Paracetamol Level 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Paracetamol Level 100 mg/ml oral solution EFG

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor, 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.
• You must 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 there is no improvement.

Contents of the 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. How to store Paracetamol Level
6. Contents of the pack and other information

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

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

This medicine is indicated for febrile conditions and for the relief of mild to moderate pain.

2. What you need to know before taking Paracetamol Level

Do not take Paracetamol Level:

• If you are allergic to paracetamol or to any of the other ingredients of this medicine (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 anaemia (reduced haemoglobin levels in the blood, due to or not associated with a reduction in red blood cells), consult your doctor before taking this medicine.
• Consumption of alcoholic beverages may cause paracetamol to cause liver damage.
• 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.

During treatment with Paracetamol Level, inform your doctor immediately 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

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

Use of Paracetamol Level with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

In particular, if you are taking medicines containing any of the following active substances, dose adjustment or discontinuation of treatment may be necessary:

• Antibiotics (chloramphenicol, flucloxacillin). In the case of flucloxacillin, due to a serious risk of blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and oestrogen 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 diarrhoea or treatment of gas.
• Colestyramine (used to lower blood cholesterol levels).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines 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 heart rhythm disorders (cardiac arrhythmias).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV).

Interference with laboratory tests

If you are due 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 such tests.

Taking Paracetamol Level with food, drinks, and alcohol

Paracetamol Level may be diluted with water, milk, or fruit juice. The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day) may damage the liver.

Pregnancy, breastfeeding, and fertility

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

If necessary, Paracetamol Level may be used during pregnancy. Use the lowest possible dose that reduces pain or fever, and use it for the shortest possible time. Contact your doctor or midwife if pain or fever do not subside or if you need to take the medicine more frequently.

Paracetamol passes into breast milk, so 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.

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

This medicine may cause allergic reactions as it contains Carmoisine (E-124). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains 169 mg of propylene glycol per ml.

If the child is under 5 years of age, consult your doctor or pharmacist, particularly if other medicines containing propylene glycol or alcohol have been administered.

If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out additional check-ups while you are taking this medicine.

If you have hepatic or renal insufficiency, do not take this medicine unless recommended by your doctor. Your doctor may carry out additional check-ups while you are taking this medicine.

This medicine contains less than 23 mg (1 mmol) of sodium per ml and is therefore essentially "sodium-free".

3. How to take Paracetamol Level

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Use in children and adolescents

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

The dose of Paracetamol Level depends on the child's weight. 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, i.e., 15 mg/kg every 6 hours, or 10 mg/kg every 4 hours.

In children under 3 years of age, it is recommended to administer the oral solution in drops (3.3 mg/drop), using the dropper cap (1) included with the 30 ml bottle.

In children aged 3 years and older, it is recommended to administer the oral solution in millilitres (ml) (100 mg/ml) using the oral syringe (2) included with the 60 ml bottle.

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

For direct calculation, multiply the child's weight in kg by 0.15; the result is the number of ml of Paracetamol Level to administer.

These doses may be repeated every 6 hours.

If the desired effects are not achieved within 3–4 hours after administration, the dosing interval may be shortened to every 4 hours, in which case 10 mg/kg should be administered.

Administration of the medicine should be based on the presence of pain or fever symptoms. As symptoms subside, this medication should be discontinued.

Instructions for correct administration of the medicine

30 ml bottle with safety dropper cap (2 ml):

1 and 2. Firmly hold the bottle in one hand. With the other hand, grasp the cap between thumb and index finger at the two triangles marked on the cap with the word “PRESS”.

3. To open, press down on both triangles and unscrew the cap by turning it to the left (counter-clockwise). Draw the required amount using the dropper cap. Administer directly or dilute the drops in water.

4. To close, turn the cap to the right (clockwise) until a “click” is heard.

5. Close the bottle tightly after each administration.

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

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

2. Insert the oral syringe by pressing it into the pierced hole in the cap.

3. Invert the bottle and withdraw the required dose.

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

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

6. Close the bottle tightly after each administration.

If you take more Paracetamol Level than you should

If you have taken more paracetamol than recommended, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and amount taken. It is advisable to bring the medicine package and leaflet to the healthcare professional.

If an overdose has been ingested, seek urgent medical attention even if there are no symptoms, as symptoms often do not appear until after 3 days, even in cases of severe poisoning. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

An overdose of paracetamol is considered when a single dose exceeding 6 g is taken 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 of ingestion.

Patients undergoing treatment with barbiturates or those with chronic alcoholism may be more susceptible to paracetamol overdose.

In general, symptomatic treatment will be provided.

If you forget to take Paracetamol Level

Do not take a double dose to make up for a missed dose.

If you have forgotten a dose, take it as soon as possible and then continue with your regular dosing 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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Paracetamol Level can cause side effects, although not everybody gets them.

Adverse reactions to paracetamol are generally 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 the available data).

Very rarely, liver damage may occur with high doses or prolonged treatment. Very rarely, skin rashes and blood disorders such as neutropenia or leucopenia may also occur.

Very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from the available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with serious illness who are using paracetamol (see section 2).

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet.

5. Storage of Paracetamol Level

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Level

• The active substance is paracetamol. Each millilitre 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 flavouring, cochineal red A (Ponceau 4R) (E-124), hydrochloric acid 5 N (q.s. to pH 5.0 ± 0.2) and water.

Appearance of the product and contents of the pack

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

• 30 ml pack: transparent plastic bottle with a 2 ml safety dropper cap.
• 60 ml pack: transparent plastic bottle with a safety cap and an oral dosing syringe of 5 ml.

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

Pol. Ind. Can Salvatella

08210 Barberá del Vallés (Barcelona), Spain

Date of the most recent revision of this leaflet: February 2025.

Detailed and up-to-date 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/.