Perfalgan 1 g Solution

PERFALGAN 1 g is an analgesic (it relieves pain), so it is used for the short-term treatment of mild to moderate pain, especially following dental procedures and minor orthopaedic surgery and the short-term treatment of fever where the oral route is unsuitable.

It is restricted to use in adults and children weighing more than 33 kg (approximately 11 years old).

You should not be given PERFALGAN 1 g:

• If you are hypersensitive (allergic) to paracetamol, or any of the other ingredients
• If you have severe liver disease

Special care should be taken with PERFALGAN 1 g:

• If you have liver or kidney disease, or alcohol abuse
• If you are taking other medicines containing paracetamol including prescription and non-prescription medicines
• If you have nutritional problems (malnutrition) or dehydration
• If you are pregnant or breastfeeding
• If you are taking or have recently taken medication, especially probenecid, salicylamide or enzyme-inducing substances

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding your baby please consult your doctor, pharmacist or other healthcare professional for advice before receiving this medicine.

Important information about some of the ingredients of PERFALGAN 1 g

PERFALGAN 1 g contains mannitol and may have a laxative effect.

DO NOT EXCEED THE RECOMMENDED DOSE. You will not be expected to give yourself PERFALGAN 1 g. It will be given to you by a person who is qualified to do so. The paracetamol solution is administered as an intravenous infusion over 15 minutes. Your doctor will prescribe the appropriate dose for you. The dose you are given is based on your weight. Do not share medicines prescribed for you, with others.

If you use more PERFALGAN 1 g than you should: Since a healthcare professional will administer this medicine, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

PERFALGAN 1 g contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdosage and notwithstanding the fact that a person may be asymptomatic, the nearest doctor, hospital or Poison Center must be contacted immediately.

PERFALGAN 1 g can have side effects. Not all side effects reported for PERFALGAN 1 g are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PERFALGAN 1 g, please consult your doctor, pharmacist or other health care professional for advice.

The following side effects may occur:

• Malaise
• A drop in blood pressure
• Changes in laboratory test results, where abnormally high levels of liver enzymes are found during blood tests. Follow up blood tests may be needed later
• A serious skin reaction or allergic reaction, stop the treatment immediately and inform your doctor
• Other changes in laboratory test results have been seen which results in 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
• Redness of the skin, flushing, itching and abnormally rapid beating of the heart, have been reported
• Pain and burning sensation at the injection site may occur

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• Store all medicines out of reach of children.
• Store at or below 30 °C. Do not refrigerate or freeze. Once opened, the vial should be used immediately.
• Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
• Do not use after the expiry date stated on the label.