Paracetamol Normon 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Normon 650 mg tablets EFG

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if fever worsens or does not improve after 3 days, or if pain persists beyond 5 days.

Leaflet contents:

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.

This medicine is used for the symptomatic treatment of mild to moderate occasional pain, such as muscle or back pain, headache, dental pain, or menstrual pain, as well as for feverish conditions.

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,

• if you have any liver disease.

  • Warnings and precautions

• Do not take more medicine than the recommended dose stated in section 3, How to take Paracetamol Normon.

• The simultaneous use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

During treatment with Paracetamol Normon, inform your doctor immediately:

• if you have anaemia (reduced haemoglobin levels in the blood, with or without a decrease in red blood cells), heart or lung conditions, or kidney dysfunction, and avoid prolonged treatment;

• if you have severe kidney disorder, the interval between doses should be at least 8 hours;

• if you regularly consume alcohol, as this may cause liver damage. If you are a chronic alcoholic, do not take more than 2 g/day of paracetamol;

• if you are an aspirin-sensitive asthmatic.

• 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 known as metabolic acidosis (an abnormality in blood and body 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 together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

• Interference with laboratory tests

If you are due to have any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of such tests.

• Use of Paracetamol Normon with other medicines:

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including oral contraceptives, herbal remedies, and medicines obtained 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. glycopyrronium, propantheline); ion-exchange resins (cholestyramine); zidovudine.

Inform your doctor or pharmacist if you are taking:

-flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).

• Pregnancy, breastfeeding and fertility

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

Paracetamol Normon may be used during pregnancy if necessary. Use the lowest effective dose needed to relieve pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever does not improve, 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, therefore breastfeeding women should consult their doctor before using this medicine.

• Driving and using machines

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

3. How to take Paracetamol Normon

Follow exactly the administration instructions for this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Paracetamol Normon is taken orally. The tablet can be divided into equal doses. Tablets may be swallowed whole or split in half and taken with a glass of water.

The recommended dose is:

Adults: Half a tablet to 1 tablet (325–650 mg) every 4–6 hours. Do not exceed 3 g in 24 hours.

The prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.

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

Children: A dosing regimen of 10 mg/kg per dose, with a minimum interval of 4 hours, or 15 mg/kg per dose every 6 hours, may be used. Approximate age ranges are provided for guidance. The following doses may be repeated with a minimum interval of 4 hours, without exceeding a total of 5 doses in 24 hours.

Children aged 6 to 10 years: half a tablet (325 mg) every 4–6 hours; maximum 2 to 3 tablets (1300–1950 mg), depending on the child's weight, every 24 hours.

Children aged 11 years: half a tablet (325 mg) every 4–6 hours; maximum 3 tablets (1950 mg) every 24 hours.

Adolescents from 12 years of age: 1 tablet (650 mg) every 4–6 hours; maximum 4 tablets (2600 mg) every 24 hours.

• If you take more Paracetamol Normon than you should

Symptoms may include vomiting, dizziness, loss of appetite, jaundice (yellowing of the skin and mucous membranes), abdominal pain, and kidney or liver failure. If an overdose has occurred, the patient must be treated promptly at a medical facility, even if there are no symptoms or significant signs, since although these may be fatal, they often do not appear immediately after ingestion but rather from the third day onwards. Death may occur due to hepatic necrosis. Acute kidney failure may also occur.

Contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20 immediately, indicating the medicine and the amount taken.

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

• If you forget to take Paracetamol Normon

Do not take a double dose to make up for a missed dose.

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

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

4. Possible adverse effects

Like all medicines, Paracetamol Normon may have adverse effects, although not everyone experiences them.

The observed adverse effects are classified according to their frequency of occurrence as follows: Very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people).

The adverse effects are generally rare or very rare.

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

Very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from the available data): A serious illness that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform 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 packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the container and other information

Composition of Paracetamol Normon 650 mg

The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.

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

Appearance of the product and contents of the container

Paracetamol Normon 650 mg are tablets. The tablets are white or almost white, elongated in shape, biconvex, scored and divisible. They are supplied in packs of 20 or 40 tablets, packed 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 500 mg tablets EFG in packs of 20 tablets.

Date of the most recent review of this leaflet: February 2025

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

https://cima.aemps.es/cima/dochtml/p/68331/P_68331.html