Efetamol 100 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Efetamol 100 mg/ml oral solution

Paracetamol

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

This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• You should consult a doctor if you worsen or do not improve after 3 days in children or 5 days in adults (2 days for sore throat).
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Efetamol is and what it is used for

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 to moderate pain, and for reducing fever.

2. What you need to know before starting to take Efetamol

Do not take Efetamol

• If you are allergic to paracetamol or any of the other ingredients of this medicine (listed 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 more than the recommended dose in section 3.
• Alcohol consumption may cause paracetamol to cause liver damage.
• In patients with kidney, heart or lung disease, and in patients with anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking the medicine.
• 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 you should consult your doctor.
• 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 breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children

For children under 3 years of age, it is recommended to consult your doctor before taking Efetamol 100 mg/ml oral solution.

Other medicines and Efetamol

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Antibiotics (chloramphenicol)
• Oral anticoagulants (acenocoumarol, warfarin)
• Oral contraceptives and estrogen treatments
• Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculosis medicines (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Activated charcoal, used for diarrhea or treatment of gas
• Colestipol (used to reduce 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 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, HIV)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with laboratory tests:

If you are scheduled 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 Efetamol with food, drinks, and alcohol

Efetamol 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 and breastfeeding

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.

In women, although no controlled studies exist, teratogenic effects have not been demonstrated. However, as a general rule, its use is not recommended during the first trimester of pregnancy, and if used, it should always be after careful assessment of the potential risks and benefits of treatment.

If necessary, it may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor or midwife if pain or fever do not decrease 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.

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

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

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

3. How to take Efetamol 100 mg/ml oral solution

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

The dose of Efetamol 100 mg/ml oral solution 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; that is, 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

The dosing of Efetamol 100 mg/ml oral solution is measured in millilitres (ml) (100 mg/ml) using the oral syringe provided in the 30 ml and 60 ml pack, which also includes a 5 ml dosing syringe.

For administration of 15 mg/kg every 6 hours, the normal dose is:

For direct calculation, the child's weight in kg may also be multiplied by 0.15; the result is the number of ml of Efetamol 100 mg/ml oral solution.

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 medication depends on the presence of painful or febrile symptoms. As these symptoms subside, the medication should be discontinued.

Instructions for correct administration of the medication

30 ml bottle: withdraw the required amount using the 1 ml syringe provided.

60 ml bottle: open the bottle following the instructions indicated on the cap. Insert the dosing device into the opening. Invert the bottle and withdraw the prescribed dose. Rinse the dosing device with water and close the bottle after each use.

If you take more Efetamol than you should

If the child has taken more Efetamol oral solution than recommended, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915620420, indicating the medication and amount used.

If an overdose has been ingested, medical attention should be sought promptly even if there are no symptoms, as symptoms often do not appear until after 3 days following the overdose, even in cases of severe poisoning. Symptoms of severe poisoning 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 for overdose is most effective if initiated within 4 hours after ingestion of the medication.

In patients undergoing treatment with barbiturates or those suffering from chronic alcoholism, increased susceptibility to paracetamol overdose may occur.

In general, symptomatic treatment will be administered.

If you forget to take Efetamol

Do not take a double dose to make up for missed 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 its regularly scheduled time. If you have any further questions about the use of this medication, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Efetamol 100 mg/ml oral solution can cause adverse effects, although not everyone experiences them.

Adverse reactions to paracetamol are generally rare (at least 1 in 110,000 patients) or very rare (less than 1 in 10,000 patients). Liver damage may very rarely occur with high doses or prolonged treatment. Skin rashes and blood disorders such as neutropenia or leucopenia may also very rarely occur.

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 or pharmacist, 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 Efetamol

Do not store above 30°C. Keep the bottle in the outer packaging to protect it from light.

Keep this medicine out of sight and reach of children.

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.

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

6. Contents of the container and other information

Composition of Efetamol

• The active substance 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), carmine red A (E-124), strawberry flavor, and water.

Appearance of the product and contents of the container

Efetamol is presented as a red, transparent oral solution with a characteristic strawberry aroma.

30 ml bottle with a 1 ml oral syringe and 60 ml bottle with a 1 ml and 5 ml oral syringe.

Marketing Authorization Holder and Manufacturing Responsible Party

ITALFARMACO S.A.

San Rafael 3, 28108-Alcobendas (Madrid)

Tel. 916572323

Date of the most recent review of this leaflet: December 2024

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