PATIENT INFORMATION LEAFLET

Paracetamol Kabi 10 mg/ml, solution for infusion 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

It is indicated

• for the short-term treatment of moderate pain, especially after surgery and
• for the short-term treatment of fever.

No use Paracetamol Kabi

• If you areallergic to paracetamolor to any of the other components of this medication (listed in section 6).
• if you haveallergy(hypersensitivity)to propacetamol(another analgesic for infusion and precursor of paracetamol).
• if you have aserious liver disease.

Warnings and precautions

Consult your doctor before using Paracetamol Kabi.

During treatment with Paracetamol Kabi, immediately report to your doctor if:

if you have serious diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from chronic malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Be especially careful with Paracetamol Kabi

• if you have anyliver or kidney disease, orchronic alcoholism.
• if you have a hereditary disorder of liver function calledMeulengracht Gilbert’s syndrome.
• if you haveglucose-6-phosphate dehydrogenase deficiency.
• if you are takingother medications containing paracetamol.
• if you are in a state ofchronic malnutritionor receiving parenteral nutrition.
• if you present dehydration
• Consult your doctor or pharmacist if you are taking or will be taking flucloxacillin. There is a risk of alterations in blood and fluids (metabolic acidosis with high anion gap) that occur by increasing plasma acidity when using paracetamol at the same time as flucloxacillin, especially in certain high-risk patient groups, for example: patients with severe kidney failure, sepsis, or malnutrition, especially if using the maximum daily doses of paracetamol. Metabolic acidosis with high anion gap is a serious disease that requires urgent treatment.

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

You should take analgesics in tablets or syrup as soon as possible instead of Paracetamol Kabi.

Other medications and paracetamol:

During treatment with Paracetamol Kabi, do not takeother medications that contain paracetamol, this should be taken into account to avoid exceeding the recommended daily dose (see the next section). Inform your doctor if you are taking other medications that contain paracetamol.

If you are being treated withprobencid(a medication used to treat gout) your doctor should consider a reduction in the necessary dose of paracetamol as probencid increases paracetamol levels in the blood.

Thesalicylamide(another pain medication) may increase paracetamol levels in the blood and therefore, may increase the risk of its toxic effects.

Therifampicin, isoniazid(antibiotics), thebarbiturates(sedatives), thetricyclic antidepressantsand theantiepileptic medications(such as carbamazepine, phenytoin, phenobarbital, primidone) may reduce the analgesic and antipyretic effects of paracetamol and, like thealcohol, may increase its toxic effects on the liver.

In case of taking paracetamol at the same time aschloramphenicol(an antibiotic) may prolong the action of the latter.

Please inform your doctor or pharmacist if you are takingoral contraceptivesbecause these may reduce the action of paracetamol.

Taking paracetamol withzidovudine(a medication used to treat HIV) increases the risk of reducing the number of certain white blood cells (neutropenia). Therefore, it increases the risk of infections.

Please inform your doctor or pharmacist if you are takingoral anticoagulants(substances that reduce blood coagulation speed). You may need more tests to evaluate the effect of the anticoagulant.

Inform your doctor or pharmacist if you are takingflucloxacillin(antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that must receive urgent treatment (see section 2).

Inform your doctor or pharmacist if you are using or have recently used any other medication, even those purchased without a prescription.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

In case of need, Paracetamol Kabi can be used during pregnancy. 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 medication more frequently.

Lactation

Paracetamol Kabi can be used during breastfeeding.

Driving and operating machines

No effects on driving and operating machines have been described.

This medication is administered via intravenous route.

Paracetamol Kabi will be administered by your doctor. It is administered through a drip (infusion).

The 100 ml vial or bag is restricted to adults, adolescents, and children weighing more than 33 kg (approximately 11 years).

The 10 ml ampoule, the 50 ml vial or bag is restricted to full-term newborns, infants, and children weighing less than 33 kg.

Careful supervision is necessary before completing the infusion, to avoid air entering the vein.

Dosage

Dose according to patient weight (see the posology table below)

*Preterm infants:No data on efficacy and safety are available for preterm infants.

**Maximum Daily Dose:The maximum daily dose described in the table above is for patients not taking other medications with paracetamol and should be adjusted accordingly taking these medications into account.

***Patients weighing less will require smaller volumes.

• The minimum interval between each administration should be at least 4 hours in patients with normal renal function..
• The minimum interval between each administration in patients with severe renal insufficiency should be at least 6 hours.
• The minimum interval between each administration in patients requiring hemodialysis should be at least 8 hours.
• The maximum daily dose should not exceed 3 g in adult patients with active or compensated chronic liver disease, with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low glutathione hepatic reserves), dehydration, Meulengracht Syndrome, or weighing less than 50 kg.

Do not administer more than 4 doses in 24 hours.

Administration Form

Paracetamol Kabi solution is administered by infusion (through a drip) in your vein for about 15 minutes. Leave an interval of at least 4 hours between each administration.

If you estimate that the action of Paracetamol Kabi is too strong or weak, inform your doctor.

If you use more Paracetamol Kabi than you should

If you have taken more Paracetamol Kabi than you should, consult your doctor or pharmacist immediately.

The most frequent symptoms in case of overdose appear within the first 24 hours and are: nausea, vomiting, anorexia, pallor, and abdominal pain. In case of overdose, inform the medical staff immediately due to the risk of irreversible liver damage.

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

As with all Paracetamol Kabi medicines, Paracetamol Kabi may cause side effects, although not everyone will experience them.

Common(may affect up to 1 in 10 people)

• Pain or burning sensation at the injection site.

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

• Abnormal blood test results (elevated liver enzymes). If this occurs, consult your doctor as you may need additional blood tests.
• Low blood pressure (hypotension)
• Discomfort

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

• Decreased levels of certain blood cells (platelets, certain white blood cells), causing possible nasal or gum bleeding and increasing the risk of infections. If this occurs, inform your doctor as you may need additional blood tests.
• Allergic reactions ranging from simple skin rash or itching to generalized allergic reaction (anaphylactic shock). Possible symptoms include swelling of the face, lips, tongue, or other parts of the body and wheezing or difficulty breathing, temporary narrowing of the airways in the lungs (bronchospasm).
• If you consider Paracetamol Kabi to be the cause of an allergic reaction, inform your doctor immediately.
• Severe skin reactions have been reported in very rare cases.
• Very rare cases of blood and fluid imbalances (high anion gap metabolic acidosis) have been reported when paracetamol is used at the same time as flucloxacillin, usually in the presence of risk factors (see section 2).

Frequency not known(cannot be estimated from available data):

• Increased heart rate (tachycardia)
• Redness of the skin, flushing, pruritus
• A severe disease that can make the blood more acidic (denominated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Effects on laboratory tests

The treatment with Paracetamol Kabi may alter the results of some tests such as uric acid determination, as well as blood glucose analysis.

If you consider that any of the side effects you experience is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in the leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep Paracetamol Kabi out of sight and reach of children.

Do not use Paracetamol Kabi after the expiration date indicated on the packaging after CAD. The expiration date refers to the last day of the month.

Do not refrigerate or freeze.

Before administration, the product must be visually inspected.

Do not use Paracetamol Kabi if you observe the presence of particles or if the solution has discolored beyond a light yellow.

Your doctor or hospital healthcare staff will normally store Paracetamol Kabi and are therefore responsible for the product's quality when it has been opened and not used immediately. However, if not used immediately, the product may be stored for a maximum of 24 hours. After dilution, the solution must not be stored for more than 6 hours (including infusion time). They are also responsible for the correct disposal of Paracetamol Kabi residues.

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

Composition of Paracetamol Kabi

• The active ingredient is paracetamol. Each ml contains 10 mg of paracetamol.
• Each ampoule of 10 ml contains 100 mg of paracetamol.
• Each vial or bag of 50 ml contains 500 mg of paracetamol.
• Each vial or bag of 100 ml contains 1000 mg of paracetamol.
• The other components are cysteine, mannitol (E421), water for injectable preparations.

Appearance of Paracetamol Kabi and contents of the package

Paracetamol Kabi 10 mg/ml, solution for infusion is a transparent slightly yellowish solution.

Paracetamol Kabi 10 mg/ml, solution for infusion is presented in glass ampoules of 10 ml and glass vials of 50 ml or 100 ml closed with stoppers and "flip-off" aluminum/plastic caps or in bags of 50 and 100 ml with closures and plastic covers that allow you to see if they have been manipulated.

Containers:

Ampoules:

10 ampoules

Vials:

1 vial

10 vials

12 vials

20 vials

Bags:

20 bags

50 bags

60 bags

Only some package sizes may be marketed.

Marketing authorization holder and responsible for manufacturing:

Marketing authorization holder:

Fresenius Kabi España, S.A.U.

Marina 16-18

08005 – Barcelona (Spain)

Responsible for manufacturing:

Fresenius Kabi Deutschland GmbH

Plant Friedberg

Freseniusstrasse 1

D-61169 Friedberg

Germany

Fresenius Kabi Austria GmbH

Hafnerstrasse, 36 - A-8055

Austria (GRAZ)

Fresenius Kabi France

6, Rue de Rempart

F-27400 Louviers

This medicinal product is authorized in the Member States of theEuropean Economic Area under the following names:

This leaflet has been revised inJanuary 2025

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The following information is intended solely for healthcare professionals:

Handling

This medicinal product is for single use only. Any unused solution must be discarded.

Before administration, the product must be visually inspected to check for the absence of particles or discoloration.

The 100 ml vial or bag is restricted to adults, adolescents, and children weighing more than 33 kg.

The 10 ml ampoule and the 50 ml vial or bag is restricted to full-term newborns, infants, and children weighing less than 33 kg.

As with all infusion solutions presented in glass vials or bags, careful monitoring is recommended, especially at the end of the infusion, regardless of the infusion route. This monitoring at the end of the infusion is particularly important in the case of central infusions, to avoid gas embolism.

Compatibility

Paracetamol Kabi 10 mg/ml infusion solution can be diluted in a sodium chloride 9 mg/ml (0.9%) solution or a glucose 50 mg/ml (5%) solution up to a tenth (one volume of Paracetamol Kabi 10 mg/ml infusion solution in nine volumes of diluent). In this case, the diluted solution must be used within 6 hours of preparation (including infusion time).

The diluted solution must be visually inspected and must not be used if opalescence, visible particles, or precipitation are observed.

Disposal

Any unused product or waste must be disposed of in accordance with local regulations.