Presar 160 mg comprimidos bucodispersables efg

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 doctor's appointments, 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 take PRESAR with another medication (e.g. a diuretic).

Use in children and adolescents (6 to 18 years old) with high blood pressure:

In patients weighing less than 35 kgThe 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 usually starts 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 heart attack, and your doctor will decide what 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 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 shouldthan 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 make up 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 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 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 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)(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 (sign of dermatitis bullosa)

• may occur allergic reactions with skin rash, itching, and hives; symptoms of serum sickness such as fever, swelling, and pain in the joints, muscle pain, swelling of the 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, 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the 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 PRESAR 160 mg buccal dispersible tablets

- The active ingredient is valsartan. Each buccal dispersible tablet contains 160 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 160 mg buccal dispersible tablets are white, oblong, and biconvex tablets.

PRESAR 160 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

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