APIRETAL 100 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Apiretal 100 mg/mloral solution

Paracetamol

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

• Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days, in case of fever, or if pain persists in children for more than 3 days (2 days for throat pain).

Package 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. Storage of Apiretal

1. Package Contents and Additional Information

1. What Apiretal is and what it is used for

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

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

2. What you need to know before taking Apiretal

Do not take Apiretal

• If you are allergic (hypersensitive) to paracetamol or any of the other components of this medicine (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 disease, and in patients with anemia (decreased hemoglobin level in the blood, due to or not due to a decrease in red blood cells), consult your doctor before taking the medicine.
• Consumption of alcoholic beverages may cause paracetamol to produce liver damage.
• If the pain persists for more than 3 days in children (2 days for throat pain) or the fever for more than 3 days, or worsens or other symptoms appear, treatment should be discontinued and a doctor consulted.

During treatment with Apiretal, inform your doctor immediately if:

• If you have severe diseases, 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 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 of discomfort (nausea) and vomiting.

Children

It is recommended to consult a doctor before administering it to children under 3 years of age.

Other Medicines and Apiretal

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

In particular, if you are using medicines that contain any of the following active ingredients, it may be necessary to modify the dose or interrupt treatment of any 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).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines 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 using allergens, etc.), inform your doctor that you are taking this medicine, 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 habitually 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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 medicine more frequently.

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

Driving and Using Machines

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

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

This medicine may cause allergic reactions because it contains azorubine.

This medicine contains less than 1 mmol of sodium (23 mg) per ml, i.e., it is essentially "sodium-free".

3. How to Take Apiretal

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

Remember to take your medicine.

Apiretal is administered orally.

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

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

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, 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 packages with a drop counter (1) are recommended, which allow the oral solution to be dosed in drops (4 mg/drop) or ml.

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

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

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

To calculate directly, you can also multiply the child's weight in kg by 0.15; the result is the ml of Apiretal to be administered.

These doses can be repeated every 6 hours.

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

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

Bottles of 15 and 30 ml with a safety dropper (2 ml):

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

3.- To open, press on the two triangles and unscrew the cap 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 cap to the right (clockwise) until you hear a “click”.

Close the bottle well after each administration.

Bottles of 60 and 90 ml with a safety screw cap, plus an oral syringe (5 ml):

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

2.- Insert the oral syringe, pressing into the perforated hole in the cap.

3.- Invert the bottle and remove the necessary dose.

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 bottle well 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you have ingested an overdose, you should go quickly to a medical center, even if there are no symptoms, since they often do 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.

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

In case the patient is being treated with barbiturates or has 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 near, skip the forgotten 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 medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Paracetamol side effects 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 the available data).

Very rarely, it can cause liver damage at high doses or prolonged treatments.

Very rare cases of serious skin reactions have been reported.

Alterations in the blood, such as neutropenia or leukopenia, can also occur very rarely.

Frequency not known (cannot be estimated from the available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting of Side Effects

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

5. Storage of Apiretal

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

Store the solution in its original package. This medicine does not require special storage conditions.

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

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

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 flavor, sodium saccharin (E-954), azorubine (carmoisine) (E-122), and water.

Appearance of the Product and Package Contents

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

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

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

Marketing Authorization Holder

Laboratorios ERN, S.A.

C/Perú, 228 - 08020 Barcelona, Spain

Manufacturers

Laboratorios ERN, S.A. C/Gorchs Lladó, 188 – Pol. Ind. Can Salvatella - 08210 Barberá del Vallés, Barcelona. Spain.

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

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