Leaflet: information for the user

Vals80mg film-coated tablets

Valsartan

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for youonly;do not pass it on to others even if they have the same symptoms as you,as it may harm them.
• If you experience any side effects,talk to your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What isValsand what it is used for

2. What you need to know before you start takingVals

3. How to takeVals

4. Possible side effects

5. Storage ofVals

6. Contents of the pack and additional information

Vals contains the active ingredient: valsartán andbelongs to a class of medications known as angiotensin II receptor antagonists that help control high blood pressure.High blood pressure is a condition where the blood vessels constrict, causing an increase in blood pressure.Valsacts by blocking the effect of angiotensin II. As a result, the blood vessels relax and blood pressure decreases.

Vals80mg film-coated tabletscan be used to treat 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 blood vessels in the brain, heart, and kidneys, and may cause a heart attack, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Reducing blood pressure to normal values reduces the risk of developing these disorders,
• to treat adult patientsafter a recent heart attack(myocardial infarction).“Recent” means here between12hours and10days,
• to treat symptomatic heart failurein adult patients.Valsis used when it is not possibleto use a group of medications called Angiotensin-Converting Enzyme Inhibitors (ACEs) (a medication for treating heart failure),orit can be added to theACEswhen it is not possibleto use othermedicationsfor the treatment of heart failure.
  Among the symptoms of heart failure are difficulty breathing and swelling of the feet and legs due to fluid retention. This is because the heart muscleis not strong enough to pump blood with sufficient force to provide all the blood needed by the body.

Do not take Vals:

• if you areallergic(hypersensitive) to valsartan or any of the other components ofthis medication (listed in section 6).
• if you havesevere liver disease,
• if you arepregnantover 3 months(it is 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 medication to lower blood pressure that contains aliskirén.

If any of the above situations apply to you, inform your doctor and do not takeVals.

Warnings and precautions:

Consult your doctor

• if you have liver disease,
• if you have 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 have a severe heart disease other than heart failure or myocardial infarction,
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Vals, stop taking Vals 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 using medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to have your potassium levels checked regularly,
• if you have aldosteronism, a condition 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 (medications to increase urine production),
• if you are taking any of the following medications used to treat high blood pressure:
• • a medication that inhibits the angiotensin-converting enzyme (ACE inhibitor) (such as enalapril, lisinopril, etc.), particularly if you have kidney problems related to diabetes
  • aliskirén
• if you are being treated with an ACE inhibitor along with other medications specifically used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) 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 may be) pregnant. Vals is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Use of Vals with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The effect of treatment with Vals may be altered if taken with certain medications. Your doctor may need to adjust your dose and/or take other precautions or, in some cases, stop treatment with one of the medications. This applies to both prescription and non-prescription medications, especially:

• other medications that lower blood pressure,especiallydiuretics(medications to increase urine production), ACE inhibitors(such as enalapril, lisinopril, etc.), or aliskirén (see also the information under the headings “Do not take Vals” and “Warnings and precautions”.
• medications that increase the amount of potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin,
• certain medications for paincalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (in the rifampicin group), a medication used to prevent rejection in a transplant (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Vals.
• litium,a medication used to treat certain types of psychiatric disorders.

Additionally:

• if you are being treated aftera myocardial infarction,it is not recommended to combine withACE inhibitors(a medication for treating a myocardial infarction),
• if you are being treated forheart failure,it is not recommended to take a triple combination withACE inhibitors and other medications specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers(such as metoprolol).

Pregnancy and breastfeeding

• You should inform your doctor if you are pregnant(or if you suspect that you may be).Your doctor will usually recommend that you stop taking Valsbefore becomingpregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of Vals. Vals is not recommended at the beginning of pregnancy, and it should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point on.

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

Driving and operating machinery

Before driving a vehicle, using tools, or operating machinery, or performing other activities that require concentration, make sure you know how Vals affects you. Like many other medications used to treat high blood pressure, Vals may cause, in rare cases, dizziness and affect concentration.

To get the best results and reduce the risk of adverse effects, take this medication alwaysexactly as your doctor tells you.In case of doubt, askyour 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 appointments with the doctor, even if you feel well.

Adult patients with high blood pressure:The recommended doseis 80mg per day. In some cases, your doctor may prescribe higher doses (e.g.160mg or320mg). You may also combineValswith another medication (e.g. a diuretic).

Adult patientsafter a recent heart attack:After a heart attackthe treatment usually starts at 12hours, normally, with a low dose of20mg, administered twice a day. Your doctor will increase this dose gradually over several weeks to a maximum of160mg twice a day. The final dose will depend on your individual tolerance.

Valscan be taken with other treatments for a heart attack, and your doctor will decide what treatment is suitable for you.

Adult patientswith heart failure:The treatment usually starts with40mgtwice a day. Your doctor will increase the dose gradually over several weeks to a maximum of160mg twice a day. The final dose will depend on your individual tolerance.

Valscan be taken with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You can takeValswith or without food. SwallowValswith a glass of water.

TakeValsapproximately at the same time every day.

If you take moreValsthan you should:

If you notice a strong dizzinessand/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 Toxicological Information Service, phone 91562 04 20 indicating the medication and the amount taken.

If you forget to takeVals

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 compensate for the missed doses.

If you interrupt the treatment withVals

If you stop takingValsyour disease may worsen. Do not stop taking the medication unless your doctor tells you to.

If you have any other doubts about the use of thismedication, ask your doctor or pharmacist..

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can 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 Vals and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects include:

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

• dizziness
• low blood pressure with or without symptoms such as dizziness and fainting when standing up
• reduction in kidney function (signs of renal deterioration)

Rare(may affect up to 1 in 100 people):

• angioedema (see section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• sensation of rotation (vertigo)
• marked reduction in kidney function (signs of acute renal insufficiency)
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia)
• shortness of breath, difficulty breathing while lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• fatigue
• weakness

Very rare(may affect fewer than 1 in 10,000 people):

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

Frequency unknown(cannot be estimated from available data):

• blistering on the skin (sign of dermatitis bullosa)
• may occur allergic reactions with skin rash, itching, and hives; symptoms of serum sickness, such as fever, swelling, and joint pain, muscle pain, swelling of lymph nodes, and/or symptoms similar to the flu
• red purpuric patches, fever, itching (signs of inflammation of blood vessels, also known as vasculitis)
• more frequent bleeding or bruising than usual (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat, or ulcers in the mouth due to infections (symptoms of low white blood cell count, also known as neutropenia)
• reduction in hemoglobin level and reduction in percentage of red blood cells in the blood (which in severe cases, may cause anemia)
• increase in potassium level in the blood (which, in severe cases, may cause muscle spasms and abnormal heart rhythm)
• elevation of liver function values (which may indicate liver damage), including an increase in bilirubin level in the blood (which, in severe cases, may cause the skin and eyes to turn yellow)
• increase in urea nitrogen level in the blood and increase in serum creatinine level (which may indicate renal anomalies)
• low sodium level in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or seizures)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and renal function reduction 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:

https://www.notificaram.es. By reporting side effects, you can contribute to

providing more information on the safety of this medicine.

• Keep out of sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 86°F (30°C). Store in the original packaging to protect it from moisture.
• Do not usethis medicationif you observe that the packaging is damaged or shows signs ofmanipulation.
• Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment..

Composition ofVals

• The active ingredient 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 coating of the tablet contains hypromellose, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

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

The tablets are presented in blister packaging with 28 tablets.

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing

TOWA PHARMACEUTICAL EUROPE, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of this leaflet: December 2024

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