VALSARTAN AUROVITAS 320 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan Aurovitas 320 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

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

Valsartan Aurovitas 320 mg film-coated tablets can be used:

? to treat high blood pressure in children and adolescents from6 toless than 18 years of age.High blood pressure increases the workload of the heart and arteries. If not treated, it can damage blood vessels in the brain, heart, and kidneys, and can 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.

2. What you need to know before you take Valsartan Aurovitas

Do not take Valsartan Aurovitas

? if you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6).

? if you have a severe liver disease.

? if you are pregnant more than 3 months(it is also preferable to avoid Valsartan Aurovitas at the start of pregnancy - see section Pregnancy).

? if you have diabetes or kidney problems and are being treated with a medicine to reduce blood pressure that contains aliskiren.

If any of the above applies to you,tell your doctor and do not take valsartan.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Valsartan Aurovitas.

? if you have a liver disease.

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

? if you have a narrowing of the kidney artery.

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

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

? inform your doctor if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema while taking other medicines (including ACE inhibitors). If these symptoms appear when 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 the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin. It may be necessary to regularly check the amount of potassium in the blood.

? if you suffer from aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take valsartan.

? if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine production).

? 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), especially if you have kidney problems related to diabetes.
• aliskiren.

? if you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.

See also the information under the heading "Do not take Valsartan Aurovitas".

You must inform your doctor if you think you are (or might become) pregnant. Valsartan is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see section Pregnancy).

Other medicines and Valsartan Aurovitas

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

The effect of treatment with valsartan may be affected if taken with certain medicines. It may be necessary to change the dose, take other precautions, or, in some cases, stop treatment with one of the medicines. This applies to both prescription and non-prescription medicines, especially:

? other medicines that lower blood pressure, especially diuretics(medicines to increase urine production), ACE inhibitors, or aliskiren (see also the information under the headings "Do not take Valsartan Aurovitas" and "Warnings and precautions").

? medicines that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin.

? certain pain medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs).

? some antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (ciclosporin), 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 types of psychiatric diseases.

In addition:

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

? if you are being treated for heart failure,it is not recommended to combine with ACE inhibitors and other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or 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, ask your doctor or pharmacist for advice before taking this medicine.

? You must tell your doctor if you are pregnant (or if you think you might be).Your doctor will normally advise you to stop taking valsartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of valsartan.

It is not recommended to use valsartan at the start of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period.

? Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use valsartan during breastfeeding, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how valsartan affects you. Like many other medicines used to treat high blood pressure, valsartan can cause dizziness and affect your ability to concentrate.

Valsartan Aurovitas containslactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Valsartan Aurovitas containssodium

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

3. How to take Valsartan Aurovitas

To get the best results and reduce the risk of side effects, follow exactly the instructions for taking this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. People with high blood pressure often do not notice any signs of the disease; many feel normal. This makes it very important to attend your doctor's appointments, even if you feel well.

Adult patients with high blood pressure

The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Valsartan can also be combined with another medicine (e.g., a diuretic).

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

In patients who weigh less than 35 kg, the recommended initial dose is 40 mg of valsartan once daily.

In patients who weigh 35 kg or more, the recommended initial dose is 80 mg of valsartan once daily.

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

In children who have difficulty swallowing tablets, it is recommended to administer the oral solution.

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

If you take more Valsartan Aurovitas than you should

If you notice a strong 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 can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan Aurovitas

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to make up for the missed dose.

If you stop taking Valsartan Aurovitas

If you stop your treatment with valsartan, your disease may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on the use of this medicine, 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 may be serious and may require immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as:

? swelling in 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 side effects include:

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

? dizziness

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

? 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 spasms, abnormal heart rhythm (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

? diarrhea

? fatigue

? weakness

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

? blisters on the skin (sign of bullous dermatitis)

? allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and pain in the joints, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness)

? red spots on the skin, fever, itching (signs of vasculitis)

? more frequent bruising or bleeding 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 hemoglobin and hematocrit levels in the blood (which, in severe cases, can lead to anemia)

? increase in potassium levels in the blood (which, in severe cases, can lead to muscle spasms and abnormal heart rhythm)

? elevation of liver function values (which may indicate liver damage), including an increase in bilirubin levels in the blood (which, in severe cases, can cause yellowing of the skin and eyes)

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

? low sodium levels in the blood (which, in severe cases, can cause fatigue, confusion, muscle twitching, and/or convulsions)

The frequency of some side effects may vary depending on your condition. For example, certain side 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.

Side effects in children and adolescents are similar to those observed in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Valsartán Aurovitas

• The active ingredient is valsartan. Each film-coated tablet contains 320 mg of valsartan.
• The other components are:

Tablet core:microcrystalline cellulose, lactose monohydrate, anhydrous colloidal 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), black iron oxide (E172).

Appearance of the Product and Container Content

Film-coated tablets of dark grey-violet color, oval, bisected, biconvex, with the mark “I” on one face and “18” on the other, with a notch separating the numbers 1 and 8.

The tablet can be divided into equal doses.

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

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

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Date of the Last Revision of this Leaflet: April 2021

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