Paracetamol B. Braun

Package Leaflet: Information for the User

Paracetamol B. Braun, 10 mg/ml, Solution for Infusion

Paracetamol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Paracetamol B. Braun and what is it used for
• 2. Important information before using Paracetamol B. Braun
• 3. How to use Paracetamol B. Braun
• 4. Possible side effects
• 5. How to store Paracetamol B. Braun
• 6. Contents of the package and other information

1. What is Paracetamol B. Braun and what is it used for

This is a pain-relieving (analgesic) and antipyretic (fever-reducing) medicine.
It is used for

• short-term treatment of moderate pain, especially in the post-operative period,
• short-term treatment of fever.

2. Important information before using Paracetamol B. Braun

When not to use Paracetamol B. Braun

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has been diagnosed with hypersensitivity (allergy) to propacetamol (another pain-relieving medicine converted to paracetamol in the body),
• if the patient has severe liver disease.

Warnings and precautions

Before starting to take Paracetamol B. Braun, discuss it with your doctor.
When to be particularly careful when using Paracetamol B. Braun

• if the patient has liver disease or severe kidney disease, or if the patient chronically abuses alcohol,
• if the patient is taking other medicines containing paracetamol. In this case, the doctor will adjust the dose of the medicine,
• in cases of nutritional disorders (malnutrition) or dehydration,
• if the patient has a genetically determined deficiency of glucose-6-phosphate dehydrogenase (G6PD) (favism).

Tell your doctor before starting treatment if any of the above cases apply to the patient.
During the use of Paracetamol B. Braun, immediately inform your doctor if the patient experiences severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
Severe metabolic acidosis (a blood and fluid disorder) has been reported in patients who have taken paracetamol regularly for a long time or have taken paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Long-term or frequent use of paracetamol is not recommended. It is recommended that this medicine be used only until the patient can take oral pain-relieving medicines again.
The doctor will ensure that the patient does not receive a higher dose than recommended. This can lead to severe and irreversible liver damage.

Paracetamol B. Braun and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.
This is especially important if the patient is taking:

• probenecid(a medicine used to treat gout): it may be necessary to reduce the dose of paracetamol;
• pain-relieving medicines containing salicylamide: it may be necessary to adjust the dose;
• liver enzyme-activating medicines: it is necessary to closely monitor the dose of paracetamol to avoid liver damage;
• any blood-thinning medicines(anticoagulants): it may be necessary to monitor their effect more closely.
• flucloxacillin (an antibiotic) due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires urgent treatment (see section 2).

The medicine contains paracetamol, and this should be taken into account if the patient is taking other medicines containing paracetamol or propacetamolto avoid overdose (see section 3).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.

• Pregnancy Paracetamol B. Braun can be given to pregnant women if necessary. The lowest effective dose should be used for the shortest possible time. If the pain is not relieved or the fever does not subside, or if it is necessary to increase the frequency of taking the medicine, consult a doctor.
• Breastfeeding Paracetamol B. Braun can be used during breastfeeding.

Paracetamol B. Braun contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per package, which means the medicine is considered "sodium-free".

3. How to use Paracetamol B. Braun

Recommended dose:

The doctor will determine the dose and bottle size suitable for the patient based solely on their body weight.

Method of administration

This medicine is administered by a doctor through intravenous infusion (intravenous administration). It takes about 15 minutes.
It is necessary to carefully and constantly monitor the patient during the infusion, especially at the end of it.
If you feel that the effect of Paracetamol B. Braun solution for infusion is too strong or too weak, tell your doctor.

Using a higher dose of Paracetamol B. Braun than recommended

Overdose is unlikely because the medicine is administered to the patient by a medical staff member.
The doctor will ensure that the patient does not receive a higher dose than recommended.
In case of overdose, symptoms usually occur within the first 24 hours and include: nausea, vomiting, loss of appetite, paleness of the skin, abdominal pain. These symptoms may indicate liver damage.
If the patient thinks they may have overdosed on the medicine, they should immediately tell their doctor. In case of overdose, it is necessary to seek immediate medical attention, even if the patient feels well, due to the risk of severe and irreversible liver damage. If necessary, the patient will receive an antidote.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may be serious. If you experience any of them, stop taking Paracetamol B. Braun and consult your doctor immediately:

Very rare (may affect up to 1 in 10,000 people)

• allergic reactions of varying severity, from skin reactions like hives to anaphylactic shock
• severe skin reactions
• abnormal low number of certain types of blood cells (platelets, white blood cells)

Other side effects include:

Rare (may affect up to 1 in 1,000 people)

• changes in laboratory test results: abnormal liver enzyme activity detected in blood tests
• decreased blood pressure
• malaise

Unknown (frequency cannot be estimated from available data)

• skin redness, hot flashes, or itching
• abnormal rapid heartbeat
• a serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

During clinical trials, frequent side effects at the injection site (pain and burning sensation) were reported.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Paracetamol B. Braun

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

6. Contents of the package and other information

What Paracetamol B. Braun contains:

The active substance of the medicine is paracetamol.
One ml contains 10 mg of paracetamol.
Each 10 ml ampoule contains 100 mg of paracetamol.
Each 50 ml bottle contains 500 mg of paracetamol.
Each 100 ml bottle contains 1000 mg of paracetamol.
Other ingredients are:
Mannitol, sodium citrate dihydrate, glacial acetic acid (for pH adjustment), water for injections.

What Paracetamol B. Braun looks like and contents of the package

Paracetamol B. Braun solution for infusion is a clear, colorless or slightly pinkish-orange solution. The perception of color may vary.
Paracetamol B. Braun is supplied in 50 ml and 100 ml polyethylene bottles or 10 ml polyethylene ampoules.
Package sizes: 20 x 10 ml, 10 x 50 ml, 10 x 100 ml
Not all package sizes may be marketed.

Marketing authorization holder

• B. Braun Melsungen AG Address: Carl-Braun-Straße 1 Mailing address: 34212 Melsungen, Germany 34209 Melsungen, Germany

Phone: +49/5661/71-0
Fax: +49/5661/71-4567

Manufacturer

• B. Braun Medical SA Carretera de Terrassa 121 08191 Rubí (Barcelona), Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Bulgaria, Czech Republic, Denmark, Estonia, Finland,
France, Hungary, Italy, Latvia, Luxembourg,
Portugal, Slovakia, Spain, Sweden, Netherlands
Paracetamol B. Braun 10 mg/ml
Belgium
Paracetamol B. Braun 10 mg/ml solution for infusion, oplossing voor infusie, Infusionslösung
Austria, Germany
Paracetamol B.Braun 10 mg/ml Infusionslösung
Lithuania
Paracetamol B. Braun 10 mg/ml infuzinis tirpalas
Romania
Paracetamol B. Braun 10 mg/ml solutie perfuzabila
Slovenia
Paracetamol B. Braun 10 mg/ml raztopina za infundiranje
Ireland, United Kingdom (Northern Ireland), Malta Paracetamol 10 mg/ml solution for infusion
Norway, Poland
Paracetamol B. Braun

Date of last revision of the package leaflet: 2025-04-18

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov
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Information intended for healthcare professionals only:

Dosing

• 100 ml polyethylene bottleis intended for use only in adults, adolescents, and children with a body weight over 33 kg.
• 50 ml polyethylene bottleis intended for use only in small children and children with a body weight from over 10 kg to 33 kg.
• 10 ml polyethylene ampouleis intended for use only in premature infants, newborns, and small children with a body weight up to 10 kg.

The administered volume of the medicine must not be greater than the specified dose. In such cases, the medicine must be diluted to the desired volume with an appropriate infusion solution (see below "Method of administration and dilution") or administered using a syringe pump.
RISK OF DOSING ERRORS
Caution should be exercised to avoid dosing errors due to confusion between milligrams (mg) and milliliters (ml). These errors can lead to unintentional overdose and patient death (see section 4.2).
Dosing is based on the patient's body weight (see the dosing table below):

*Premature infants:
Data on the safety and efficacy of use in premature infants are not available.
**Maximum daily dose:
The maximum daily dose given in the above table applies to patients who are not taking other medicinal products containing paracetamol. It should be reduced accordingly, taking into account the use of these products.
***Patients with lower body weight should be given correspondingly smaller volumes.
The minimum interval between consecutive doses must be at least 4 hours.
The minimum interval between consecutive doses in patients with severe renal impairment must be at least 6 hours.
No more than 4 doses should be given in 24 hours.
Severe renal impairment:
When administering paracetamol to patients with severe renal impairment (creatinine clearance ≤ 30 ml/min), it is recommended to reduce the dose and increase the minimum interval between each administration to 6 hours.
Adults with liver impairment, chronic alcoholism, chronic malnutrition (low glutathione reserves in the liver), dehydration:
The maximum daily dose must not exceed 3 g (see "Warnings and precautions").
Method of administration and dilution
Paracetamol B. Braun can also be diluted in a 9 mg/ml (0.9%) sodium chloride infusion solution or a 50 mg/ml (5%) glucose infusion solution, or a mixture of these solutions, in a ratio of up to 1:10 (one volume of Paracetamol B. Braun in nine volumes of diluent).
For single use only. The medicine should be used immediately after opening the package. All unused portions of the solution should be discarded.
As with all infusion solutions administered in containers with an internal air space, it is necessary to carefully monitor, especially at the end of the infusion, regardless of the route of administration. Monitoring at the end of the infusion is particularly important for central venous infusions, to avoid air embolism.
Shelf life after first opening the package
Infusion should start immediately after connecting the container to the infusion set.
Shelf life after dilution
Chemical and physical stability after opening (including infusion time) has been demonstrated for 48 hours at 23°C.
From a microbiological point of view, the product should be used immediately. If it is not used immediately after opening, the responsibility for the storage time and conditions lies with the user.
Before administration, the medicine should be visually inspected for any visible particles or discoloration. The product should only be used if the solution is clear, colorless, or slightly pinkish-orange, and the container and its closure are undamaged.