PARACETAMOL NORMON 100 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Paracetamol Normon 100 mg/ml Oral Solution EFG

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

• Keep this package leaflet, as you may need to read it again.

• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if they have the same symptoms as you.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

This medicine is used for the symptomatic treatment of febrile states and mild or moderate pain in children between 3 and 32 kg in weight (approximately from 0 to 10 years).

2. What you need to know before taking Paracetamol Normon

Do not take Paracetamol Normon

• If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
• If you have phenylketonuria (a hereditary disease diagnosed at birth).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine.

• Do not exceed the recommended dose in "section 3 - How to take Paracetamol Normon". Check that you are not using other medicines that contain paracetamol at the same time.
• In patients with kidney, heart, or lung disease, and in patients with anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells), consult your doctor before taking the medicine.
• If you have liver problems (including Gilbert's syndrome) or kidney problems, or if you suffer from chronic malnutrition or dehydration, consult your doctor, as you may need a reduction in the dose of paracetamol.
• If you are an asthmatic sensitive to acetylsalicylic acid, consult your doctor before using this medicine.
• Consuming alcoholic beverages can cause paracetamol to damage the liver.

During treatment with Paracetamol Normon, inform your doctor immediately:

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 serious 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 unwell (nausea) and vomiting.

Children

In children from 10 years old (weight over 32 kg), it is recommended to use other presentations. For more information, consult your doctor or pharmacist.

Other medicines and Paracetamol Normon

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

In particular, if you are taking medicines that contain any of the following active ingredients, as it may be necessary to modify the dose or interrupt 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).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• 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).
• Medicines used for the treatment of gout (probenecid and sulfinpyrazone)
• Medicines used for the 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, the cause of AIDS).

Interference with analytical tests

If you are going to have any analytical tests (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 Paracetamol Normon with food, drinks, and alcohol

This medicine 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, 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 medicine.

In case of need, this medicine 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.

Paracetamol Normon contains aspartame (E-951)

This medicine contains 6 mg of aspartame per milliliter.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Paracetamol Normon contains azorubine (E-122)

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Paracetamol Normon contains benzyl alcohol

This medicine contains 0.000016 mg of benzyl alcohol per milliliter of solution. Benzyl alcohol can cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks old) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years old unless indicated by your doctor or pharmacist.

Paracetamol Normon contains sodium

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

3. How to take Paracetamol Normon

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

This medicine is administered orally.

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

The dose of paracetamol 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, that is, 15 mg/kg every 6 hours, or 10 mg/kg every 4 hours.

In children under 2-3 years, it is recommended to dose the oral solution with the oral syringe included in the 30 ml packages.

In children 3 years or older, it is recommended to dose the oral solution with the oral syringe included in the 60 ml and 90 ml packages.

The dosing of the solution is done in milliliters (ml) using the oral syringe included in the 30 ml, 60 ml, and 90 ml packages.

For the 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 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.

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

Instructions for the correct administration of the medicine

1. Open the bottle by following the instructions indicated on the cap (on the first opening, the seal will break).
2. Insert the oral syringe, pressing on the hole in the perforated cap.
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 intake. Close the bottle well after each administration.

If you take more Paracetamol Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you have ingested an overdose, you should go quickly to a medical center, 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 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 weight in children. Treatment of the overdose is more effective if it is started within 4 hours of ingestion of the medicine.

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

In general, symptomatic treatment will be performed.

If you forget to take Paracetamol Normon

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 stop taking Paracetamol Normon

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Paracetamol's adverse reactions are, in general, rare or very rare.

Rare (may affect up to 1 in 1,000 people): discomfort, increased liver transaminases, and low blood pressure.

Very rare (may affect up to 1 in 10,000 people): serious skin reactions, liver disorders (such as jaundice), low blood sugar, blood disorders (thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia), cloudy urine, and kidney disorders.

Very rarely, it can damage the liver at high doses or prolonged treatments. Very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from the available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Normon

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

Once the package is opened, it should not be used after 12 months.

This medicine does not require special storage conditions.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Normon

• The active ingredient is paracetamol. Each milliliter of solution contains 100 mg of paracetamol.
• The other ingredients (excipients) are macrogol, glycerol, sodium saccharin, aspartame (E-951), raspberry flavor (contains benzyl alcohol), azorubine (E-122), and purified water.

Appearance of Paracetamol Normon and package contents

Red and transparent oral solution with a raspberry odor.

It is presented in bottles containing 30 ml, 60 ml, or 90 ml of oral solution.

Package with 30 ml bottle:

Each package contains a transparent plastic (PET) bottle with a pressure adapter for inserting the dosing syringe and a child-resistant screw cap (HDPE), plus a 2 ml oral syringe graduated in ml.

Packages with 60 ml and 90 ml bottles:

Each package contains a transparent plastic (PET) bottle with a pressure adapter for inserting the dosing syringe and a child-resistant screw cap (HDPE), plus a 5 ml oral syringe graduated in ml.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

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

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

You can access detailed and updated information about this medicine by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89145/P_89145.html