PARACETAMOL NEURAXPHARM 1 g TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Neuraxpharm 1 g Tablets 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 or pharmacist.
• This medicine has been prescribed to you, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Paracetamol Neuraxpharm 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 moderate pain and fever in adults and adolescents over 15 years of age and weighing more than 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 in section 3 or as indicated by your doctor. Do not take other medicines that contain paracetamol at the same time.

Talk to your doctor or pharmacist before starting to take this medicine.

• If you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells).
• If you suffer from chronic malnutrition or are dehydrated.
• If you are asthmatic and sensitive to acetylsalicylic acid.

• When you are being treated with any medicine for epilepsy, as the efficacy of paracetamol may be reduced and hepatotoxicity increased, especially with high doses of paracetamol.
• In chronic alcoholics, do not take more than 2 g of paracetamol in 24 hours.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, you should consult your doctor and reassess the clinical situation.

During treatment with Paracetamol Neuraxpharm, 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 suffer from 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 unwell (nausea) and vomiting.

Children and adolescents

In children and adolescents under 15 years of age, consult your doctor or pharmacist, as there are other formulations with doses that are suitable for this group of patients.

Other medicines and Paracetamol Neuraxpharm

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Paracetamol may interact with the following medicines:

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

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

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.

Paracetamol may alter the values of analytical determinations of uric acid and glucose.

Taking Paracetamol Neuraxpharm with food and drinks:

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

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

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

Small amounts of paracetamol may appear in breast milk, so it is recommended that you consult your doctor or pharmacist before taking this medicine.

In case of necessity, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces the pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible or nil.

3. How to take Paracetamol Neuraxpharm

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

This medicine should be taken orally.

According to your preferences, the tablets can be swallowed directly or broken in half, with the help of a glass of liquid, preferably water. The tablets are scored, which allows them to be broken 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 gram per dose, and if necessary, you can take 1 tablet every 6-8 hours, up to 4 times a day. Do not take more than 4 tablets in 24 hours, spaced at least 4 hours apart.

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

Patient with kidney disease: They should reduce the dose of paracetamol. Their doctor will indicate the appropriate dose.

Due to the dose, 1 gram of paracetamol, the medicine should not be used in patients with moderate or severe kidney disease.

Elderly patients: They should consult their doctor.

Use in children

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

If you think that the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

When lower doses of paracetamol are required, other formulations of paracetamol 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 ingested an overdose, you should go immediately to a medical center, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, 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.

Treatment of overdose is more effective if started within 4 hours of ingestion of the medicine.

Patient being treated with barbiturates or 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 forgotten dose when you remember, taking the next doses with the indicated interval (at least 4 hours).

4. Possible side effects

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

Rare side effects that may occur (up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Paracetamol may damage the liver when taken in high doses or for prolonged periods. Very rare cases of severe skin reactions have been reported.

Side effects with unknown frequency (cannot be estimated from the 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).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side 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 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 is the last day of the month indicated.

“Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.”

6. Contents of the pack and further information

Composition of Paracetamol Neuraxpharm

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

Appearance of the product and pack contents

Oblong tablets, white in color, and scored on one side, packaged in aluminum-PVC-PVDC blisters and presented in packs of 20 and 40 tablets.

Not all 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 Alcala de Henares - Madrid

Spain

“or”

Farmalider, S.A.

C/ Aragoneses,

2 28108 Alcobendas – Madrid

Spain

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

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