APIRETAL 100 mg/ml ORAL SOLUTION CHERRY FLAVOR

Introduction

Package Leaflet: Information for the User

Apiretal 100 mg/ml Cherry Flavored Oral Solution

Paracetamol

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

Follow the administration instructions for the medication 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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if you do not improve or if the fever persists for more than 3 days or the pain for more than 3 days in children or 5 days in adults (2 days for throat pain).

Contents of the Package Leaflet:

1. What Apiretal is and what it is used for
2. What you need to know before you or your child take Apiretal
3. How to take Apiretal
4. Possible side effects
5. Storage of Apiretal
6. Package Contents and Additional Information

1. What Apiretal is and what it is used for

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

This medication is indicated for febrile states with a duration of less than 3 days and for the relief of mild or moderate pain.

2. What you need to know before you or your child take Apiretal

Do not take Apiretal

• If you or your child are allergic (hypersensitive) to paracetamol or any of the other components of Apiretal.
• If you or your child have any liver disease.
• If you or your child have severe hemolytic anemia.

Warnings and Precautions

• Do not exceed the recommended dose in section 3.
• In patients with kidney, heart, or lung disease, and in patients with anemia (decrease in hemoglobin in the blood, due to or not due to a decrease in red blood cells), or with low levels of a blood enzyme called glucose-6-phosphate dehydrogenase, consult your doctor before taking the medication.
• In patients with a weight of less than 50 kg due to anorexia, malnutrition, or dehydration, as it may increase liver toxicity.
• Consumption of alcoholic beverages may cause paracetamol to damage the liver.
• In case of high fever (>39°C), ask your doctor before using Apiretal.
• If the pain persists for more than 3 days in children or 5 days in adults (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 damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in 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 and Adolescents

Consult your doctor before giving this medication to children under 3 years of age.

Other Medications and Apiretal

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

In particular, if you or your child are using medications that contain any of the following active ingredients, it may be necessary to modify the dose or discontinue 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).
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to relieve stomach, intestine, and bladder spasms or cramps (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 or your child are going to have any analytical tests (including blood tests, urine tests, skin tests using allergens, etc.), tell your doctor that you or your child are taking this medication, as it may alter the results of these tests.

Taking Apiretal 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 drinks 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 before taking this medication.

In case of necessity, 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 Using Machines

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

Apiretal contains azorubine (E-122), propylene glycol, and sodium (in the form of sodium saccharin)

This medication may cause allergic reactions because it contains azorubine (E-122).

This medication contains 15 mg of propylene glycol per ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications that contain propylene glycol or alcohol.

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

3. How to Take Apiretal

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Apiretal is reserved for children with a weight of up to 32 kg (approximately from 0 months to 10 years). It is necessary to respect the dosage defined based on the child's body weight and therefore select the appropriate dose of the oral solution in ml.

The approximate ages based on body weight are given for informational purposes only.

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

In children under 3 years, it is recommended to dose the oral solution in drops (4 mg/drop), with the drop counter cap (1) included in the 30 ml package.

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 ml and 90 ml packages.

For the administration of 15 mg/kg every 6 hours, the schedule is as follows:

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

In children, these doses should be administered every 6 hours, including at night.

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.

For children with a weight of less than 7 kg (6 months), the use of suppositories should be considered, if available, except in cases where administration in this form is not possible for clinical reasons (e.g., diarrhea).

Never exceed the maximum daily dose of 60 mg/kg/day without medical recommendation.

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 the Correct Administration of the Preparation

Apiretal is administered orally.

Bottles of 30 ml with a safety drop counter cap (2 ml):

1 and 2.- Hold the bottle firmly with one hand. With the other, take 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 drop counter cap. Administer directly or dilute the drops with water.

4.- To close, turn the cap to the right (clockwise) until it clicks.

5.- 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 intake.

6.- Close the bottle well after each administration.

If you take more Apiretal than you should

If you or your child 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 medication and the amount used. It is recommended to take the package and package leaflet of the medication to the healthcare professional.

If you have ingested an overdose, you or your child 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 the ingestion of a single dose of more than 6 g in adults and more than 100 mg per kg of weight in children. Treatment of the overdose is more effective if started within 4 hours after ingestion of the medication.

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 or your child 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 very close, skip the forgotten dose and take the next dose at the usual time.

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

4. Possible Side Effects

Like all medications, Apiretal can cause side effects, although not everyone gets them.

Paracetamol's adverse reactions are, in general, rare (affect between 1 and 10 patients out of 10,000), very rare (affect less than 1 patient out of 10,000), or of unknown frequency (cannot be estimated from available data).

Rare side effects are discomfort, hypotension, and increased liver enzyme levels.

Very rarely, it can damage the liver at high doses or prolonged treatments. Also, very rarely, hypoglycemia, cloudy urine, renal adverse effects, skin rashes, urticaria, anaphylactic shock, and blood alterations such as neutropenia or leucopenia may appear.

Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from 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 does not appear in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Apiretal

Keep this medication out of sight and reach of children.

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

Keep the bottle in the outer packaging. It does not require any special storage temperature.

After the first opening, keep the bottle in the outer packaging.

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

Medications should not be thrown away through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications 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: Macrogol 600, glycerol (E-422), cherry flavor (aromatizing substances, propylene glycol, and triethyl citrate), sodium saccharin (E-954), azorubine (carmoisine) (E-122), and purified water.

Appearance of the Product and Package Contents

Apiretal is presented in the form of a transparent, red-colored oral solution, packaged in a 30, 60, or 90 ml plastic bottle.

• 30 ml packages:Transparent plastic bottles with a 2 ml child-resistant drop counter cap.
• 60 and 90 ml packages:Transparent plastic bottles with a child-resistant safety 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 and Manufacturer

Marketing Authorization Holder

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Phone: +34 93 314 80 11

Fax: +34 93 314 40 96

Manufacturer

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