Flucloxacillin Kabi

Flucloxacillin Kabi

Active ingredient(s): Flucloxacillin sodium monohydrate (floo-klox-s-SILL-in)

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Consumer Medicine Information (CMI)

This leaflet answers some common questions about Flucloxacillin Kabi. 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 Flucloxacillin Kabi.

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 Flucloxacillin Kabi against the benefits they expect it will have for you.

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

Keep this leaflet in a safe place.

You may need to read it again

Where to find information in this leaflet:

1. Why am I being given Flucloxacillin Kabi?
2. What should I know before I am given Flucloxacillin Kabi?
3. What if I am taking other medicines?
4. How am I given Flucloxacillin Kabi?
5. What should I know after receiving Flucloxacillin Kabi?
6. Are there any side effects?
7. Product details

1. Why am I being given Flucloxacillin Kabi?

Flucloxacillin Kabi is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection.

Flucloxacillin Kabi, like other antibiotics, will not work against infections caused by viruses such as colds or the flu.

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

Your doctor may have prescribed it for another reason.

This medicine is not addictive.

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

2. What should I know before I am given Flucloxacillin Kabi?

Warnings

Do not use Flucloxacillin Kabi if:

1. You have had an allergic reaction to flucloxacillin or other penicillins. Symptoms of an allergic reaction may include skin rash, itching, difficulty breathing or swelling.
2. You have had an allergic reaction to cephalosporin antibiotics.
   You may have an increased chance of being allergic to Flucloxacillin Kabi if you are allergic to cephalosporins.
3. You have a previous history of inflammation of the liver or yellow skin caused by flucloxacillin.
4. The packaging is torn or shows signs of tampering.
5. The expiry date (exp) printed on the pack has passed. If you use this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should be given Flucloxacillin Kabi, talk to your doctor.

WARNING Flucloxacillin can cause jaundice (yellowing of skin and/or eyes) and severe liver disease which may be last for a long time. This reaction is more frequent in older patients (particularly those over 55 years of age) and those who take the drug for more than 14 days.

Before you are given it

Tell your doctor or pharmacist if:

1. You have any type of allergic reaction to penicillin, amoxicillin or cephalosporin antibiotics.

You may have an increased chance of being allergic to Flucloxacillin Kabi if you are allergic to cephalosporins.

2. You have any allergies to any other medicines or any other substances such as foods, preservatives or dyes. This may include medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
3. You have, or have ever had, any other medical conditions including:

• asthma, hayfever or hives
• liver problems
• kidney problems
• glandular fever (infectious mononucleosis)

4. Your skin and/or eyes have turned yellow (jaundice) while, or soon after, receiving any antibiotics.

If you have not told your doctor or pharmacist any of the above, tell them before you are given Flucloxacillin Kabi 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 breastfeeding, intend to become pregnant or breastfeed. Your doctor will discuss the possible risks and benefits of using Flucloxacillin Kabi during pregnancy.

Check with your doctor if you are breast-feeding or plan to breast-feed. Your doctor will discuss the possible risks and benefits of using Flucloxacillin Kabi while breast-feeding.

3. What if I am taking other medicines?

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may be affected by Flucloxacillin Kabi, or they may affect how well it works.

These include:

• probenecid, a medicine used to treat gout
• paracetamol
• aminoglycosides; a group of antibiotic medicines used to treat some infections.

Some antibiotics may decrease the effectiveness of some birth control pills. Talk to your doctor about the need for an additional method of contraception whilst receiving Flucloxacillin Kabi.

You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor will advise you.

Your doctor may have more information on medicines to be careful with or to avoid while taking Flucloxacillin Kabi.

4. How am I given Flucloxacillin Kabi

Flucloxacillin Kabi is available in two strengths – 500mg and 1000mg.

Flucloxacillin Kabi 500mg and 1000mg injection is diluted and then given:

• as an injection into a vein
• as a deep injection into a large muscle
• in fluids given into a vein
• into the space around the lungs
• within a joint

Flucloxacillin Kabi must only be given by a doctor or nurse.

Your doctor will decide what dose and how long you will receive Flucloxacillin Kabi.

This depends on your infection and other factors, such as your weight. For most infections, Flucloxacillin Kabi is usually given in divided doses throughout the day.

If you receive too much (overdose)

As Flucloxacillin Kabi is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

However, if you experience severe side effects after being given this medicine, tell your doctor immediately.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Flucloxacillin Kabi. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may include the side effects listed below in the 6. Are there any side effects? section but are usually of a more severe nature.

5. What should I know after receiving Flucloxacillin Kabi?

Things you must do

Call your doctor straight away if:

• the symptoms of your infection do not improve within a few days, or if they become worse
• you develop itching with swelling or skin rash or difficulty breathing while you are receiving Flucloxacillin Kabi.
• you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after Flucloxacillin has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.
• you get a sore white mouth or tongue while being treated with or soon after stopping Flucloxacillin Kabi.
• you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of Flucloxacillin Kabi allows fungi to grow and the above symptoms to occur. Flucloxacillin Kabi does not work against fungi.

If you become pregnant while you are receiving Flucloxacillin Kabi, tell your doctor.

If you are about to start taking any new medicine, tell your doctor and pharmacist that you are receiving Flucloxacillin Kabi.

If you have to have any blood or urine tests, tell your doctor you are being given Flucloxacillin Kabi.

Flucloxacillin Kabi may affect the results of some blood or urine tests.

Tell all the doctors dentists and pharmacists who are treating you that you are being given Flucloxacillin Kabi.

Things you must do

Do not take any diarrhoea medicine without first checking with your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how flucloxacillin affects you.

This medicine does not generally cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, flucloxacillin may cause dizziness in some people.

If you experience dizziness, do not drive.

If you drink alcohol, dizziness may be worse.

Looking after your medicine

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

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine (as relevant)

Flucloxacillin Kabi should be stored in the pharmacy or in the ward.

The powder for injection is kept in a cool dry place where the temperature stays below 25°C.

6. Are there any side effects?

Check with your doctor as soon as possible if you have any problems while being treated with Flucloxacillin Kabi, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, Flucloxacillin Kabi can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

If you are over 65 years of age you may have an increased chance of getting side effects.

You may not experience any of them.

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

Less serious side effects

Less serious side effects	What to do
oral thrush – white, furry, sore tongue and mouth vaginal thrush – sore and itchy vagina and/or discharge nausea, stomach upsets mild diarrhoea or constipation dizziness or headaches pain or an uncomfortable feeling in the stomach or belching after eating.	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

signs 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 red and/or itchy skin, rash or hive on the skin difficulty breathing swelling yellowing of the skin and/or eyes (these may be symptoms of a type of liver disease called jaundice) nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching and dark coloured urine (these may be symptoms of a type of liver disease called hepatitis)

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 Flucloxacillin Kabi contains

Active ingredient (main ingredient)	Flucloxacillin sodium monohydrate
Other ingredients (inactive ingredients)	Flucloxacillin Kabi does not contain any other ingredient.
Potential allergens	Flucloxacillin Kabi does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

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

What Flucloxacillin Kabi looks like

Flucloxacillin Kabi is white or almost white crystalline powder for injection contained in a vial. (Aust R 340130 and 340131).

Who distributes Flucloxacillin Kabi

Flucloxacillin Kabi is supplied in Australia by:

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia
Tel: (02) 9391 5555

This leaflet was prepared in Oct 2023.