INFORMATION FOR CONSUMERS
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This leaflet answers some common questions about FLUCLOXIN. FLUCLOXIN is administered by injection.
This leaflet does not contain all the available information.
It does not take the place of talking to your doctor and pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of taking FLUCLOXIN against the benefits this medicine is expected to have for you.
If someone else is injecting FLUCLOXIN for you, it is important they read this leaflet carefully and learn to recognise adverse effects this medicine may produce.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine
You may need to read it again.
FLUCLOXIN is an antibiotic belonging to a group of medicines called penicillin. This medicine works by killing or stopping the growth of bacteria, which cause infection.
It is used to:
FLUCLOXIN will not work against infections caused by viruses such as colds or the flu.
FLUCLOXIN is used to treat only infections that will respond to it. Some infections are resistant to the effects of FLUCLOXIN.
Your doctor may have prescribed FLUCLOXIN for another reason.
Ask your doctor if you have any questions about why FLUCLOXIN has been prescribed for you.
This medicine is available only with a doctor's prescription.
Do not use FLUCLOXIN if you have a history of allergic reaction to penicillins, cephalosporins or other allergens.
Symptoms of an allergic reaction may include:
Do not use FLUCLOXIN if you have a previous history of flucloxacillin-associated jaundice (yellowing of the skin) or liver dysfunction.
Do not use FLUCLOXIN if the packaging is torn or shows signs of tampering.
Do not use FLUCLOXIN after the expiry date (EXP) printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as
well.
Tell your doctor, surgeon, dentist or pharmacist if you are allergic to any other medicines, foods, dyes or preservatives.
An allergic reaction is more frequent following administration by
injection.
Severe allergic reactions require emergency medical treatment.
Tell your doctor if you are pregnant or intend to become pregnant.
There is insufficient safety information regarding the use of FLUCLOXIN during
the first trimester of pregnancy.
Use in the second and third trimester of pregnancy, and when breast feeding, has
shown no significant risk to the newly born baby.
However, there is a possibility of sensitisation, diarrhoea, thrush, and/or
skin rash developing in the infant if you take this medicine while pregnant or
breast feeding.
Your doctor will discuss the risks and benefits of taking this medicine during
pregnancy.
Caution should be exercised when administering FLUCLOXIN to newly born or
premature babies.
Flucloxacillin may cause hyperbilirubinaemia (high levels of bilirubin in the
blood). Bilirubin is produced when red blood cells are broken down. Usually the
liver processes bilirubin but in new born and premature babies, the liver is not
fully developed. High levels of bilirubin will cause jaundice and may lead to
brain damage. Babies using FLUCLOXIN must be monitored closely.
FLUCLOXIN remains in the body longer in newly born babies and the elderly
due to incomplete or decreased kidney function.
They are more likely to experience side effects.
During prolonged therapy, your doctor should carry out periodic tests to assess kidney and liver function and blood cell formation.
Hepatitis (swelling of the liver) is associated with flucloxacillin
therapy.
Hepatitis is more frequent with increasing age and prolonged therapy. Jaundice
(yellowing of the skin) may appear several weeks after therapy and is a sign of
liver problems. Although liver function does eventually return, hepatitis in
some cases is fatal.
Pseudomembranous colitis (inflammation of the small intestine and colon)
is associated with taking antibiotics.
Diarrhoea is a common symptom of Pseudomembranous colitis and may be mild to
severe. Tell your doctor immediately if you get diarrhoea during or shortly
after treatment has ended.
Be aware that superinfections may occur.
This is a new infection resulting from the invasion of bacteria resistant to
flucloxacillin. FLUCLOXIN should be discontinued and another therapy commenced.
FLUCLOXIN is unlikely to produce an effect on the ability to drive or use machinery, however, care should be taken until you know how this medicine affects you.
There is no evidence this medicine is addictive.
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with FLUCLOXIN.
FLUCLOXIN should not be mixed with blood products or other fluids containing protein.
Your doctor and pharmacist may have more information on medicines to be careful with or to avoid while taking this medicine
You and your caregiver must carefully follow all directions given to you by your doctor or pharmacist. Their directions may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
Your doctor will decide the dose by factoring in your medical condition and age.
The usual dose is as follows:
Intramuscular - muscle tissue
250 mg every 6 hours
Slow intravenous injection (I.V.) - direct access to a vein
250 mg to 1 g every 6 hours
Intrapleural - the membrane (pleura) surrounding the lungs and the
chest cavity
250 mg once daily
Intraarticular - within a joint
250 mg to 500 mg once daily
Your doctor, nurse, caregiver or yourself will make the FLUCLOXIN injection with sterile water or another diluent depending on the method of administration. The solutions should be thoroughly mixed by vigorous shaking and checked for the presence of particulate matter before use.
Needles for injection are purchased separately.
Follow your doctor's instructions carefully on how to make the injection solution and use the needle safely.
Your doctor, nurse, caregiver or yourself will inject directly into muscle
tissue or they (not yourself) may inject directly into the infusion
tubing, pleura or joints.
The solution for injection must be used immediately or within 72 hours when
stored at 5°C.
If pain is experienced during intramuscular injection, a sterile solution of lignocaine HCl may be used in place of water to alleviate the pain. Ask your doctor or pharmacist about these options.
If it is almost time for your next dose, skip the dose you missed and inject your next dose when you are meant to. Otherwise, take it as soon as you remember and then go back to taking it as you would normally.
Do not inject a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you develop a rash, hay fever, breathing difficulties or swelling, stop taking FLUCLOXIN immediately and seek medical treatment.
If the symptoms of your infection do not improve within days, or they become worse, tell your doctor.
If you become pregnant while you are taking FLUCLOXIN tell your doctor.
If you are about to start taking a new medicine tell your doctor and pharmacist that you are taking FLUCLOXIN.
Do not stop taking FLUCLOXIN or lower the dosage without checking with your doctor. You should take the full course of FLUCLOXIN even if you feel well or the infection may reappear.
Do not give FLUCLOXIN to anyone else, even if they have the same condition as you.
Do not take FLUCLOXIN to treat any other complaints unless your doctor tells you to.
All medicines can have side effects. Sometimes they are serious, most of the time they are not.
If you develop a rash, hay fever, breathing difficulties or swelling, stop taking FLUCLOXIN immediately and seek medical treatment.
See your doctor immediately if you or your care-giver notice the following:
Other side effects not listed above may occur in some patients.
Tell your doctor or pharmacist if you notice anything else that is making you unwell.
Immediately telephone a doctor, or the Poisons Information Centre (telephone 0800 POISON or 0800 764 766) or go to the accident and Emergency Department at your nearest hospital, if you think you or anyone else may have injected or swallowed too much FLUCLOXIN. Do this even if there are no signs of discomfort or poisoning.
Store FLUCLOXIN in a cool place protected from light and moisture.
Do not store FLUCLOXIN in the bathroom or near a sink. Do not leave it in the car on hot days. Heat and dampness can destroy some medicines.
Keep FLUCLOXIN in the original pack it is provided in until it is time to use it. The solution for injection must be used immediately.
Keep FLUCLOXIN and injection needles out of reach of children. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop using this medicine or it has passed it's expiry date, ask your pharmacist what to do with any vials that are left over.
250 mg injection: Type III glass vials containing a white powder for reconstitution and labelled with the appropriate content of flucloxacillin.
500 mg injection: Type III glass vials containing a white powder for reconstitution and labelled with the appropriate content of flucloxacillin.
1 g injection: Type III glass vials containing a white powder for reconstitution and labelled with the appropriate content of flucloxacillin.
All strengths of FLUCLOXIN come in packs of 5 vials.
Needles for injection are purchased separately.
FLUCLOXIN injection is compatible with the following infusion fluids for a period not exceeding 1 hour at room temperature: Dextrose 5%, Dextrose/Saline, Hartman's Ringers, 0.9% sodium chloride, dextrans.
FLUCLOXIN injection is stable when reconstituted in water for injection for
at least 72 hours when stored at 5°C.
It is compatible with the following infusion fluids for up to 72 hours when
stored at 5°C: Dextrose 5%, 0.9% sodium chloride and dextrose/saline.
Douglas Pharmaceuticals Ltd
Central Park Drive, Lincoln
Auckland 1008
Date of Preparation: 30th January 2004