Paracetamol 10 mg/mL solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Paracetamol 10 mg/mL solution for infusion is and what it is used for
2. What you need to know before you use Paracetamol 10 mg/mL solution for infusion
3. How to use this medicine
4. Possible side effects
5. How to store Paracetamol 10 mg/mL solution for infusion
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to propacetamol (another analgesic agent used for infusions, a precursor of paracetamol).
• if you suffer from serious liver disease.

Talk to your doctor, pharmacist or nurse before using this medicine.

Take special care with Paracetamol 10 mg/mL solution for infusion if you

• are taking other paracetamol-containing medicines
• suffer from liver disease, Gilbert disease
• have severe reduced kidney function
• suffer from chronic and excessive alcohol consumption
• suffer from chronic malnutrition
• are dehydrated
• weight less than 50 kg
• have deficiency in glucose-6-phosphatase dehydrogenase (which can cause excessive breakdown of red blood cells, a blood disease)

Before starting treatment, tell your doctor if any of the above situations applies to you.

Your doctor will take care not to give you higher doses than those recommended. This can lead to serious liver damage.

Use a suitable oral analgesic treatment as soon as this route of administration is possible. Prolonged or frequent use of this medicine is not recommended.

During treatment with Paracetamol 10 mg/mL solution for infusion, 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).

This medicine contains paracetamol: this should be taken into account if you are using other paracetamol-based medicines, so that you do not exceed the recommended daily dose (see section below). Tell your doctor if you are taking any other paracetamol-containing medicines.

Tell your doctor, pharmacist or nurse if you are using or have recently used or might used any other medicines, in particular with:

• medicines containing probenecid (used in the treatment of gout): a reduction in the dose of paracetamol should be considered.
• medicines containing salicylamide (used to treat pain): a dose adjustment may be necessary.
• medicines that activate liver enzymes: strict control of the dose of paracetamol is necessary to avoid liver damage.
• oral anticoagulants (used to thin the blood): closer monitoring of the effect of the anticoagulant may be necessary.
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

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

Pregnancy and breast-feeding

If necessary, this medicine 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 take the medicine more often. Your doctor will assess whether this treatment is appropriate and may be used while breast-feeding.

Ask your doctor, pharmacist or nurse for advice before taking any medicine.

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

This medicine contains 25.2 mg sodium (main component of cooking/table salt) in each 10-mL bag.

This is equivalent to 1.26 % of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 126 mg sodium (main component of cooking/table salt) in each 50-mL bag.

This is equivalent to 6.3 % of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 252 mg sodium (main component of cooking/table salt) in each 100-mL bag.

This is equivalent to 13 % of the recommended maximum daily dietary intake of sodium for an adult.

Talk to your doctor or pharmacist if you need this medicine daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

The dose will depend on your weight and your general condition. Your doctor will calculate your body weight and will determine the dose you should receive.

RISK OF MEDICATION ERRORS

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

This medicine will be given by infusion into one of your veins. The infusion will last approximately 15 minutes.

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

In case of an overdose, symptoms generally appear within the first 24 hours and comprise of nausea, vomiting, anorexia, pallor, abdominal pain and liver damage may occur. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Please inform your doctor if you notice any of these symptoms.

• Very rare side effects (may affect up to 1 in 10 000 people)
  • Serious skin reactions
  • Anaphylactic shock: sudden, severe allergic reaction with breathing difficulty (shortness of breath), swelling, light headedness, fast heartbeat, sweating and loss of consciousness.
  • Itchy rash (urticaria)
  • Rash
  In the above cases, stop your treatment immediately and tell your doctor.

• Rare side effects (may affect up to 1 in 1 000 people)
  • Malaise.
  • Decreased blood pressure (hypotension).
  • Increased levels of liver enzymes indicates that the liver is under stress and may lead to liver problems.

• Very Rare side effects (may affect up to 1 in 10 000 people)
  • Low level of blood platelets which can lead to bleeding and bruising.
  • Low levels of white blood cells.
  • Low levels of neutrophils, a type of white blood cell that fights infection.
  In the above cases, tell your doctor because this may require additional blood test.
• Pain and burning sensation at the injection site even diffuse.

• Not known (frequency cannot be estimated from the available data)
  • Itching (pruritus)
  • Rapid heartbeat (tachycardia).
  • Reddening of the skin (flushing, erythema).
  • A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2)

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:

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.

• The active substance is paracetamol:

Each mL of solution for infusion contains 10 mg of paracetamol.

Each 10-mL bag of solution for infusion contains 100 mg paracetamol.

Each 50-mL bag of solution for infusion contains 500 mg paracetamol.

Each 100-mL bag of solution for infusion contains 1 000 mg paracetamol.

• The other ingredients are sodium acetate trihydrate, glacial acetic acid, sodium hydroxide 1N (for pH adjustment), water for injections.

This medicine is available as a solution for infusion.

10-mL overwrapped polyolefin bags equipped with a collection site are available in packs containing 1, 10, 15, 20 or 50 bags.

50-mL overwrapped polyolefin bags equipped with an infusion site are available in packs containing 1, 5, 10, 40, 45, 50 or 60 bags.

100-mL overwrapped polyolefin bags equipped with an infusion site are available in packs containing 1, 5, 10, 40, 45, 50 or 55 bags.

50-mL overwrapped polyolefin bags equipped with a collection site and an infusion site are available in packs containing 1, 5, 10, 40, 45, 50 or 60 bags.

100-mL overwrapped polyolefin bags equipped with a collection site and an infusion site available in packs containing 1, 5, 10, 40, 45, 50 or 55 bags.

Not all pack sizes may be marketed.