SUMMARY CMI
PARACETAMOL-AFT
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
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?
Things you should do |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using PARACETAMOL-AFT? in the full CMI.
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.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
PARACETAMOL-AFT
Active ingredient(s): Paracetamol
Consumer Medicine Information (CMI)
This leaflet provides important information about using PARACETAMOL-AFT. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using PARACETAMOL-AFT.
Where to find information in this leaflet:
1. Why am I using PARACETAMOL-AFT?
2. What should I know before I use PARACETAMOL-AFT?
3. What if I am taking other medicines?
4. How is PARACETAMOL-AFT given?
5. What should I know while using PARACETAMOL-AFT?
6. Are there any side effects?
7. Product details
1. Why am I using PARACETAMOL-AFT?
PARACETAMOL-AFT contains the active ingredient Paracetamol. PARACETAMOL-AFT is an analgesic medicine which relives pain and reduces fever.
PARACETAMOL-AFT is used to relieve pain or reduce fever following surgery.
Your doctor may have prescribed PARACETAMOL-AFT for another reason. Ask your doctor if you have any questions about why PARACETAMOL-AFT has been prescribed for you.
This medicine is available only with a doctor's prescription. PARACETAMOL-AFT is not addictive.
2. What should I know before I use PARACETAMOL-AFT?
Warnings
Do not use PARACETAMOL-AFT if:
- You are allergic to paracetamol, or any of the ingredients listed at the end of this leaflet. 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. - Always check the ingredients to make sure you can use this medicine.
- You must not be given PARACETAMOL-AFT if you have liver failure or severe liver disease.
Check with your doctor if you:
- have any other medical conditions:
- 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) - take any medicines for any other condition.
- have allergies to any other medicines, foods, preservatives, or dyes.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins, or supplements that you buy 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 medication, including over the counter or pharmacy medication, which contains paracetamol. This may affect the dosage of PARACETAMOL-AFT which you should receive.
Tell your doctor if you drink alcohol.
Some medicines may interfere with PARACETAMOL-AFT and affect how it works.
Medicines that may interfere with PARACETAMOL-AFT 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
- Myleron® or Busulfex® (busulfan) a cancer drug
- Dolobid® (diflunisal) an anti-inflammatory drug
- Barbiturates such as amytal sodium, phenobarbitone
- Retrovir® (zidovudine) - a HIV drug or other drugs 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®
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affects PARACETAMOL-AFT.
4. How is PARACETAMOL-AFT given?
How much is given
- Your doctor will decide how much PARACETAMOL-AFT you should receive and for how long you should receive it.
- 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 PARACETAMOL-AFT is given
- PARACETAMOL-AFT is given as a slow infusion (drip) into a vein.
- PARACETAMOL-AFT must only be given by a doctor or nurse.
If too much PARACETAMOL-AFT is given
PARACETAMOL-AFT is given under the close supervision of your doctor; therefore, it is very unlikely that you will receive too much.
If you think that you have received too much PARACETAMOL-AFT, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using PARACETAMOL-AFT?
Things you should do
Tell any other doctors, dentists, and pharmacists who are treating you that you are being given PARACETAMOL-AFT.
If you are about to be started on any new medicine, tell your doctor, dentist, or pharmacist that you are being given PARACETAMOL-AFT.
Call your doctor straight away 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/hives on the skin
Remind any doctor, dentist, or pharmacist you visit that you are using PARACETAMOL-AFT.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PARACETAMOL-AFT affects you.
PARACETAMOL-AFT may cause dizziness in some people.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may interfere with PARACETAMOL-AFT.
Looking after your medicine
- PARACETAMOL-AFT will be stored in the pharmacy or on the ward.
- The injection should be kept in a cool dry place, protected from light.
- This medicine is kept below 25°C.
When to discard your medicine
The hospital staff will dispose of any leftover PARACETAMOL-AFT.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
Neurological:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
Allergic reaction:
| Go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What PARACETAMOL-AFT contains
Active ingredient (Main ingredient) | paracetamol 10 mg/mL |
Other ingredients (Inactive ingredients) | Mannitol Cysteine hydrochloride Dibasic sodium phosphate Sodium hydroxide Hydrochloric acid Water for injections. |
Potential allergens | Paracetamol |
Do not take this medicine if you are allergic to any of these ingredients.
What PARACETAMOL-AFT looks like
PARACETAMOL-AFT is available in colourless glass vials closed with a dark gray rubber stopper and sealed with an aluminium lever capsule with gold lever.
Each vial contains 100 mL of a clear, colourless to slightly yellowish solution.
Each 100 mL vial contains 1 g of paracetamol. AUST R 191802.
Who distributes PARACETAMOL-AFT
In Australia:
AFT Pharmaceuticals Pty Ltd
113 Wicks Road
North Ryde
Sydney, NSW 2113
Email: [email protected]
In New Zealand:
AFT Pharmaceuticals Ltd.
P.O. Box 33-203
Takapuna Auckland New Zealand
Email: [email protected]
This leaflet was prepared in September 2023.
Published by MIMS November 2024