B. BRAUN PARACETAMOL

B. BRAUN PARACETAMOL

Active ingredient: paracetamol

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Consumer Medicine Information (CMI)

This leaflet provides important information about B. BRAUN PARACETAMOL. You should also speak to your doctor or healthcare professional if you would like further information or if you have any concerns or questions about being given B. BRAUN PARACETAMOL.

Where to find information in this leaflet:

1. Why am I being given B. BRAUN PARACETAMOL?
2. What should I know before being given B. BRAUN PARACETAMOL?
3. What if I am taking other medicines?
4. How is B. BRAUN PARACETAMOL given?
5. What should I know while being given B. BRAUN PARACETAMOL?
6. Are there any side effects?
7. Product details

1. Why am I being given B.BRAUN PARACETAMOL?

B. BRAUN PARACETAMOL contains the active ingredient paracetamol. B. BRAUN PARACETAMOL belongs to the group of medicines called analgesics.

B. BRAUN PARACETAMOL is used to relieve pain or reduce fever when intravenous administration is clinically necessary.

2. What should I know before being given B. BRAUN PARACETAMOL?

Warnings

You must not be given B. BRAUN PARACETAMOL if:

• you are allergic to paracetamol or any of the ingredients listed at the end of this leaflet. 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 and rash, itching or hives on the skin.
• always check the ingredients to make sure you can use this medicine.
• you have liver failure.
• you have severe liver disease.

Check with your doctor if you:

• have any other medical conditions such as:
  – liver disease (including Gilbert’s syndrome)
  – kidney disease
  – alcoholism
  – dehydration
  – eating disorders (anorexia, bulimia)
  – a wasting syndrome including unexplained weight loss, fatigue, weakness and loss of appetite (cachexia)
  – malnutrition (low reserves of glutathione)
  – porphyria metabolic condition called glucose-6-phosphate dehydrogenase deficiency (G6PD)
  – hypovolaemia (decreased blood volume)

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 (especially if you are in the third trimester of pregnancy) or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor can discuss with you the risks and benefits involved.

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.

Some medicines may be affected by B. BRAUN PARACETAMOL or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor will advise you.

Medicines that may interfere with the effect of B. BRAUN PARACETAMOL include:

• Pro-Cid (probenecid) – a medicine used to treat gout, or that is given with antibiotics
• Anticonvulsants – medicines used to treat epilepsy or fits such as Dilantin (phenytoin), Tegretol or Teril (carbamazepine)
• Myleron or Busulfex (busulfan) – an anticancer drug
• Dolobid (diflusinal) – an anti-inflammatory drug
• Barbiturates (such as amytral sodium or phenobarbitone)
• Retrovir (zidovudine) – an anti-HIV drug or other drugs containing zidovudine
• Anti-coagulants, which are used to stop the blood from clotting (including warfarin)
• Isoniazid – an anti-tuberculosis drug
• Antibiotics containing amoxicillin plus clavulanic acid (such as Clamoxyl or Clavulan) or flucloxacillin.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect B. BRAUN PARACETAMOL.

4. How is B. BRAUN PARACETAMOL given?

How much is given

• This medicine will be given to you by your doctor who will decide what dose is right for you.
• Tell your doctor if you have been taking other forms of paracetamol (e.g. tablets, capsules, liquid preparations) and the quantity that you have been taking.

When is B. BRAUN PARACETAMOL used

• B. BRAUN PARACETAMOL is used to relieve pain and reduce fever when oral forms of paracetamol are not suitable.

How is B. BRAUN PARACETAMOL given

• The doctor or nurse will give you B. BRAUN PARACETAMOL.
• It will be given as a slow infusion (drip) into a vein.

If you have been given too much B. BRAUN PARACETAMOL

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.

If you are given too much B. BRAUN PARACETAMOL, 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 being given B. BRAUN PARACETAMOL?

Remind any doctor, nurse or pharmacist you visit that you were given B. BRAUN PARACETAMOL, particularly when starting a new medicine.

Things you should do

Tell your doctor immediately if you develop a rash or other symptom 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 and rash, itching or hives on the skin.

Things you should not do

• Do not drink alcohol while you are being given B. BRAUN PARACETAMOL.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how B. BRAUN PARACETAMOL affects you.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Your doctor may advise you to avoid alcohol as it may interfere with B. BRAUN PARACETAMOL.

How to store B. BRAUN PARACETAMOL

• Store B. BRAUN PARACETAMOL below 25°C.
• Do not refrigerate or freeze.
• Use immediately after first opening.
• Keep in the carton until use to protect from light.

Follow the instructions on the carton on how to take care of the medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight.

Keep it where young children cannot reach it.

If diluted in 0.9% Sodium Chloride or 5% Glucose, the solution should be used immediately. However, if the solution is not used immediately, do not store for more than one hour (infusion time included).

When to discard B. BRAUN PARACETAMOL

Do not use B. BRAUN PARACETAMOL after the expiry date which is stated on the ampoules/bottles and the outer carton.

Getting rid of any unwanted medicine

Any remaining product must be disposed of. As it is limited to hospital use the waste drug elimination is carried out directly by the hospital. These measures will help to protect the environment.

Do not use this medicine after the expiry date.

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
Feeling unwell dizziness, light-headedness bleeding or bruising more easily than normal vomiting, nausea constipation	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 – 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.	Call your doctor straight away, or 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 B. BRAUN PARACETAMOL contains

Active ingredient (main ingredient)	paracetamol
Other ingredients (inactive ingredients)	Mannitol Sodium citrate dihydrate Acetic acid (for pH adjustment) Water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What B. BRAUN PARACETAMOL looks like

B. BRAUN PARACETAMOL is a clear and colourless to slightly pinkish-orangish solution. Perceptions may vary.

B. BRAUN PARACETAMOL comes in:

• 10 mL plastic ampoules x 20 ampoules – AUST R 275360
• 50 mL plastic bottles x 10 bottles (in 100 mL bottles) – AUST R 275358
• 100 mL plastic bottles x 10 bottles – AUST R 275359

Who distributes B. BRAUN PARACETAMOL

B. Braun Australia Pty Ltd
Level 5, 7-9 Irvine Place
Bella Vista NSW 2153
Australia

Toll free number: 1800 251 705

This leaflet was prepared in September 2023.