PARACETAMOL NORMON 10 mg/ml SOLUTION FOR INFUSION

2. What you need to know before you use Paracetamol Normon

Do not use Paracetamol Normon:

• If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to propacetamol (another analgesic for infusion and paracetamol precursor).
• If you have severe liver disease.

Warnings and precautions:

Talk to your doctor or pharmacist before starting to take Paracetamol Normon:

• If you have any liver disease.

• If you have severe kidney disease.

• If you have chronic alcoholism.
• If you are in a state of chronic malnutrition.
• If you are dehydrated.

Before treatment, inform your doctor if any of the above conditions apply to you.

Use an appropriate oral analgesic treatment as soon as possible via this route of administration.

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

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 suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious 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 breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Other medicines and Paracetamol Normon:

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

This medicine contains paracetamol, and this should be taken into account if other medicines containing paracetamol or propacetamol are used, to avoid exceeding the recommended daily dose (see section 3. How to use). Inform your doctor if you are taking other medicines that contain paracetamol or propacetamol.

In simultaneous treatment with probenecid (a medicine for the treatment of gout), a reduction in the dose should be considered.

Tell your doctor or pharmacist if you are taking oral anticoagulants. It may be necessary to perform more frequent checks on the anticoagulant effect.

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 and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

If necessary, paracetamol 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.

Paracetamol Normon can be used during breastfeeding.

Paracetamol Normon contains sodium:

This medicine contains 241 mg of sodium (main component of table/cooking salt) in each 100 ml. This is equivalent to 12.05% of the maximum recommended daily sodium intake for an adult.

3. How to use Paracetamol Normon

Paracetamol Normon is a solution that is administered intravenously, as an infusion over a period that should never be less than 15 minutes.

The 100 ml bag is restricted to adults, adolescents, and children who weigh more than 33 kg.

Careful supervision is necessary before finishing the infusion.

Dosage:

Dose according to patient weight (see posology table below):

• Maximum daily dose: the maximum daily dose described in the table above is for patients who are not taking other medicines with paracetamol and should be adjusted accordingly taking into account these medicines.

The patients with lower weight will require smaller volumes.

The minimum interval between administrations must be at least 4 hours.

The minimum interval between administrations in patients with severe renal failure must be at least 6 hours.

No more than 4 doses should be administered in 24 hours.

Method of administration:

The paracetamol solution is administered as an intravenous infusion over a period that should never be less than 15 minutes.

If you think that the action of Paracetamol Normon is too strong or too weak, tell your doctor or pharmacist.

If you use more Paracetamol Normon than you should:

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20.

Doses higher than recommended may cause very serious liver damage.

The most frequent symptoms in case of overdose are: nausea, vomiting, anorexia (loss of appetite), pallor, abdominal pain, and signs of risk of liver damage.

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

4. Possible side effects

Like all medicines, Paracetamol Normon can cause side effects, although not everybody gets them.

The following side effects have been reported:

• Rare (more than 1 in 10,000, less than 1 in 1,000 patients)
• Discomfort
• Reduction in blood pressure
• Alterations in liver enzyme levels (transaminases)

• Very rare (less than 1 in 10,000 patients, including isolated cases)
• Various allergic reactions (from simple skin rash or itching to generalized allergic reaction). If this occurs, stop treatment immediately and notify your doctor.
• Very rare cases of severe skin reactions have been reported
• Local reactions at the injection site: pain, phlebitis, erythema
• Decrease in blood platelet levels, causing possible bleeding, such as nosebleeds or gum bleeding. If this occurs, consult your doctor.
• Cases of skin redness, flushing, itching, and abnormally fast heart rate.
• 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).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 out of the sight and reach of children.

Do not store above 25°C.

Store in the original packaging to protect from light.

Do not refrigerate or freeze.

Do not use Paracetamol Normon after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice any particles or if the solution is not colorless or slightly colored.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Normon 10 mg/ml solution for infusion

• The active ingredient is paracetamol. One ml contains 10 mg of paracetamol.
• The other ingredients are sodium chloride, sodium acetate, sodium edetate, hydrochloric acid or sodium hydroxide, and water for injectable preparations.

Appearance of the product and packaging contents

Paracetamol Normon 10 mg/ml is a clear, colorless or slightly colored solution for infusion.

Paracetamol Normon 10 mg/ml solution for infusion is presented in 100 ml bags. The packaging contains 1, 12, or 50 bags (EC).

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.

Paracetamol Normon 650 mg Tablets EFG.

Date of the last revision of this leaflet:February 2025

You can access detailed and updated information about 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/71530/P_71530.html