of symptomatic heart failure in adult patients
  Vanatex may be used in adult patients for the treatment of symptomatic heart failure. Vanatex is used when a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors (medicines used in the treatment of heart failure) cannot be used, or Vanatex may be used in combination with ACE inhibitors when other medicines used in the treatment of heart failure cannot be administered. 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 with sufficient force to supply adequate blood flow to the entire body.

2. Important information before using Vanatex

When not to use Vanatex:

• 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 beyond the 3rd month of pregnancy (it is also advisable to avoid using Vanatex during early pregnancy – see section on pregnancy);
• 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 apply, Vanatex must not be used.
Warnings and precautions
Before starting Vanatex, discuss with your doctor or pharmacist:

• if the patient has liver disease;
• if severe kidney disease has been diagnosed or if the patient is on dialysis;
• if there is narrowing of the renal artery;
• if the patient has recently undergone kidney transplantation (received a new kidney);
• if the patient is being treated after a heart attack or due to 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 blood potassium levels. This includes potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. Regular monitoring of blood potassium levels may be necessary.
• if the patient is under 18 years of age and taking Vanatex in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), the doctor will regularly monitor kidney function and blood potassium levels;
• if the patient has aldosteronism; a condition in which the adrenal glands produce excessive amounts of a hormone called aldosterone. If this condition is present, use of Vanatex is not recommended.
• if the patient has experienced significant fluid loss (dehydration) due to diarrhoea, vomiting, or use of high doses of diuretic medicines (water tablets);
• if the patient has ever experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform the doctor. If such symptoms occur while taking Vanatex, the medicine must 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 kidney problems related to diabetes;
• 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 treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g.
potassium) at regular intervals.
See also information under the heading “When not to use Vanatex”.
Inform the doctor if the patient thinks she is pregnant (or might become pregnant). Vanatex 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 at this stage (see section “Pregnancy and breastfeeding”).

If any of the above conditions apply, inform the doctor before using Vanatex.
Vanatex 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.
Taking Vanatex with certain other medicines may affect treatment. Dose adjustments, 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 and the medicine aliskiren;
• medicines that increase blood potassium levels; including potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• certain types of painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs);
• lithium (a medicine used to treat certain psychiatric conditions).

Additionally:

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

The treating doctor may need to adjust the dose and/or take additional precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings “When not to use Vanatex” and “Warnings and precautions”);
• if the patient is taking an ACE inhibitor together 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 may be taken with or without food.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

• Inform the doctor if the patient thinks she is pregnant (or might become pregnant). The doctor will usually advise stopping Vanatex before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Vanatex 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 beyond the third month of pregnancy.
• Inform the doctor if the patient is breastfeeding or intends to breastfeed. Vanatex is not recommended for breastfeeding mothers; the doctor may choose an alternative treatment for patients who intend to breastfeed, especially if the newborn is premature.

Driving and operating machinery
Before driving, using tools, operating machinery, or performing any activity requiring concentration, each patient should determine how Vanatex affects them. Like many other medicines used to treat high blood pressure, Vanatex may rarely cause dizziness and affect the ability to concentrate.
Vanatex contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Vanatex

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms. Many of them feel quite well. For this reason, it is all the more important to attend regular check-ups with your doctor, even when 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 together with an additional medicine (e.g. a diuretic).

Children and adolescents (aged 6 to 18 years) with high blood pressure:
For patients with body weight below 35 kg, the usual dose of valsartan is 40 mg once daily. For patients with body weight of 35 kg or more, the usual starting dose is 80 mg of valsartan once daily. In some cases, your doctor may recommend higher doses (the dose may be increased up to 160 mg, and maximally up to 320 mg).

Condition following a recent heart attack in adult patients:
Treatment usually begins within 12 hours after the heart attack, typically with a low dose of 20 mg twice daily. The 20 mg dose is obtained by splitting 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 the patient tolerates the medicine.
Vanatex may be given together with other medicines used in the treatment of heart attack, and your doctor will decide which treatment is appropriate in each individual case.

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 the patient tolerates the medicine.
Vanatex may be given together with other medicines used in the treatment of heart failure, and your doctor will decide which treatment is appropriate in each individual case.

Vanatex may be taken with or without food. Swallow the tablet with a glass of water.
Vanatex should be taken every day at approximately the same time.

Taking more Vanatex than recommended
If severe dizziness and/or fainting occur, lie down and contact your doctor immediately. If too many tablets have been taken by accident, contact your doctor, pharmacist, or hospital immediately.

Missing a dose of Vanatex
If a dose is missed, take it as soon as remembered. 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 Vanatex
Stopping treatment with Vanatex may worsen the condition. Do not change the treatment without first consulting 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: affects more than 1 in 10 patients,
• common: affects less than 1 in 10 patients;
• uncommon: affects less than 1 in 100 patients;
• rare: affects less than 1 in 1,000 patients;
• very rare: affects less than 1 in 10,000 patients;
• unknown: frequency cannot be determined from available data.

Symptoms requiring immediate medical attention:
Symptoms of angioedema may occur, such as:

• swelling of the face, lips, tongue or throat,
• difficulty breathing or swallowing,
• hives, itching. If any of these symptoms occur, contact your doctor immediately.

Adverse reactions:
Common:

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

Uncommon:

• angioedema (see "Symptoms requiring immediate medical attention"),
• sudden loss of consciousness (fainting),
• sensation of spinning (dizziness),
• severe kidney function disorders (symptoms of acute kidney failure),
• muscle cramps, heart rhythm disturbances (symptoms of hyperkalaemia),
• 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.

Unknown:

• 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 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, so-called neutropenia),
• decreased haemoglobin concentration and reduced proportion 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 heart rhythm disturbances in severe cases),
• decreased sodium levels in blood (which may cause fatigue, disorientation, muscle twitching and/or seizures in severe cases),
• increased liver function parameters (which may indicate liver damage), including: increased bilirubin levels in blood (which may cause yellowish skin and eyes in severe cases),
• increased blood urea nitrogen levels and increased serum creatinine levels (which may indicate impaired kidney function).

The frequency of some adverse reactions may vary depending on the disease.
For example, adverse reactions such as dizziness and kidney function disorders
have been observed less frequently in patients treated for high blood pressure than in 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 adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Vanatex

Vanatex 80 mg: Do not store above 25°C. Keep in the original packaging to protect from light.
Vanatex 160 mg: Do not store above 25°C.
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.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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.
• Other ingredients are:
  Tablet core: monohydrate lactose, sodium croscarmellose, anhydrous colloidal silicon dioxide, magnesium stearate.
  Tablet coating: hypromellose 6 cp, macrogol 400, titanium dioxide (E171), iron oxide, red (E172); tablets of 160 mg 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 division line.
Vanatex 160 mg film-coated tablets are light brown, oblong, biconvex tablets with a division line.
The tablets can be divided into equal doses.
1 pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Pelplińska Street 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01