Vals 80 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vals80mg film-coated tablets

Valsartan

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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.

Contents of the leaflet

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

1. What Vals is and what it is used for

Vals 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, resulting in increased blood pressure. Vals works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Vals 80 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in adults. High blood pressure increases the workload of the heart and arteries. If left untreated, it can 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 here between 12 hours and 10 days,
• to treat symptomatic heart failure in adult patients. Vals is used when a group of medicines called Angiotensin-Converting Enzyme inhibitors (ACE inhibitors) (a medication for treating heart failure) cannot be used, or may be used in addition to ACE inhibitors when other heart failure medications cannot be used. Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This is due to the heart muscle being unable to pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Vals

Do not take Vals:

• if you are allergic (hypersensitive) 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 better to avoid Vals 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, tell your doctor and do not take Vals.

Warnings and precautions:

Consult your doctor

• 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 undergone a kidney transplant (received a new kidney),
• if you have a serious heart disease 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 develop these symptoms while taking Vals, stop treatment with Vals immediately and never take it again. See also section 4 “Possible side effects”.
• if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Vals. Your doctor will decide whether to continue treatment. Do not stop taking Vals on your own.
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium, 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 Vals 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 (ACEI) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskiren
• if you are being treated with an ACEI together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

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

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

You must inform your doctor if you think you are (or could be) pregnant. Vals is not recommended in early pregnancy, and 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 Pregnancy section).

Use of Vals with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

The effect of treatment with Vals may be altered if taken together with certain medicines. Your doctor may need to adjust your dose and/or 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 Vals” and “Warnings and precautions”).
• medicines that increase potassium levels in blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Vals.
• 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, triple combination with ACE inhibitors and other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol) is not recommended.

Pregnancy and breastfeeding

• Tell your doctor if you are pregnant (or think you might be). Your doctor will usually advise you to stop taking Vals before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Vals. Vals 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.

• Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Vals is not recommended during breastfeeding, and your doctor will choose another treatment for you if you intend to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

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

3. How to take Vals

To achieve the best results and reduce the risk of adverse effects, always take this medicine exactly as your doctor has instructed. If in doubt, ask your doctor or pharmacist. People with high blood pressure often do not experience 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). Vals may also be combined with another medicine (e.g. a diuretic).

Adult patients after a recent heart attack: Treatment is usually started 12 hours after the heart attack, typically with a low starting dose of 20 mg, administered twice daily. 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.

Vals may be given 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 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.

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

Vals can be taken with or without food. Swallow the tablet with a glass of water.

Take Vals at approximately the same time each day.

If you take more Vals 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 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Vals

If you miss 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 forgotten doses.

If you stop taking Vals

If you discontinue treatment with Vals, 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 Vals 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 spasms, 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
• diarrhea
• fatigue
• weakness

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

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

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

• blisters on the skin (signs 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 easily 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)
• reduced hemoglobin levels and reduced percentage of red blood cells in the blood (which in severe cases may lead to anemia)
• increased blood potassium levels (which in severe cases may cause muscle spasms and irregular heartbeat)
• elevated 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 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.

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 may also report them directly via 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 Vals

• Keep out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. 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 moisture.
• 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 in doubt, ask your pharmacist how to properly dispose of medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vals

• The active substance is valsartan. Each film-coated tablet contains 80 mg of valsartan.
• The other components are microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, magnesium stearate.
• The tablet coating contains hypromellose, titanium dioxide (E171), polyethylene glycol 8000, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the product and contents of the container

The Vals 80 mg film-coated tablets are light red, round, with a notch on one side. They are marked with the letter “D” on one side of the notch and “V” on the other side of the notch, and “NVR” on the opposite face of the tablet. The notch is intended only to facilitate tablet splitting and swallowing, but not for dividing into equal doses.

The tablets are presented in blister packs containing 28 tablets.

Marketing Authorization Holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer

TOWA PHARMACEUTICAL EUROPE, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Date of the most recent revision of this leaflet: December 2024

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