Consumer medicine information

1. Why am I using PARACETAMOL-AFT?

PARACETAMOL-AFT contains the active ingredient paracetamol. PARACETAMOL-AFT is used to relieve pain or reduce fever following surgery.
For more information, see Section 1. Why am I using PARACETAMOL-AFT? in the full CMI.

2. What should I know before I use PARACETAMOL-AFT?

Do not use if you have ever had an allergic reaction to PARACETAMOL-AFT or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use PARACETAMOL-AFT? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PARACETAMOL-AFT and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is PARACETAMOL-AFT given?

Your doctor will decide what dose you will be given, and for how long you will be given PARACETAMOL-AFT.
PARACETAMOL-AFT is given as a slow infusion (drip) into a vein. PARACETAMOL-AFT must only be given by a doctor or nurse.
More instructions can be found in Section 4. How is PARACETAMOL-AFT given? in the full CMI.

5. What should I know while using PARACETAMOL-AFT?

6. Are there any side effects?

• Rare and usually mild: feeling unwell, dizziness, light-headedness, bleeding or bruising more easily than normal, vomiting, nausea, constipation, a faster heart rate, unusual tiredness or weakness, fatigue, redness of the skin. Speak to your doctor if you have any of these less serious side effects and they worry you.

• Very serious side effects: 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. Go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

1 Name of Medicine

Paracetamol.

2 Qualitative and Quantitative Composition

Paracetamol-AFT solution for infusion contains 10 mg/mL of paracetamol (100 mL vial contains 1 g of paracetamol).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Paracetamol-AFT (paracetamol) solution for infusion is a clear, colourless to slightly yellowish solution. It contains 10 mg/mL of paracetamol.

4 Clinical Particulars

4.9 Overdose

There is a risk of poisoning, particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzyme inducers. Poisoning may be fatal in these cases. Acute overdose with paracetamol may also lead to acute renal tubular necrosis.
Symptoms generally appear within the first 24 hours and comprise of nausea, vomiting, anorexia, pallor and abdominal pain. Overdose, 7.5 g or more of paracetamol in a single administration in adults or 140 mg/kg of body weight in a single administration in children, causes cytolytic hepatitis likely to induce complete and irreversible hepatic necrosis, resulting in acute or fulminant hepatic failure, hepatocellular insufficiency, metabolic acidosis and encephalopathy which may lead to coma and death.
Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with decreased prothrombin levels that may appear 12 to 48 hours after administration. Clinical symptoms of liver damage are usually evident initially after two days, and reach a maximum after 4 to 6 days.
The Rummack-Matthews nomogram relates plasma levels of paracetamol and the time after oral ingestion to the predicted severity of liver injury. The relation of parental paracetamol levels in overdose to liver toxicity has not been examined. Advice or treatment protocols based on oral paracetamol overdoses may not accurately predict the incidence of liver toxicity or need for antidote therapy in Paracetamol-AFT overdose.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
Emergency measures. Immediate hospitalisation.
Before beginning treatment, take blood for plasma paracetamol assay, as soon as possible after the overdose.
Treatment of paracetamol overdose may include the antidote N-acetyl cysteine (NAC) by the IV or oral route. In overdoses of oral paracetamol NAC is administered, if possible, before 10 hours but may give some degree of protection from liver toxicity even after this time. The optimal time for administration of NAC and necessary duration of therapy have not been established for overdoses of Paracetamol-AFT.
Symptomatic treatment.
Hepatic tests must be carried out at the beginning of treatment and repeated every 24 hours. In most cases hepatic transaminases return to normal in one to two weeks with full restitution of the liver function. In very severe cases, however, liver transplantation may be necessary.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Paracetamol was not mutagenic in the bacterial mutagenicity assay, but it was clastogenic in mammalian cell assay systems in vitro (mouse TK, human lymphocyte) and in a mouse micronucleus assay in vivo. The clastogenic effect was dose dependent, and the mechanism appears to involve inhibition of replicative DNA synthesis and ribonucleotide reductase at above threshold doses. The clinical significance of clastogenic findings is equivocal as positive findings in vivo only occurred at exposures (ca. 8 times the maximum anticipated clinical exposure, based on C_max) greater than that for hepatotoxicity, and at doses that were associated with significant cytotoxicity.
Carcinogenicity. No evidence of carcinogenic potential was observed for paracetamol in long-term oral studies in mice (up to 3000 mg/m²/day, similar to human exposure) and male rats (up to 1800 mg/m²/day, 0.7 times human exposure). Equivocal evidence of carcinogenic potential (mononuclear cell leukaemia) was observed only in female rats at 1900 mg/m²/day, or 0.7 times the maximum anticipated clinical exposure on a mg/m² basis.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Paracetamol is a white crystalline solid or powder chemically described as 4-acetamidophenol. It is soluble in water (1 in 70), soluble in alcohol (1 in 7), acetone (1 in 13), glycerol (1 in 40), propylene glycol (1 in 9) and also soluble in solutions of the alkali hydroxides.
C₈H₉NO₂.
Molecular weight: 151.2.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPARACE.gif CAS number. 103-90-2.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PARAFTST.gif