VALSARTAN ALTER 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Valsartan Alter 80mg 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 Alter and what is it used for
2. What you need to know before you take Valsartan Alter
3. How to take Valsartan Alter
4. Possible side effects
5. Storage of Valsartan Alter

Contents of the pack and further information

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

Valsartan Alter contains the active substance valsartan and 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 Alter 80mg can be used for three different conditions:

• to treat high blood pressure in adults and in children and adolescents from 6 to less than 18 years of age.High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels of 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 adult 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 (ACEIs) (a medication to treat heart failure) or may be used in addition to 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 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 Alter

Do not take Valsartan Alter

• if you are allergicto the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you have a severe liver disease,
• if you are pregnantof more than 3 months(it is also better to avoid Valsartan Alter during the first months of pregnancy – see section “Pregnancy and lactation”),
• if you have diabetes or kidney problems and are being treated with a medicine to reduce blood pressure that contains aliskiren.

If any of these situations apply to you, inform your doctor and do not take Valsartan Alter.

Warnings and precautions

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

• if you have liver disease,
• if you have severe kidney disease or are undergoing dialysis,
• if you have a narrowing of the kidney artery,
• if you have recently undergone a kidney transplant (received a new kidney),
• 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 medications (including ACEIs), inform your doctor. If you have these symptoms when taking Valsartan Alter, stop treatment with Valsartan Alter immediately and never take it again. See also section 4 “Possible side effects”,
• if you are taking 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. It may be necessary to regularly monitor 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 Alter,
• if you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines to increase urine elimination),
• if you are taking any of the following medicines used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACEI) (such as enalapril, lisinopril, etc.) especially if you have kidney problems related to diabetes
  • aliskiren
• if you are being treated with an ACEI along with other specific medications for the treatment of 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 Valsartan Alter. Your doctor will decide whether to continue treatment. Do not stop taking Valsartan Alter on your own.

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

See also the information under the heading “Do not take Valsartan Alter”.

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

Other medicines and Valsartan Alter

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

The effect of treatment with Valsartan Alter 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 elimination), ACEIs (such as enalapril, lisinopril, etc.) or aliskiren (see also the information under the headings “Do not take Valsartan Alter” 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 medications, and heparin,
• certain pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),
• certain antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (ciclosporin) or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan Alter,
• 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 ACEIs(a medication to treat a heart attack),
• if you are being treated for heart failure,it is not recommended to combine with ACEIs and other specific medications for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers(such as metoprolol).

Pregnancy and lactation

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 inform your doctor if you are pregnant(or if you think you might be pregnant).Your doctor will normally advise you to stop taking Valsartan Alter before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Valsartan Alter. It is not recommended to use Valsartan Alter at the start of pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used after this period.

• Tell your doctor if you are breastfeeding or will start breastfeeding.It is not recommended to use Valsartan Alter 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 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 Alter affects you. Like many other medicines used to treat high blood pressure, Valsartan Alter can cause dizziness and affect your ability to concentrate.

3. How to take Valsartan Alter

To get the best results and reduce the risk of side effects, always take this medicine exactly as your doctor tells you. If you are unsure, 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 80mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160mg or 320mg). You may also be given valsartan in combination with another medicine (e.g., a diuretic).

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

In patients who weigh less than 35kg, the recommended initial dose of valsartan is 40mg once daily.

In patients who weigh 35kg or more, the recommended initial dose of valsartan is 80mg once daily.

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, other commercial presentations are available in oral solution with the same active substance.

Adult patients after a recent heart attack:after a heart attack, treatment is usually started at 12 hours, normally with a low dose of 20mg, given twice daily. 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 daily. The final dose will depend on your individual tolerance.

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

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

Valsartan can be given 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 at approximately the same time each day.

If you take more Valsartan 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 also call the Toxicology Information Service, telephone 91562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan 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 make up for forgotten doses.

If you stop taking Valsartan Alter

If you stop taking valsartan, your disease 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 medicine, 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 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 Valsartan Alter 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 side effects may be serious and may require 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(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 joint pain, 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 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 lead to anemia),
• increase in potassium levels in the blood (which, in severe cases, can lead to muscle spasms and an 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 the skin and eyes to turn yellow),
• 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 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 side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through 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 Alter

Keep this medication out of 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 at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofValsartán Alter

• The active ingredient is valsartan. Each film-coated tablet contains 80 mg of valsartan.
• The other components are: microcrystalline cellulose, povidone, crospovidone, anhydrous colloidal silica, magnesium stearate.

The tablet coating contains hypromellose, titanium dioxide (E171), glycerol triacetate.

Appearance of the Product and Package Contents

White, round, and biconvex film-coated tablets.

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

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

Date of the Last Revision of this Leaflet:February 2025

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