Paracetamol Normon 1000 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Normon 1000 mg tablets EFG

paracetamol

Read all of this 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they 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.

It is indicated for the treatment of pain and fever symptoms.

2. What you need to know before taking Paracetamol Normon

Do not take Paracetamol Normon:

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

Take special care with Paracetamol Normon:

• Do not take more than the recommended dose indicated in section 3, "How to take Paracetamol Normon".
• In aspirin-sensitive asthmatic patients, consult your doctor before taking this medicine.
• If you have kidney, liver, 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 are being treated with antiepileptic medicines, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxic potential of paracetamol, especially with high-dose paracetamol regimens.
• In chronic alcoholics, caution should be taken not to exceed 2 g of paracetamol within 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, consult your doctor and reassess the clinical situation.
• For children under 15 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

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 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 difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Taking other medicines and Paracetamol Normon

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines to treat tuberculosis: (isoniazid, rifampicin)
• Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower blood cholesterol levels: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used to treat 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

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

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).

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

Interference with laboratory tests:

If you are scheduled to have 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 results of such tests.

Taking Paracetamol Normon with food, drinks, and alcohol:

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

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

Driving and use of machines:

The influence of paracetamol on the ability to drive and operate machinery is none or negligible.

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

3. How to take Paracetamol Normon

Follow these instructions unless your doctor has given you different ones. Remember to take your medicine. Paracetamol should be taken orally.

The usual dose is:

Adults and children over 15 years of age: The usual dose is 1 tablet (1000 mg paracetamol) 3 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.

Patients with liver disease: You must consult your doctor before taking this medicine. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.

Do not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: You must consult your doctor before taking this medicine. Take a maximum of 500 milligrams per dose.

Due to the dosage (1000 mg paracetamol), this product is not indicated for this group of patients.

Elderly patients: You should consult your doctor.

Use in children: Do not use in children under 15 years of age.

If you think the effect of Paracetamol is too strong or too weak, tell your doctor or pharmacist. When doses lower than 1000 milligrams of paracetamol per dose are required, other paracetamol formulations suitable for the required dosage should be used.

If you take more Paracetamol Normon than you should:

You should consult your doctor or pharmacist immediately.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

If you have taken an overdose, 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. Treatment for overdose is most effective if started within 4 hours of taking the medicine.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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 forget to take Paracetamol Normon:

Do not take a double dose to make up for forgotten doses. Simply take the missed dose when you remember, 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 between 1 and 10 out of 10,000 people) are: malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in less than 1 out of 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). Very rare cases of severe skin reactions have been reported.

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 patients with severe illness who use paracetamol (see section 2).

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

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 can also report them directly via the Spanish System for Pharmacovigilance of Human Medicinal Products: 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.

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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly 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 ParacetamolNormon:

Each tablet contains 1000 mg of paracetamol as the active substance.

The other components (excipients) are sodium glycolate starch of potato (Type A), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and contents of the pack:

Paracetamol Normon is presented as tablets for oral administration.

The tablets are oblong, biconvex, white in colour, with a score on one side and marked "PC" on the other side.

Available in packs of 20 and 40 tablets and hospital pack of 500 tablets, packed in PVC/PVdC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Manufacturer

SAG Manufacturing S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat

08950 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 Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/84218/P_84218.html