Aurovalsart

Package leaflet: Information for the user

AuroValsart, 80 mg, film-coated tablets
AuroValsart, 160 mg, film-coated tablets
Valsartanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What AuroValsart is and what it is 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 AuroValsart is and what it is used for
AuroValsart contains the active substance: valsartan and belongs to a group of medicines called
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. 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 conditions:

• treatment of high blood pressure in adult patients and children and adolescents aged 6 to below 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, which may result in stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of these complications.
• treatment of adult patients following a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.
• treatment of symptomatic heart failure in adult patients. AuroValsart is used when angiotensin-converting enzyme (ACE) inhibitors (medicines used in the treatment of heart failure) cannot be used, or as additional treatment alongside ACE inhibitors when other types of medicines used in the treatment of heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. These are caused by the heart muscle being unable to pump blood with sufficient force to supply the required amount of blood throughout the body.

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

• treatment of high blood pressure in adult patients and children and adolescents aged 6 to below 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, which may result in stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of these complications.
• treatment of adult patients following a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.
• treatment of symptomatic heart failure in adult patients. AuroValsart is used when angiotensin-converting enzyme (ACE) inhibitors (medicines used in the treatment of heart failure) cannot be used, or as additional treatment alongside ACE inhibitors when other types of medicines used in the treatment of heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. These are caused by the heart muscle being unable to pump blood with sufficient force to supply the required amount of blood throughout the body.

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 use AuroValsart during early pregnancy – see section “Pregnancy, breastfeeding and fertility”);
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, do not take AuroValsart.
Warnings and precautions
Before starting AuroValsart, tell your doctor or pharmacist if:

• you have liver disease;
• you have severe kidney disease or are on dialysis;
• you have renal artery stenosis;
• you have recently received a kidney transplant (you have received a new kidney);
• you have severe heart disease other than heart failure or heart attack;
• you have ever experienced swelling of the tongue or face due to an allergic reaction called angioedema while taking another medicine (including ACE inhibitors), inform your doctor. If these symptoms occur while taking AuroValsart, stop taking it immediately and never take it again. See also section 4 “Possible side effects”;
• you are taking medicines that increase potassium levels in the blood. This includes potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines and heparin. Regular monitoring of blood potassium levels may be necessary;
• you have aldosteronism (a condition in which the adrenal glands produce too much of a hormone called aldosterone), do not use AuroValsart;
• you have significant fluid loss (dehydration) due to diarrhoea, vomiting or use of high doses of diuretics (water tablets);
• you are taking any of the following medicines used to treat high blood pressure:
  • ACE inhibitors (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 in heart failure treatment, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).
    Your doctor may monitor kidney function, blood pressure and electrolyte levels (e.g. potassium) at regular intervals.
    See also information under the heading “When not to take AuroValsart”.
    Tell your doctor if you suspect you are pregnant (or are planning to become pregnant). It is not recommended to use AuroValsart during early pregnancy and it must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used during this period (see section “Pregnancy”).
    If you experience abdominal pain, nausea, vomiting or diarrhoea after taking AuroValsart, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking AuroValsart on your own.

AuroValsart and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking AuroValsart with certain other medicines may affect your treatment. Your doctor may need to adjust the dose, take other precautions or, in some cases, discontinue one of the medicines. This applies to both prescription and over-the-counter medicines, particularly:

• other blood pressure-lowering medicines, especially diuretics (water tablets), angiotensin-converting enzyme (ACE) inhibitors such as enalapril, lisinopril, etc., or aliskiren (see also information under “When not to take AuroValsart” and “Warnings and precautions”);
• medicines that increase potassium levels in the blood; 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);
• certain antibiotics (rifamycin group), medicines used to prevent transplant rejection (cyclosporine) or antiretroviral medicines used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of AuroValsart;
• lithium (a medicine used to treat certain types of mental illness).

In addition:

• after a heart attack, combination treatment with ACE inhibitors (medicines used to treat heart attack) is not recommended;
• in the case of heart failure treatment, it is not recommended to use AuroValsart together with ACE inhibitors, other medicines used in heart failure treatment known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) and beta-blockers (e.g. metoprolol).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

• Tell your doctor if you think you are pregnant (or are planning to become pregnant). Your doctor will usually advise you to stop taking AuroValsart before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of AuroValsart. It is not recommended to use AuroValsart during early pregnancy and it must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used after the third month of pregnancy.

• Inform your doctor if you are breastfeeding or intend to breastfeed. AuroValsart is not recommended for breastfeeding mothers; your doctor may choose another treatment for you if you plan to breastfeed. This is particularly important for feeding newborns or premature infants.

Driving and using machines
Before driving, using tools or operating machinery, or performing any activity requiring concentration, each patient should determine how AuroValsart affects them. Like many other medicines used to treat high blood pressure, AuroValsart may cause dizziness and affect the ability to concentrate.

AuroValsart contains lactose
This medicinal product contains lactose monohydrate. If your doctor has informed you of an intolerance to certain sugars, you should consult your doctor before using this medicine.

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

3. How to take AuroValsart

You must always take this medicine exactly as prescribed by your doctor in order to achieve the best possible results and reduce the risk of adverse effects. If you have any doubts, consult your doctor or pharmacist. People with high blood pressure often do not notice any symptoms of this condition and may feel perfectly well. For this reason, it is important to attend regular medical check-ups, even if you feel 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 AuroValsart together with an additional medicine (e.g. a diuretic).

Children and adolescents (aged 6 to below 18 years) with high blood pressure
For patients with body weight less than 35 kg, the usual starting 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 prescribe higher doses (the dose may be increased up to 160 mg and a maximum of 320 mg).
For children who cannot swallow tablets, an oral solution is recommended.

Treatment 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 up to a maximum dose of 160 mg twice daily. The final dose depends on the patient's tolerance to the medicine.
AuroValsart 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: The usual starting dose is 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum dose of 160 mg twice daily. The final dose depends on the individual patient's tolerance to the medicine.
AuroValsart 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.

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

Taking more AuroValsart than prescribed
If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. In case of accidental overdose, contact your doctor, pharmacist, or hospital immediately.

If you forget to take AuroValsart
If you miss a dose, take it as soon as possible. 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
Stopping treatment with AuroValsart may worsen your condition. Do not discontinue the medicine unless instructed by 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.
Some adverse reactions may be serious and require immediate medical attention:
Symptoms of angioedema (a specific allergic reaction) may occur, such as:

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

If any of these symptoms occur, treatment with AuroValsart must be stopped immediately
and a doctor should be contacted (see also section 2 "Warnings and precautions").
Other adverse reactions:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• angioedema (see "Some 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 hyperkalemia),
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (symptoms of heart failure),
• headache,
• cough,
• abdominal pain,
• nausea,
• diarrhea,
• feeling of fatigue,
• weakness.

Very rare (may affect up to 1 in 10,000 people):

• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Unknown frequency (cannot be estimated from available data)

• skin blisters (symptoms of bullous dermatitis),
• allergic reactions with rash, itching and hives; symptoms such as fever, swelling, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (symptoms of serum sickness),
• 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 hemoglobin concentration and reduced proportion of red blood cells in blood (which may lead to anemia in severe cases),
• increased potassium levels in blood (which may cause muscle cramps and heart rhythm disturbances in severe cases),
• increased liver function test 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 and increased serum creatinine levels (which may indicate impaired kidney function),
• low sodium concentration in blood (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases).

The frequency of some adverse reactions may vary depending on the underlying disease.
For example, adverse reactions such as dizziness and kidney function disorders have been 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.
Adverse reactions observed in children and adolescents are similar to those seen in adult patients.
Reporting of adverse reactions
If any adverse reactions occur, including any 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
Phone: +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 authorization holder.
Reporting adverse reactions helps to 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 stated on the blister and the outer cardboard
package following EXP. The expiry date refers to the last day of the stated month.
Store 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. This will help protect the environment.

6. Contents of the packaging and other information

What AuroValsart contains
The active substance is valsartan. Each coated tablet contains 80 mg or 160 mg of valsartan.
The other ingredients are:
Tablet core: Microcrystalline cellulose, monohydrate lactose, anhydrous colloidal silicon dioxide,
crospovidone (Type B), hypromellose, sodium lauryl sulfate, talc, magnesium stearate.
Coating: Hypromellose, titanium dioxide (E 171), macrogol 8000, iron oxide yellow (E 172), iron oxide red (E 172).

What AuroValsart looks like and contents of the pack
AuroValsart 80 mg, coated tablets
Light red, round, bevelled-edged, biconvex coated tablets, with the imprint "I" on one side and "74" on the other, with a dividing line separating 7 and 4.
The tablet can be divided into equal doses.

AuroValsart 160 mg, coated tablets
Grey-orange, oval, bevelled-edged, biconvex coated tablets, with the imprint "I" on one side and "75" on the other, with a dividing line separating 7 and 5.
The tablet can be divided into equal doses.

AuroValsart coated tablets are available in blister packs.
Pack sizes: 14, 28 and 56 coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
Poland

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 European Economic Area countries under the following names:
Poland AuroValsart
Portugal Valsartan Aurovitas
Spain VALSARTÁN AUROVITAS 40 mg/ 80 mg/ 160 mg/ 320 mg
comprimidos recubiertos con película EFG