Valsartan Aurovitas 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Valsartán Aurovitas 40 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Valsartán Aurovitas is and what it is used for
2. What you need to know before taking Valsartán Aurovitas
3. How to take Valsartán Aurovitas
4. Possible side effects
5. How to store Valsartán Aurovitas
6. Contents of the pack and other information

1. What Valsartán Aurovitas is and what it is used for

Valsartán Aurovitas contains the active substance: valsartan and belongs to a class of medicines known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, leading to increased blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Aurovitas 40 mg film-coated tablets can be used for three different conditions:

? to treat high blood pressure in children and adolescents aged 6 to under 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may damage the blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these disorders.

? to treat adult patients after a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.

? to treat symptomatic heart failure in adult patients. Valsartan is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication for treating heart failure) cannot be used, or may be used in addition to ACE inhibitors when other heart failure treatments are not possible.

Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This occurs because the heart muscle cannot pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Valsartán Aurovitas

Do not take Valsartán Aurovitas

? if you are allergic to valsartan or to 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 advisable to avoid Valsartán Aurovitas in early pregnancy – see section on Pregnancy).

? if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, inform your doctor and do not take valsartan.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valsartán Aurovitas.

? if you have liver disease.

? if you have severe kidney disease or are undergoing dialysis.

? if you have a narrowing of the artery to the kidney (renal artery stenosis).

? if you have recently undergone a kidney transplant (received a new kidney).

? if you have severe heart disease other than heart failure or heart attack.

? inform your doctor if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors). If these symptoms occur while you are taking valsartan, stop taking the medicine immediately and never take it again. See also section 4 “Possible side effects”.

? if you are taking medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. Regular monitoring of blood potassium levels may be necessary.

? if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, taking valsartan is not recommended.

? if you have lost a large amount of fluid (dehydration) due to diarrhoea, vomiting, or high doses of diuretics (medicines that increase urine output).

? if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

? if you are being treated with an ACE inhibitor together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (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) at regular intervals.

See also the information under the heading “Do not take Valsartán Aurovitas”.

You should inform your doctor if you think you are (or might be) pregnant. The use of valsartan is not recommended during early pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used during this period (see section on Pregnancy).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking valsartan. Your doctor will decide whether to continue treatment. Do not stop taking valsartan on your own.

Other medicines and Valsartán Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of treatment with valsartan may be altered if taken together with certain medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases discontinue treatment with one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

? other medicines that lower blood pressure, particularly diuretics (medicines that increase urine output), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the headings “Do not take Valsartán Aurovitas” and “Warnings and precautions”).

? medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.

? certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).

? some antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of valsartan.

? lithium, a medicine used to treat certain psychiatric disorders.

In addition:

? if you are being treated after a heart attack, combination with ACE inhibitors (a medication used to treat heart attack) is not recommended.

? if you are being treated for heart failure, the triple combination with ACE inhibitors and other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol) is not recommended.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

? You must inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking valsartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.

Valsartan is not recommended during early pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from this stage onward.

? Inform your doctor if you are breastfeeding or planning to breastfeed. The use of valsartan during breastfeeding is not recommended, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving, operating tools or machinery, or engaging in other activities requiring concentration, make sure you know how valsartan affects you. Like many other medicines used to treat high blood pressure, valsartan may cause dizziness and affect your ability to concentrate.

Valsartán Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Valsartán Aurovitas contains sodium

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

3. How to take Valsartán Aurovitas

To achieve the best results and reduce the risk of adverse effects, follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. People with high blood pressure often do not notice any symptoms of the condition; many feel perfectly normal. This makes it very important to attend your medical appointments regularly, even if you feel well.

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

In patients weighing less than 35 kg, the recommended starting dose is 40 mg of valsartan once daily.

In patients weighing 35 kg or more, the recommended starting dose is 80 mg of valsartan once daily.

In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

For children who have difficulty swallowing tablets, administration of the oral solution is recommended.

Adult patients after a recent heart attack

After a heart attack, treatment is usually started within 12 hours, typically with a low starting dose of 20 mg given twice daily. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan may be administered together with other treatments for heart attack, and your doctor will decide which treatment is appropriate for you.

Adult patients with heart failure

Treatment is usually started at 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan may be administered together with other treatments for heart failure, and your doctor will decide which treatment is appropriate for you.

You can take Valsartán Aurovitas with or without food. Swallow the tablet with a glass of water. Take the medicine at approximately the same time each day.

If you take more Valsartán Aurovitas 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. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Valsartán Aurovitas

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 the forgotten dose.

If you stop taking Valsartán Aurovitas

If you discontinue treatment with valsartan, your condition may worsen. Do not stop taking the medicine unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious and may require immediate medical attention:

You 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 Valsartan Aurovitas and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other adverse effects include:

Common (may affect up to 1 in 10 people):

? dizziness

? low blood pressure with or without symptoms such as dizziness and fainting upon standing

? reduced kidney function (signs of kidney impairment)

Uncommon (may affect up to 1 in 100 people):

? angioedema (see section “Some symptoms require immediate medical attention”)

? sudden loss of consciousness (syncope)

? sensation of spinning (vertigo)

? marked reduction in kidney function (signs of acute kidney failure)

? muscle cramps, irregular heartbeat (signs of hyperkalemia)

? shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)

? headache

? cough

? abdominal pain

? nausea

? diarrhoea

? fatigue

? weakness

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

? intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (cannot be estimated from available data):

? blisters on the skin (sign of bullous dermatitis)

? allergic reactions may occur with skin rash, itching and hives; symptoms of fever, swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (signs of serum sickness)

? purplish red spots, fever, itching (signs of inflammation of blood vessels, also called vasculitis)

? bleeding or bruising more than usual (signs of thrombocytopenia)

? muscle pain (myalgia)

? fever, sore throat or mouth ulcers due to infections (symptoms of low white blood cell count, also called neutropenia)

? reduction in haemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anaemia)

? increased blood potassium levels (which, in severe cases, may cause muscle cramps and irregular heartbeat)

? elevation of liver function test values (which may indicate liver injury), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes)

? increased blood urea nitrogen and increased serum creatinine levels (which may indicate kidney function abnormalities)

? low blood sodium levels (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures)

The frequency of some adverse effects may vary depending on your condition. For example, certain adverse effects such as dizziness and reduced kidney function were 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 effects in children and adolescents are similar to those observed in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartan Aurovitas

• The active substance is valsartan. Each film-coated tablet contains 40 mg of valsartan.
• The other components are:

Tablet core: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone (type B), hypromellose, sodium lauryl sulfate, talc, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol 8000, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the pack

Yellow, oval, bevelled, biconvex film-coated tablets, marked with "I" on one side and "73" on the other, with a score line separating the numbers 7 and 3.

The tablet can be divided into equal doses.

Valsartan Aurovitas film-coated tablets are available in blister packs.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

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 member states under the following names:

Spain:	Valsartan Aurovitas 40 mg film-coated tablets EFG
Portugal:	Valsartan Aurovitas

Date of the last revision of this leaflet: August 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).