Package Insert: Information for the Patient

Valsartan Alter 160mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again..
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

Valsartán Alter contains the active ingredient valsartán and 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 Alter 160mgcan be used to treat three different conditions:

• to treat high blood pressure in adults and in children and adolescents from6 toless than 18years of age.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 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 adult patients after a recent heart attack(myocardial infarction).“Recent” means here between 12hours and 10days,
• 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 (ACEIs)(a medication to treat heart failure) or it can be used added to the ACEIs 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 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 Alter

• if you areallergicto the active ingredient or to any of the other components of this medication (listed in section 6),
• if you have aserious liver disease,
• if you arepregnantmore than 3 months(it is better to avoid Valsartán Alter during the first months of pregnancy – see section “Pregnancy and breastfeeding”),
• 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 take Valsartán Alter.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsartán Alter.

• if you have liver disease,
• if you have a serious 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 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 IECAs), inform your doctor. If you have these symptoms when taking Valsartán Alter, stop taking it immediately and never take it again. See also section 4 “Possible side effects”,
• 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 disease in which the adrenal glands produce too much aldosterone hormone. In this case, it is not recommended to take Valsartán Alter,
• 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 converts angiotensin to angiotensin II (IECA) (such as enalapril, lisinopril, etc.), especially if you have kidney problems related to diabetes
  • aliskirén
• if you are being treated with an IECA along with 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).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartán Alter. Your doctor will decide whether to continue treatment. Do not stop taking Valsartán Alter in monotherapy.

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 Valsartán Alter”.

You should inform your doctor if you think you are (or could be) pregnant. Valsartán Alter is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it could cause serious harm to your baby if used during this period (see section “Pregnancy and breastfeeding”).

Other medications and Valsartán Alter

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

The effect of treatment with Valsartán Alter 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), IECAs (such as enalapril, lisinopril, etc.) or aliskirén (see also the information under the headings “Do not take Valsartán Alter” 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 group of rifampicin), a medication used to protect against rejection in a transplant (ciclosporina) or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Valsartán Alter,
• lithium,a medication used to treat certain types of psychiatric disorders.

Additionally:

• if you are being treated aftera heart attack,it is not recommended to combine withIECAs(a medication for treating a heart attack),
• if you are being treated forheart failure,it is not recommended to take a triple combination withIECAs 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

If you are pregnant or breastfeeding, 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).Your doctor will usually recommend that you stop taking Valsartán Alter before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Valsartán Alter. Valsartán Alter is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it could cause serious harm to your baby if used during this period.

• Inform your doctor if you are breastfeeding or plan to start. Valsartán Alter 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 machines, or performing other activities that require concentration, make sure you know how Valsartán Alter affects you. Like many other medications used to treat high blood pressure, Valsartán Alter may cause dizziness and affect concentration.

To get the best results and reduce the risk of adverse effects, take this medication exactly as your doctor tells you to. If you are unsure, ask your doctor or pharmacist. People with high blood pressure often do not notice any symptoms of the disease; many feel normal. This makes it very important to attend your appointments with your doctor, even if you feel well.

Adult patients with high blood pressure:The recommended dose is 80mg per day. In some cases, your doctor may prescribe higher doses (e.g. 160mg or 320mg). You may also combine valsartan with another medication (e.g. a diuretic).

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

In patients weighing less than 35kg, the recommended starting dose for valsartan is 40mg once a day.

In patients weighing 35kg or more, the recommended starting dose for valsartan is 80mg once a day.

In some cases, your doctor may prescribe higher doses (the dose may be increased to 160mg and up to a maximum of 320mg).

In children who have difficulty swallowing tablets, there are available commercial oral solutions with the same active ingredient.

Adult patients after a recent heart attack:After a heart attack, treatment usually starts at 12hours, typically with a low dose of 20mg, administered twice a day. The 20mg dose is obtained by dividing the 40mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum of 160mg twice a day. The final dose will depend on your individual tolerance.

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

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

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

You can take valsartan with or without food. Swallow the tablets with a glass of water.

Take valsartan approximately at the same time every day.

If you take more Valsartán Alter 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 alsocall the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Valsartán Alter

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 withValsartán Alter

If you stop taking valsartan, 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 throat,
• difficulty breathing or swallowing,
• hives, itching.

If you experience any of these symptoms, stop taking Valsartán Alter 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 side effects may be serious and may 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 people)

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

Frequency not known(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 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 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 the 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 this medication out of the sight and reach of children.

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 store above 86°F (30°C). Store in the original packaging to protect it from moisture.

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

Composition ofValsartán Alter

• The active ingredient is valsartan. Each film-coated tablet contains 160 mg of valsartan.

• The other components are:microcrystalline cellulose, polyvidone, crospovidone, anhydrous colloidal silica, magnesium stearate.

The tablet coating contains:hypromellose, titanium dioxide (E171), triacetin.

Appearance of the product and contents of the packaging

Film-coated tablets ofwhite color, round, biconvex with a cross engraved.

The tablets are presented in blister packs with 28 and 56 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

or

Pharmex Advanced Laboratories, S.L.

Ctra. A-431, Km. 19

14720 Almodóvar del Río, Córdoba

Spain

Last review date of this leaflet:February 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/.