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 any not listed in this leaflet, please tell 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 narrow, 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 in 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 reduces 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 to 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 buildup. They are caused by the heart muscle not being able to pump blood with enough force to supply the body with the blood it needs.

AuroValsart 160 mg film-coated tablets can be used to treat three different diseases:

• to treat high blood pressure in adult patients and in 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 reduces 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 to 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 buildup. They are caused by the heart muscle not being able to pump blood with enough force to supply the body with the blood it 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, breast-feeding 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 applies 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 kidney arteries;
• you have recently had a kidney transplant (you have received a new kidney);
• 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), tell your doctor. 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 in the blood 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");

In addition:

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or 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 are planning to become pregnant. Your doctor will normally advise you to stop taking Valsartan Aurovitas 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 breast-feeding or about to start breast-feeding.

AuroValsart is not recommended for mothers who are breast-feeding, and your doctor may choose a different treatment for you if you want to breast-feed, especially if you are feeding 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 make sure they know how AuroValsart affects them. Like many other medicines used to treat high blood pressure, AuroValsart can cause dizziness and affect the 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, but it is very important to follow your doctor's advice and take the medicine as prescribed.

High blood pressure in adult patients:

The usual dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (such as 160 mg or 320 mg). Your doctor may also prescribe AuroValsart in combination with another medicine (such as a diuretic).

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

For patients with a body weight less than 35 kg, the recommended initial dose is 40 mg once daily. For patients with a body weight of 35 kg or more, the recommended initial dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (up to 160 mg or a maximum of 320 mg). If the child 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. The dose will be gradually increased over several weeks to a maximum dose of 160 mg twice daily. The final dose will depend on how well you tolerate the medicine. AuroValsart can be given with other medicines used to treat heart attack, and your doctor will decide what treatment is suitable for you.

Heart failure in adult patients:

The usual starting dose is 40 mg twice daily. The dose will be gradually increased over several weeks to a maximum dose of 160 mg twice daily. The final dose will depend on how well you tolerate the medicine. AuroValsart can be given with other medicines used to treat heart failure, and your doctor will decide what treatment is suitable for you. AuroValsart can be taken with or without food. AuroValsart should be swallowed with a glass of water. AuroValsart should be taken at the same time each day.

Take more AuroValsart than prescribed

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.

Miss a dose of AuroValsart

If you forget to take 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.

Stop taking AuroValsart

Stopping treatment with AuroValsart may cause your disease 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, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention:

Some patients may experience symptoms of angioedema (a specific allergic reaction), 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),
• feeling of spinning (vertigo),
• 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.

Rare (may affect up to 1 in 1,000 people)

• blisters on the skin (symptoms of blistering skin rash),
• 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 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),
• low hemoglobin and low red blood cell count (which can lead to anemia in severe cases),
• high potassium levels in the blood (which can cause muscle cramps and irregular heartbeat in severe cases),
• increased liver enzyme levels (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).
• low sodium levels in the blood (which can cause tiredness, confusion, muscle twitching, and/or seizures in severe cases).

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

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme at www.mhra.gov.uk/yellowcard. 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, silica colloidal anhydrous, 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

Orange-brown, 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