Leaflet: information for the user

Paracetamol Normon 10 mg/ml infusion solution EFG

Read this leaflet carefully before you start using the medicine.

• 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 for you and should not be given to others even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What it isParacetamol Normonand what it is used for

2. What you need to know before you start usingParacetamol Normon

3. How to useParacetamol Normon

4. Possible side effects

5. Storage ofParacetamol Normon

6. Contents of the pack and additional information

This product belongs to the group of medicines called “analgesics” and “antipyretics”, which acts by relieving pain and reducing fever.

Paracetamol Normonis indicated for the short-term treatment of moderate pain, especially after surgery, and for the short-term treatment of fever, when intravenous administration is justified by an urgent need to treat pain or fever, and/or when other administration routes are not possible.

Do not use Paracetamol Normon:

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

Warnings and precautions:

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

• If you have any liver disease.

• If you have a severe kidney disease.

• If you have chronic alcoholism.
• If you are chronically malnourished.
• If you are dehydrated.

Inform your doctor if any of the above conditions apply to you before treatment.

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

During treatment with Paracetamol Normon, inform your doctor immediately 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other medications and Paracetamol Normon:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

This medication contains paracetamol, and this should be taken into account if other medications 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 medications containing paracetamol or propacetamol.

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

Inform your doctor or pharmacist if you are taking oral anticoagulants. It may be necessary to perform anticoagulant effect controls more frequently.

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 must receive urgent treatment (see section 2).

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

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.

Paracetamol Normon can be used during breastfeeding.

Paracetamol Normon contains sodium::

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

Paracetamol Normonis a solution that is administered intravenously, as a perfusion for a time that should never be less than 15 minutes.

The 100 ml bag is restricted to adults, adolescents, and children who weigh more than33 kg.

Careful supervision is necessary before completing the perfusion.

Dosage:

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

*Maximum daily dose:The maximum daily dose described in the table above is for patients not taking other medications with paracetamol and should be adjusted accordingly taking these medications into account.

**Patients with lower weights will require smaller volumes.

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

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

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

Administration form:

The paracetamol solution is administered as an intravenous perfusion for a time that should never be less than 15 minutes.

If you estimate that the action ofParacetamol Normonis too strong or too weak, inform 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 Toxicological Information Service, phone: 91 562 04 20 immediately.

Doses greater than those recommended can 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 function alterations.

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

Like all medications,Paracetamol Normonmay cause adverse effects, although not all people will experience them.

The following adverse effects have been reported:

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

• Very rare(less than 1 in 10,000 patients, including isolated cases)
• Different allergic reactions (from simple skin rash or itching to generalized allergic reaction). If this occurs, discontinue treatment immediately and notify your doctor.
• Severe skin reactions have been reported very rarely
• Local reactions at the site of administration: pain, phlebitis, erythema.
• Decreased platelet levels in the blood, causing possible bleeding, such as nasal or gum bleeding. If this occurs, consult your doctor.
• Cases of skin redness, flushing, itching, and abnormally fast heart rate.
• Unknown frequency (cannot be estimated from available data):
• Aserious diseasethat can make the blood more acidic (known as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor,pharmacistor nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not store at a temperature above25 °C.

Store in the original packaging to protect it from light.

Do not refrigerate or freeze.

Do not useParacetamol Normonafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe any particles or if the solution is not colorless or slightly colored.

Medicines should not be thrown down the drains or in the trash.Deposit the containers and the

medicines that you do not need at the SIGREpoint of the pharmacy.Ask your pharmacist how to dispose of the containers and the medicines that you do not need. In this way, you will help protect the environment.

Composition of Paracetamol Normon 10 mg/ml infusion solution

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

Appearance of the product and content of the packaging

Paracetamol Normon 10 mg/mlis a transparent, colorless, or slightly colored infusion solution.

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

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 Normon500 mg EFG tablets.

Paracetamol Normon650 mg EFG tablets.

Date of the last review 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 smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/71530/P_71530.html