PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol B. Braun 10 mg/ml solution for infusion

Paracetamol
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
➢ Keep this leaflet. You may need to read it again.
➢ If you have any questions, ask your doctor or pharmacist.
➢ If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Paracetamol B. Braun is and what it is used for.
What you need to know before using Paracetamol B. Braun.
How to use Paracetamol B. Braun.
Possible side effects.
How to store Paracetamol B. Braun.
Contents of the pack and other information.

1. WHAT PARACETAMOL B. BRAUN IS AND WHAT IT IS USED FOR

This medicinal product is an analgesic (relieves pain) and antipyretic (reduces fever).
It is used for
➢ short-term treatment of moderate pain, particularly after surgery.
➢ short-term treatment of fever.

2. WHAT YOU NEED TO KNOW BEFORE USING PARACETAMOL B. BRAUN

Do not use Paracetamol B. Braun
➢ if you are allergic to paracetamol or to any of the other ingredients of this medicine
(listed in section 6);
➢ if you are allergic (hypersensitive) to propacetamol (another analgesic which is converted into paracetamol in the body);
➢ if you have severe liver disease.

Warnings and precautions
Talk to your doctor before receiving Paracetamol B. Braun.
Be especially careful with Paracetamol B. Braun:
➢ if you have liver disease, severe kidney disease, or chronic alcohol abuse;
➢ if you are taking other medicines containing paracetamol. In this case, your doctor will adjust the dose;
➢ if you have nutritional disorders (undernourishment, malnutrition) or dehydration;
➢ if you have a genetic disorder of the enzyme glucose-6-phosphate dehydrogenase (favism).

Inform your doctor before treatment if any of the above conditions apply to you.
During treatment with Paracetamol B. Braun, inform your doctor immediately if you develop serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.

Prolonged or frequent use of paracetamol is not recommended. This medicine should be used only until you are able to take oral analgesics again.
Your doctor will ensure that you do not receive doses higher than those recommended. Doses exceeding the recommended amount may cause severe liver damage.

Other medicines and Paracetamol B. Braun
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking:
➢ a medicine called probenecid (used in the treatment of gout): a reduction in the paracetamol dose may be necessary;
➢ analgesics containing salicylamide: the dose may need to be adjusted;
➢ medicines that induce liver enzymes: the paracetamol dose must be carefully monitored to avoid liver damage;
➢ any medicines that thin the blood (anticoagulants): the effects of these medicines may need to be monitored more closely;
➢ flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

This medicine contains paracetamol, which must be taken into account if you are taking other medicines containing paracetamol or propacetamol, to avoid overdose (see section 3).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.

➢ Pregnancy
Paracetamol B. Braun may be used during pregnancy if necessary. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible time. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.

➢ Breastfeeding
Paracetamol B. Braun may be used during breastfeeding.

Paracetamol B. Braun contains sodium
This medicine contains less than 1 mmol of sodium (23 mg), i.e., essentially “sodium-free”.

3. HOW TO USE PARACETAMOL B. BRAUN

Recommended dose:
The dose will be individually adjusted by the physician according to body weight and general condition.
Method of administration
This medicinal product will be administered to you by a doctor through an intravenous infusion (intravenous use). The administration lasts approximately 15 minutes. You will be closely monitored during and, especially, at the end of the infusion.
If you feel that the effect of Paracetamol B. Braun infusion solution is too strong or too weak, consult your doctor.
If you receive more Paracetamol B. Braun than you should
Overdose is unlikely because the medicine will be administered by a healthcare professional.
The doctor will ensure that you do not receive doses higher than those recommended.
In case of overdose, symptoms generally appear within the first 24 hours and include nausea, vomiting, anorexia (loss of appetite), pale skin, and abdominal pain. These symptoms may indicate liver damage.
If you think you have been given too high a dose, inform your doctor immediately. In case of overdose, seek immediate medical advice, even if you feel well, to avoid the risk of severe and irreversible liver damage. If necessary, an antidote may be administered.
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions can be serious. If you experience any of these reactions, stop using
Paracetamol B. Braun and consult a doctor immediately.
Very rare (may affect up to 1 in 10,000 people)
➢ allergic reactions of varying severity, which may range from skin reactions such as urticaria to
anaphylactic shock;
➢ severe skin reactions;
➢ unusually low levels of certain blood cells (platelets, white blood cells) may occur.
Other adverse reactions include:
Rare (may affect up to 1 in 1,000 people)
➢ changes in laboratory test results: unusually high levels of liver enzymes, detected during blood
tests;
➢ drop in blood pressure;
➢ malaise.
Not known (frequency cannot be estimated from the available data)
➢ skin redness, hot flushes, or itching;
➢ unusually fast heartbeat;
➢ severe condition causing blood to become excessively acidic (called metabolic acidosis), in patients
with severe illness receiving paracetamol (see section 2).
In clinical studies, frequent adverse reactions at the injection site (pain and burning sensation) have been reported.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PARACETAMOL B. BRAUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the container in the outer packaging to protect the medicine from light.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Paracetamol B. Braun contains
The active substance is paracetamol.
Each ml contains 10 mg of paracetamol.
Each 10 ml vial contains 100 mg of paracetamol.
Each 50 ml bottle contains 500 mg of paracetamol.
Each 100 ml bottle contains 1000 mg of paracetamol.
The other components are:
Mannitol, sodium citrate dihydrate, glacial acetic acid (to adjust pH), water for injectable preparations.

Description of the appearance of Paracetamol B. Braun solution for infusion and contents of the package
Paracetamol B. Braun solution for infusion is a clear solution ranging from colourless to pale pink-orange. Perception may vary.
Paracetamol B. Braun is supplied in 50 ml or 100 ml plastic bottles or in a 10 ml plastic vial.
Pack sizes: 20x10 ml, 10x50 ml, 10x100 ml
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
B. Braun Melsungen AG
Address:
Carl-Braun-Straße 1
34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Telephone: +49/5661/71-0
Fax: +49/5661/71-4567

Manufacturer
Manufacturer:
B. Braun Medical S. A.
Carretera de Terrassa 121
08191 Rubí (Barcelona), Spain

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria, Germany Paracetamol B. Braun 10 mg/ml
Infusionslösung
Belgium Paracetamol B. Braun 10 mg/ml solution
pour perfusion, oplossing voor infusie,
Infusionslösung
Bulgaria, Czech Republic, Estonia, Finland, France, Paracetamol B. Braun 10 mg/ml
Luxembourg, Portugal, Slovakia, Sweden, Netherlands
Ireland, United Kingdom (Northern Ireland), Malta Paracetamol 10 mg/ml solution for infusion
Latvia Paracetamol B. Braun 10 mg/ml šķīdums
infūzijām
Lithuania Paracetamol B. Braun 10 mg/ml infuzinis
tirpalas
Denmark, Norway, Poland Paracetamol B. Braun
Romania Paracetamol B. Braun 10 mg/ml solutie
perfuzabila
Slovenia Paracetamol B. Braun 10 mg/ml raztopina
za infundiranje
Italy Paracetamolo B. Braun 10 mg/ml soluzione
per infusione
Spain Paracetamol B.Braun 10 mg/ml solución
para perfusión EFG

Further information
More detailed information on this medicinal product is available on the website of AIFA (Italian Medicines Agency):
https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home

The following information is intended exclusively for doctors or healthcare professionals:

Dosage
➢ The 100 ml polyethylene bottle is intended for adults, adolescents and children weighing
more than 33 kg.
➢ The 50 ml polyethylene bottle is intended for children and children weighing more than 10
kg up to 33 kg.
➢ The 10 ml polyethylene vial is intended for full-term neonates, infants and children weighing
up to 10 kg.
The volume to be administered must not exceed the established dose. If necessary, the selected
volume should be diluted in a suitable infusion solution prior to administration (see below “Instructions for administration and dilution”), or a syringe pump should be used.
RISK OF ADMINISTRATION ERRORS
Take care to avoid dosage errors due to confusion between milligrams (mg) and millilitres
(ml), which may lead to accidental overdose and patient death.
Prolonged or frequent use is not recommended; it is advised to switch to appropriate oral therapy as soon as this route of administration becomes feasible.
The dose depends on the patient's body weight (see dosage table below).

10 ml vial
Patient weight	Dose per administration	Volume per administration	Maximum volume of Paracetamol B. Braun (10 mg/ml) per administration based on the upper weight limits of the patient group (ml)***	Maximum daily dose**
≤10 kg*	7.5 mg/kg	0.75 ml/kg	7.5 ml	30 mg/kg
50 ml vial
Patient weight	Dose per administration	Volume per administration	Maximum volume of Paracetamol B. Braun (10 mg/ml) per administration based on the upper weight limits of the patient group (ml)***	Maximum daily dose**
> 10 kg and ≤33 kg	15 mg/kg	1.5 ml/kg	49.5 ml	60 mg/kg not exceeding 2 g
100 ml vial
Patient weight	Dose (per administration)	Volume per administration	Maximum volume of Paracetamol B. Braun (10 mg/ml) per administration based on the upper weight limits of the patient group (ml)***	Maximum daily dose**
> 33 kg and ≤ 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

Severe renal impairment
When administering paracetamol to patients with severe renal dysfunction (creatinine clearance ≤30 ml/min), it is recommended to reduce the dose and extend the minimum interval between administrations to 6 hours.

Adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), or dehydration.
The maximum daily dose must not exceed 3 g (see section "Warnings and precautions").

Method of administration and dilution
Paracetamol B. Braun may be diluted in infusion solutions of sodium chloride 9 mg/ml (0.9%) or in infusion solutions of glucose 50 mg/ml (5%), up to a ratio of one to ten (one volume of Paracetamol B. Braun and nine volumes of diluent).

For single use only. The medicinal product must be used immediately after opening.
Discard any unused solution.

As with all infusion solutions presented in containers with headspace, close monitoring at the end of the infusion is required, regardless of the route of administration. This end-of-infusion monitoring is particularly important in central administration to prevent gas embolism.

Shelf life after first opening
Infusion must begin immediately after connecting the container to the administration set.

Shelf life after dilution
Chemical and physical in-use stability has been demonstrated for 48 hours at 23°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user.

Before administration, the medicinal product should be visually inspected for the presence of particles and discoloration. The medicinal product should be used only if the solution is clear and colourless or pale pink-orange (perception may vary) and if the container and its closure are intact.