PARACETAMOL 100 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Paracetamol Level 100 mg/ml Oral Solution EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.
• You should consult a doctor if your symptoms worsen or if the fever persists for more than 3 days or the pain for more than 3 days in children or 5 days in adults (2 days for throat pain) or if it does not improve.

Contents of the Package Leaflet

1. What Paracetamol Level is and what it is used for
2. What you need to know before taking Paracetamol Level
3. How to take Paracetamol Level
4. Possible side effects
5. Storage of Paracetamol Level
6. Package contents and additional information

1. What Paracetamol Level is and what it is used for

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 or moderate pain.

2. What you need to know before taking Paracetamol Level

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 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 with your doctor before taking the medication.
• Consumption of alcoholic beverages can 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 the fever for more than 3 days, or worsens or other symptoms appear, treatment should be discontinued and a doctor consulted.

During treatment with Paracetamol Level, inform your doctor immediately if:

• If you have severe diseases, such as severe renal 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 the 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

It is recommended to consult a doctor before administering it to children under 3 years of age.

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 (chloramphenicol, flucloxacillin). In the case of flucloxacillin, due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).
• 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 decrease blood cholesterol levels).
• Medications used for gout treatment (probenecid and sulfinpyrazone).
• Medications used for relief of 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 (hypertension) and heart rhythm disorders (cardiac arrhythmias).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, which causes AIDS).

Interference with analytical tests

If you are going to have any analytical tests (including blood tests, urine tests, 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 habitually consume alcohol (three or more alcoholic beverages per day) can damage the liver.

Pregnancy, breastfeeding, and fertility

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

In case of necessity, 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 using machines

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

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

This medication may cause allergic reactions because it contains Red Cochineal A (E-124). It can 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 of age, consult your doctor or pharmacist, especially if they have been given other medications that contain propylene glycol or alcohol.

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

If you have liver or kidney failure, do not take this medication unless it is 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".

3. How to take Paracetamol Level

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of 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 information 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.

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

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 package.

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

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

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 symptoms disappear, this medication should be discontinued.

Instructions for correct administration of the preparation

60 ml bottle with safety screw cap, plus 5 ml oral syringe:

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

2.-Insert the oral syringe, pressing into the perforated cap hole.

3.-Invert the bottle and withdraw the necessary dose.

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

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

6.-Close the bottle well 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the package and package leaflet of the medication to the healthcare professional.

If you have ingested an overdose, you should go quickly to a medical center, even if there are no symptoms, since they often do not manifest until 3 days after ingestion of the overdose, even in cases of severe poisoning. The symptoms of overdose may 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/kg of body weight in children. Treatment of the overdose is more effective if started within 4 hours of ingestion of the medication.

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

In general, symptomatic treatment will be performed.

If you forget to take Paracetamol Level

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 medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Paracetamol Level can cause side effects, although not everyone will experience them.

Paracetamol's adverse reactions are, in general, rare (may affect up to1 in 1,000 patients) or very rare (may affect up to1 in 10,000 patients) or of unknown frequency (cannot be estimated from available data).

Very rarely, it can damage the liver at high doses or prolonged treatments. Also, very rarely, skin rashes and blood alterations such as neutropenia or leukopenia may appear.

Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from 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).

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

5. Storage of Paracetamol Level

Keep this medication out of sight and reach of children.

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

Do not use this medication after the expiration date that appears on the package after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

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), hydrochloric acid 5 N (c.s.p. pH 5.0 + 0.2), and water.

Appearance of the product and package contents

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

• 30 ml package:transparent plastic bottle with 2 ml drop counter cap.
• 60 ml package:transparent plastic bottle with safety cap plus 5 ml oral syringe.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturer

Laboratorios ERN, S.A.

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

Date of the last revision of this package leaflet:February 2025.

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