PARACETAMOL NORMON 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Normon 500 mg Tablets EFG

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

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if the fever worsens or does not improve after 3 days and the pain after 5 days.

Contents of the Package 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. Contents of the pack and further information

1. What is Paracetamol Normon 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 occasional pain of mild or moderate intensity, such as muscle or back pain, headache, toothache, or menstrual pain. Febrile states.

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,
• if you suffer from any liver disease.
  • Warnings and precautions

-Do not take more medicine than recommended in section 3. How to take Paracetamol Normon.

-The simultaneous use of this medicine with other medicines that contain paracetamol, such as flu and cold medicines, should be avoided, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.

During treatment with Paracetamol Normon, inform your doctor immediately if:

• you have anemia (decrease in hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), heart or lung conditions, or kidney dysfunction, avoiding prolonged treatments;
• you have severe kidney disorder, the interval between two doses will be at least 8 hours;
• you habitually consume alcohol, as it may cause liver damage. If you are a chronic alcoholic, do not take more than 2 g/day of paracetamol;
• you are asthmatic and sensitive to acetylsalicylic acid.
• 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 serious disease called metabolic acidosis (an anomaly in 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 of discomfort (nausea) and vomiting.

Interference with analytical tests

If you are going to undergo any analytical test (including blood tests, 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.

• Use of Paracetamol Normon with other medicines:

Tell your doctor or pharmacist if you are using or have recently used other medicines, including oral contraceptives, herbal medicines, and those purchased without a prescription.

Paracetamol interacts with: oral anticoagulants (e.g., acenocoumarol, warfarin); ethyl alcohol; anticonvulsants (e.g., phenytoin, phenobarbital, methylphenobarbital, primidone); chloramphenicol; estrogens; loop diuretics; isoniazid; lamotrigine; probenecid; propranolol; rifampicin; anticholinergics (e.g., glycopyrrolate, propanteline); ion exchange resins (cholestyramine); zidovudine.

Tell 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).

• Pregnancy, breastfeeding, and fertility

Pregnancy:Consult your doctor or pharmacist before using any medicine.

If necessary, Paracetamol Normon can be used during pregnancy. You should use the lowest possible dose that reduces 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.

Breastfeeding:Consult your doctor or pharmacist before using any medicine. Paracetamol passes into breast milk, so breastfeeding women should consult their doctor before using this medicine.

• Driving and using machines

There is no evidence of effects on the ability to drive vehicles or use machinery.

3. How to take Paracetamol Normon

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Paracetamol Normon should be taken orally. The tablet can be divided into equal doses. The tablets can be taken directly or broken in half with the help of a glass of water.

The recommended dose is:

Adults:Dose of half a tablet to 1 tablet (250-500 mg) every 4-6 hours. Do not exceed 3 g in 24 hours.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

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, you should discontinue treatment and consult your doctor.

Children: A dosage schedule of 10 mg/kg body weight per dose, with a minimum interval of 4 hours, or 15 mg/kg body weight per dose, every 6 hours, can be established. The approximate ages are given for guidance.

The following doses can be repeated with a minimum interval of 4 hours, without exceeding a total of 5 doses in 24 hours.

Children from 6 to 10 years: half a tablet (250 mg) every 4-6 hours; maximum 1 to 3 tablets (1250 mg-1500 mg), depending on the child's weight, every 24 hours.

Children from 11 years: half a tablet (250 mg) every 4-6 hours; maximum 4 tablets (2000 mg) every 24 hours.

Adolescents from 12 years: 1 tablet (500 mg) every 4-6 hours; maximum 5 tablets (2500 mg) every 24 hours.

• If you take more Paracetamol Normon than you should

The symptoms that appear are vomiting, dizziness, loss of appetite, jaundice (evidenced by yellowing of the skin and mucous membranes), abdominal pain, kidney and liver failure. If an overdose has been ingested, the patient should be treated promptly in a medical center, even if there are no symptoms or significant signs, as they can cause death, but often do not manifest immediately after ingestion, but from the third day onwards. Liver necrosis can occur. Acute kidney failure can also occur.

Consult your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount used.

Information for the doctor:In all cases, gastric aspiration and lavage will be performed, preferably within 4 hours after ingestion. There is a specific antidote for paracetamol toxicity: N-acetylcysteine.

• If you forget to take Paracetamol Normon

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time for the next dose is near, skip the forgotten dose and take the next dose at the usual time.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Paracetamol Normon can have side effects, although not everyone gets them.

The side effects observed are classified according to their frequency of presentation in: Very common (May affect more than 1 in 10 patients); common (May affect up to 1 in 10 patients); uncommon (May affect up to 1 in 100 patients); rare (May affect up to 1 in 1,000 patients); very rare (May affect up to 1 in 10,000 patients).

The side effects are generally rare or very rare.

General disorders and administration site conditions. Rare:Discomfort. Very rare:Allergic reactions ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction). Gastrointestinal disorders:Rare:Increased levels of liver transaminases (liver enzymes). Very rare:Hepatotoxicity (jaundice). Metabolism and nutrition disorders:Very rare:Decreased blood glucose. Blood and lymphatic system disorders:Very rare:Decreased blood cells. Vascular disorders:Rare:Hypotension (decreased blood pressure). Renal and urinary disorders:Very rare:Sterile pyuria (cloudy urine), kidney side effects.

Very rare cases of severe skin reactions have been reported.

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

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

5. Storage of Paracetamol Normon

Keep out of the reach and sight of children.

No special storage conditions are required. Store in the original package.

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

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Normon 500 mg

The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.

The other ingredients are: Povidone, pregelatinized corn starch, and stearic acid.

Appearance of the product and contents of the pack

Paracetamol Normon 500 mg are tablets. The tablets are white or almost white, round, flat, scored, and divisible. They are presented in packages of 20 tablets in PVC/Aluminum blisters.

Marketing authorization holder and manufacturer:

Laboratorios Normon, S.A.

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

Other presentations

Paracetamol Normon 650 mg tablets EFG in packages of 20 and 40 tablets.

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/

You can access detailed and updated information about this medicine by scanning the QR code included in the package 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/68330/P_68330.html