Leaflet: information for the user

Valsartán Almus 160 mg film-coated tablets

Read this leaflet carefully before you start to take 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 you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Valsartán belongs to a class of medications 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 constrict, resulting in increased blood pressure. Valsartán acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán 160 mg film-coated tabletscan be used to treat three different conditions:

• to treat high blood pressure in adults andin children and adolescents aged 6 to 18 years.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 causea stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.
• to treat people after a recent heart attack(myocardial infarction). “Recent” means here between 12 hours and 10 days.
• to treat symptomatic heart failure in adult patients.Valsartán is used when it is not possible to use a group of medications 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 medicationsfor the treatment of heart failure.

Among the symptoms of heart failure aredifficulty breathingand swelling of feet and legs due to fluid retention. This is because the heart muscle is not strong enough to pump blood with sufficient force to provide all the blood needed by the body.

Do not take Valsartán

• if you areallergicto valsartán or to any of the other ingredients in this medicine(listed in section 6).

• if you havesevere liver disease.
• if you aremore than 3 months pregnant(it is better to avoid this medicine during the first months of pregnancy - see section “Pregnancy”).
• if you have diabetes or kidney failure and are being treated with a blood pressure medicine that contains aliskirén.

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

Warnings and precautions

Consult your doctor:

• if you have liver disease,
• if you have severe kidney disease or if you are undergoing dialysis,
• if you have a narrowing of the kidney artery,

• if you have recently undergone a kidney transplant(you received a new kidney),

• if you are being treated for a heart attack or heart failure, your doctor may check your kidney function,
• if you have a 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 Valsartán Almus, stop taking it immediately and do not take it again. See also section 4, “Possible side effects”.
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartán Almus. Your doctor will decide whether to continue treatment. Do not stop taking Valsartán Almus on your own.
• if you are using 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. 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 Valsartán Almus.
• 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:

• a medicine that converts angiotensin to angiotensin II (ACE inhibitor) (such as enalapril, lisinopril, etc.), especially if you have kidney problems related to diabetes
• aliskirén

• if you are being treated with an ACE inhibitor along with other medicines specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Your doctor may check your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

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

You should inform your doctor if you think you are (or might become) pregnant. Valsartán Almus is not recommended at the beginning of pregnancy, and it should 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 the pregnancy section).

Using Valsartán Almus with other medicines

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

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

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

Additionally:

• if you are beingtreated aftera heart attack,it is not recommended to combine withACE inhibitors (a medicationfor treating a heart attack)
• if you are beingtreated for heart failure,it is not recommended to take a triple combination withACE inhibitors andother medicines 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

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

• You should inform your doctor if you are pregnant (or if you suspect you might be).Generally, your doctor will advise you to stop taking valsartán before becoming pregnant or as soon as you know you are pregnant, and recommend taking another blood pressure medicine instead. Valsartán Almus is not recommended at the beginning of pregnancy, and it should 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.

• Inform your doctor if you are planning to start or are breastfeeding,as it is not recommended to administer Valsartán Almus during this period. Your doctor may decide to give you a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

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 Valsartán affects you. Like many other medicines used to treat high blood pressure, Valsartán may cause, in rare cases, dizziness and affect concentration.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.People with high blood pressure often do not notice any signs of the disease, many feel normal. This makes it very important to keep your appointments with the doctor even if you feel well.

Adult patients with high blood pressure:The recommended dose is 80 mg per day. In some cases, your doctor may prescribe higher doses (for example 160 mg or 320 mg). You may also combine Valsartán Almus with an additional medication (for example a diuretic).

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

In patients weighing less than 35 kg, the recommended dose is 40 mg of valsartan once a day. In patients weighing 35 kg or more, the initial recommended dose is 80 mg of valsartan once a day. 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:After a heart attack, treatment usually starts at 12 hours, typically with a low dose of 20 mg, administered twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

Valsartán may be taken together with other medications for heart attack, and your doctor will decide what treatment is suitable for you.

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

Valsartán may be taken with or without food. Swallow the tablet with a glass of water.

Take Valsartán Almus approximately at the same time every day.

If you take more Valsartán than you should

If you noticea strong dizziness and/or fainting,contact your doctor immediately andlie down.If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. You can also call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forget to take Valsartán

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 with Valsartán Almus

If you stop taking Valsartán Almus, your 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 this medication, ask your doctor or pharmacist.

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

Some side effects may 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 and itching

If you experience any of these symptoms, stop taking Valsartán Almus and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects include:

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

• 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 patients):

• 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 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 up to 1 in 10,000 patients):

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

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

• blistering on the skin (sign of dermatitis bullosa)
• may occur allergic reactions withskin rash, itching, and hives; symptoms of serum sickness, such as fever, swelling, and pain in the joints, muscle pain, swelling of the lymph nodes, and/or symptoms similar to the flu
• red purpuric spots, fever, itching (signs of inflammation of the 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 convulsions)

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and reduction in 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.

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

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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of the medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30 °C. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging is damaged or shows signs of deterioration.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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Composition of Valsartán Almus

The active ingredient is Valsartán. Each tablet contains 160 mg of Valsartán.

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

Appearance of the product and content of the packaging

The film-coated Valsartán 160 mg tablets are film-coated, yellow, oblong, convex, and scored on one face. The tablet can be divided into two equal doses. It is presented in packs of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing:

LABORATORIOS LESVI, S.L.

Avda. de Barcelona, 69 - Sant Joan Despí (Barcelona) - 08970 - Spain

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande, No 2 - Abrunheira, Sintra - 2710-089 – Portugal

Last review date of this prospectus:March 2025

The 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/