Presar 160 mg comprimidos bucodispersables efg
Introduction
Leaflet: information for theuser
PRESAR 160 mg buccal dispersible tablets EFG
Valsartán
Read this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.
1. What is PRESAR and what is it used for
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 and in children and adolescents aged 6 to 18 years.High blood pressureaffects the heart and arteries, increasing the workload on 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.
·to treat adult patientsafter a recent heart attack(myocardial infarction). “Recent” means here between 12 hours and 10 days,
·to treat symptomatic heart failure in adult patients.PRESAR is used when it is notpossibleto usea group of medications called Angiotensin-Converting Enzyme Inhibitors (ACEIs) (a medication for treating heart failure), or it can be usedaddedto the ACEIs, when it is not possible to use other medications for the treatment of heart failure.
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.
2. What you need to know before starting to take PRESAR
Do not take PRESAR:
- if you areallergic(hypersensitive) to valsartán or any of the other ingredients in this medication(listed in section 6).
- if you have aserious liver disease.
- if you arepregnant more than 3 months(it is better to avoid PRESAR during the first months of pregnancy - see section Pregnancy).
- if you havediabetesorkidney insufficiencyand are being treated with a medication to reduce blood pressure that contains aliskirén.
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 a liver disease.
- if you have a serious kidney disease or are undergoing dialysis.
- if you have a narrowing of the renal 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 myocardial infarction.
- if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (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 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 medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, 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 (medications to increase urine production).
- if you are taking any of the following medications used to treat high blood pressure:
- a renin-angiotensin-aldosterone system (RAAS) inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly ifyou have kidney problems related to diabetes.
- Aliskirén
- if you are being treated with an ACE inhibitor along with other medications 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 monitor 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 beginning 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 used during this period (see section Pregnancy).
Other medications and PRESAR
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
The effect of treatment with PRESAR may be altered if taken with certain medications. Your doctor may need to adjust your dose and/or take other precautions or, in some cases, stop one of the medications. This applies to both prescription and non-prescription medications, especially:
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: 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): Rare (may affect up to 1 in 100 people): Very rare (may affect up to 1 in 10,000 people)(may affect up to 1 in 10,000 people) Frequency not known (cannot be estimated from available data): 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.4. Possible Adverse Effects
5. PRESAR Storage
6. Contents of the packaging and additional information
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