Consumer medicine information

What is in this leaflet

Please read this leaflet carefully before you are given Paracetamol BNM.

This leaflet answers some common questions about Paracetamol BNM. It does not contain all the available information.

Reading this leaflet 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 giving you Paracetamol BNM against the benefits this medicine is expected to have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may want to read it again.

What Paracetamol BNM is used for

Paracetamol BNM contains paracetamol, an analgesic medicine which relieves pain and reduces fever.

Paracetamol BNM is a sterile solution for infusion which is given by intravenous infusion directly into a vein, and is used to relieve pain or reduce fever following surgery.

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why it has been prescribed for you.

Paracetamol BNM is available only with a doctor's prescription.

Paracetamol BNM is not addictive.

Before you are given Paracetamol BNM

Paracetamol BNM is not suitable for everyone.

When you must not be given it

You must not be given Paracetamol BNM if:

• you are allergic to any medicine containing paracetamol or any of the ingredients listed at the end of this leaflet
• you have liver failure or severe liver disease.

Symptoms of an allergic reaction 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.

Paracetamol BNM must not be used after the expiry date printed on the pack, or if the packaging is torn or shows signs of tampering. The solution must be clear before use.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

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

• liver disease
• kidney disease
• alcoholism
• malnutrition, including low reserves of glutathione
• dehydration
• eating disorders (anorexia, bulimia)
• cachexia, a wasting syndrome including unexplained weight loss, fatigue and loss of appetite
• a metabolic condition called glucose-6-phosphate dehydrogenase deficiency (G6PD)
• an inherited condition called Gilbert’s syndrome (also known as familial hyperbilirubinaemia)
• hypovolaemia (decreased blood volume).

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

If you have not told your doctor about any of the above, tell them before you are given Paracetamol BNM.

Using other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. It is especially important to tell your doctor if you are taking any other medicines, including over the counter or pharmacy medicines, which contain paracetamol (for example, Panadol®). This may affect the dosage of Paracetamol BNM which you should receive.

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

Tell your doctor or pharmacist if you are taking flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

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

• probenecid, a medicine used to treat gout or given with antibiotics
• anticonvulsants, medicines used to treat epilepsy or fits, such as phenytoin, carbamazepine, amytal sodium, and phenobarbitone
• other forms of paracetamol, such as tablets, capsules or liquid preparations
• busulfan, a medicine used in cancer therapy
• diflunisal, a non-steroidal anti-inflammatory medicine
• barbiturates
• zidovudine, a medicine for HIV treatment
• anticoagulants, medicines used to stop blood from clotting, such as warfarin
• isoniazid, a medicine used to treat tuberculosis
• antibiotics containing amoxicillin plus clavulanic acid.

The above medicines may be affected by Paracetamol BNM, or may affect how well it works. You may need different amounts of Paracetamol BNM, or you may need to use different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid whilst being given Paracetamol BNM.

How Paracetamol BNM is given

How it will be given

Paracetamol BNM will be given by slow intravenous infusion (drip) into a vein. This medicine must only be given by a doctor or a nurse.

How much will be given

Your doctor will decide how many infusions you need, and how often you should receive them. The need for more doses will depend on how well your body responds to the treatment.

Tell your doctor if you have been taking other forms of paracetamol (tablets, capsules, liquid preparations) and the quantity that you have been taking.

While you are being given Paracetamol BNM

Things you must do

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are being given Paracetamol BNM. Likewise, tell any other doctors, dentists and pharmacists who are treating you that you are being given this medicine.

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

Symptoms of an allergic reaction 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.

In case of overdose

Your doctor has information on how to recognise and treat an overdose.

Ask your doctor or nurse if you have any concerns.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are being given Paracetamol BNM.

Like all medicines, Paracetamol BNM may occasionally cause side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical attention 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 heartbeat
• 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:

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

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

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

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

After being given Paracetamol BNM

Storage

Paracetamol BNM will be stored in the pharmacy or on the ward under the recommended storage conditions.

It should be kept in a cool dry place, protected from light, where the temperature stays below 25ºC. Do not refrigerate or freeze.

Disposal

Any Paracetamol BNM which has passed its expiry date, or is left in the container after use, will be disposed of in a safe manner by your doctor, nurse or pharmacist.

Product description

What it looks like

Paracetamol BNM is a clear and slightly brownish sterile solution for infusion.

It is available in 100 mL transparent plastic bags. A box contains 12 bags.

One 100 mL bag contains 1 g of paracetamol.

Ingredients

Active ingredient:

• paracetamol

Inactive ingredients:

• mannitol
• povidone
• sodium hydroxide (for pH adjustment)
• dibasic sodium phosphate dihydrate
• water for injections.

Paracetamol BNM does not contain any preservatives.

Sponsor details

Boucher & Muir Pty Ltd
Level 9, 76 Berry Street
North Sydney NSW 2010

AUST R 201870

Date of preparation

This leaflet was prepared on 6 September 2022

Published by MIMS October 2022

1 Name of Medicine

Paracetamol.

2 Qualitative and Quantitative Composition

Paracetamol BNM (paracetamol) solution for infusion contains 1000 mg/100 mL of paracetamol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Paracetamol BNM solution for infusion is clear to slightly brownish solution.
The pH of the solution is adjusted to remain between 4.5 and 6.5 during the approved shelf life. The solution is isotonic and slightly hypobaric.

4 Clinical Particulars

4.9 Overdose

For overdose in general, the mainstay of treatment is supportive and symptomatic care.
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 bodyweight 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 (aspartate aminotransferase (AST), alanine aminotransferase (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 overdose.
Emergency measures. Immediate hospitalisation.
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 8 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.
Take blood for plasma paracetamol assay, as soon as possible after the overdose.
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.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

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

Chemical structure. Paracetamol is 4-acetamidophenol. The structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPARACT.gif Molecular formula: C₈H₉NO₂.
Molecular weight: 151.2.
Paracetamol is a white crystalline solid or powder. 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.
CAS number. 103-90-2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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