PRESAR 40 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for theuser

PRESAR 40 mg oral dispersible tablets EFG

Valsartan

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

1. What is PRESAR and what is it used for
2. What you need to know before you take PRESAR
3. How to take PRESAR
4. Possible side effects
5. Storage of PRESAR
6. Contents of the pack and other information

1. What is PRESAR and what is it used for

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

PRESAR can be used for three different conditions:

• to treat high blood pressure in children and adolescents from 6 to 18 years 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 lead to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels 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.PRESAR is used when it is not possible to use a group of medicines called Angiotensin-Converting Enzyme Inhibitors (ACEIs) (a medication for treating 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 PRESAR

Do not takePRESAR

• if you are allergic(hypersensitive) to valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe liver disease.
• if you are pregnant for more than 3 months(it is also better to avoid PRESAR 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 situations apply to you, inform your doctor and do not takePRESAR.

Warnings and precautions:

Consult your doctor

• 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 PRESAR, stop treatment with PRESAR immediately and never take it again. See also section 4 "Possible side effects".
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking PRESAR. Your doctor will decide whether to continue treatment. Do not stop taking PRESAR 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. 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 PRESAR.
• 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 medications used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACEI) (such as enalapril, lisinopril, ramipril), 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).

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 PRESAR".

You must inform your doctor if you think you are (or might become) pregnant. PRESAR 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).

Other medicines and PRESAR

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The effect of treatment with PRESAR may be altered if taken with certain medicines.

Your doctor may need to modify your dose and/or take other precautions or, in some cases, interrupt 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 PRESAR" and "Warnings and precautions").
• medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• certain pain-relieving medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• certain antibiotics (from the rifampicin group), a medicine used to protect against rejection in a transplant (cyclosporin) or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of PRESAR.
• lithium, a medicine used to treat certain types of psychiatric illnesses.

In addition:

• if you are being treated after a heart attack, it is not recommended to combine with ACEIs (a medication for treating 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 your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

TakingPRESARwith food and drinks

You can take PRESAR with or without food.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

You must inform your doctor if you are pregnant (or think you might be).Your doctor will normally advise you to stop taking PRESAR before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of PRESAR. It is not recommended to use PRESAR 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 time.

Breastfeeding

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

PRESAR contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially, "sodium-free".

3. How to take PRESAR

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, 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 doctor's appointments, even if you feel well.

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Use in children and adolescents (6 to18years of age) with high blood pressure:

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

In patients who weigh 35 kg or more, the recommended starting 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 within 12 hours, normally with a low dose of 20 mg, given twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. Your doctor will gradually increase this dose over several weeks to a maximum of 160 mg twice a day. The final dose will depend on your individual tolerance.

PRESAR can be administered together with other treatments for heart attack, and your doctor will decide which 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.

PRESAR can be administered together with other treatments for heart failure, and your doctor will decide which treatment is suitable for you.

Place the tablet on the tongue, where it will start to dissolve with saliva. Swallow afterwards.

You can take PRESAR with or without food.

Take PRESAR approximately at the same time each day.

If you take morePRESARthan you should

If you notice a strong dizziness and/or fainting, contact your doctor immediately and lie down.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to takePRESAR

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 missed doses.

If you stop takingPRESAR

If you stop taking PRESAR, 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 PRESAR and contact your doctor immediately (see 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.
• reduced kidney function (signs of kidney impairment).

Uncommon (may affect up to 1 in 100 people):

• angioedema (see section "Some symptoms 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.

Very rare(may affect up to 1 in 10,000 people)

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

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

• blisters on 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 vasculitis, also called inflammation of the blood vessels).
• 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 level and reduction in the percentage of red blood cells in the blood (which, in severe cases, can cause anemia).
• increase in potassium level 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 level 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 level (which may indicate kidney function abnormalities).
• low sodium level 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 side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use, website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of PRESAR

Store below 30°C.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of PRESAR 40 mg Orally Disintegrating Tablets

• The active ingredient is valsartan. Each orally disintegrating tablet contains 40 mg of valsartan.
• The other components (excipients) are: microcrystalline cellulose, crospovidone, sodium saccharin, orange flavor, fantasy flavor, sodium lauryl sulfate, and magnesium stearate.

Appearance of the Product and Container Content

PRESAR 40 mg orally disintegrating tablets are white, round, flat, and scored tablets.

PRESAR 40 mg orally disintegrating tablets are available in PVC-PE-PVDC/Al-PVDC blister packs of 14 or 28 tablets.

Marketing Authorization HolderandManufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the Last Revision of this Leaflet:January 2025

Other Sources of Information

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