Label: information for theuser

PRESAR 320 mg buccal dispersible tablets EFG

Valsartán

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

• Keep this label, 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 should not give it to others, 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 label.Seesection4.

PRESAR belongs to a class of medications known as angiotensin II receptor antagonists that 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.

PRESARmay be used:

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

Do not take PRESAR

• if you areallergic(hypersensitive) to the active ingredient valsartán or any of the other ingredients in this medicine (listed in section 6).
• if you have aserious liver disease.
• if you aremore than 3 months pregnant(it is also best to avoid taking PRESAR during the first months of pregnancy - see section Pregnancy).
• if you have diabetes or kidney problems and are being treated with a blood pressure lowering medicine that contains aliskirén.

If any of these 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 a serious 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 a serious 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. You may need to have your potassium levels in the blood 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 that increase urine production).
• ifyou 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), particularly if you have kidney problems related to diabetes.

• aliskirén

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 (or might be) pregnant. PRESAR is not recommended at the start of pregnancy, and 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 the Pregnancy section).

Other medicines and PRESAR

Inform your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicine.

The effect of treatment with PRESAR may be altered if taken with certain medicines. Your doctor may need to adjust your dose and/or take other precautions or, in some cases, stop one of the medicines. This applies to both prescription and non-prescription medicines, especially:

-other medicines that lower blood pressure,especiallydiuretics(medicines that increase urine production), ACE inhibitors (such as enalapril, lisinopril, etc) or aliskirén (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.

-certain medicines for paincalled non-steroidal anti-inflammatory drugs (NSAIDs),

- some antibiotics (of the rifampicin group), a medicine used to protect against rejection in a transplant (ciclosporina) 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 mental illness.

Taking PRESAR with food and drink

You can take PRESAR with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant or are planning 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 you might be).Your doctor will usuallyrecommend that you stop taking PRESAR before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medicine instead of PRESAR. It is not recommendedto use PRESAR at the start of pregnancy, and in any caseshould not be administered from the thirdmonth of pregnancy as it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start.

It is not recommended to use PRESAR 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 machinery

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 may cause, in rare cases, dizziness and affect concentration.

PRESAR contains sodium

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

To obtain 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 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 kgThe recommended dose is 40 mg of valsartan once a day.

In patients weighing 35 kg or more, the initial recommended 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).

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 PRESARthan 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 Toxicological 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 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 (sign of dermatitis herpetiformis)

• 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 the 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 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. By doing so, you will help protect the environment.

Composition of PRESAR320 mg buccal dispersible tablets

- The active ingredient is valsartan. Each buccal dispersible tablet contains320 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 content of the packaging

PRESAR320 mg buccal dispersible tablets are white, oblong, biconvex, and smooth tablets.

PRESAR320 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 of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.