Paracetamol Neuraxpharm 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Neuraxpharm 1 g tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 or pharmacist.

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

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

Leaflet contents

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

1. What Paracetamol Neuraxpharm 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 moderate pain and fever in adults and adolescents aged 15 years and older, weighing over 50 kg.

2. What you need to know before taking Paracetamol Neuraxpharm

Do not take Paracetamol Neuraxpharm

• If you are allergic to paracetamol, propacetamol, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Do not take more than the recommended dose stated in section 3 or as prescribed by your doctor. Do not take other medicines containing paracetamol at the same time.

Consult your doctor or pharmacist before starting to take this medicine:

• If you have liver, 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).

• If you suffer from chronic malnutrition or are dehydrated.

• If you are an asthmatic and sensitive to acetylsalicylic acid.

• If you are taking any medication for epilepsy, as concomitant use may reduce the effectiveness of paracetamol and increase its hepatotoxic potential, especially with high-dose paracetamol regimens.

• In chronic alcoholics, caution should be taken not to exceed 2 g of paracetamol in 24 hours.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you should consult your doctor and re-evaluate your clinical condition.

During treatment with Paracetamol Neuraxpharm, 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 concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

For children and adolescents under 15 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

Other medicines and Paracetamol Neuraxpharm

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis: (isoniazid, rifampicin)
• Medicines for depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: (cholestyramine)
• Medicines used to increase urine output (loop diuretics such as furosemide)
• Medicines used in the treatment of gout: (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking another medicine. In patients treated with oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Interference with diagnostic tests:

If you are scheduled for 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 these tests.

Paracetamol may affect the analytical results of uric acid and glucose measurements.

Taking Paracetamol Neuraxpharm with food and drink:

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

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.

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

If necessary, paracetamol 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 if pain or fever do not improve, or if you need to take the medicine more frequently.

Driving and using machines

The effect of paracetamol on the ability to drive and use machines is negligible or none.

3. How to take Paracetamol Neuraxpharm

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

This medicine is for oral use.

The tablets may be taken whole or split in half, according to your preference, with a glass of liquid, preferably water. The tablets are scored, which allows them to be split in half to facilitate swallowing.

Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults and adolescents over 15 years of age (and weighing more than 50 kg): The recommended dose is 1 tablet (1 g of paracetamol) 3 times a day. Do not exceed 1 g per dose. If necessary, 1 tablet may be taken every 6–8 hours, up to 4 times a day. Do not take more than 4 tablets in 24 hours, divided into several doses, with intervals of at least 4 hours between doses.

Patients with liver disease: Should take the amount of medicine prescribed by their doctor, with a minimum interval of 8 hours between doses. They should not take more than 2 g of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: Should reduce the dose of paracetamol. Your doctor will advise you on the appropriate dose.

Due to the dosage (1 g of paracetamol), this medicine should not be used in patients with moderate or severe kidney disease.

Elderly patients: Should consult their doctor.

Use in children

Do not use in children or adolescents under 15 years of age.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

When lower doses than 1 g of paracetamol per administration are required, other paracetamol formulations should be used.

If you take more Paracetamol Neuraxpharm than you should

Consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after 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.

Treatment for overdose is most effective if started within 4 hours of taking the medicine.

Patients undergoing treatment with barbiturates or those suffering from chronic alcoholism may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Neuraxpharm

Do not take a double dose to make up for forgotten doses. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

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

Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, drop in blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects (occurring in up to 1 in 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Paracetamol may cause liver damage when taken in high doses or during prolonged treatment. Very rare cases of severe skin reactions have been reported.

Adverse effects with frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in severely ill patients using paracetamol (see section 2).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Neuraxpharm

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

This medicine requires no special storage conditions.

Do not use this medicine after the expiry date stated on the container (after EXP.). The expiry date is the last day of the month indicated.

"Medicines should 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 have any doubts, 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 Neuraxpharm

• The active substance is paracetamol. Each tablet contains 1 gram of paracetamol.
• The other components are: pregelatinized corn starch, stearic acid, povidone K-30, crospovidone, microcrystalline cellulose and vegetable-source magnesium stearate.

Appearance of the medicine and contents of the pack

Oblong white tablets, scored on one side, packed in aluminum-PVC-PVDC blisters and available in pack sizes of 20 and 40 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.
Avenida Barcelona 69, 08970 Sant Joan Despí,
Barcelona

Manufacturer

Toll Manufacturing Services, S.L.
C/ Aragoneses, 2
28108 Alcobendas – Madrid
Spain

“or”

Frosst Ibérica, S.A.
Vía Complutense, 140
28805 Alcalá de Henares - Madrid
Spain

“or”

Farmalider, S.A.
C/ Aragoneses, 2
28108 Alcobendas – Madrid
Spain

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

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”