Prospect: information for the user

PRESAR 80 mg buccal dispersible tablets EFG

Valsartan

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people, even if they 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 prospect.Seesection4.

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

PRESARcan be used to treat three different conditions:

-to treat high blood pressure in adults, children, and adolescents aged 6 to 18 years.High blood pressureaffects the heart and arteries, increasing their workload. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and cause a stroke, heart failure, or kidney failure. High blood pressurealso increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

-to treat adult patientsafter a recent heart attack(myocardial infarction). “Recent” here means between 12 hours and 10 days,

-to treat symptomatic heart failure in adult patients.PRESARis used when it is notpossibleto usea group of medications called Angiotensin-Converting Enzyme Inhibitors (ACEIs) (a medication for treating heart failure), orit can be usedaddedtoACEIs when it is not possible to use other medications for heart failure treatment.

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 is unable to pump blood with sufficient force to provide all the blood needed by the body.

Do not takePRESAR:

• if you areallergic(hypersensitive) to valsartan or any of the other components of this medicine (listed in section 6).
• if you havesevere liver disease.
• if you aremore than 3 months pregnant(it is better to avoid taking PRESAR during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a medicine to lower blood pressure that contains aliskiren.

If any of the above situations apply to you, inform 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 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 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 medicines (including ACE inhibitors), inform your doctor. If you have these symptoms when taking PRESAR, stop taking PRESAR immediately and never take it again. See also the 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 medicines that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, 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 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:

• a medicine that blocks the conversion of angiotensin (ACE inhibitor) (such as enalapril, lisinopril, ramipril), especially ifyou have kidney problems related to diabetes.

• aliskiren

• if you are being treated with an ACE inhibitor along with other medicines specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

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 PRESAR”.

You should inform your doctor if you think you are (or could be) pregnant. PRESAR is not recommended at the start 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 you use it during this period (see Pregnancy section).

Other medicines and PRESAR

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

Youmayneedyourdoctortomodifyyourdoseand/ortakeotherprecautionsor,insomecases,stopthetreatmentofoneofthemedicines.This applies to both prescription and non-prescription medicines, especially:

-other medicines that lower blood pressure,especiallydiuretics(medicines to increase urine production), ACE inhibitors (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 potassiumin the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medicines, and heparin.

-some pain-relieving medicinescalled non-steroidal anti-inflammatory drugs (NSAIDs),

-some 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 mayincrease the effect of PRESAR.

-lithium,a medicine used to treat certain types of psychiatric disorders.


Additionally:

• if you are being treated aftera heart attack,it is not recommended to combine withACE inhibitors(a medication for treating a heart attack).
• if you are being treated forheart failure,it is not recommended to take the triple combination withACE inhibitors and other medicines specifically used to treat your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers(such as metoprolol).

Taking PRESAR with food and drinks

You can take PRESAR with or withoutfood.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect that you might be).Your doctor will usuallyrecommend that you stop taking PRESAR as soon as you know you are pregnant and recommend that you take another medicine instead of PRESAR. It is not recommendedto usePRESARat the start of pregnancy, and in any caseit should not be administered after the thirdmonth of pregnancy as it may cause serious harm to your baby if used during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start.PRESAR is not recommended during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machines

Before driving a vehicle, using tools, or operating machines, or engaging in other activities that require concentration, make sure you know how PRESAR affects you. Like many other medicines used to treat high blood pressure, PRESAR may cause, in rare cases, dizziness and affect concentration.

PRESAR contains sodium

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

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 signs of the disease; many feel normal. This makes it very important to attend your appointments with your doctor, even if you feel well.

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

The recommended dose is:

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 PRESAR with another medication (e.g. a diuretic).

Use in children and adolescents (6 to 18 years of age) 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 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 is usually started at 12 hours, usually with a low dose of 20 mg administered 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 taken with other treatments for a heart attack, and your doctor will decide what treatment is suitable for you.

Adult patients with heart failure:Treatment is usually started 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 taken with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

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

You can take PRESAR with or without food.

Take PRESAR approximately at the same time every day.

If you take more PRESAR than you should:

If you experience severe 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 medication and the amount ingested).

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 the next dose, skip the missed dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with PRESAR:

If you stop taking PRESAR, 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 can cause side effects, although not everyone will experience them.

Some side effects can 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.
• reduction in kidney function (signs of renal deterioration).

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

• angioedema (see section "Some symptoms require immediate medical attention").
• sudden loss of consciousness (syncope).
• sensation of rotation (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)(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 available data):

• blistering on the skin (signs 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, 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 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, can cause fatigue, confusion, muscle fasciculation, and/or convulsions).

The frequency of some side effects may vary depending on your condition. For example, certain side effects such as dizziness and kidney function reduction 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, website:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store below 30°C.

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 use PRESAR 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 medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of PRESAR80 mg buccal dispersible tablets

- The active ingredient is valsartan. Each buccal dispersible tablet contains 80 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 contents of the packaging

PRESAR 80 mg buccal dispersible tablets are white, round, and flat tablets.

PRESAR 80 mg buccal dispersible tablets are available in a PVC-PE-PVDC/Al-PVDC blister pack containing 28 tablets.

Marketing authorization holderandManufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Last review date of this leaflet:January 2025

Other sources of information

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