Aurovalsart

Package Leaflet: Information for the User

AuroValsart, 80 mg, film-coated tablets

AuroValsart, 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.

Table of Contents of the Package Leaflet

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

1.

What is AuroValsart and what is it used for

AuroValsart contains the active substance valsartan and belongs to a group of medicines called 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. AuroValsart works by blocking the action of angiotensin II. As a result, blood vessels widen, and blood pressure is lowered. AuroValsart 80 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 less than 18 years of age.High blood pressure increases the workload on the heart and arteries. If not treated, 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 attack. Lowering blood pressure to normal levels can reduce the risk of these complications.
• 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 patients.AuroValsart is used when an ACE inhibitor (a type of medicine used to treat heart failure) cannot be used or as additional treatment with an ACE inhibitor 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, which are caused by the heart muscle not being able to pump blood with sufficient force to meet the body's needs.

AuroValsart 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 less than 18 years of age.High blood pressure increases the workload on the heart and arteries. If not treated, 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 attack. Lowering blood pressure to normal levels can reduce the risk of these complications.
• 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 patients.AuroValsart is used when an ACE inhibitor (a type of medicine used to treat heart failure) cannot be used or as additional treatment with an ACE inhibitor 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, which are caused by the heart muscle not being able to pump blood with sufficient force to meet the body's needs.

2. Important information before taking AuroValsart

When not to take AuroValsart

• if you are allergic to 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 not recommended to take AuroValsart early in pregnancy - see section "Pregnancy, breastfeeding and fertility");
• if you have diabetes or kidney problems and are treated with aliskiren, a medicine used to lower blood pressure.

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

Warnings and precautions

Before taking AuroValsart, tell your doctor or pharmacist if:

• you have liver disease;
• you have severe kidney disease or are on dialysis;
• you have narrowing of the arteries that supply blood to the kidneys;
• you have recently had a kidney transplant;
• you have severe heart disease other than heart failure or heart attack;
• you have ever had swelling of the face, lips, throat, or tongue after taking another medicine (including ACE inhibitors), known as angioedema. If you get these symptoms while taking AuroValsart, stop taking it and do not take it again (see also section 4 "Possible side effects");
• you are taking medicines that increase potassium levels in the blood, such as potassium supplements, potassium-sparing diuretics, or heparin. Regular monitoring of potassium levels may be necessary;
• you have aldosteronism (a condition where the adrenal glands produce too much of a hormone called aldosterone) - do not take AuroValsart;
• you have significant fluid loss (dehydration) due to diarrhea, vomiting, or high doses of diuretics;
• you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under "Do not take AuroValsart" and "Warnings and precautions");

Tell your doctor if you are taking any of these medicines. Your doctor may need to monitor your blood pressure, kidney function, and potassium levels regularly.

AuroValsart with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those obtained without a prescription.

• other medicines to lower blood pressure, such as diuretics, ACE inhibitors (e.g., enalapril, lisinopril), or aliskiren (see also the information under "Do not take AuroValsart" and "Warnings and precautions");
• medicines that increase potassium levels in the blood, including potassium supplements, potassium-sparing diuretics, or heparin;
• certain types of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs);
• certain antibiotics (such as rifamycin), medicines to prevent transplant rejection (cyclosporin), or antiretroviral medicines used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of valsartan;
• lithium (a medicine used to treat certain mental illnesses).

In addition:

• after a heart attackit is not recommended to take AuroValsart with ACE inhibitors;
• for heart failure treatmentit is not recommended to take AuroValsart with ACE inhibitors, other heart failure medicines known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone), and beta-blockers (e.g., metoprolol).

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.

• Tell your doctor if you think you are pregnant or plan to become pregnant. Your doctor will normally advise you to stop taking AuroValsart before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of AuroValsart. Do not take AuroValsart if you are more than 3 months pregnant, as it may seriously harm your baby.
• Tell your doctor if you are breastfeeding or plan to breastfeed.

AuroValsart is not recommended for mothers who are breastfeeding, especially if they are feeding newborns or premature babies. Your doctor may choose a different treatment for you if you want to breastfeed.

Driving and using machines

Before driving, using tools, or operating machinery, you should make sure you know how AuroValsart affects you. Like many other medicines used to treat high blood pressure, AuroValsart may cause dizziness and affect your ability to concentrate.

AuroValsart contains lactose

This medicinal product contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

AuroValsart contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take AuroValsart

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. People with high blood pressure often do not feel unwell. However, it is important to keep your appointments with your doctor, even if you feel fine.

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 AuroValsart with another medicine (e.g., a diuretic).

Children and adolescents (from 6 to less than 18 years of age) with high blood pressure

For patients with a body weight of less than 35 kg, the recommended initial dose is usually 40 mg once daily. For patients with a body weight of 35 kg or more, the recommended initial dose is usually 80 mg of valsartan once daily. In some cases, your doctor may prescribe higher doses (up to 160 mg and a maximum of 320 mg). For children who cannot swallow tablets, an oral solution is recommended.

After a recent heart attack in adult patients:

Treatment usually starts at 12 hours to 10 days after the heart attack, with a low dose of 20 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.

Heart failure in adult patients:

The usual starting dose is 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.

Taking AuroValsart

AuroValsart can be taken with or without food. Swallow AuroValsart with a glass of water. Take AuroValsart at the same time each day.

If you take more AuroValsart than you should

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

If you forget to take AuroValsart

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 AuroValsart treatment

Stopping treatment with AuroValsart may cause your illness to get worse. Do not stop taking AuroValsart unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, AuroValsart can cause side effects, although not everybody gets them.

Some side effects can be serious and 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 you experience any of these symptoms, stop taking AuroValsart and contact your doctor immediately (see also section 2 "Warnings and precautions").

Other side effects:

Common (may affect up to 1 in 10 people)

• 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(may affect up to 1 in 100 people)

• angioedema (see "Some side effects can be serious and require immediate medical attention"),
• sudden loss of consciousness (fainting),
• spinning sensation (vertigo),
• severe kidney problems (symptoms of acute kidney failure),
• muscle spasms, 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.

Rare(cannot be estimated from the available data)

• blisters on the skin (symptoms of blistering skin disease),
• allergic reactions with rash, itching, and hives; symptoms may include fever, swelling, and joint or muscle pain, swollen 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 low platelet count),
• muscle pain (myalgia),
• fever, sore throat, or mouth ulcers due to infection (symptoms of low white blood cell count, also known as neutropenia),
• decreased hemoglobin and red blood cell count (which may lead to anemia in severe cases),
• increased potassium levels in the blood (which may cause muscle spasms and irregular heartbeat in severe cases),
• increased liver enzyme levels (which may indicate liver damage), including increased bilirubin levels in the blood (which may cause yellowing of the skin and eyes in severe cases),
• increased urea and creatinine levels in the blood (which may indicate kidney problems).
• low sodium levels in the blood (which may cause tiredness, confusion, muscle twitching, and/or convulsions in severe cases).

The frequency of some side effects may vary depending on the disease. For example, dizziness and kidney problems 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 in children and adolescents are similar to those 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. You can also report side effects directly to the national reporting system via the contact details below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AuroValsart

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 blister and carton after EXP. The expiry date refers to the last day of that month. Store in a temperature below 30°C. 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 AuroValsart contains

The active substance is valsartan. Each film-coated tablet contains 80 mg or 160 mg of valsartan. The other ingredients are:

Tablet core:microcrystalline cellulose, lactose monohydrate, silicon dioxide, crospovidone (Type B), hypromellose, sodium lauryl sulfate, talc, magnesium stearate.

Coating:hypromellose, titanium dioxide (E 171), macrogol 8000, yellow iron oxide (E 172), red iron oxide (E 172).

What AuroValsart looks like and contents of the pack

AuroValsart, 80 mg, film-coated tablets

Light red, round, with a beveled edge, biconvex, film-coated tablets, with "I" engraved on one side and "74" on the other side, with a score line separating 7 and 4. The tablet can be divided into equal doses.

AuroValsart, 160 mg, film-coated tablets

Grey-orange, oval, with a beveled edge, biconvex, film-coated tablets, with "I" engraved on one side and "75" on the other side, with a score line separating 7 and 5. The tablet can be divided into equal doses.

AuroValsart film-coated tablets are available in blisters.

Pack sizes:14, 28, and 56 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warszawa

Manufacturer/Importer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Italy

VALSARTAN AUROBINDO ITALIA

Poland

AuroValsart

Portugal

Valsartan Aurovitas

Spain

VALSARTÁN AUROVITAS 40 mg/ 80 mg/ 160 mg/ 320 mg

comprimidos recubiertos con película EFG

Date of last revision of the package leaflet: 04/2021