Leaflet: Information for the user

Paracetamol Level 100 mg/ml oral solution EFG

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or 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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.
• You should consult a doctor 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) or if they do not improve.

Paracetamol Level belongs to a group of medications called analgesics and antipyretics.

This medication is indicated for febrile states and for the relief of mild to moderate pain.

Do not take Paracetamol Level:

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Paracetamol Level.

• Do not exceed the recommended dose in Section 3 - “How to take Paracetamol Level”.
• In patients with kidney, heart or lung diseases and in patients with anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking the medication.
• The consumption of alcoholic beverages may cause paracetamol to damage the liver.
• 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 new symptoms appear, discontinue treatment and consult your doctor.

Inform your doctor immediately during treatment with Paracetamol Level 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 have chronic malnutrition, alcoholism or if you are 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

It is recommended to consult your doctor before administering it to children under 3 years old.

Use of Paracetamol Level with other medications

Inform your doctor or pharmacist if you are using, have used 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 of any of them:

• Antibiotics (cloranfenicol, flucloxacillin).In the case of flucloxacillin, due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that must receive urgent treatment (see section 2).
• Oral anticoagulants (acenocumarol, warfarin).
• Oral contraceptives and hormone treatments.
• Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Antituberculosos (isoniazid, rifampicin).
• Barbiturates (used as sleep inducers, sedatives and anticonvulsants).
• Activated charcoal, used for diarrhea or gas treatment.
• Colestiramina (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 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, causing AIDS).

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 Paracetamol Level with food, drinks and alcohol

Paracetamol Level 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, breastfeeding and fertility

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

In case of need, Paracetamol Level 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 breastfeeding women 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.

Paracetamol Level contains Red C (E-124), propylene glycol (E-1520) and sodium (as sodium hydroxide and sodium saccharin)

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

This medication contains 169 mg of propylene glycol per ml.

If the child is under 5 years old, consult your doctor or pharmacist, especially if other medications containing propylene glycol or alcohol have been administered.

If you are pregnant or breastfeeding, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney insufficiency, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

This medication contains less than 23 mg (1 mmol) per ml, which is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

Use in children and adolescents

Paracetamol Level is administered orally. It is intended for use in children between 3 and 32 kg (approximately 0 to 10 years).

The dose of Paracetamol Level 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.

In children under 3 years, it is recommended to dose the oral solution in drops (3.3 mg/drop), with the dropper included in the 30 ml container.

In children 3 years or older, it is recommended to dose the oral solution in milliliters (ml) (100 mg/ml) using the oral syringe included in the 60 ml container.

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

To make a direct calculation, the child's weight in kg can also be multiplied by 0.15; the result is the ml of Paracetamol Level to be administered.

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 feverish symptoms. As these symptoms disappear, this medication should be discontinued.

Instructions for correct administration of the preparation

60 ml container with tamper-evident screw cap, plus oral syringe (5 ml):

1.-Open the container following the instructions indicated on the cap (in the first opening the seal will break).

2.-Insert the oral syringe, pressing on the perforated cap orifice.

3.-Invert the container and remove the necessary dose.

4.-Administer directly or dilute with water, milk, or fruit juice.

5.-The oral syringe must be washed with water after each dose.

6.-Close the container tightly after each administration.

If you take more Paracetamol Level than you should

If you have taken more paracetamol than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the container and the medication leaflet to the healthcare professional.

If you have ingested an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe intoxication. The symptoms of an overdose may 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/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 cases where the patient is being treated with barbiturates or suffers from chronic alcoholism, they may be more susceptible to a paracetamol overdose.

Generally, symptomatic treatment will be performed.

If you forgot to take Paracetamol Level

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 the usual schedule. However, if the next dose is due soon, skip the missed dose and take the next dose at the usual time.

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

Like all medications, Paracetamol Level may produce adverse effects, although not all people will experience them.

Paracetamol adverse reactions are, in general, rare (may affect up to 1 in 1,000 patients) or very rare (may affect up to 1 in 10,000 patients) or of unknown frequency (cannot be estimated from available data).

Very rarely, it may damage the liver at high doses or prolonged treatment. Also very rarely, skin eruptions and blood alterations such as neutropenia or leucopenia may appear.

Very rarely, severe skin reactions have been reported.

Unknown frequency (cannot be estimated from available data): A serious disease that may make the blood more acidic (designated metabolic acidosis) in patients with serious disease using paracetamol (see section 2).

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

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

Store the solution in its original container. No special storage conditions are required.

Do not usethis medicationafter the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

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

Composition of Paracetamol Level

• The active ingredient is paracetamol. Each milliliter of solution contains 100 milligrams of paracetamol.
• The other components are: citric acid, sodium hydroxide, sodium saccharin (E-954), propylene glycol (E-1520), macrogol, strawberry flavor, red cochineal A (Ponceau 4R) (E-124), 5 N hydrochloric acid (c.s.p. pH 5.0 + 0.2) and water.

Appearance of the product and contents of the packaging

Paracetamol Level is presented as a transparent red-colored solution with a characteristic strawberry aroma, packaged in a 30 or 60 ml plastic bottle.

• 30 ml packaging: Transparent plastic bottle with a 2 ml dropper cap.
• 60 ml packaging: Transparent plastic bottle with a safety cap and a 5 ml oral syringe.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Responsible for manufacturing

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188 - 08210 Barberá del Vallés, Barcelona, Spain

Last review date of this leaflet: February 2025.

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