EFETAMOL 100 mg/ml ORAL SOLUTION

2. What you need to know before taking Efetamol

Do not take Efetamol

• If you are allergic to paracetamol or any of the other components 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:

• Do not take more doses than recommended in section 3.
• Consumption of alcoholic beverages can cause paracetamol to damage the liver.
• In patients with kidney, heart, or lung disease, and in patients with anemia (decrease in hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), consult your doctor before taking the medicine.
• 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.
• If you have severe diseases, such as severe kidney 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

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

Other Medicines and Efetamol

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

In particular, if you are using medicines 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)
• 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 lower blood cholesterol levels)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Medicines used to relieve stomach, intestine, and bladder spasms or contractions (anticholinergics)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Propranolol used in the treatment of high blood pressure and heart rhythm disorders (arrhythmias)
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with analytical tests:

If you are going to have any analytical test (including blood tests, urine tests, skin tests that use 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) can 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 there are no controlled studies, no teratogenic effects have been found. However, as a general rule, its use is not recommended during the first trimester of pregnancy, and in case of use, it should always be done weighing 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 medicine more frequently.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor before using this medicine.

Driving and Using Machines

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

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

Efetamol contains Methyl Parahydroxybenzoate Sodium Salt (E-219).This medicine may cause allergic reactions (possibly delayed), because it contains Methyl Parahydroxybenzoate Sodium Salt (E-219).

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

3. How to take Efetamol 100 mg/ml Oral Solution

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

Remember to take your medicine.

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

The dose of Efetamol 100 mg/ml oral solution depends on the child's weight. The approximate age is given for informational purposes.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, 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 done in milliliters (ml) (100 mg/ml) using the oral syringe included with the 30 ml and 60 ml packages of 5 ml.

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

For a direct calculation, you can also multiply the child's weight in kg by 0.15; the result is the ml of Efetamol 100 mg/ml oral solution.

These doses can be repeated every 6 hours. If after 3-4 hours of administration the desired effects are not obtained, the dose can be advanced every 4 hours, in which case 10 mg/kg will be administered.

Administration of the preparation is subject to the appearance of painful or febrile symptoms. As these disappear, this medication should be discontinued.

Instructions for the correct administration of the medicine

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

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

If you take more Efetamol than you should

If the child has taken more Efetamol oral solution than they should, consult your doctor or pharmacist or the Toxicology Information Service, phone 915620420, indicating the medicine and the amount used.

If an overdose has been ingested, you 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 severe poisoning can 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 body weight in children. Treatment of the overdose is more effective if started within 4 hours of ingestion of the medicine.

In the case of a patient being treated with barbiturates or suffering from chronic alcoholism, they may be more susceptible to a paracetamol overdose.

In general, symptomatic treatment will be performed.

If you forget to take Efetamol

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

In case you 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 medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

Paracetamol's adverse reactions are, in general, rare (at least 1 in 110,000 patients) or very rare (less than 1 in 10,000 patients). Very rarely, it can damage the liver at high doses or with prolonged treatment. Also, very rarely, skin rashes 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 the available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Medicines and Healthcare Products Agency's (AEMPS) online system: https://www.notificaram.es. By reporting side 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 the sight and reach of children.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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6. Package Contents and Additional Information

Composition of Efetamol

• The active ingredient is paracetamol. Each ml of solution contains 100 mg of paracetamol.
• The other ingredients (excipients) are: macrogol, glycerol (E-422), sodium cyclamate, sodium saccharin, trisodium citrate, citric acid, methyl parahydroxybenzoate sodium salt (E-219), Red Cochineal A (E-124), strawberry flavor, and water.

Appearance of the Product and Package Contents

Efetamol is presented as a clear, red oral solution with a characteristic strawberry flavor.

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

Marketing Authorization Holder and Manufacturer

ITALFARMACO S.A.

San Rafael 3, 28108-Alcobendas (Madrid)

Tel. 916572323

Date of the Last Revision of this Package Leaflet:December 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/