Patient leaflet - Paracetamol 10 mg / ml solution for infusion
1. What Paracetamol is and what it is used for
This medicine contains the active substance paracetamol, and it 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. This 100 ml presentation of Paracetamol 10 mg/ml solution for infusion is restricted to adults, adolescents and children weighing more than 33 kg. Paracetamol 10 mg/ml solution will be referred as Paracetamol throughout the leaflet.
2. What you need to know before you use Paracetamol
Do not use Paracetamol
- If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- If you are allergic to propacetamol (this is another painkiller that the body converts to paracetamol)
- If you have any severe liver disease.
Warnings and precautions
Talk to your doctor or pharmacist before using Paracetamol, if any of these apply to you:
- if you could take painkillers through the mouth (orally) instead, since that is the recommended administration route;
- if you have reduced liver or kidney function, or if you drink too much alcohol;
- if you are taking other medicines that have paracetamol in them;
- in cases of malnutrition or dehydration
- in case of glucose-6-phosphatase dehydrogenase deficiency (may lead to haemolytic anaemia), a blood disease.
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 Package leaflet: Information for the user Paracetamol 10 mg/ml solution for infusion paracetamol
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).
Adequate oral analgesic treatment is advised as soon as this route of administration is possible.
Other medicines and Paracetamol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Paracetamol can affect and be affected by other medicines:
- other medicines that contain paracetamol or propacetamol, so that you do not take more than the recommended daily dose (see section 3 “How to use Paracetamol”).
- probenecid: a lower dose of paracetamol may be needed;
- salicylamide, an anti-inflammatory drug;
- anticoagulants taken by mouth. It may be necessary to control the effect of the anticoagulant;
- medicines that activate liver enzymes: strict control of the paracetamol dose is required in order to avoid liver damage;
- flucloxacillin (antiobitic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).
Paracetamol with alcohol
Limit the use of alcohol during treatment with this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Paracetamol may be used during pregnancy. However, in this case the doctor must evaluate if the treatment is advisable.
Breast-feeding
Paracetamol may be used during breast-feeding.
Driving and using machines
Paracetamol has no or negligible influence on the ability to drive or use machines.
Paracetamol contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 100 ml bottle, that is to say essentially ‘sodium-free’.
3. How to use Paracetamol
Paracetamol will be administered to you by a healthcare professional by infusion into one of your veins, for approximately 15 minutes. The dose will be individually adjusted by your doctor, based on your weight and general condition.
This 100 ml presentation of Paracetamol 10 mg/ml solution for infusion is restricted to adults, adolescents and children weighing more than 33 kg.
If you have the impression that the effect of Paracetamol is too strong or too weak, talk to your doctor.
If you receive 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. However, in overdose cases, symptoms generally appear within the first 24 hours and comprise: nausea, vomiting, anorexia, pallor, abdominal pain and a risk of liver injury. If you receive more Paracetamol than you should, talk to your doctor immediately. 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)
The following may occur:
- pain and burning sensation at injection site.
Rare (may affect up to 1 in 1,000 people)
The following may occur:
- malaise
- a drop in blood pressure
- changes in laboratory test results: abnormally high levels of hepatic enzymes found during blood checks. Should this occur, inform your doctor as regular blood checks may be required later.
Very rare (may affect up to 1 in 10,000 people)
The following may occur:
- Serious skin rash or allergic reaction (in the form of anaphylactic shock, urticaria, erythema). Stop the treatment immediately and inform your doctor.
- Other changes in laboratory test results have been observed which have necessitated regular blood checks: abnormally low levels of some types of blood cells (platelets, white cells), possibly leading to bleeding from the nose or gums. Should this occur, inform your doctor.
- Very rare cases 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, generally in the presence of risk factors (see section 2).
Not known (frequency cannot be estimated from the available data)
- Cases of redness of the skin, flushing, itching and abnormally rapid beating of the heart have been reported.
A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 bottle after EXP. The expiry date refers to the last day of that month. Do not store above 25ºC.
Store in the original package in order to protect from light. Do not refrigerate or freeze.
For single use. After opening, the product should be used immediately. Any unused solution should be discarded.
Before the administration the product should be visually inspected. Do not use Paracetamol if you notice any particulate matter or discoloration. 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. 1 ml contains 10 mg of paracetamol.
Each bottle (100 ml) contains 1,000 mg of paracetamol.
- The other ingredients are disodium edetate, disodium hydrogen phosphate dihydrate, hydrochloric acid, mannitol, sodium hydroxide and water for injections.
What Paracetamol looks like and contents of the pack Bottles containing 100 ml of solution for infusion.
Paracetamol is a clear solution, free of visible particles, packed in a polypropylene bottle either with twin head or pull-off polypropylene caps with a polyisoprene rubber closure. Paracetamol is given in packages containing 10 or 50 bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder
SVP Pharma Ltd
Unit 1, 39 Mahoney Green, Rackheath, Norwich, NR13 6JY,
United Kingdom
Manufacturer
Laboratórios Basi - Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15, 16 3450-232 Mortágua
Portugal
Packpharm Limited
Ground Floor, Unit 1, 39 Mahoney Green, Rackheath, Norwich, NR13 6JY,
United Kingdom
This leaflet was last revised in July 2025.
* Patients weighing less will require smaller volumes.
**Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol-containing medicinal products and should be adjusted accordingly taking such products into account.
Method of administration
The paracetamol solution is meant to be administered as a 15 minutes intravenous infusion.
The medicine must be used immediately after opening the bottle.
Before the administration, the medicine must be visually inspected to detect the present of any particulate matter and discolouration. For single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Patient weight > 33 kg to ≤ 50 kg > 50 kg with additional risk factors for hepatotoxicity > 50 kg and with no additional risk factors for hepatotoxicity | Dose per administration 15 mg/kg 1 g 1 g | Volume per administration 1.5 ml/kg 100 ml 100 ml | Maximum volume of Paracetamol (10 mg/ml) per administration based on upper weightlimits of group (ml)* 75 ml 100 ml 100 ml |
The following information is intended for healthcare professionals only:
Intravenous use.
This 100 ml presentation of Paracetamol 10 mg/ml solution is restricted to adults, adolescents and children weighing more than 33 kg.
Close monitoring is needed before the end of infusion.
Posology
Information before preparation of the dose:
- The minimum interval between each administration must be at least 4 hours.
- The minimum interval between each administration in patients with renal impairment must be at least 6 hours.
- No more than 4 doses to be given in 24 hours.
Risks of dosing errors
Take care to avoid dosing errors due to confusion between milligram (mg) and millilitre (ml), which could result in accidental overdose and death.
Dosing based on patient weight (please see the dosing table here below):
Maximum daily dose** 60 mg/kg not overcoming 3 g 3 g 4 g |