APIRETAL 500 mg ORALLY DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

apiretal 500 mg orodispersible tablets

Paracetamol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult your doctor if it worsens or does not improve after 3 days in children or 5 days in adults (2 days for throat pain).

Contents of the Package Leaflet

1. What apiretal is and what it is used for
2. What you need to know before taking apiretal
3. How to take apiretal
4. Possible side effects
5. Storage of apiretal
6. Package Contents and Additional Information

1. What apiretal is and what it is used for

apiretal belongs to the group of analgesic and antipyretic medications.

This medication is used in adolescents and children from 33 kg of weight (approximately 10 years) in febrile states and for the relief of occasional mild or moderate pain.

2. What you need to know before taking apiretal

Do not take apiretal:

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
  • If you have phenylketonuria (a hereditary disease diagnosed at birth).

Warnings and Precautions

• Do not take more medication than recommended in section 3 of this package leaflet "How to take apiretal";
• You should avoid using this medication simultaneously with other medications that contain paracetamol, such as medications for the flu and colds, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

Consult your doctor or pharmacist before starting to take apiretal:

• If you have glucose-6-phosphate dehydrogenase deficiency;
• If you have anorexia, bulimia, cachexia, or chronic malnutrition;
• If you have dehydration or hypovolemia;

• In patients with kidney, heart, or lung disease and in patients with anemia (decrease in hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), consult your doctor before taking the medication;

Excessive consumption of alcoholic beverages (3 or more alcoholic beverages per day) can cause paracetamol to damage the liver;

• If you have asthma and are sensitive to acetylsalicylic acid;
  • If you are taking a medication to treat epilepsy, you should consult your doctor before taking this medication, as when used at the same time, it decreases the efficacy and increases the toxicity of paracetamol on the liver, especially in high-dose paracetamol treatments (see below in this section "Other medications and apiretal");
  • If you have Gilbert's disease (also known as Meulengracht's disease);

• If the pain persists for more than 3 days in children or 5 days in adults (2 days for throat pain) or the fever for more than 3 days, or worsens or other symptoms appear, you should discontinue treatment and consult your doctor.

During treatment with apiretal, inform your doctor immediately if:

• If you have severe illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and Adolescents

This medication should not be used in children with a body weight of less than 33 kg (approximately 10 years). For children with lower weight, there are other suitable formats of apiretal; consult your doctor or pharmacist for more information.

Other Medications and apiretal

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

In particular, if you are using medications that contain any of the following active ingredients, it may be necessary to modify the dose or interrupt treatment of either of them:

• Antibiotics (chloramphenicol, flucloxacillin). In the case of flucloxacillin, due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and estrogen treatments.

• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

• Antituberculars (isoniazid, rifampicin).
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants).
• Activated charcoal, used for diarrhea or gas treatment.
• Colestyramine (used to decrease blood cholesterol levels).
• Medications used to treat gout (probenecid and sulfinpyrazone).

• Medications used to relieve stomach, intestine, and bladder spasms or contractions (anticholinergics).

• Metoclopramide and domperidone (used to prevent nausea and vomiting).

• Propranolol used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS).

Interference with Analytical Tests:

If you are going to undergo any analytical test (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Taking apiretal with Food, Beverages, and Alcohol

This medication can be taken with food or beverages. The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day) can damage the liver.

Pregnancy and Breastfeeding

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

In case of need, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time.

Contact your doctor or midwife if the pain or fever does not decrease or if you need to take the medication more frequently.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor before using this medication.

Driving and Using Machines

No effects have been described that modify the ability to drive and use machines.

apiretal contains aspartame (E-951);each tablet contains 24 mg of aspartame. Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

3. How to Take apiretal

Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of adverse effects such as liver damage increases.

If the pain persists for more than 5 days (3 days in children), the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, you should discontinue treatment and consult your doctor.

Use in Children and Adolescents

In children, the recommended daily dose of paracetamol depends on weight and is approximately 60 mg/kg/day, divided into 4 or 6 doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• In children with a weight between 33 and 40 kg (from 10to 12 years)the dose is 1 tablet per dose, repeating if necessary after 6 hours, up to a maximum of 4 tablets per day.
• In children with a weight between 41 and 49 kg (from 12to 15 years)the dose is 1 tablet per dose, repeating if necessary after 4-6 hours, up to a maximum of 5 tablets per day.
• In adolescents with a weight of 50 kg or more(over 15 years)the dose is 1 tablet per dose, repeating if necessary after 4 hours, up to a maximum of 6 tablets per day.

These tablets contain 500 mg of paracetamol and allow for more precise dosing of children and adolescents with a weight of over 33 kg (approximately from 9 years); for other children, there are other presentations of the medication that are more suitable.

In adults and adolescents from 15 years (body weight over 50 kg), do not take more than 3 g of paracetamol in 24 hours (6 tablets). The doses should be separated by at least 4 hours.

Patients with kidney or liver disease and the elderly should consult their doctor before taking this medication.

The administration of the medication is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, this medication should be suspended.

Remember to take your medication.

Method of Administration:

This medication is administered orally.

Let the tablet dissolve in your mouth before swallowing. It can also be dispersed in water.

If you take more apiretal than you should

If you have taken more paracetamol than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to take the package and package leaflet of the medication to the healthcare professional.

If you have ingested an overdose, you should go quickly to a medical center, even if there are no symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning. The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Paracetamol overdose is considered to be the ingestion of a single dose of more than 6 g in adults and more than 100 mg per kg of body weight in children. Treatment of the overdose is more effective if started within 4 hours of ingestion of the medication.

In the case of a patient being treated with barbiturates or suffering from chronic alcoholism, they may be more susceptible to a paracetamol overdose.

In general, symptomatic treatment will be performed.

If you forget to take apiretal

Do not take a double dose to make up for forgotten doses.

In case you have forgotten a dose, take another as soon as possible and continue with the usual schedule. However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Paracetamol's adverse reactions are, in general, rare (up to 1 in 1,000 people), very rare (up to 1 in 10,000 people), or of unknown frequency (cannot be estimated from available data).

Rare:(may affect up to 1 in 1,000 people)

• low blood pressure (hypotension);
• increase in liver enzymes;
• discomfort.

Very Rare:(may affect up to 1 in 10,000 people)

• may cause changes in the blood, including changes in blood cell counts (such as abnormally low levels of certain blood elements that can cause, for example, bleeding through the nose or gums) and bleeding;
• allergic reactions (symptoms such as edema, shortness of breath, sweating, nausea, sudden drop in blood pressure);
• decrease in blood sugar;
• jaundice (yellowing of the skin), liver failure;
• skin reactions such as allergic dermatitis, urticaria, itching, skin rash, and other severe skin reactions;
• changes in urination (difficult or painful urination, decreased urine output, and blood in the urine);

Frequency Not Known:(cannot be estimated from available data)

• a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of apiretal

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the carton after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of apiretal

• The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other components are: ethylcellulose, microcrystalline cellulose, guar gum, crospovidone, aspartame (E-951), colloidal silica, mannitol (E-421), talc, magnesium stearate, grape flavor.

Appearance of apiretal and Package Contents

The orodispersible tablets are round and white and come in Alu/Alu blister packs, available in boxes of 12 or 24 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturer:

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain

Date of Last Revision of this Package Leaflet:February 2025.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.