Leaflet: information for the user

Valsartan Almus 320 mg film-coated tablets

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 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.

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

2. What you need to know before you start taking Valsartan Almus

3. How to take Valsartan Almus

4. Possible side effects

5. Storage of Valsartan Almus

6. Contents of the pack and additional information

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.

ValsartánAlmus can be used

• to treat high blood pressurein adults and in 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 cause astroke, 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.

Do not take Valsartán Almus:

• if you areallergicto valsartán or to any of the other components of this medication (listed in section 6),
• if you havesevere liver disease,
• if you aremore than 3 months pregnant(it is better to avoid this medication 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 takeValsartán Almus.

Warnings and precautions

Consult your doctor:

• if you have liver disease,
• if you have severe kidney disease or are being treated with dialysis,
• if you have a narrowing of the kidney artery,
• if you have recently undergone 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 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 medications (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 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 Valsartán,
• 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 (hypertension):
• • a medication that blocks the conversion of angiotensin (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskirén

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 ifyou think you are (or could be) pregnant.Valsartán Almus is not recommended at the beginning of pregnancy,and should not be taken if you are more than 3 months pregnant, as it could cause serious harm to your baby if you use it during this period (see Pregnancy section).

Taking Valsartán Almus 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 Valsartán treatment 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 Valsartán Almus” 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,
• some pain medicationscalled nonsteroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (in the rifampicin group), a medication used to prevent transplant rejection (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán Almus.
• lithium,a medication used to treat certain types of psychiatric disorders.

Pregnancy and breastfeeding

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

• You should inform your doctor if you are pregnant(or if you suspect you may be).Generally, your doctor will advise you to stop taking valsartán before becoming pregnant or as soon as you become pregnant, and recommend taking another blood pressure medication instead. Valsartán Almus is not recommended at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. 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 attend your doctor's appointments, 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 (e.g., 160 mg or 320 mg). You may also combine Valsartán Almus with another medication (e.g., 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).

You can take Valsartán Almus 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 Almus 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 can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Valsartán Almus

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 treatment with Valsartán

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

If you have any other questions 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 pharynx
• 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 renal 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 rotation (vertigo)
• marked reduction in renal 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 presenting 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 fever,swelling, and pain in the joints, muscle pain, swelling of the lymph nodes, and/or symptoms similar to the flu (signs of serum sickness)
• red purpuric patches, fever, itching (signs of inflammation of the blood vessels,alsocalled 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 called 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 renal function reduction were observed less frequently in patients treated for hypertension than in 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, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use. Website: ww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this 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 Valsartán Almus 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 Valsartán if you observe that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Valsartán Almus

• The active ingredient is valsartan. Each tablet contains 320 mg of valsartan.

• 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), iron oxide (E172), and black iron oxide (E172).

Appearance of the product and contents of the packaging

Valsartán 320 mg film-coated tablets are film-coated, brown, oval, convex, and scored on one face. The score is intended to facilitate division to aid swallowing, but not to divide into equal doses. They are 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

Telephone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, 2, Abrunheira, 2710 – 089 Sintra

Portugal

Laboratorios Lesvi, S.L.

Avda. Barcelona, 69. 08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this prospectus:March 2025

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