Leaflet: information for the user

Paracetamol B. Braun 10 mg/ml infusion solution EFG

Read 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, consult your doctor or pharmacist.
• 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 Paracetamol B. Braun is and what it is used for

2. What you need to know before you start using Paracetamol B. Braun

3. How to use Paracetamol B. Braun

4. Possible side effects

5. Storage of Paracetamol B. Braun

6. Contents of the pack and additional information

This medication 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.

Do not use Paracetamol B. Braun

• if you are allergic to paracetamol or any of the other components of this medicine (listed in section 6);
• if you are allergic (hypersensitive) to propacetamol (another analgesic that is converted to paracetamol in your body);
• if you have a severe liver disease.

Warnings and precautions

Consult your doctor before starting to receive Paracetamol B. Braun.

Be especially careful with Paracetamol B. Braun

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

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

The prolonged or frequent use of paracetamol is strongly discouraged. It is recommended that this medicine be used only until you can take oral analgesics again.

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

Other medicines and Paracetamol B. Braun

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

This is especially important if you are taking:

• a medicine calledprobenecid(used to treat gout): in this case, it may be necessary to reduce the paracetamol dose;
• analgesics that containsalicylamide: in this case, it may be necessary to adjust the dose;
• medicines that activate liver enzymes: in these cases, it is essential to strictly control the paracetamol dose to avoid liver damage;
• blood thinners(anticoagulants): it may be necessary to perform more frequent checks on the effect of these medicines;
• a medicine calledflucloxacillin(antibiotic): due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and that may occur particularly in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

This medicine contains paracetamol, so this should be taken into account if you are takingother medicines that contain paracetamol or propacetamolto avoid an overdose (see section 3).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

• Pregnancy

Paracetamol B. Braun can be used during pregnancy if necessary. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever do not decrease or if you need to take the medicine more frequently.

• Breastfeeding

Paracetamol B. Braun can be used during breastfeeding.

Paracetamol B. Braun contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per package; this is essentially “sodium-free”.

The recommended dose is:

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

Administration form

Your doctor will administer this medication through an IV (intravenous) line. This process takes about 15 minutes. You will be under strict supervision during the infusion and especially towards the end of it.

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

This is unlikely to happen, as the medication will be administered by healthcare personnel.

Your doctor will ensure that you do not receive a dose higher than the recommended one.

However, if you are given more medication than you should, symptoms usually appear within the first 24 hours and may include: dizziness, nausea, loss of appetite, pallor, and abdominal pain. These symptoms may indicate liver damage.

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects may be serious. If any of them occur, discontinue 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 some 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 on blood tests;
• low blood pressure;
• generalized discomfort or weakness

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

• Severe skin reactions have been reported very rarely

Unknown frequency (cannot be estimated from available data)

• redness of the skin, flushing, or pruritus;
• increased heart rate.

During clinical studies, the frequent appearance of adverse effects at the injection site (pain or burning sensation) has been observed.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is not listed in this prospectus.You can also report them directly through theSpanish 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 this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F (30°C).

Store the packaging in the outer packaging to protect it from light.

Composition of Paracetamol B. Braun:

The active ingredient is paracetamol.

One ml contains 10 mg of paracetamol.

Each ampoule of 10 ml contains 100 mg of paracetamol.

Each bottle of 50 ml contains 500 mg of paracetamol.

Each bottle of 100 ml contains 1000 mg of paracetamol.

The other components are:

Manitol, sodium citrate dihydrate, glacial acetic acid (for pH adjustment), water for injection.

Appearance of the product and contents of the package

Paracetamol B. Braun solution for infusion is a transparent and colorless to slightly pink-orange solution. Perception may vary.

Paracetamol B. Braun is packaged in 50 ml and 100 ml plastic bottles or a 10 ml plastic ampoule.

Package sizes: 20 x 10 ml, 10 x 50 ml, 10 x 100 ml

Only some package sizes may be marketed.

Marketing Authorization Holder

B. Braun Melsungen AG,

Address:

Carl-Braun-Straße 1,Postal address:

34212 Melsungen, Germany34209 Melsungen, Germany

Phone: +49/5661/71-0

Fax: +49/5661/71-4567

Manufacturer

B. Braun Medical S. A.

Carretera de Terrassa 121

08191 Rubí (Barcelona), Spain

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

Last review date of this leaflet: August 2022

Other sources of information

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices.//www.aemps.gob.es/

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This information is intended solely for healthcare professionals.

Dosage

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

The administered volume must not exceed the determined dose.If so, before administration, the desired volume must be diluted in an appropriate infusion solution (see below "Administration and dilution form"), or a syringe pump must be used.

The prolonged or frequent use of paracetamol is strongly discouraged. It is recommended that this medication be used only until you can take oral analgesics again.

Dose based on patient weight (please see the dosing table below)

*Preterm newborns:

No safety and efficacy data are available for preterm newborns.

**Maximum daily dose:

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

***Patients with lower weights 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 in 24 hours.

Severe renal impairment:

In the case of 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 cell insufficiency, chronic alcoholism, chronic malnutrition (low glutathione hepatic reserves) or dehydration:

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

Administration and dilution form

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

For single use only. The medication must be used immediately after opening. Dispose of unused solution.

As with all infusion solutions presented in containers with air spaces inside, it should be remembered that a close monitoring is required, particularly at the end of the infusion, regardless of the administration route. This monitoring at the end of the infusion that applies particularly to central infusions, in order to avoid gas embolism.

Valid period after opening the container

The infusion must be initiated immediately after connecting the container to the administration equipment.

Valid period after dilution

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

From a microbiological point of view, the medication must be administered immediately. If not used immediately, the times and conditions of conservation in use are the responsibility of the user.

The solution must be visually inspected to see if it presents particles or changes/alterations in color before administration. Do not use if the solution is not transparent and colorless to slightly pink-orange (perception may vary), or if the container or its closure are damaged or show any visible sign of deterioration.