Valsartan Aurovitas 80 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Valsartan Aurovitas 80 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as 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 you should not give it to other people, even if they have the same symptoms as you, because 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:
- What Valsartan Aurovitas is and what it is used for
- What you need to know before taking Valsartan Aurovitas
- How to take Valsartan Aurovitas
- Possible side effects
- How to store Valsartan Aurovitas
- 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 80 mg film-coated tablets can be used for three different conditions:
? to treat high blood pressure in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure increases the workload of the heart and arteries. If left untreated, it may damage the blood vessels of 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 here between 12 hours and 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 used to treat heart failure) cannot be used, or may be used in addition to ACE inhibitors when other medicines for the treatment of heart failure cannot be used.
Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This is 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 Pregnancy section).
? 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, tell 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 narrowing of the artery to the kidney (renal artery stenosis).
? if you have recently had a kidney transplant (received a new kidney).
? if you have a serious heart condition other than heart failure or heart attack.
? tell 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 potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. You may need regular monitoring of potassium levels in your blood.
? if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, valsartan is not recommended.
? if you have lost a lot 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 must inform your doctor if you think you are (or might be) pregnant. Use of valsartan is not recommended in early pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).
Talk to 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 other 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 information under the headings “Do not take Valsartán Aurovitas” and “Warnings and precautions”).
? medicines that increase potassium levels in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
? certain pain medicines 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 conditions.
In addition:
? if you are being treated after a heart attack, combination with ACE inhibitors (a medicine 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 instead of valsartan.
Valsartan is not recommended during early pregnancy, and must not be given from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.
? Inform your doctor if you are breastfeeding or plan to breastfeed. 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, handling 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 told you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
Valsartán Aurovitas contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this 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 as 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.
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 may also be combined with another medicine (e.g. a diuretic).
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 dose of 20 mg administered twice daily. The 20 mg dose is obtained by splitting 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 initiated with 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 may 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 medicine 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 missed dose.
If you stop treatment with 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 renal failure)
? muscle cramps, irregular heartbeat (signs of hyperkalaemia)
? shortness of breath, difficulty breathing when lying down, swelling of 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 accompanied by 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 blood vessel inflammation, 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 reduction in the proportion of red blood cells in the blood (which, in severe cases, may lead to 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 damage), 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 twitching, 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 which is stated on the carton 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines 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 80 mg of valsartan.
- The other components are:
Tablet core: microcrystalline cellulose, monohydrate lactose, 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).
Appearance of the product and contents of the pack
Light red, round, bevelled, biconvex, film-coated tablets marked with "I" on one side and "74" on the other, with a score line separating the numbers 7 and 4.
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 Authorization Holder and Manufacturer
Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
Spain: | Valsartan Aurovitas 80 mg film-coated tablets EFG |
Poland: | AuroValsart |
Portugal: | Valsartan Aurovitas |
Date of the most recent review of this leaflet: August 2025
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).