Consumer medicine information

Perfalgan®

Paracetamol

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Perfalgan®. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Perfalgan against the benefits that are expected. This leaflet does not contain everything about Perfalgan. Your doctor has been provided with full information and can answer any questions you may have. Follow your doctor’s advice even if it differs from what is in this leaflet.

Please read this leaflet carefully and keep it in a safe place so you may refer to it later.

What Perfalgan is used for

Perfalgan contains paracetamol an analgesic medicine which relives pain and reduces fever. Perfalgan is a solution of paracetamol which is given by intravenous infusion (IV) directly into a vein, and is used to relieve pain or reduce fever following surgery.

This medicine is available only with a doctor’s prescription.

Before you are given Perfalgan

When you must not be given Perfalgan

You must not be given Perfalgan if you have an allergy to paracetamol or to any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction to Perfalgan may include:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

You must not be given Perfalgan if you have liver failure or severe liver disease.

If you are not sure whether you should be given Perfalgan, talk to your doctor or pharmacist.

Before you are given Perfalgan

Tell your doctor or pharmacist if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes

Tell your doctor or pharmacist if you are pregnant. Perfalgan may be given to pregnant women, but your doctor must be told if you are pregnant.

Tell your doctor or pharmacist if you are breast-feeding. Perfalgan may be given to women who are breast-feeding, but your doctor must be told if you are breast-feeding.

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:

  • liver disease
  • kidney disease
  • alcoholism
  • suffer from malnutrition
  • dehydration
  • eating disorders (anorexia, bulimia)
  • a wasting syndrome including unexplained weight loss, fatigue, weakness and loss of appetite (cachexia)
  • malnutrition (low reserves of glutathione)
  • a metabolic condition called glucose-6-phosphate dehydrogenase deficiency (G6PD)
  • hypovolaemia (decreased blood volume)

If you have not told your doctor or pharmacist about any of the above, tell them before you are given Perfalgan.

Taking other medicines

It is especially important to tell your doctor if you are taking any other medication, including over the counter or pharmacy medication, which contains paracetamol. This may affect the dosage of Perfalgan which you should receive.

Tell your doctor if you drink alcohol. Your doctor may advise you to avoid alcohol as it may interfere with Perfalgan.

Some medicines and Perfalgan may interfere with each other. These include:

  • Pro-Cid (probenecid) – a medicine used to treat gout or given with antibiotics
  • Anticonvulsants – medicines used to treat epilepsy or fits, such as Dilantin (phenytoin), Tegretol or Teril (carbamazepine), amytal sodium, phenobarbitone
  • Other forms of paracetamol, such as tablets, liquid preparations or capsules
  • Myleran or Busulfex (busulfan) a cancer drug
  • Dolobid (diflunisal) an anti-inflammatory drug
  • Barbiturates
  • Retrovir (zidovudine) – a HIV drug or other drug containing zidovudine
  • Anticoagulants which are used to stop the blood from clotting
  • Isoniazid (isoniazid) a tuberculosis drug
  • Antibiotics containing amoxicillin plus clavulanic acid such as Clamoxyl, Clavulan

These medicines may be affected by Perfalgan, or may affect how well Perfalgan works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while receiving Perfalgan.

How Perfalgan is given

How much is given

Your doctor will decide what dose you will be given, and for how long you will be given Perfalgan. Tell your doctor if you have been taking other forms of Paracetamol (tablets, capsules, liquid preparations) and the quantity that you have been taking.

How it is given

Perfalgan is given as a slow infusion (drip) into a vein. Perfalgan must only be given by a doctor or nurse.

Overdose

Your doctor has information on how to recognise and treat an overdose. Ask your doctor or nurse if you have any concerns.

While you are being given Perfalgan

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you that you are being given Perfalgan.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are being given Perfalgan.

Perfalgan can cause serious skin reactions. Tell your doctor immediately if you develop a rash or other symptoms of an allergic reaction.

These symptoms may be:

  • shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Perfalgan. Perfalgan helps most people with pain and fever, but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you.

  • feeling unwell
  • dizziness, light-headedness
  • bleeding or bruising more easily than normal
  • vomiting, nausea
  • constipation
  • a faster heart beat
  • unusual tiredness or weakness, fatigue
  • redness of the skin

These side effects are rare and usually mild.

If any of the following happen, tell your doctor or a nurse immediately.

These are very serious side effects. You may need urgent medical attention.

  • allergic reaction – shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.
  • yellowing of the skin and/or eyes, also called jaundice

Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

Do not be alarmed by possible side effects. You may not experience any of them.

Product description

What it looks like

Perfalgan is a clear and slightly yellowish solution, in glass vials, available in vials containing 50mL or 100mL.

One 50mL vial contains 500mg paracetamol and one 100mL vial contains 1g of paracetamol.

Ingredients

Active Ingredient: paracetamol 10mg/mL

Other Ingredients:

  • mannitol,
  • cysteine hydrochloride,
  • sodium phosphate – dibasic dihydrate,
  • sodium hydroxide,
  • hydrochloric acid,
  • water for injections.

Storage

Perfalgan will be stored in the pharmacy or on the ward. The injection should be kept in a cool dry place where the temperature stays below 30°C.

Sponsored by

Bristol-Myers Squibb Australia Pty Ltd,
4 Nexus Court, Mulgrave,
Victoria 3170, Australia

Registration Number:

  • AUST R 99870 – 500mg/50mL
  • AUST R 99869 – 1g/100mL

Date of preparation – June 2014

AU_CMI_Perfalgan_V9.0_Jun14.docx

Published by MIMS September 2014