ApiRedol 100 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Apiredol 100 mg/ml oral solution

Paracetamol

Read all of this 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 more information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• If symptoms worsen or if fever persists for more than 3 days or pain for more than 3 days in children or 5 days in adults (2 days for sore throat), you must consult a doctor.
• You should consult a doctor if you do not feel better or if you feel worse, or if fever persists for more than three days or pain lasts for more than 3 days in children or 5 days in adults (2 days for sore throat).

Contents of the leaflet

1. What Apiredol is and what it is used for
2. What you need to know before taking Apiredol
3. How to take Apiredol
4. Possible side effects
5. How to store Apiredol
6. Contents of the pack and other information

1. What Apiredol is and what it is used for

Apiredol 100 mg/ml oral solution belongs to a group of medicines called analgesics and antipyretics.

This medicine is indicated for febrile conditions lasting less than 3 days and for the relief of mild to moderate pain.

You should consult a doctor if you do not feel better, or if you feel worse, or if fever persists for more than three days or pain continues for more than 3 days in children or 5 days in adults (2 days for sore throat).

2. What you need to know before taking Apiredol

Do not take Apiredol

• If you/your child are allergic to paracetamol or to any of the other components of Apiredol (listed in section 6).

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to take Apiredol.
• Consult your doctor before giving this medicine to children under 3 years of age.
• Do not exceed the recommended dose stated in section 3.
• In patients with kidney, heart, or lung disease, and in patients with anaemia (low haemoglobin levels in the blood, with or without a reduction in red blood cells), or with low levels of an enzyme in the blood called glucose-6-phosphate dehydrogenase, consult your doctor before taking this medicine.
• If you have liver problems (including Gilbert's syndrome), consult your doctor, as you may require a reduced dose and/or an increased interval between doses.
• In patients weighing less than 50 kg due to anorexia, malnutrition, or dehydration, as this may increase the risk of liver toxicity.
• Consumption of alcoholic beverages may cause paracetamol to cause liver damage.
• In case of high fever (>39°C), consult your doctor before using Apiredol.
• If pain persists for more than 3 days in children or 5 days in adults (2 days for sore throat), or if fever lasts longer than 3 days, or if symptoms worsen or new symptoms appear, treatment should be stopped and medical advice sought.
• During treatment with Apiredol, inform your doctor immediately if you develop serious conditions 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 serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these circumstances 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 breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Taking Apiredol with other medicines

Consult your doctor or pharmacist if you/your child are taking, have recently taken, or might need to take any other medicine.

In particular, if you/your child are taking medicines containing any of the following active substances, as it may be necessary to adjust the dose or discontinue treatment with one or more of them:

• 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
• Antiepileptic drugs (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
• Cholestyramine (used to lower blood cholesterol levels)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Medicines used to relieve spasms or cramps in the stomach, intestines, and bladder (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 human immunodeficiency virus, HIV, which causes AIDS)

Interference with laboratory tests:

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

Taking Apiredol with food, drinks, and alcohol

Apiredol 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 cause liver damage.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

If necessary, Apiredol may be used during pregnancy. Use the lowest effective dose needed to relieve pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Therapeutic doses of paracetamol may be used during pregnancy and breastfeeding.

Driving and using machines

No effects affecting the ability to drive or operate machinery have been reported.

Apiredol contains cochineal carmine and sodium (from sodium saccharin)

This medicine may cause allergic reactions.

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

3. How to take Apiredol

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Apiredol is intended for children weighing up to 32 kg (approximately from 0 months to 10 years of age). It is essential to follow the dosage 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 provided for informational purposes only.

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

In children under 3 years of age, it is recommended to measure the oral solution in drops (4 mg/drop), using the dropper cap (1) provided in the 30 ml pack.

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

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

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

In children, these doses should be given every 6 hours, including during the night.

If the desired effects are not achieved within 3-4 hours after administration, the dosing interval may be reduced to every 4 hours; in this case, administer 10 mg/kg.

For children weighing less than 7 kg (under 6 months of age), suppositories should be considered if available, except when clinical conditions prevent the use of this pharmaceutical form (e.g., diarrhea).

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

Patients with liver or kidney disease should refer to section 2, Warnings and precautions.

Administration of this preparation should only occur when painful or febrile symptoms appear. As symptoms subside, this medication should be discontinued.

Instructions for correct administration of the preparation

Apiredol is administered orally.

30 ml bottle 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.

60 ml bottle with safety screw cap, including an oral 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 by pressing it into the perforated 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.

Close the bottle tightly after each administration.

If you take more Apiredol than you should

If you/your child has taken more paracetamol than prescribed, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the name of the medication and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If an overdose has been ingested, you/your child should go immediately to a medical center even if no symptoms are present, 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 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 suffering from chronic alcoholism may be more susceptible to paracetamol overdose.

In general, symptomatic treatment will be provided.

If you forget to take Apiredol

Do not take a double dose to make up for missed doses.

If you/your child has forgotten a dose, take it as soon as possible and then continue with the regular dosing schedule. However, if the next dose is due shortly, skip the missed dose and take the next dose at the usual time.

If you stop treatment with Apiredol

If you have any further questions about the use of this medicine, consult 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 (affecting between 1 and 10 out of every 10,000 patients) or very rare (affecting fewer than 1 in every 10,000 patients).

Rare adverse effects include malaise, hypotension, and increased levels of liver enzymes.

Liver damage may very rarely occur at high doses or with prolonged treatment. Hypoglycemia, cloudy urine, renal adverse effects, skin rashes, urticaria, anaphylactic shock, and blood disorders such as neutropenia or leucopenia may also occur very rarely.

Very rare cases of serious skin reactions have been reported.

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 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 Apiredol

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Store the bottle in the outer packaging. No special storage temperature requirements.

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

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Apiredol

• The active substance is paracetamol. Each ml of solution contains 100 mg of paracetamol.
• The other components (excipients) are: Macrogol 600, glycerol, raspberry flavour, sodium saccharin (E-954), azorubine (carmoisine) (E-122) and purified water.

Appearance of Apiredol and contents of the pack

Apiredol is presented as a red, clear oral solution, packed in a 30 ml or 60 ml plastic bottle.

• 30 ml pack: transparent plastic bottle with a child-resistant safety dropper cap of 2 ml.
• 60 ml pack: transparent plastic bottle with a child-resistant safety closure and a 5 ml oral dosing syringe.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

IONFARMA, S.L.U.

Perú, 228

08020 Barcelona

Spain

Tel.: +34 93 314 80 11 Fax.: +34 93 314 40 96

Manufacturer

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberà del Vallès, Barcelona

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Spain Apiredol 100 mg/ml oral solution

Germany Apiredol 100 mg/ml solution for oral use

France Dolstic 100 mg/ml oral solution

Dolstic 100 mg/ml oral drops solution

Italy Apiredol 100 mg/ml oral solution

Poland Pedicetamol

Portugal Apiredol 100 mg/ml Oral Solution

Date of latest revision of this leaflet: February 2025

Other sources of information

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/