VALSARTAN ALMUS 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valsartan Almus 160 mg Film-Coated Tablets EFG

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 and other information

1. What is Valsartan Almus and what is it used for
2. What you need to know before you take Valsartan Almus
3. How to take Valsartan Almus
4. Possible side effects
5. Storing Valsartan Almus
6. Pack contents and further information

1. What is Valsartan Almus and what is it used for

Valsartan 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. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartan 160 mg film-coated tablets can be used for three different conditions:

• to treat high blood pressure in adults andin children and adolescents from 6 to 18 years of age.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 blood pressure to normal reduces the risk of developing these disorders.
• to treat 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.Valsartan 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 may be used in addition to ACE inhibitors when it is not possible to use other medications for 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 muscle cannot pump blood with enough force to provide all the blood needed for the body.

2. What you need to know before you take Valsartan Almus

Do not take Valsartán

• if you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6).

• if you have severe liver disease.
• if you are pregnant for more than 3 months(it is also better to avoid this medicine 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 Valsartan Almus.

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 kidney artery,

• if you have recently received a kidney transplant (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 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 Valsartan Almus, stop treatment with Valsartan Almus immediately and never take it again. See also section 4, "Possible side effects".
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartan Almus. Your doctor will decide whether to continue treatment. Do not stop taking Valsartan Almus 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 Valsartan Almus.
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine output),

• 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 blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Valsartan Almus".

You must inform your doctor if you think you are (or might become) pregnant. Valsartan Almus is not recommended at the start of pregnancy, and must 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 the section on pregnancy).

Using Valsartan Almus with other medicines

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

The effect of treatment with Valsartan Almus 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 output), ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the headings "Do not take Valsartan 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-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (of the rifampicin group), a medicine used to prevent transplant rejection (ciclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan Almus,
• 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 a 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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You must tell your doctor if you are pregnant (or think you might be).Normally, your doctor will advise you to stop taking valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another blood pressure-lowering medicine instead. Valsartan Almus is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

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

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 Valsartan Almus affects you. Like many other medicines used to treat high blood pressure, Valsartan Almus may cause, in rare cases, dizziness and affect your ability to concentrate.

3. How to take Valsartan Almus

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. People with high blood pressure often do not notice any symptoms. This makes it very important to keep your appointments with your doctor, 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). Valsartan Almus may also be used in combination with a diuretic (a medicine that increases urine output).

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

In patients who weigh less than 35 kg, the recommended dose is 40 mg of valsartan once daily. In patients who weigh 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:after a heart attack, treatment is usually started at 12 hours, normally 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 the dose over several weeks to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

Valsartan may be given with other medicines 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.

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

You can take Valsartan Almus with or without food. Swallow the tablet with a glass of water.

Take Valsartan Almus at approximately the same time each day.

If you take more Valsartan 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 Valsartan

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 Valsartan Almus

If you stop taking Valsartan Almus, your condition may worsen. Do not stop taking the medicine unless your doctor tells you to.

If you have any further questions on the use of this product, 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 and itching

If you experience any of these symptoms, stop taking Valsartan Almus 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 that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known(frequency 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 pain in the joints, muscle pain, swelling of the lymph nodes, and/or symptoms similar to those of the flu (signs of serum sickness)
• red purple spots, fever, itching (signs of inflammation of the blood vessels, also called vasculitis),
• bleeding or bruising more often 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 cause anemia)
• increase in potassium levels in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm)
• elevation of 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 are 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 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 Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán Almus

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

Do not store above 30 ºC. Keep in the original packaging.

Do not use this medicine after the expiry date which is stated on the carton after CAD. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

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6. Package Contents and Additional Information

Composition of Valsartán Almus

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

The other ingredients (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 Package Contents

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

LABORATORIOS LESVI, S.L.

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

ATLANTIC PHARMA - PRODUÇÕES FARMACÊUTICAS, S.A.

Rua De Tapada Grande 2 - Abrunheira, Sintra - 2710-228 – Portugal

Date of the Last Revision of this Prospectus:March 2025

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