INFORMATION FOR PATIENTS

Please read this leaflet carefully before this medicine is administered. It gives an outline of the more important things you should know. If you want to know more about this medicine or you are not sure about anything, ask your doctor, nurse or pharmacist. You should keep this leaflet throughout your course of treatment.

THE NAME OF YOUR MEDICINE IS FLUCLOXACILLIN FOR INJECTION 250MG, 500MG and 1G

Flucloxacillin for Injection contains the active ingredient flucloxacillin as flucloxacillin sodium monohydrate. Each vial contains 250mg, 500mg or 1g of the active ingredient only, there are no excipients.

Flucloxacillin for Injection is a white powder for solution for injection/infusion.

Flucloxacillin for Injection 250mg, 500mg and 1g are available in packs containing 10 vials. The sodium content of each vial is 0.57mmol, 1.13mmol and 2.26mmol respectively and this must be taken into consideration by patients on a controlled sodium diet.

HOW DOES YOUR MEDICINE WORK?

Flucloxacillin belongs to a group of medicines called penicillins, which are antibiotics. These medicines work by killing bacteria that cause infections.

WHAT IS FLUCLOXACILLIN FOR INJECTION FOR?

Flucloxacillin for Injection is used for the treatment of a range of bacterial infections including bone and joint infections, infections of the heart and blood stream, and to prevent and treat infections caused by surgical operations.

BEFORE ADMINISTRATION OF THIS MEDICINE

Flucloxacillin for Injection should not be administered if:

• You are allergic to flucloxacillin, cephalosporins, penicillin, or any other β-lactam antibiotic. You should also let your doctor know if you are allergic to any other drugs (besides penicillin) before the injection is administered.
• You have had jaundice (yellow skin and whites of eyes) or other liver problems when you have been given flucloxacillin previously.
• Flucloxacillin should not be given into the eye.

You should let your doctor know if you are pregnant or breast-feeding or wish to become pregnant or start breast-feeding before this medicine is administered.

Taking another medicine when Flucloxacillin for Injection is administered can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines while you are being treated with Flucloxacillin for Injection unless you have told your doctor, nurse or pharmacist and asked their advice. This includes medicines you may have bought yourself.

Examples of medicines that can affect Flucloxacillin for Injection are:

• Oral contraceptives that contain oestrogen e.g. the combined pill.
• Probenecid, a drug used for the treatment of gout.
• Methotrexate, a drug used in the treatment of cancer.
• Certain other “bacteriostatic” antibiotics, such as chloramphenicol and tetracycline

If you have any doubts about whether you should be given this medicine then talk to your doctor.

 

ADVICE WHEN FLUCLOXACILLIN FOR INJECTION IS ADMINISTERED.

• If you are using an oral contraceptive ("the pill") you should take other precautions as well while you are having flucloxacillin and for at least seven days afterwards. If these seven days run beyond the end of a packet you should start the next packet immediately, without a break.
• Care is required if you are given a high dose, especially if you have liver, kidney or heart problems. You will be carefully monitored throughout your treatment. Care is also required if you are being treated for more than two weeks or are elderly.
• Care is required if you have syphilis (a sexually transmitted disease) or porphyria (a blood disorder). You should let your doctor or nurse know.
• Special care is needed in newborn babies, who are prone to jaundice.

ADMINISTERING THIS MEDICINE

Your doctor or nurse will prepare your injection by mixing your medicine with a diluent, either in the vial or in another container. The mixture is usually injected intramuscularly (into a muscle) or intravenously (into a vein) which will be done slowly over three to four minutes using a syringe or drip (infusion). In certain circumstances it can be injected directly into an infected joint or the chest wall, or breathed in as a mist.

The usual adult dose by intramuscular injection is 250mg every six hours. The usual adult dose by intravenous injection is 250mg to 1g every six hours.

The usual dose for children aged two to ten years is half the adult dose. The usual dose for children under two years old is a quarter of the adult dose.

Your doctor will decide the dose that is best for you. If you do not understand, or are in any doubt, ask your doctor or nurse.

ARE THERE ANY SIDE-EFFECTS?

Like many medicines flucloxacillin may cause side-effects in some patients, particularly when it is first given. Flucloxacillin for Injection may cause allergic reactions such as rash, itching, redness and blistering of the skin, fever, aching joints, swelling, headache, feeling generally unwell, sore eyes, jaundice, kidney problems and blood in the urine. You should tell your doctor immediately if you develop any of these, even if they occur some weeks after you have stopped having the injections.

The side effects that some other patients have had with flucloxacillin include feeling sick, vomiting, sore mouth, blood problems (causing sore throat, mouth ulcers, or a tendency to bleed easily), fits (convulsions) and other problems affecting the nervous system, and high salt levels in the blood. Serious effects on liver function, hepatitis (inflammation of the liver) and jaundice can occur and may be long lasting. They are more likely in the elderly or patients who have been given flucloxacillin for more than two weeks. Tell your doctor if you develop loss of appetite, stomach upset, tenderness of the upper abdomen or jaundice (yellow skin and whites of eyes), even if it is a month or two since you had the injections.

Antibiotic treatment can affect the normal bacteria in the gut, causing new infection (colitis). You should tell your doctor if you develop diarrhoea.

Patients who have syphilis have occasionally suffered from a type of reaction (Jarisch-Herxheimer reaction) after the injection, with fever, chills, headache and heart problems.

Occasionally if you have had an intravenous injection, there may be swelling around the area of injection.

If you experience any other side-effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist.

SAFE KEEPING FOR THIS MEDICINE

• This medicine should not be administered if the expiry date on the label has passed or if the powder shows signs of discoloration.
• The vials should not be stored above 25°C.
• Flucloxacillin for Injection should be kept in a secure place where children cannot reach or see it.