Paracetamol B.Braun 10 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol B. Braun 10 mg/ml solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

What this leaflet contains

1. What Paracetamol B. Braun is and what it is used for
2. What you need to know 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 pack and other information

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

This medicine is an analgesic (relieves pain) and an antipyretic (reduces fever).

It is used for

• short-term treatment of moderate pain, especially 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 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 your body);
• if you have severe liver disease.

Warnings and precautions

Consult your doctor before starting treatment with Paracetamol B. Braun.

Take special care with Paracetamol B. Braun

• if you have severe liver or kidney disease, or chronic alcoholism;
• if you are taking other medicines containing paracetamol. In this case, your doctor will adjust the dose;
• in cases of nutritional problems (states of malnutrition or undernutrition) or dehydration;
• if you have a genetic disorder of the enzyme glucose-6-phosphate dehydrogenase (favism).

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

During treatment with Paracetamol B. Braun, inform your doctor immediately if you develop serious illnesses 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 or chronic alcoholism, or if you 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 circumstances 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 in breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Prolonged or frequent use of paracetamol is strongly discouraged. It is recommended that this medicine be used only until you are able to resume oral analgesics.

Your doctor will ensure that you do not receive a dose higher than recommended, as this may cause serious liver damage.

Other medicines and Paracetamol B. Braun

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is especially important if you are taking:

• a medicine called probenecid (used to treat gout): in this case, the dose of paracetamol may need to be reduced;
• analgesics containing salicylamide: in this case, the dose may need to be adjusted;
• medicines that induce liver enzymes: in such cases, the dose of paracetamol must be strictly monitored to prevent liver damage;
• medicines to thin the blood (anticoagulants): more frequent monitoring of the effect of these medicines may be required;
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis), which must be treated urgently (see section 2).

This medicine contains paracetamol, so this 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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

• Pregnancy

Paracetamol B. Braun 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.

• 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) per container; it is essentially “sodium-free”.

3. How to use paracetamol B. Braun

Recommended dose:

Your doctor will adjust the dose individually for you based on your body weight and clinical condition.

Method of administration

Your doctor will administer this medicine through an intravenous infusion (into a vein). This process takes about 15 minutes. You will be under close monitoring during the infusion and especially towards its end.

If you feel that the effect of Paracetamol B. Braun infusion solution is too strong or too weak, inform your doctor.

If you receive more Paracetamol B. Braun than you should

It is unlikely that this will happen, as the medicine will be administered by healthcare professionals.

Your doctor will ensure that you do not receive more than the recommended dose.

However, if you are given more medicine than required, symptoms usually appear within the first 24 hours and may include: feeling unwell, nausea, anorexia (loss of appetite), pallor, and abdominal pain. These symptoms could indicate liver damage.

If you think you may have received an excessive dose, inform your doctor immediately. In the event of an overdose, you must consult a doctor immediately, even if you feel well, to prevent the risk of severe and irreversible liver damage. If necessary, an antidote will be administered.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects can be serious. If any of these occur, stop treatment with Paracetamol B. Braun and inform your doctor immediately.

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

• allergic reactions of varying severity, ranging from skin rash such as urticaria to anaphylactic shock;
• severe skin reactions;
• abnormal decrease in levels of certain types of blood cells (platelets, white blood cells) may occur.

Other possible adverse effects:

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

• changes in laboratory test results: abnormally high levels of liver enzymes in blood tests;
• low blood pressure;
• general malaise or weakness.

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

• very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from available data)

• skin redness, flushing, or pruritus;
• increased heart rate;
• a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in critically ill patients receiving paracetamol (see section 2).

During clinical studies, injection site reactions (such as pain or burning sensation) have been frequently observed.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may 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 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 container after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep the container in the outer packaging to protect from light.

6. Contents of the package and other information

Composition of Paracetamol B. Braun:

The active substance is paracetamol.

One ml contains 10 mg of paracetamol.

Each 10 ml ampoule contains 100 mg of paracetamol.

Each 50 ml vial contains 500 mg of paracetamol.

Each 100 ml vial contains 1000 mg of paracetamol.

The other components are:

Mannitol, sodium citrate dihydrate, glacial acetic acid (for pH adjustment), water for injections.

Appearance of the product and contents of the container

Paracetamol B. Braun solution for infusion is a clear solution ranging from colourless to slightly pink-orange. Appearance may vary.

Paracetamol B. Braun is supplied in 50 ml and 100 ml plastic vials or 10 ml plastic ampoules.

Pack sizes: 20 × 10 ml, 10 × 50 ml, 10 × 100 ml

Only some pack sizes may be marketed.

Marketing Authorization Holder

• Braun Melsungen AG,

Address:

Carl-Braun-Straße 1, Postal address:

34212 Melsungen, Germany 34209 Melsungen, Germany

Telephone: +49/5661/71-0

Fax: +49/5661/71-4567

Manufacturer

• Braun Medical S. A.

Carretera de Terrassa 121

08191 Rubí (Barcelona), Spain

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

Date of the most recent review of this leaflet: 01/2025

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products: //www.aemps.gob.es/

This information is intended exclusively for healthcare professionals.

Dosage

• The polyethylene bottle containing 100 ml is restricted to adults, adolescents, and children weighing more than 33 kg.
• The polyethylene bottle containing 50 ml is restricted to full-term newborns, infants, and children weighing more than 10 kg up to 33 kg.
• The polyethylene ampoule containing 10 ml is restricted to full-term newborns and children from 28 days up to less than 24 months of age weighing up to 10 kg.

The administered volume must not exceed the determined dose. If applicable, before administration, the desired volume should be diluted in an appropriate infusion solution (see below "Method of administration and dilution"), or an automatic syringe should be used.

Prolonged or frequent use of paracetamol is strongly discouraged. It is recommended that this medication be used only until oral analgesics can be resumed.

Dosage based on patient's body weight (please refer to the dosing table included below)

*Premature newborns:

Safety and efficacy data are not available for premature infants.

**Maximum daily dose:

The maximum daily dose indicated in the table above refers to patients who are not receiving other medications containing paracetamol. The dose should be adjusted taking into account these other medications.

*** Patients with lower body weight will require smaller volumes.

The minimum interval between each administration must be at least 4 hours.

The minimum interval between each administration in patients with severe renal impairment must be at least 6 hours.

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

Severe renal impairment:

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

Adults with hepatic insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), or dehydration:

The maximum daily dose should not exceed 3 g (see section "Warnings and precautions").

Method of administration and dilution

Paracetamol B. Braun may be diluted up to one-tenth (one volume of Paracetamol B. Braun in nine volumes of diluent) in a 9 mg/ml (0.9%) sodium chloride infusion solution or in a 50 mg/ml (5%) glucose solution, or a combination of both solutions.

For single use only. The medicine should be used immediately after opening. Discard any unused solution.

As with all infusion solutions presented in containers with air space inside, close monitoring is required, particularly at the end of the infusion, regardless of the route of administration. This monitoring at the end of the infusion applies particularly to central line infusions, in order to avoid gas embolism.

Shelf life after opening the container

Infusion must be started immediately after connecting the container to the administration set.

Shelf life after dilution

Chemical and physical stability of the product has been demonstrated (including infusion time) for 48 hours at 23 °C.

From a microbiological standpoint, the medicine should be administered immediately. If not used immediately, the times and conditions of storage during use are the responsibility of the user.

The solution should be inspected visually for particles or changes/alterations in color before administration. Do not use if the solution is not clear and colorless to slightly pink-orange (perception may vary), or if the container or closure is damaged or shows any visible signs of deterioration.