Paracetamol 10 mg/ml solution for infusion – patient leaflet, side effects, dosage

1. What Paracetamol is and what it is used for

2. What you need to know before you are

given Paracetamol

1. 3. How Paracetamol is given
2. 4. Possible side effects
3. 5. How to store Paracetamol
4. 6.

   information

5. 1. What Paracetamol is and what it is used for

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

It is indicated

• for the short-term treatment of

  moderate pain, especially following surgery, and

• for the short-term treatment of fever.
• What you need to know before you are given Paracetamol

Paracetamol must not be given

• if you are allergic to paracetamol,

  propacetamol hydrochloride (another pain killer and a precursor of paracetamol) or any of the other ingredients of this medicine (listed in section 6).

• if you suffer from a severe liver disease.

Warnings and precautions

Talk to your doctor before you are given Paracetamol.

During treatment with Paracetamol, tell your doctor straight away if:

If you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Take special care with Paracetamol

• if you suffer from a liver or kidney

  disease, or from alcohol abuse.

• if you suffer from a inherited liver

  function disorder called Meulengracht Gilbert's syndrome.

• if you suffer from glucose-6-phosphate

  dehydrogenase deficiency.

• if you are taking other medicines

  containing paracetamol.

• if you suffer from a severe lack of

  nutrition (malnutrition) or get parenteral nutrition.

• if you suffer from exsiccation.

• talk to your doctor or pharmacist if you

  are taking or will be taking flucloxacillin. There is a risk of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when paracetamol is used concomitantly with flucloxacillin, particularly in certain groups of patients at risk, such as patients with severe kidney impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used. High anion gap metabolic acidosis is a serious disease that must have urgent treatment.

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

You should switch to taking pain killing tablets or syrup instead of Paracetamol as soon as is possible.

Children and adolescents

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

Other medicines and Paracetamol

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Inform your doctor if you are taking the following medicines:

• Other medicines containing

  paracetamol. You should not take other medicines containing paracetamol if you are getting Paracetamol, in order not to exceed the recommended daily dose (see following section).

• Probenecid (a medicine used for the

  treatment of gout). Your doctor should consider reducing the dose of paracetamol you need, as probenecid increases the levels of paracetamol in your blood.

• Salicylamide (another pain killer), as it

  may increase the levels of paracetamol

  in your blood and may therefore increase the risk of its toxic effects.

  • Rifampicin, isoniazid (antibiotics), barbiturates (sedatives), tricyclic antidepressants and medicines to treat epileptic fits (antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone), as they may reduce the analgesic and antipyretic effects of paracetamol and may increase as well as alcohol its liver toxic effects.
  • Chloramphenicol (an antibiotic), as taking it together with paracetamol may prolong its action.
  • Oral contraceptives as these may shorten the action of paracetamol.

  • Zidovudine (a medicine used to treat

    HIV), as taking it together with paracetamol may lead to an increased risk of a reduction in the number of certain white blood cells (neutropenia). This increases your risk of getting infections.

  • Oral anticoagulants (substances that slow blood clotting). More check-ups to assess the effect of the anticoagulant might be needed.
  • Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before you are given this medicine.

Pregnancy

If necessary, Paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to receive the medicine more often.

Breast-feeding

Paracetamol may be used during breast-feeding.

Driving and using machines

Paracetamol has no influence on the ability to drive or use machines.

Paracetamol contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.

3. How Paracetamol is given

This medicine is for intravenous (into a vein) use.

Your doctor will administer Paracetamol to you. It is administered by drip (infusion). The dosage will be adjusted individually by your doctor, depending on your weight and general conditions.

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

Your doctor should closely monitor you before the end of the infusion, in order to avoid air entering your vein.

Dosage

Dosing based on patient weight (please see the dosing table here below):

*Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account.

**Patients weighing less will require smaller volumes.

• The minimum interval between each administration must be at least 4 hours.
• No more than 4 doses to be given in 24 hours.

Renal impairment

In patients with renal insufficiency, the minimum interval between each administration must be modified according to the following scheme:

place

for

place

for

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Hepatic impairment

In adult patients with chronic liver failure or compensated active liver disease, hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), dehydration, Gilbert's disease or weighing less than 50 kg, the maximum daily dose must not exceed 3 g.

Older patients

Dose adjustment is not required in the elderly. However, it should be taken into account that renal and/or hepatic insufficiency is more common in patients above 65 years of age.

Administration

RISK OF MEDICATION ERRORS

Take care to avoid dosing errors due to confusion between milligram (mg) and millilitre (ml), which could result in accidental overdose and death.

Paracetamol solution is administered as an infusion (via a drip) into your vein over 15 minutes.

An interval of at least 4 hours must be left between administrations.

If you have the impression that the effect of Paracetamol is too strong or too weak, talk to your doctor.

If you are given more Paracetamol than you should

Talk to a doctor at once if you are given too much of this medicine even if you feel well. This is because too much paracetamol can cause serious liver damage. Overdose is unlikely as a health care professional will give you this medicine. Your doctor will make sure not to give you doses higher than the recommended dose in your case.

In overdose cases, symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, loss of appetite, paleness and belly ache. Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage.

If you have any further questions on 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.

Common (may affect up to 1 in 10 people)

• Pain and burning sensation at the

  injection site.

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

• Changes in laboratory test results

  (abnormally high levels of liver enzymes found in blood tests). Should this occur, inform your doctor as regular blood tests may be required.

• Low blood pressure (hypotension)
• Feeling unwell (malaise)

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

• Reduced number of certain blood cells

  (platelets, certain white blood cells), possibly leading to bleeding from the nose or gums and an increased risk of infections. Should these occur, inform your doctor, as regular blood tests may be required.

• Allergic reactions ranging from simple

  skin rash or hives to severe allergic reactions (anaphylactic shock). Possible symptoms include swelling of the face, lips, tongue or other parts of the body and shortness of breath, wheezing or difficulty breathing, temporary narrowing of the airways into the lungs (bronchospasm). If you think that Paracetamol is causing an allergic reaction, tell your doctor immediately.

• Very rare cases of serious skin reactions

  have been reported.

Not known (frequency cannot be estimated from the available data)

• Fast heart beat (tachycardia)
• Redness of the skin, flush, itching

• A serious condition that can make blood

  more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2)

Effects on laboratory tests

Treatment with Paracetamol may alter the results of some laboratory tests for uric acid, as well as of the test for blood glucose.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamol

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or bottle label after 'EXP'.

The expiry date refers to the last day of the month.

Keep the bottles in the outer carton in order to protect from light.

Before administration, the product should be inspected visually.

Do not use this medicine if you notice any particles in the solution or discolouration .

Your doctor or the hospital staff will normally store Paracetamol and they are responsible for the quality of the product when it has been opened and if it is not used immediately.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Paracetamol contains

• The active substance is paracetamol.

  Each 1 ml of solution contains 10 mg paracetamol.

  Each bottle of 100 ml contains 1000 mg paracetamol.

• The other ingredients are

  Monothioglycerol, Mannitol (E421), Sodium citrate dihydrate, Acetic acid (for pH-adjustment), Sodium hydroxide (for pH-adjustment) and Water for Injections.

What Paracetamol looks like and contents of the pack

Paracetamol 10 mg/ml solution for infusion is a clear and colourless solution for infusion.

Paracetamol 10 mg/ml solution for infusion is available in 100 ml LDPE bottle.

Pack sizes:

10 bottles

40 bottles

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi Limited

Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA7 1NT

UK

Manufacturer

Fresenius Kabi Polska Sp. z.o.o.

ul. Sienkiewicza 25,

PL-99-300 Kutno,

Poland

This leaflet was last revised in July 2026. ________________________________

The following information is intended for healthcare professionals only:

Intravenous use.

The medicinal product is restricted to adults, adolescents and children weighing more than 33 kg.

Handling

For single use only. Any unused solution should be discarded.

Before administration, the product should be visually inspected for any particulate matter and/or discolouration.

After first opening

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

After dilution:

Shelf life after dilution with sodium chloride 9 mg/ml (0.9%) solution or 50 mg/ml glucose (5%) solution or mixture of both: Chemical and physical in-use stability has been demonstrated for 48 hours up to 30 °C.

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the

responsibility of the user.

As for all solutions for infusion presented in bottles, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of infusion route. This monitoring at the end of the infusion applies particularly for central route infusions, in order to avoid air embolism.

Compatibility

Paracetamol 10 mg/ml solution for infusion can be diluted in sodium chloride 9 mg/ml (0.9%) solution or 50 mg/ml glucose (5%) solution up to one tenth (one volume Paracetamol 10 mg/ml solution for infusion into nine volumes diluent) or a mixture of both.

The diluted solution should be visually inspected and should not be used in the presence of opalescence, visible particulate matter or precipitate.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

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