PARACETAMOL 1000 mg Tablets

Contents of the leaflet

1. Introduction
2. What is Paracetamol Normon and what is it used for
3. What you need to know before taking Paracetamol Normon
4. How to take Paracetamol Normon
5. Possible side effects
6. Storage of Paracetamol Normon
7. Package contents and additional information

Introduction

Leaflet: Information for the User

Paracetamol Normon 1000 mg Coated Tablets EFG

paracetamol

Read the entire leaflet carefully before starting to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the 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. Package contents and additional information

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

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

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

2. What you need to know before taking Paracetamol Normon

Do not take Paracetamol Normon:

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

Be careful with Paracetamol Normon:

• Do not take more than the recommended dose in section 3. How to take Paracetamol Normon.
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have kidney, liver, heart, or lung disease, or have anemia (decreased hemoglobin level in the blood, with or without a decrease in red blood cells), consult your doctor before taking this medicine.
• When taking medication to treat epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially with high doses of paracetamol.
• In chronic alcoholics, be careful not to take more than 2 g/24 hours of paracetamol.

• If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, consult your doctor and reevaluate the clinical situation.
• In children under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

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 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Taking other medicines and Paracetamol Normon

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

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 cholesterol levels in the blood: (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 and heart rhythm disorders (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 (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

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 test (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:

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor... 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 plan to become pregnant, consult your doctor before taking this medicine.

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

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

Driving and using machines:

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

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

3. How to take Paracetamol Normon

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

The normal dose is:

Adults and children over 15 years: the usual dose is 1 tablet (1000 mg of paracetamol) 3 times a day. The 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: before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval of 8 hours between each dose.

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

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

Due to the dose, 1000 mg of paracetamol, it is not indicated for this group of patients.

Elderly patients: should consult their doctor.

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

If the effect of Paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses of 1000 milligrams of paracetamol per dose are required, other presentations of paracetamol that adapt to the required dosage should be used.

If you take more Paracetamol Normon than you should:

Consult your doctor or pharmacist immediately.

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

If you have taken an overdose, go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning. Treatment of the overdose is more effective if started within 4 hours of taking the medicine.

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

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

If you forget to take Paracetamol Normon

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 everyone gets them.

Rare side effects that may occur (between 1 and 10 in 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (in less than 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

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

Paracetamol can damage the liver when taken in high doses or for prolonged periods.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's pharmacovigilance 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 Normon

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Paracetamol Normon:

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

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

Appearance of the product and package contents:

Paracetamol Normon is presented in oral tablets.

The tablets are oblong, biconvex, white, with a score line on one face and marked with PC on the other face.

In packages of 20 and 40 tablets and a clinical package of 500 tablets, packaged 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 last revision of this 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/

You can access detailed and updated information on this medicine by scanning the QR code included in the 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/84218/P_84218.html