Paracetamol Normon 10 mg/ml solution for infusion EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Paracetamol Normon is and what it is used for
- 2. What you need to know before using Paracetamol Normon
- 3. How to use Paracetamol Normon
- 4. Possible adverse effects
- 5. Storage of Paracetamol Normon
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Paracetamol Normon 10 mg/ml solution for infusion EFG
Read the entire leaflet carefully before you start using this medicine.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Paracetamol Normon is and what it is used for
- What you need to know before using Paracetamol Normon
- How to use Paracetamol Normon
- Possible side effects
- How to store Paracetamol Normon
- Contents of the pack and other information
1. What Paracetamol Normon is and what it is used for
This product belongs to a group of medicines called "analgesics" and "antipyretics", which work by relieving pain and reducing fever.
Paracetamol Normon is indicated for short-term treatment of moderate pain, particularly 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 routes of administration are not possible.
2. What you need to know before using Paracetamol Normon
Do not use Paracetamol Normon:
- If you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to propacetamol (another analgesic for infusion and a precursor of paracetamol).
- If you have 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 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 when this route of administration becomes feasible.
During treatment with Paracetamol Normon, inform your doctor immediately 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 called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
Other medicines and Paracetamol Normon:
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
This medicine contains paracetamol, which should be taken into account if you are using other medicines containing paracetamol or propacetamol, so as not to exceed the recommended daily dose (see section 3. How to use). Inform your doctor if you are taking other medicines containing paracetamol or propacetamol.
When used concomitantly with probenecid (a medicine used to treat gout), a dose reduction should be considered.
Inform your doctor or pharmacist if you are taking oral anticoagulants. More frequent monitoring of the anticoagulant effect may be necessary.
Inform your doctor or pharmacist if you are taking:
- flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).
Pregnancy and breastfeeding:
Consult your doctor or pharmacist before using any medicine.
Paracetamol may be used during pregnancy if necessary. Use the lowest possible dose that relieves 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.
Paracetamol Normon may be used during breastfeeding.
Paracetamol Normon contains sodium:
This medicine contains 241 mg of sodium (the main component of table/cooking salt) in each 100 ml. This corresponds to 12.05% of the maximum daily sodium intake recommended for an adult.
3. How to use Paracetamol Normon
Paracetamol Normon is a solution administered intravenously as an infusion over a period of time that must never be less than 15 minutes.
The 100 ml bag is restricted to adults, adolescents, and children weighing more than 33 kg.
Careful monitoring is required before completing the infusion.
Dosage:
Dose according to patient's body weight (see dosing table below):
Body weight | Dose per administration | Volume per administration | Maximum volume of Paracetamol Normon (10 mg/ml) per administration according to upper weight limits of the group (ml)** | Maximum daily dose* |
>33 kg to ≤50 kg | 15 mg/kg | 1.5 ml/kg | 75 ml | 60 mg/kg, not exceeding 3 g |
>50 kg with additional risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 3 g |
>50 kg without additional risk factors for hepatotoxicity | 1 g | 100 ml | 100 ml | 4 g |
- Maximum daily dose: the maximum daily dose described in the table above is for patients who are not taking other medications containing paracetamol and must be adjusted accordingly considering these medications.
** Patients with lower body weight will require smaller volumes.
The minimum interval between doses must be at least 4 hours.
The minimum interval between doses in patients with severe renal impairment must be at least 6 hours.
No more than 4 doses should be administered within 24 hours.
Administration method:
RISK OF MEDICATION ERRORS Take care to avoid dosing errors due to confusion between milligrams (mg) and milliliters (mL), which may result in accidental overdose and death. |
Paracetamol solution is administered as an intravenous infusion over a period of time that must never be less than 15 minutes.
If you think that the effect 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20.
Doses higher than recommended may cause severe liver damage.
The most frequent symptoms in case of overdose are: nausea, vomiting, anorexia (loss of appetite), pallor, abdominal pain, and signs indicating risk of liver abnormalities.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Paracetamol Normon may cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported:
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Rare (more than 1 in 10,000, less than 1 in 1,000 patients):
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Malaise.
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Reduction in blood pressure.
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Changes in liver enzyme levels (transaminases).
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Very rare (less than 1 in 10,000 patients, including isolated cases):
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Various allergic reactions (ranging from simple skin rash or itching to generalized allergic reaction). If this occurs, stop treatment immediately and inform your doctor.
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Very rare cases of serious skin reactions have been reported.
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Local reactions at the site of administration: pain, phlebitis, erythema.
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Decrease in platelet levels in blood, possibly causing bleeding such as nosebleeds or gum bleeding. If this occurs, consult your doctor.
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Cases of skin redness, flushing, pruritus, and abnormally rapid heart rate.
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Frequency not known (cannot be estimated from available data):
-
A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Paracetamol Normon
Keep out of sight and reach of children.
Do not store above 25 ºC.
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 refers to the last day of the month indicated.
Do not use this medicine if you notice any particles or if the solution is not colourless or slightly coloured.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. 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 substance 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 injections.
Appearance of the product and contents of the pack
Paracetamol Normon 10 mg/ml is a clear, colourless or slightly coloured solution for infusion.
Paracetamol Normon 10 mg/ml solution for infusion is supplied in 100 ml bags. The packs contain 1, 12 or 50 bags (EC).
Marketing Authorisation Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid (SPAIN)
OTHER PACK SIZES
Paracetamol Normon 500 mg Tablets EFG.
Paracetamol Normon 650 mg Tablets EFG.
Date of latest review of this leaflet: February 2025
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71530/P_71530.html