Leaflet: information for the user

apiretal 500 mg buccal dispersible tablets

Paracetamol

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

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

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

• Consult your doctor if your condition worsens or does not improve after 3 days in children or 5 days in adults (2 days for sore throat).

apiretal belongs to the group of analgesic and antipyretic medications.

This medication is usedin adolescents and in children weighing at least 33 kg (approximately 10 years)in febrile states and for the relief of occasional mild or moderate pain.

Do not take Apiretal:

-If you are allergic to the active ingredient or to 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 prospectus “How to take Apiretal”;

- Avoid taking this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not take more than one medication containing 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 diseases, and in patients with anemia (decreased hemoglobin levels in the blood, due or not 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) may cause paracetamol to cause liver damage;

- If you have asthma and are sensitive to acetylsalicylic acid;

• If you are taking an antiepileptic medication, consult your doctor before taking this medication, as it may decrease the effectiveness and increase the toxicity of paracetamol on the liver, especially in high-dose 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 sore throat) or fever for more than 3 days, or worsens or new symptoms appear, discontinue treatment and consult your doctor.

Inform your doctor immediately if:

• During treatment with Apiretal, you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress 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 old). For children with lower weights, there are other suitable Apiretal formats available. Consult your doctor or pharmacist for more information.

Other Medications and Apiretal

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

Particularly, if you are using medications that contain any of the following active ingredients, as it may be necessary to modify the dose or discontinue treatment with any of them:

• Antibiotics (chloramphenicol, flucloxacillin). In the case of flucloxacillin, due to aserious risk of blood and fluid anomaly (denominated metabolic acidosis) that requires urgent treatment (see section 2).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and hormone replacement therapy.

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

• Tuberculosis medications (isoniazid, rifampicin).
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants).
• Activated charcoal, used for diarrhea or gas treatment.
• Colestiramine (used to reduce blood cholesterol levels).
• Medications used to treat gout (probencid and sulfinpyrazone).

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

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

• Propranolol used to treat high blood pressure (hypertension) and cardiac arrhythmias.
• Zidovudine (used to treat patients infected with the human immunodeficiency virus, causing AIDS).

Interference with Analytical Tests:

If you are to undergo any analytical test (including blood, urine, 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, Drinks, and Alcohol

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

Pregnancy and Breastfeeding

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

Paracetamol can be used during pregnancy if necessary. 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 women in the breastfeeding period should consult their doctor before using this medication.

Driving and Operating Machines

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

Apiretal contains aspartame (E-951);each tablet contains 24 mg of aspartame. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Follow exactly the administration instructions of this medication as contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.Do not use high daily doses of paracetamol for prolonged periods of time as this increases the risk of adverse effects such as liver damage.

If the pain persists for more than 5 days (3 days in children), the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, you must interrupt the treatment and consult your doctor.

Use in children and adolescents

The recommended daily dose of paracetamol in children depends on their weight and is approximately 60 mg/kg/day, which is divided into 4 or 6 doses, that is15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• In children weighing between33 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 weighing between41 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 weighing50 kg or more (over15 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 the most precise dosing of children and adolescents weighing over 33 kg (approximately from 9 years old); for other children, there are other presentations of the medication available that are more suitable.

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

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

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

Remember to take your medication.

Administration form:

This medication is administered orally

Leave the tablet to dissolve in the mouth before swallowing. It can also be dissolved 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

If you have ingested an overdose, you should go quickly to a medical center even if you do not have symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning. The symptoms of an overdose can be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

An overdose of paracetamol 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. The treatment of an overdose is more effective if it is initiated within 4 hours of ingestion of the medication.

In cases where the patient is being treated with barbiturates or suffers from chronic alcoholism, they may be more susceptible to a paracetamol overdose.

Generally, symptomatic treatment will be performed.

If you forgot to take Apiretal

Do not take a double dose to compensate for the missed doses.

If you have forgotten a dose, take another as soon as possible and continue with your regular schedule. However, if the time for the next dose is near, skip the missed dose and take the next dose at your regular time.

Like all medications, this medication mayproduce adverse effects, although not all people will experience them.

The adverse reactions of paracetamol 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 may cause, for example, bleeding through the nose or gums) and bleeding;
• allergic reactions (symptoms such as swelling, shortness of breath, sweating, nausea, sudden drop in blood pressure);
• decreased blood sugar;
• jaundice (yellow discoloration of the skin), liver insufficiency;
• 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);

Unknown Frequency:(cannot be estimated from available data)

• a serious disease that may make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting Adverse Effects

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

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 that appears on the packaging after “CAD”.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition ofapiretal

• The active ingredient isparacetamol. 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, and grape essence.

Appearance ofapiretaland contents of the packaging

The buccal dispersible tablets are round and white in color and are presented in Alu/Alu blister packs, available in boxes of12or24 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder:

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Responsible for Manufacturing:

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain

Last review date of this leaflet:February 2025.

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