Apiretal 250 mg orodispersible tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

apiretal 250 mg orodispersible tablets

Paracetamol

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

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

• Keep this leaflet, as you may need to read it again.

• If you need advice or further information, consult your pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

  • You should consult your doctor if your condition worsens or if you do not improve after 3 days in children or 5 days in adults (2 days for sore throat).

Leaflet Contents

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. How to store apiretal
6. Contents of the pack and other information

1. What apiretal is and what it is used for

apiretal belongs to the group of analgesic and antipyretic medicines.

This medicine is used in adolescents and children weighing at least 16 kg (approximately 4 years of age) for febrile conditions and for relief of mild to moderate occasional pain.

2. What you need to know before taking apiretal

Do not take apiretal

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

Warnings and precautions

• Do not take more medicine than recommended in section 3 of this leaflet, “How to take apiretal”;
• You should avoid taking this medicine together with other medicines containing paracetamol, such as cold and flu remedies, because high doses may cause liver damage. Do not take more than one medicine containing paracetamol without consulting your doctor.

Consult your doctor or pharmacist before taking apiretal:

• If you have glucose-6-phosphate dehydrogenase deficiency;

• If you have anorexia, bulimia, cachexia, or chronic malnutrition;

• If you are dehydrated or have hypovolemia;

• In patients with kidney, heart, or lung disease, and in patients with anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine;

• Excessive consumption of alcoholic beverages (3 or more alcoholic drinks per day) may cause paracetamol to cause liver damage;

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

• If you are taking a medicine for epilepsy, you should consult your doctor before taking this medicine, as its simultaneous use may reduce efficacy and increase the liver toxicity of paracetamol, especially with high-dose paracetamol treatments (see below in this section “Other medicines and apiretal”);

• If you have Gilbert’s disease (also known as Meulengracht’s disease);

• If pain persists for more than 3 days in children or 5 days in adults (2 days for sore throat), or if fever lasts longer than 3 days, or if symptoms worsen or new symptoms appear, treatment should be stopped and you should consult your doctor.

During treatment with apiretal, inform your doctor immediately if:

• You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

This medicine should not be used in children weighing less than 16 kg (approximately 4 years of age). For children of lower weight, other suitable formulations of apiretal are available. Consult your doctor or pharmacist for further information.

Other medicines and apiretal

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

In particular, if you are taking medicines containing any of the following active substances, dosage adjustment or discontinuation of treatment may be necessary:

• Antibiotics (chloramphenicol, flucloxacillin). In the case of flucloxacillin, due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

• Oral anticoagulants (acenocoumarol, warfarin).

• Oral contraceptives and estrogen treatments.

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

• Antituberculosis agents (isoniazid, rifampicin).

• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants).

• Activated charcoal, used for diarrhea or treatment of gas.

• Cholestyramine (used to lower blood cholesterol levels).

• Medicines used to treat gout (probenecid and sulfinpyrazone).

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

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

• Propranolol, used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias).

• Zidovudine (used in the treatment of patients infected with human immunodeficiency virus, the cause of AIDS).

Interference with diagnostic tests:

If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking apiretal with food, drinks, and alcohol

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

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 medicine.

If necessary, paracetamol may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time.

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

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor before using this medicine.

Driving and using machines

No effects affecting the ability to drive or operate machinery have been reported.

Apiretal contains aspartame (E-951); each tablet contains 12 mg of aspartame. Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take apiretal

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

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

Use in children and adolescents

In children, the recommended daily dose of paracetamol depends on body 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 weighing 16 to 24 kg (aged 4 to 7 years), the dose is 1 tablet per dose, repeated if necessary after 6 hours, up to a maximum of 4 tablets per day.
• In children weighing 25 to 32 kg (aged 7 to 10 years), the dose is 1 tablet per dose, repeated if necessary after 4 hours, up to a maximum of 6 tablets per day.
• In children weighing 33 to 40 kg (aged 10 to 12 years), the dose is 2 tablets per dose, repeated if necessary after 6 hours, up to a maximum of 8 tablets per day.
• In children weighing 41 to 49 kg (aged 12 to 15 years), the dose is 2 tablets per dose, repeated if necessary every 4–6 hours, up to a maximum of 10 tablets per day.
• In adolescents weighing 50 kg or more (aged 15 years and above), the dose is 2 tablets per dose, repeated if necessary every 4 hours, up to a maximum of 12 tablets per day.

These tablets contain 250 mg of paracetamol and allow for more precise dosing in children weighing 16–25 kg (approximately from 4 to 7 years of age); for other children, other formulations of the medicine are available that may be more appropriate.

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

Administration of the medicine should only occur when pain or fever symptoms appear. As symptoms subside, this medication should be discontinued.

Remember to take your medicine.

Method of administration:

This medicine is administered orally.

Allow the tablet to dissolve in the mouth before swallowing. It may also be dispersed in water.

If you take more apiretal than you should

If you have taken more paracetamol than recommended, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken. It is advisable to bring the medicine packaging and leaflet to the healthcare professional.

If an overdose has been ingested, seek urgent medical attention even if no symptoms are present, as symptoms often do not appear until after 3 days, even in cases of severe poisoning. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

An overdose of paracetamol is considered when a single dose exceeding 6 g is ingested in adults or more than 100 mg per kg of body weight in children. Treatment for overdose is most effective if initiated within 4 hours of ingestion.

Patients undergoing treatment with barbiturates or suffering from chronic alcoholism may be more susceptible to paracetamol overdose.

In general, symptomatic treatment will be provided.

If you forget to take apiretal

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

If you have missed a dose, take it as soon as possible and continue with your regular schedule. However, if the next dose is due soon, skip the missed dose and take the next dose at the usual time.

4. Possible adverse effects

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

Adverse reactions to paracetamol are generally rare (affecting up to 1 in 1,000 people), very rare (affecting up to 1 in 10,000 people), or of unknown frequency (cannot be estimated from the available data).

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

• low blood pressure (hypotension);
• increased liver enzymes;
• malaise.

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

• blood abnormalities may occur, including changes in blood cell counts (such as abnormally low levels of certain blood components which may cause, for example, bleeding from the nose or gums) and bleeding;
• allergic reactions (symptoms such as edema, shortness of breath, sweating, nausea, sudden drop in blood pressure);
• decreased blood sugar;
• jaundice (yellowing of the skin), liver failure;
• skin reactions such as allergic dermatitis, urticaria, itching, skin rash, and other serious skin reactions;
• changes in urination (difficulty or pain when urinating, decreased amount of urine, blood in the urine).

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

• a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Apiretal

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date refers to the last day of the month indicated.

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 have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Apiretal

• The active substance is paracetamol. Each tablet contains 250 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 flavouring.

Appearance of Apiretal and contents of the pack

The orodispersible tablets are round and white in colour, and are supplied in Alu/Alu blister packs contained in cardboard boxes of 12 or 24 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation 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 the most recent revision of this leaflet: February 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.