Flucloxacillin 1g Powder for Solution for Injection or Infusion

• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Flucloxacillin 250mg, 500mg and 1g Powder for Solution for Injection or Infusion. In the rest of this leaflet it is called Flucloxacillin Injection.

1. What Flucloxacillin Injection is and what it is used for
2. What you need to know before you use Flucloxacillin Injection
3. How to use Flucloxacillin Injection
4. Possible side effects
5. How to store Flucloxacillin Injection
6. Contents of the pack and other information

• If you are allergic to flucloxacillin or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to cephalosporins, penicillin, or any other β-lactam antibiotic
• If you have had jaundice (yellow skin and whites of eyes) or other liver problems when you have been given flucloxacillin previously.

Talk to your doctor before using Flucloxacillin Injection:

• If you have had any allergies especially to any other drugs (particularly penicillin)
• If you are suffering from liver or kidney problems
• If you have heart failure
• If you have syphilis (a sexually transmitted disease)
• If you have leptospirosis (Weil’s disease)
• If you suffer from porphyria (an inherited blood disorder)
• If you are taking or will be taking paracetamol.

The use of flucloxacillin, especially in high doses, may reduce the potassium levels in the blood (hypokalaemia). Your doctor may measure your potassium levels regularly during the therapy with higher doses of flucloxacillin.

There is a risk of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, particularly in certain groups of patients at risk, e.g. patients with severe renal impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used. High anion gap metabolic acidosis is a serious disease that must have urgent treatment.

Special care should be taken in newborn babies to avoid overdose or high levels of a chemical in the blood which can lead to brain damage.

If any of the above statements apply to you, speak to your doctor or nurse before you are given Flucloxacillin Injection.

Taking other medicine while you are being given Flucloxacillin Injection can affect how it or the other medicine works. Tell your doctor if you are taking, have recently taken or might take any other medicines.

Please particularly check with your doctor if you are taking or need to take any of the following:

• oral contraceptives that contain oestrogen e.g. the combined pill. If you are using this type of medicine you should take additional precautions to prevent pregnancy while you are receiving Flucloxacillin Injection and for at least seven days afterwards. If these seven days run beyond the end of a packet of contraceptive pills you should start the next packet immediately without a break
• probenecid, a drug used for the treatment of gout
• methotrexate, a drug used in the treatment of cancer
• certain other “bacteriostatic” antibiotics (antibiotics that stop bacteria growing but do not kill them), such as chloramphenicol and tetracycline
• voriconazole (used against fungal infections).

Flucloxacillin Injection may interfere with various laboratory tests.

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

You should let your doctor know immediately if you are pregnant or trying for a baby before this medicine is administered.

You should not breast-feed whilst being given Flucloxacillin Injection. You should let your doctor know if you are breast-feeding while you are having treatment with Flucloxacillin Injection.

Flucloxacillin Injection is not known to affect your ability to drive or use machines.

Flucloxacillin Injection 250mg contains less than 1mmol sodium (23mg) per vial i.e. essentially sodium free.

Flucloxacillin Injection 500mg and 1g contain 1.13mmol and 2.26mmol of sodium per vial respectively. To be taken into consideration by patients on a controlled sodium diet.

The recommended dose by intramuscular injection or infusion is 250mg every six hours. The recommended adult dose by intravenous injection is 250mg to 1g every six hours. These doses may be doubled in severe infections. Doses of up to 8g a day may be required for osteomyelitis or endocarditis. To prevent surgical infections you will be given 1 to 2g with your anaesthetic followed by 500mg every six hours.

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

Special care should be taken in newborn babies to prevent the risk of overdosing.

The usual doses are:

• into infected joint - 250 to 500mg once a day
• into chest - 250mg once daily
• by inhaler - 125 to 250mg every six hours.

If you have severe kidney failure you may be given a lower dose or you may receive your doses less frequently.

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.

A doctor or nurse will give you this medicine. If you think you may have received too much Flucloxacillin Injection, please tell your doctor or nurse immediately. Symptoms of an overdose may include fits, behaviour disorders, fever, weakness, breathlessness, bleeding more easily and longer than usual, or changes to the salt levels in the blood.

A doctor or a nurse will give you this medicine. If you think you have missed a dose, please tell your doctor or nurse.

• rash
• itching
• redness and blistering of the skin
• fever
• aching joints
• swelling of the face, throat or hands
• difficulty breathing
• anaemia
• kidney problems
• blood problems (causing a sore throat, mouth ulcers, repeated infections or a tendency to bleed easily)
• fits (convulsions) and other problems affecting the nervous system
• serious skin reactions
• a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis).

• tenderness of the upper abdomen which may indicate inflammation of the liver or jaundice (yellow skin and whites of eyes)
• severe diarrhoea. Treatment with Flucloxacillin can affect the normal bacteria in the gut, causing a new infection (pseudomembranous colitis).

Hepatitis (inflammation of the liver) and jaundice may be long lasting. They are more likely in the elderly or patients who have been given flucloxacillin for more than two weeks.

Other side effects include:

• shortness of breath
• difficulty in breathing or wheezing
• tender red lumps under the skin
• blistering of the skin
• red or purple skin discolouration
• inflammation of blood vessels, often with skin rash
• severe attacks of porphyria (an inherited blood disorder)
• hallucinations
• feeling sick
• being sick
• thrush in the mouth
• coma
• high salt levels in the blood
• redness and pain around the area of infusion.

Very rare (may affect up to 1 in 10,000 people):

Very rare cases of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors (see section 2).

Not known (cannot be estimated from the available data):

• Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythm.

Patients who have syphilis or leptospirosis (Weil’s disease) have occasionally suffered from a type of reaction (Jarisch-Herxheimer reaction) shortly after their injection, with fever, chills, headache and sometimes heart or eye problems.

Your doctor may take blood tests during your treatment to check your liver, kidneys and blood, particularly if you receive high doses or a long course of treatment.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is flucloxacillin as flucloxacillin sodium monohydrate.

There are no other ingredients.

Flucloxacillin Injection is a white or almost white powder for solution for injection/infusion. Flucloxacillin Injection is supplied in glass vials fitted with a grey bromobutyl rubber stopper and sealed with an aluminium crimped flip-off cap.

Flucloxacillin Injection is available in packs of 10 vials.

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