Leaflet: Information for the User

Paracetamol Normon 500 mg Tablets EFG

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

- Keep this leaflet, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

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

- You should consult a doctor if the fever worsens or does not improve after 3 days and the pain does not improve after 5 days.

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

2. What you need to know before starting to take Paracetamol Normon

3. How to take Paracetamol Normon

4. Possible side effects

5. Storage of Paracetamol Normon

6. Contents of the pack and additional information

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

This medicine is used for the symptomatic treatment of occasional mild to moderate pain, such as muscle pain or back pain, headache, toothache, or menstrual pain. Feverish states.

• Do not take Paracetamol Normon:

- if you are allergic (hypersensitive) to paracetamol or to any of the other components of this medication,

- if you suffer from any liver disease.

• Warnings and precautions

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

- Avoid simultaneous use of this medication with other medications that contain paracetamol, for example, medications for the flu and cold, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

Inform your doctor immediately during treatment with Paracetamol Normon if:

- you suffer from anemia (decrease in hemoglobin levels in the blood, due or not to a decrease in red blood cells), heart or lung conditions, or kidney dysfunction, avoiding prolonged treatments;

- you suffer from severe kidney disease, 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 an asthmatic sensitive to acetylsalicylic acid.

- If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interference with analytical tests

If you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results of these tests.

• Use of Paracetamol Normon with other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including oral contraceptives, herbal remedies, and those acquired without a prescription.

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

Inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a severe 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 medication

In case of need, 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 pain or fever do not decrease or if you need to take the medication more frequently.

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

• Driving and operating machinery

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

The recommended dose is:

Adults:Half 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 for prolonged periods of time as this increases the risk of adverse effects such as liver damage.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, discontinue treatment and consult your doctor.

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

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

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

Children 11 years: half 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 yellow skin and mucous membranes), abdominal pain, renal and hepatic insufficiency. If an overdose has been ingested, the patient should be treated quickly in a medical center, even if there are no significant symptoms or signs, as these can cause death, although they often do not appear immediately after ingestion, but rather from the third day. Liver necrosis can cause death, and acute renal failure can also occur.

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

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

• If you forget to take Paracetamol Normon

Do not take a double dose to compensate for the missed doses.

If you forget to take your dose, take it as soon as you remember. However, if the next dose is due soon, skip the missed dose and take the next dose at its usual time.

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

Like all medications, Paracetamol Normon may have adverse effects, although not all people may experience them.

The observed adverse effects are classified according to their frequency of presentation as: Very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 10 patients); infrequent (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).

Adverse 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 severe type of 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:Purulent urine, renal adverse effects.

Very rarely, severe skin reactions have been reported.

Unknown frequency (cannot be estimated from available data): A severe disease that may cause blood to become more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of reach and sight of children.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Paracetamol Normon 500 mg

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

The other components are: Povidone, pregelatinized cornstarch and stearic acid.

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Normon, S.A.

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

Other presentations

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

Date of the last review of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/68330/P_68330.html