Apiretal 100 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Apiretal 100 mg/ml oral solution

Paracetamol

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

• Follow exactly the instructions for administration provided in this leaflet or those given by your doctor, pharmacist, or nurse. 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, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not feel better after 3 days in case of fever, or if pain in children persists for more than 3 days (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 a group of medicines called analgesics and antipyretics.

This medicine is indicated for febrile conditions and for the relief of mild to moderate pain.

2. What you need to know before taking apiretal

Do not take apiretal

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking apiretal.

• Do not exceed the recommended dose stated in section 3.
• In patients with kidney, heart or lung disease, and in patients with anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
• Consumption of alcoholic beverages may increase the risk of liver damage caused by paracetamol.
• If pain persists for more than 3 days in children (2 days for sore throat) or fever for more than 3 days, or if symptoms worsen or new symptoms appear, stop treatment and 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 over a prolonged period or when paracetamol is taken together 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 a doctor before administering this medicine to children under 3 years of age.

Other medicines and apiretal

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

In particular, if you are taking medicines containing any of the following active substances, the dose or duration of treatment may need to be adjusted:

• 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 oestrogen 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 diarrhoea or treatment of gas).
• 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 human immunodeficiency virus, HIV, which causes AIDS).

Interference with laboratory tests:

If you are due to have any laboratory 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 100 mg/ml oral solution with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

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. Apiretal may be used during pregnancy if necessary. Use the lowest effective dose that controls 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 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., essentially "sodium-free".

3. How to take Apiretal

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in 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 of age).

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

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

In children under 3 years of age, the 15 ml and 30 ml pack sizes are recommended, which include a dropper cap (1) allowing the oral solution to be measured either in drops (4 mg/drop) or in milliliters (ml).

In children 3 years of age and older, it is recommended to measure the oral solution in milliliters (ml) (100 mg/ml) using the oral dosing syringe (2) provided with the 60 ml and 90 ml pack sizes.

The oral dosing syringe must not be used to measure doses in drops.

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

For a direct calculation, the child's weight in kg may also be multiplied by 0.15; the result is the number of ml of Apiretal to administer.

These doses may be repeated every 6 hours.

If the desired effects are not achieved within 3-4 hours after administration, the dose may be given every 4 hours, in which case 10 mg/kg should be administered.

Administration of the preparation is dependent on the presence of painful or febrile symptoms. As these symptoms subside, this medication should be discontinued.

Instructions for correct administration of the preparation

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

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

3. To open, press down on both triangles and unscrew the cap by turning it to the left (counterclockwise). Draw up the required amount using the dropper cap. Administer directly or dilute the drops with water.

4. To close, turn the cap to the right (clockwise) until a “click” is heard.

Close the bottle tightly after each administration.

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

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

2. Insert the oral syringe, pressing it into the pierced hole in the cap.

3. Invert the bottle and withdraw the required 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 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If an overdose has been ingested, medical attention should be sought immediately even if there are no symptoms, as symptoms often do not appear until 3 days after the overdose, 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 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 of overdose is most effective if started within 4 hours of ingestion of the medicine.

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 forgotten doses.

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

If you stop treatment with Apiretal

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

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 patients), very rare (up to 1 in 10,000 patients), or of unknown frequency (cannot be estimated from available data).

Very rarely, liver damage may occur at high doses or with prolonged treatment.

Very rare cases of serious skin reactions have been reported.

Very rarely, blood disorders such as neutropenia or leucopenia may occur.

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 serious 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 may 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.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

After opening the bottle, the contents should be used within a maximum period of 6 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Apiretal

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

Appearance of the product and contents of the container

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

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

In all cases, the bottles have different capacities depending on the volume they contain.

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 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/