Leaflet: information for the user

Apiretal 100 mg/ml oral solution

Paracetamol

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

• Followexactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days, in case offeveror ifthe pain persistsin children for more than 3 days (2 days for sore throat).

6. Contents of the pack and additional information

Apiretal belongs to a group of medications called analgesics and antipyretics.

This medication is indicated for febrile states and for the relief of mild or moderate pain.

Do not take Apiretal

• If you are allergic (hypersensitive) to paracetamol or any of the other components of this medication (listed in section 6).
• If you have any liver disease.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Apiretal.

• Do not exceed the recommended dose in section 3.
• In patients with kidney, heart, or lung diseases and in patients with anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking the medication.
• The consumption of alcoholic beverages may cause paracetamol to damage the liver.
• If the pain persists for more than 3 days in children (2 days for throat pain) or fever for more than 3 days, or worsens or other 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

It is recommended to consult your doctor before administering it to children under 3 years old.

Other Medications and Apiretal

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

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

• Antibiotics (cloranfenicol, flucloxacillin). In the case of flucloxacillin, due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and hormone replacement therapy.
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Antituberculosos (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 heart rhythm disorders (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 using allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results of these tests.

Taking Apiretal 100 mg/ml Oral Solution with Food, Drinks, and Alcohol

Apiretal can be diluted with water, milk, or fruit juice.The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day) may damage the liver.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. If necessary, Apiretal 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 Operating Machines

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

Apiretal Contains Azorubine (E-122) and Sodium (in the form of saccharin sodium)

This medication may cause allergic reactions because it contains azorubine.

This medication contains less than 1 mmol of sodium (23 mg) per ml, which is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Apiretal is administered orally.

It is intended for use in children between 3 and 32 kg (approximately 0 to 10 years old).

The Apiretal dose depends on the child's weight. The approximate age is given for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 daily doses, i.e. 15 mg/kg every 6 hours, or 10 mg/kg every 4 hours.

In children under 3 years, the 15 and 30 ml containers with a safety dropper (1) are recommended, which allows the oral solution to be dosed in drops (4 mg/drop) or ml.

In children 3 years or older, the oral solution is recommended to be dosed in milliliters (ml) (100 mg/ml) using the oral syringe (2) included in the 60 and 90 ml containers.

The oral syringe should not be used to dose in drops.

To administer 15 mg/kg every 6 hours, the following schedule is followed:

To make a direct calculation, the child's weight in kg can also be multiplied by 0.15; the result is the ml of Apiretal to be administered.

These doses can be repeated every 6 hours.

If the desired effects are not obtained 3-4 hours after administration, the dose can be advanced every 4 hours, in which case 10 mg/kg will be administered.

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

Instructions for correct administration of the preparation

15 and 30 ml containers with safety dropper (2 ml):

1 and 2.- Hold the container firmly with one hand. With the other hand, grasp the dropper between the thumb and index finger on the two triangles indicated on the dropper with the word “PRESS”.

3.- To open, press on the two triangles and unscrew the dropper by turning it to the left (counterclockwise). Remove the necessary amount with the help of the dropper. Administer directly or dilute the drops with water.

4.- To close, turn the dropper to the right (clockwise) until the “click”.

Close the container tightly after each administration.

60 and 90 ml containers with safety screw cap, plus oral syringe (5 ml):

1.- Open the container following the instructions indicated on the cap (the seal will break on the first opening).

2.- Insert the oral syringe, pressing on the perforated cap.

3.- Invert the container and remove the necessary amount.

4.- Administer directly or dilute with water, milk, or fruit juice.

5.- The oral syringe should be washed with water after each use.

6.- Close the container tightly after each administration.

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 container and the medication leaflet to the healthcare professional.

If you have ingested an overdose, you should go to a medical center immediately, even if you do not have symptoms, as symptoms may not appear until 3 days after ingestion of the overdose, 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.

A paracetamol overdose is considered to be the ingestion of a single dose of more than 6 g in adults and more than 100 mg/kg of body weight in children. The treatment of overdose is more effective if initiated within 4 hours of medication ingestion.

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

Generally, symptomatic treatment will be performed.

If you forget 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 the usual schedule. However, if the next dose is due soon, skip the missed dose and take the next dose at the usual time.

If you interrupt treatment with Apiretal

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

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

The adverse reactions of paracetamol are, in general, rare (up to 1 in 1,000 patients) or very rare (up to 1 in 10,000 patients) or of unknown frequency (cannot be estimated from available data).

Very rarely, it may damage the liver at high doses or prolonged treatment.

Very rarely, severe skin reactions have been reported.

Very rarely, there may be blood abnormalities such as neutropenia or leucopenia.

Unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated metabolic acidosis) in patients with severe disease using 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 possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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.

Preserve the solution in its original container. This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Once the bottle is opened, the contents must be used within a maximum period of 6 months.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of apiretal

• The active ingredient is paracetamol. Each ml of solution contains 100 mg of paracetamol.
• The other components are: polyethylene glycol, glycerol (E-422), raspberry essence, sodium saccharin (E-954), azorubine (carmoisine) (E-122) and water.

Appearance of the product and contents of the packaging

Apiretal is presented as a transparent solution of red color and with a characteristic raspberry aroma, packaged in a plastic bottle of 15, 30, 60 or 90 ml.

• Packaging of 15 and 30 ml:Transparent plastic bottles with a 2 ml safety dropper cap.
• Packaging of 60 and 90 ml:Transparent plastic bottles with a safety cap and a 5 ml oral syringe.

In any case, the bottles are of different capacity depending on the volume to be contained.

Holder of the marketing authorization

Laboratorios ERN, S.A.

C/Perú, 228 - 08020 Barcelona, Spain

Manufacturing responsible parties

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