Apiretal 500 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

apiretal 500 mg orodispersible tablets

Paracetamol

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

Always follow exactly the instructions for administration as described in this leaflet or as advised 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

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

Contents of the 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 adverse 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 medicinal products.

This medicine is used in adolescents and children weighing 33 kg or more (approximately 10 years of age) for feverish conditions and for the 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 ingredients 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 using this medicine together with other medicines containing paracetamol, such as cold and flu remedies, as high doses may cause liver damage. Do not use 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 drinks (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 when used together, the effectiveness of paracetamol may be reduced and its liver toxicity increased, 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 more 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 suffer from 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 for 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 with body weight below 33 kg (approximately 10 years of age). For children with lower body 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 currently using, have recently used, or might need to use any other medicines.

In particular, if you are using 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 medicines (isoniazid, rifampicin).

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

• Activated charcoal, used for diarrhea or gas treatment.

• Colestyramine (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 the human immunodeficiency virus, HIV).

Interference with diagnostic tests:

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

Taking apiretal with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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.

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 do 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 24 mg of aspartame. Aspartame contains 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 over 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 33 to 40 kg (aged 10 to 12 years), the dose is 1 tablet per dose, which may be repeated if necessary after 6 hours, up to a maximum of 4 tablets per day.
• In children weighing 41 to 49 kg (aged 12 to 15 years), the dose is 1 tablet per dose, which may be repeated if necessary after 4–6 hours, up to a maximum of 5 tablets per day.
• In adolescents weighing 50 kg or more (over 15 years of age), the dose is 1 tablet per dose, which may be repeated if necessary every 4 hours, up to a maximum of 6 tablets per day.

These tablets contain 500 mg of paracetamol and allow for more precise dosing in children and adolescents weighing over 33 kg (approximately from 9 years of age); for younger children, other formulations of the medicine are available that are more appropriate.

In adults and adolescents aged 15 years and over (body weight above 50 kg), no more than 3 g of paracetamol should be taken within 24 hours (6 tablets). Doses should be spaced at least 4 hours apart.

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 3 days after the overdose, even in cases of severe intoxication. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

A paracetamol overdose is considered to occur 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 who suffer from chronic alcoholism may be more susceptible to paracetamol overdose.

In general, symptomatic treatment will be administered.

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 then continue with your regular dosing schedule. However, if the next dose is due shortly, 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 experiences them.

Adverse reactions to paracetamol are generally rare (up to 1 in 1,000 people), very rare (up to 1 in 10,000 people), or frequency not known (cannot be estimated from 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, rash, and other serious skin reactions;
• changes in urination (painful or difficult urination, decreased amount of urine, blood in the urine);

Frequency not known: (cannot be estimated from 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, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of deapiretal

• The active substance 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 deapiretal and contents of the pack

The orodispersible tablets are round and white in color, and are supplied in Alu/Alu blister packs, available in boxes containing 12 or 24 tablets.

Only certain 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 Barberà del Vallès (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/.