Valsartan Tarbis 160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartán Tarbis 160 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Valsartán Tarbis belongs to a group 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, resulting in increased blood pressure. Valsartán Tarbis works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Tarbis can be used for three different conditions:

- To treat high blood pressure in adults and in children and adolescents aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it may damage the blood vessels of the brain, heart, and kidneys, leading 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 following a recent heart attack (myocardial infarction). "Recent" means within 12 hours to 10 days.

- To treat symptomatic heart failure in adult patients. Valsartán Tarbis is used when a group of medicines called Angiotensin-Converting Enzyme Inhibitors (ACE inhibitors) (a medication used to treat heart failure) cannot be used, or it may be added to ACE inhibitors when other heart failure treatments are not suitable. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This condition 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 Tarbis

Do not take Valsartán Tarbis

• if you are allergic (hypersensitive) to valsartan or to any of the other ingredients of this medicine (listed in section 6).
• if you have a severe liver disease
• if you are more than 3 months pregnant (Valsartán Tarbis is also best avoided during the first months of 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, do not take Valsartán Tarbis.

Warnings and precautions

Take special care with Valsartán Tarbis

• if you have a liver disease.
• if you have a severe kidney disease or are undergoing dialysis.
• if you have a narrowing of the renal artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you are being treated for a heart attack or heart failure, your doctor may monitor your kidney function.
• if you have a serious heart condition other than heart failure or heart attack.
• 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), inform your doctor. If you experience these symptoms while taking Valsartán Tarbis, stop treatment 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 are under 18 years of age and are taking Valsartán Tarbis in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (medicines that lower blood pressure), your doctor may regularly monitor your kidney function and blood potassium levels.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, taking Valsartán Tarbis is not recommended.
• if you have lost a large amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine output).
• you must inform your doctor if you think you are (or could be) pregnant. The use of Valsartán Tarbis is not recommended in early 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 (see Pregnancy section).
• if you are taking any of the following medicines used to treat hypertension (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 the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

If any of the above apply to you, inform your doctor before taking Valsartán Tarbis.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.

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

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

Taking Valsartán Tarbis with other medicines

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

The effect of treatment with Valsartán Tarbis 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.
• medicines that increase blood potassium levels. 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 (from the rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartán Tarbis.
• lithium, a medicine used to treat certain psychiatric disorders.
• if you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Valsartán Tarbis” and “Warnings and precautions”).
• if you are being treated with an ACE inhibitor together with other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

In addition:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medicine to treat a heart attack) is not recommended.
• if you are being treated for heart failure, the triple combination with ACE inhibitors and beta-blockers (a medicine to treat a heart attack) is not recommended.

Taking Valsartán Tarbis with food and drink

You may take Valsartán Tarbis with or without food.

Pregnancy and breastfeeding

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

• You must inform your doctor if you suspect you are pregnant or could be pregnant. Generally, your doctor will advise you to stop taking Valsartán Tarbis before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Valsartán Tarbis. The use of Valsartán Tarbis is not recommended in early 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 after the third month of pregnancy.
• Inform your doctor if you are breastfeeding or about to start breastfeeding. The use of Valsartán Tarbis is not recommended in breastfeeding mothers, and your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if your baby is a newborn or was premature.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or engaging in other activities requiring concentration, make sure you are aware of how you react to the effects of Valsartán Tarbis. Like many other medicines used to treat high blood pressure, Valsartán Tarbis may rarely cause dizziness and affect your ability to concentrate.

3. How to take Valsartán Tarbis

To achieve the best results and reduce the risk of adverse effects, always take Valsartán Tarbis exactly as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts. People with high blood pressure often do not experience any symptoms and may feel perfectly normal. Therefore, it is very important to keep your medical appointments even if you feel well.

Adult patients with high blood pressure:

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

Use in children and adolescents (6 to 18 years of age) with high blood pressure:

In patients weighing less than 35 kg, the recommended 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).

Adult patients after a recent heart attack:

Treatment is usually started within 12 hours after a heart attack, typically beginning with a low 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.

Valsartán Tarbis 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.

Valsartán Tarbis 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 Tarbis with or without food. Swallow the tablet with a glass of water.

Take Valsartán Tarbis at approximately the same time each day.

If you take more Valsartán Tarbis 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 call the Toxicology Information Service at 91-562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartán Tarbis

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 missed dose.

If you stop taking Valsartán Tarbis

If you discontinue treatment with Valsartán, your condition may worsen. Do not stop taking this 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 experiences them.

These adverse effects may occur with certain frequencies defined as follows:

• very common: may affect more than 1 in 10 people,
• common: may affect between 1 and 10 in 100 people,
• uncommon: may affect between 1 and 10 in 1,000 people,
• rare: may affect between 1 and 10 in 10,000 people,
• very rare: may affect fewer than 1 in 10,000 people,
• frequency not known: frequency cannot be estimated from available data.

Some symptoms requiring 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 Valsartán Tarbis and contact your doctor immediately (see also section 2 “Take special care with Valsartán Tarbis”)

Adverse effects include:

Common

• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting upon standing
• reduced kidney function (signs of kidney impairment)

Uncommon

• angioedema (see section “Some symptoms requiring immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of spinning (vertigo)
• marked reduction in kidney function (signs of acute renal failure)
• muscle cramps, abnormal heart rhythm (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

• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea

Frequency not known

• 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 frequently 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 lead to anaemia)
• increased potassium levels in blood (which, in severe cases, may cause muscle cramps and abnormal heart rhythm)
• elevated 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 sodium levels in blood (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 hypertension than in adult patients treated for heart failure and after a recent heart attack.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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

5. Storage of Valsartan Tarbis

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.

Do not store above 30°C. Keep in the original packaging to protect from light.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents and additional information

Composition of Valsartán Tarbis

The active substance is valsartan. Each film-coated tablet contains 160 mg of valsartan.

The other components are: microcrystalline cellulose, powdered cellulose, crospovidone, and magnesium stearate. The tablet coating contains hypromellose, titanium dioxide (E171), Macrogol 8000, red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172).

Appearance of the product and contents of the container

Valsartán Tarbis 160 mg film-coated tablets are film-coated, orange-yellow, oblong tablets, scored on one side.

They are available in packs of 14, 28, 30, 56, and 90 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

Laboratorios Lesvi, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

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

Portugal: Valsartan Qualigen

Spain: Valsartán Tarbis 160 mg film-coated tablets EFG

Date of the most recent review of this summary: February 2025

Detailed and up-to-date 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/.