PRESAR 320 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for theuser

PRESAR 320 mg orodispersible 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 experience 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. Storing 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:

• to treat high blood pressure in adults and in 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 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.

2. What you need to know before you take PRESAR

Do not take PRESAR

• if you are allergic(hypersensitive) to the active substance valsartan or any of the other ingredients of this medicine (listed in section 6).
• if you have a severe liver disease.
• if you are more than 3 months pregnant(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 applies to you, tell your doctor and do not take PRESAR.

Warnings and precautions:

Consult your doctor

• if you have liver disease.
• if you have severe kidney disease or are on dialysis.
• if you have narrowing of the kidney artery.
• if you have recently had 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 medicines (including ACE inhibitors), inform your doctor. If you have these symptoms when taking PRESAR, stop taking it 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 taking medicines that increase the amount of potassium in your 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 your 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 production).
• 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

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 PRESAR".

If you think you might be pregnant, tell your doctor. PRESAR is not recommended at the start of pregnancy, and should 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 section Pregnancy).

Other medicines and PRESAR

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

The effect of treatment with PRESAR may be altered 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 production), ACE inhibitors, 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 your blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin.
• certain pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs),
• some antibiotics (of the rifampicin group), a medicine used to protect against transplant rejection (ciclosporin), 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 diseases.

Taking PRESAR with food and drinks

You can take PRESAR with or without food.

Pregnancy, breast-feeding, and fertility

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

Pregnancy

Tell 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. PRESAR 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 if used after this period.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding.

PRESAR is not recommended during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, 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 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; 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 exactly as told by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is:

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). You may also be given PRESAR in combination with another medicine (e.g., a diuretic).

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).

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

You can take PRESAR with or without food.

Take PRESAR at about the same time each day.

If you take more PRESAR than 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 taken).

If you forget to take PRESAR

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 PRESAR

If you stop taking PRESAR, 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, 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:

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 damage).

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.

Very 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):

• 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 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 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. 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, website: www.notificaram.es.

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

5. Storing 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 refers to 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. Contents of the pack and other information

Composition of PRESAR320 mg orodispersible tablets

• The active substance is valsartan. Each orodispersible tablet contains 320 mg of valsartan.
• The other ingredients (excipients) are: microcrystalline cellulose, crospovidone, sodium saccharin, orange flavor, fantasy flavor, sodium lauryl sulfate, and magnesium stearate.

Appearance and packaging

PRESAR 320 mg orodispersible tablets are white, oblong, biconvex, and smooth.

PRESAR 320 mg orodispersible tablets are available in PVC-PE-PVDC/Al-PVDC blister packs of 28 tablets.

Marketing authorization holder and manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of last revision of this leaflet:January 2025.

Other sources of information

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