VALS 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vals80mg film-coated tablets

Valsartan

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 Vals is and what it is used for
2. What you need to know before you take Vals
3. How to take Vals
4. Possible side effects
5. Storage of 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 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. Vals works by blocking the effect of angiotensin II. As a result, the 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 not treated, it can damage the blood vessels in the brain, heart, and kidneys, and may lead to a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering the blood pressure to normal reduces the risk of developing these disorders,
• to treat adult patients after a recent heart attack(myocardial infarction). “Recent” here means between 12 hours and 10 days,
• to treat symptomatic heart failure in adult patients. Vals is used when it is not possible to use a group of medicines called Angiotensin-Converting Enzyme Inhibitors (ACE inhibitors) (a medication for treating heart failure), or it can be used in addition to ACE inhibitors when it is not possible to use other medications for the treatment of heart failure. 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 with enough force to supply the body with the blood it needs.

2. What you need to know before you take Vals

Do not take Vals:

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease,
• if you are pregnantfor more than 3 months(it is also better to avoid Vals during the first months 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 Vals.

Warnings and precautions:

Consult your doctor

• if you have liver disease,
• if you have severe kidney disease or are on dialysis,
• if you have narrowing of the kidney artery,
• if you have recently had a kidney transplant (received a new kidney),
• if you have severe heart disease other than heart failure or heart attack,
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Vals, stop taking it immediately and never take it again. See also section 4 “Possible side effects”.
• if you experience abdominal pain, nausea, vomiting, or diarrhea 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 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 have aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Vals,
• 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 medications 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 Vals”.

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

Using Vals with other medicines

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

The effect of treatment with Vals may be affected if taken with certain medicines. Your doctor may need to change your dose and/or 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 (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Vals” and “Warnings and precautions”.
• 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,
• certain pain-relieving medicines called non-steroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (from the rifampicin group), a medicine used to prevent rejection in a transplant (ciclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Vals,
• 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 for treating heart attack),
• if you are being treated for heart failure, it is not recommended to combine with ACE inhibitors and other specific medications 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

• You should inform your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Vals before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Vals. 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 after this period.

• Tell your doctor if you are breast-feeding or about to start breast-feeding. Vals is not recommended during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, 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 Vals affects you. Like many other medicines used to treat high blood pressure, Vals can cause dizziness and affect your ability to concentrate.

3. How to take Vals

To get the best results and reduce the risk of side effects, always take this medicine exactly as your doctor tells you. If you are unsure, ask your doctor or pharmacist. 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). Vals can also be used in combination with another medicine (e.g., a diuretic).

Adult patients after a recent heart attack:treatment is usually started at 12 hours, normally with a low dose of 20 mg, given twice daily. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Vals can be given with other treatments for heart attack, and your doctor will decide what treatment is suitable for you.

Adult patients with heart failure:treatment is usually started with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Vals can be given with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You can take Vals with or without food. Swallow Vals with a glass of water.

Take Vals at about the same time each day.

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

If you forget to take Vals

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 forgotten doses.

If you stop taking Vals

If you stop taking Vals, your illness may get worse. 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 can be serious and may need 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 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 need immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling 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

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

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

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

• blistering of the skin (sign of bullous dermatitis)
• allergic reactions with skin rash, itching, and hives; symptoms of fever, swelling, and joint pain, muscle pain, swelling of the lymph nodes, and/or symptoms similar to flu (signs of serum sickness)
• red spots on the skin, fever, itching (signs of vasculitis)
• more frequent bleeding or bruising 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 reduction in the percentage of red blood cells in the blood (which, in severe cases, can lead to anemia)
• increase in potassium levels in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm)
• increase in 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 increase in 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.

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 via the Spanish Pharmacovigilance System for Human Use:

https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vals

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month shown.
• Do not store above 30°C. Store in the original package to protect from moisture.
• Do not use this medicine if you notice the packaging is damaged or shows signs of tampering.
• Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Packaging Content and Additional Information

Composition ofVals

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

Appearance of the Product and Packaging Content

The Vals 80 mg film-coated tablets are light red, round, with a score line on one side. They have the mark “D” on one side of the score line and “V” on the other side of the score line and “NVR” on the opposite face of the tablet. The score line is only for the purpose of facilitating breaking and swallowing, but not for dividing into equal doses.

The tablets are presented in blister packs of 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 Last Revision of this Leaflet: December 2024

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