Presar 40 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

PRESAR 40 mg orodispersible tablets EFG

Valsartan

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What PRESAR is and what it is used for

PRESAR belongs to a class of medicines 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 narrow, resulting in increased 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 aged 6 to 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage the 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" refers to the period between 12 hours and 10 days after the event.
• to treat symptomatic heart failure in adult patients. PRESAR is used when a group of medicines called Angiotensin-Converting Enzyme Inhibitors (ACE inhibitors) (a medication used to treat heart failure) cannot be used, or it may be added to ACE inhibitors when other heart failure treatments are not suitable.

Symptoms of heart failure include difficulty breathing and swelling of the feet and legs due to fluid retention. This occurs because the heart muscle is unable to pump blood strongly enough to supply the body's needs.

2. What you need to know before taking PRESAR

Do not take PRESAR

• if you are allergic (hypersensitive) to valsartan or to any of the other components of this medicine (listed in section 6).
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is also best to avoid PRESAR during the first months of pregnancy – see Pregnancy section).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, tell your doctor and do not take PRESAR.

Warnings and precautions:

Talk to your doctor

• if you have liver disease.
• if you have severe kidney disease or are undergoing dialysis.
• if you have narrowing of the artery to the kidney (renal artery stenosis).
• if you have recently undergone a kidney transplant (received a new kidney).
• if you have a serious heart condition other than heart failure or heart attack.
• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you develop these symptoms while 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 blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medications, and heparin. Regular monitoring of blood potassium levels may be necessary.
• if you have aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, taking PRESAR is not recommended.
• if you have lost a significant amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine output).
• 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), particularly if you have kidney problems related to diabetes.
  • aliskiren.
  • if you are being treated with an ACE inhibitor together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) 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 be) pregnant. PRESAR is not recommended in early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Other medicines and PRESAR

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

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

Your doctor may need to adjust your dose and/or take other precautions, or in some cases, discontinue treatment with one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• other medicines that lower blood pressure, particularly diuretics (medicines that increase urine output), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take PRESAR” and “Warnings and precautions”).
• medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of PRESAR.
• lithium, a medicine used to treat certain psychiatric disorders.

In addition:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medication used to treat heart attack) is not recommended.
• if you are being treated for heart failure, triple combination therapy with ACE inhibitors and other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol), is not recommended.

Taking PRESAR with food and drink

You may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking PRESAR before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. PRESAR is not recommended during early pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of PRESAR during breastfeeding is not recommended, and your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Before driving, operating tools, handling machinery, or engaging in any activity requiring concentration, make sure you know how PRESAR affects you. Like many other medicines used to treat high blood pressure, PRESAR may rarely 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 achieve the best results and reduce the risk of adverse effects, always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. People with high blood pressure often do not experience any symptoms and may feel perfectly well. This makes it very important to keep your medical appointments, even if you feel fine.

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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 daily.

In patients weighing 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).

Adult patients after a recent heart attack: treatment is usually started within 12 hours after a heart attack, normally with a low starting dose of 20 mg, administered twice daily. The 20 mg dose is obtained by splitting the 40 mg tablet. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

PRESAR may be administered together with other treatments for heart attack, and your doctor will decide which treatment is appropriate for you.

Adult patients with heart failure: treatment is usually initiated with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose will depend on your individual tolerance.

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

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

PRESAR may be taken regardless of meals.

Take PRESAR at approximately the same time each 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20 (indicating the medicine 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 your next dose, skip the missed dose.

Do not take a double dose to make up for a missed dose.

If you stop taking PRESAR

If you discontinue treatment with PRESAR, your condition may worsen. Do not stop taking this medicine unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious and may require 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 adverse effects include:

Common (may affect up to 1 in 10 people):

• dizziness.
• low blood pressure with or without symptoms such as dizziness and fainting upon standing.
• 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).
• sensation of spinning (vertigo).
• marked reduction in kidney function (signs of acute renal failure).
• muscle cramps, irregular heartbeat (signs of hyperkalemia).
• shortness of breath, difficulty breathing when lying down, swelling of 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 causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• skin blisters (signs of bullous dermatitis).
• allergic reactions may occur with skin rash, itching, and hives; symptoms of fever, swelling and joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms (signs of serum sickness).
• purplish red skin spots, fever, itching (signs of blood vessel inflammation, also called vasculitis).
• bleeding or bruising more easily 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 levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia).
• increased blood potassium levels (which, in severe cases, may cause muscle cramps and irregular heartbeat).
• elevated liver function test values (which may indicate liver injury), including increased blood bilirubin levels (which, in severe cases, may cause yellowing of the skin and eyes).
• increased blood urea nitrogen and increased serum creatinine levels (which may indicate kidney function abnormalities).
• low blood sodium levels (which, in severe cases, may cause fatigue, confusion, muscle twitching, and/or seizures).

The frequency of some adverse effects may vary depending on your condition. For example, certain adverse 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.

Adverse effects in children and adolescents are similar to those observed in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, website: www.notificaram.es.

By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of PRESAR 40 mg orodispersible tablets

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

Appearance of the product and contents of the pack

PRESAR 40 mg orodispersible tablets are white, round, flat tablets with a score line.

PRESAR 40 mg orodispersible tablets are available in PVC-PE-PVDC/Al-PVDC blisters containing 14 or 28 tablets.

Marketing Authorization Holder and Manufacturer

Meiji Pharma Spain, S.A.
Avda. de Madrid, 94
28802 Alcalá de Henares, Madrid (Spain)

Date of the most recent review of this leaflet: January 2025

Other sources of information

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