Paracetamol Normon 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Normon 100 mg/ml oral solution EFG

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

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

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

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

2. What you need to know before taking Paracetamol Normon

Do not take Paracetamol Normon

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking this medicine.

• Do not exceed the recommended dose stated in section 3 - "How to take Paracetamol Normon". Check that you are not simultaneously using other medicines containing paracetamol.
• If you have kidney, heart, or lung disease, or if you have anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
• If you have liver or kidney problems (including Gilbert's syndrome) or suffer from chronic malnutrition or dehydration, consult your doctor, as you may require a reduced dose of paracetamol.
• If you are an aspirin-sensitive asthmatic, consult your doctor before using this medicine.
• Alcohol consumption may increase the risk of liver damage caused by paracetamol.

During treatment with Paracetamol Normon, 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 imbalance in blood and body fluids) has been reported in patients under these circumstances 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, malaise (nausea), and vomiting.

Children

In children aged 10 years and older (weighing more than 32 kg), other formulations are recommended. For further information, consult your doctor or pharmacist.

Other medicines and Paracetamol Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, if you are taking medicines containing any of the following active substances, as it may be necessary to adjust the dose or discontinue treatment:

• Antibiotics (chloramphenicol, flucloxacillin). In the case of flucloxacillin, due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and oestrogen-containing therapies.
• Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Antituberculosis agents (isoniazid, rifampicin).
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants).
• Activated charcoal (used for diarrhoea or gas treatment).
• Cholestyramine (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 human immunodeficiency virus (HIV), the cause of AIDS).

Interference with diagnostic tests

If you are scheduled to undergo any laboratory tests (including blood and urine analyses, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the test results.

Taking Paracetamol Normon with food, drinks, and alcohol

This medicine may 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) may cause liver damage.

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, this medicine may be used during pregnancy. Use the lowest possible dose that controls pain or fever, and use it for the shortest possible duration. Contact your doctor or midwife if pain or fever do not improve, or if you need to take the medicine more frequently.

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor before using this medicine.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

Paracetamol Normon contains aspartame (E-951)

This medicine contains 6 mg of aspartame per millilitre.

Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it properly.

Paracetamol Normon contains cochineal red A (E-122)

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

Paracetamol Normon contains benzyl alcohol

This medicine contains 0.000016 mg of benzyl alcohol per millilitre of solution. Benzyl alcohol may cause allergic reactions.

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

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

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

Do not administer this medicine to your newborn (up to 4 weeks of age) unless recommended by your doctor.

This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Paracetamol Normon contains sodium

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

3. How to take Paracetamol Normon

Follow exactly the administration instructions contained in this leaflet or those provided by your doctor or pharmacist. If in 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 of age).

The dose of paracetamol 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, 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 2–3 years of age, it is recommended to measure the oral solution using the oral syringe provided with the 30 ml pack.

In children aged 3 years and older, it is recommended to measure the oral solution using the oral syringe provided with the 60 ml and 90 ml packs.

The dosage of the solution is measured in millilitres (ml) using the oral syringe included in the 30 ml, 60 ml, and 90 ml packs.

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

For direct calculation, the child's weight in kg may also be multiplied by 0.15; the result is the number of ml of paracetamol 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 reduced to every 4 hours, in which case 10 mg/kg should be administered.

Administration of the preparation is dependent upon the presence of painful or febrile symptoms. As these symptoms subside, this medication should be discontinued.

Instructions for correct administration of the medicine

1. Open the bottle following the instructions indicated on the cap (on first opening, the seal will break).
2. Insert the oral syringe, pressing it into the perforated 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. Close the bottle tightly 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If an overdose has been ingested, prompt medical attention is required even in the absence of symptoms, as symptoms often do not appear until after 3 days following the overdose, 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 to occur when a single dose exceeding 6 g is ingested in adults, or more than 100 mg per kg of body weight in children. Treatment of overdose is most effective if initiated within 4 hours of ingestion of the medicine.

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 Normon

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

If you have forgotten a dose, take it as soon as possible and continue with your regular schedule. However, if the next dose is due shortly, skip the missed dose and take the next dose at its scheduled time.

If you stop taking Paracetamol Normon

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse reactions to paracetamol are generally rare or very rare.

Rare (may affect up to 1 in 1,000 people): malaise, increased levels of liver transaminases, and hypotension.

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

Liver damage may very rarely occur at high doses or with prolonged treatment. Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from available data): A serious condition that may make the blood more acidic (called metabolic acidosis) in critically ill patients using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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.

After opening the container, do not use beyond 12 months.

This medicine does not require any special storage conditions.

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 drains or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Normon

• The active substance is paracetamol. Each millilitre of solution contains 100 mg of paracetamol.
• The other components (excipients) are macrogol, glycerol, sodium saccharin, aspartame (E-951), raspberry flavour (containing benzyl alcohol), azorubine (E-122) and purified water.

Appearance of Paracetamol Normon and contents of the pack

Red, transparent oral solution with a raspberry odour.

Presented in bottles containing 30 ml, 60 ml or 90 ml of oral solution.

Pack with 30 ml bottle:

Each pack contains one transparent plastic bottle (PET) with a plastic press-on adapter (LDPE) to insert the oral dosing syringe and a child-resistant plastic screw cap (HDPE), plus a 2 ml oral dosing syringe graduated in ml.

Packs with 60 ml and 90 ml bottles:

Each pack contains one transparent plastic bottle (PET) with a plastic press-on adapter (LDPE) to insert the oral dosing syringe and a child-resistant plastic screw cap (HDPE), plus a 5 ml oral dosing syringe graduated in ml.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of this leaflet: February 2025

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