Leaflet: information for the user

Efetamol 100 mg/ml oral solution

Paracetamol

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

This medicine can be obtained without a prescription. However, for the best results, it should be used properly.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• Consult a doctor if you get worse or do not improve after 3 days in children or 5 days in adults (2 days for sore throat).
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

This medicine is indicated for the symptomatic treatment of mild or moderate pain, and to reduce fever.

Do not take Efetamol

- If you are allergic to paracetamol or any of the other components of this medication (listed in section 6).(including in section 6).

- If you have any liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Efetamol.

During treatment with Efetamol, inform your doctor immediately if:

• You do not take the recommended dose in section 3.
• The consumption of alcoholic beverages may cause paracetamol to damage the liver.
• In patients with kidney, heart, or lung diseases and in patients with anemia (decrease in hemoglobin levels in the blood, due or not to a decrease in red blood cells), consult your doctor before taking the medication.
• If the pain persists for more than 3 days in children or 5 days in adults (2 days for throat pain) or fever for more than 3 days, or worsens or other symptoms appear, treatment should be interrupted and the doctor consulted.
• If 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 are malnourished, chronically alcoholic, or 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 respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

Children under 3 years old should consult their doctor before taking Efetamol 100 mg/ml oral solution.

Other medications and Efetamol

Inform your doctor or pharmacist if you are using, 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 ingredients, as it may be necessary to modify the dose or discontinue treatment for any of them:

• Antibiotics (cloranfenicol)
• Oral anticoagulants (acenocumarol, warfarin)
• Oral contraceptives and hormone replacement therapy
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, metharbital, primidone, carbamazepine)
• Antituberculars (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 cardiac arrhythmias
• Zidovudine (used to treat patients infected with the human immunodeficiency virus, causing AIDS)
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

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 Efetamol with food, drinks, and alcohol

Efetamol 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 and lactation

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

In women, although there are no controlled studies, there is no evidence of teratogenic effects. However, as a general rule, it is not recommended to use it during the first trimester of pregnancy, and in the case of use, it should always be evaluated considering the possible risks and benefits of treatment.

If necessary, it 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 women breastfeeding should consult their doctor before using this medication.

Driving and operating machinery

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

Efetamol contains cochineal red (E-124).This medication may cause allergic reactions because it contains Cochineal Red A (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Efetamol contains sodium parahydroxybenzoate (E-219).This medication may cause allergic reactions (possibly delayed), because it contains sodium parahydroxybenzoate (E-219).

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

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

Remember to take your medication.

This medication must be taken orally. It is intended for use in children between 3 and 32 kg (approximately 0 to 10 years old).

The dose of Efetamol 100 mg/ml oral solution 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.

The dosing of Efetamol 100 mg/ml oral solution is performed in milliliters (ml) (100 mg/ml) using the oral syringe included in the 30 ml and 60 ml containers of 5 ml.

To administer 15 mg/kg every 6 hours, the normal dose is:

To perform a direct calculation, the child's weight in kg can also be multiplied by 0.15; the result is the ml of Efetamol 100 mg/ml oral solution.

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 medication

30 ml container: remove the amount to be taken with the help of the 1 ml syringe.

60 ml container: open the container following the instructions indicated on the cap. Insert the dosifier into the orifice. Invert the container and remove the prescribed dose. Wash the dosifier with water and close the container after each dose.

If you take more Efetamol than you should

If the child has taken more Efetamol oral solution than they should have, consult your doctor or pharmacist immediately or the Toxicological Information Service, telephone 915620420, indicating the medication and the amount used.

If you have ingested an overdose, you should go to a medical center as soon as possible, even if there are no symptoms, as symptoms often do not appear until 3 days after ingestion of the overdose, even in cases of severe intoxication. The symptoms of severe intoxication can 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 per kg of body weight in children. The treatment of an overdose is more effective if it is initiated within 4 hours of ingestion of the medication.

In the case of patients undergoing barbiturate treatment or suffering from chronic alcoholism, they may be more susceptible to a paracetamol overdose.

Generally, symptomatic treatment will be performed.

If you forget to take Efetamol

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 your regular schedule. However, if the next dose is due soon, skip the missed dose and take the next dose at its regular time. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Efetamol 100 mg/ml oral solution may produce adverse effects, although not all people will experience them.

Paracetamol adverse reactions are generally rare (at least 1 in 110,000 patients) or very rare (less than 1 in 10,000 patients). Very rarely, it may damage the liver at high doses or with prolonged treatment. Very rarely, skin eruptions and blood alterations such as neutropenia or leucopenia may also occur.

Severe skin reactions have been reported very rarely.

Unknown frequency (cannot be estimated from available data): A serious disease that may 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 or pharmacist,even if it is about 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 about the safety of this medication.

Do not store at a temperature above 30°C. Store the bottle in the outer packaging to protect it from light.

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

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

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

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Composition of Efetamol

-The active ingredient is paracetamol. Each ml of solution contains 100 mg of paracetamol.

-The other components (excipients) are:macrogol, glycerol (E-422), sodium cyclamate, sodium saccharin, trisodium citrate, citric acid, sodium methyl parahydroxybenzoate (E-219), red cochineal A (E-124), strawberry essence and water.

Appearance of the product and contents of the packaging

Efetamol is presented in the form of a transparent, red-colored oral solution with a characteristic strawberry aroma.

Bottle of 30 ml with oral syringe of 1 ml and bottle of 60 ml with oral syringe of 1 ml and 5 ml.

Holder of the marketing authorization and responsible for manufacturing

ITALFARMACO S.A.

San Rafael 3, 28108-Alcobendas (Madrid)

Tel. 916572323

Date of the last review of this leaflet:December 2024

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