Patient leaflet - Flucloxacillin capsules BP 250 mg
1. WHAT FLUCLOXACILLIN CAPSULES
ARE AND WHAT THEY ARE USED FOR
Do not take Flucloxacillin capsules:
If you know you are allergic to flucloxacillin
or to any of the other ingredients (listed in
If you have ever had an allergic reaction
(e.g. rash, itching, shortness of breath) to
β-lactam antibiotics (e.g. penicillins or
cephalosporins) in the past
If you have a previous history of jaundice or
liver problems associated with taking
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.
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.
Warning and precautions
Talk to your doctor or pharmacist before
taking Flucloxacillin Capsules
- If you are pregnant or breast-feeding
If you suffer from kidney problems, as you
may require a lower dose than normal
(convulsions may occur very rarely in
patients with kidney problems who take
high doses)
If you suffer from liver problems, as this
medicine could cause them to worsen
- If you are 50 years of age or older
If you have other serious illnesses (apart
from the infection this medicine is treating).
If you are taking this medicine for a long
time as regular tests of liver and kidney
function are advised.
- If you are on a sodium-restricted diet
you are giving this medicine to a newborn
child
- are taking or will be taking paracetamol
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLOXACILLIN CAPSULES
If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.
Other medicines and Flucloxacillin Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:
- probenecid or sulfinpyrazone (used to treat gout)
- methotrexate (a chemotherapy drug)
- oral typhoid vaccine (antibiotics can make this less effective)
- sugammadex (used with general anaesthetics)
- piperacillin (an antibiotic taken by injection)
- warfarin (medicine to prevent blood clotting)
- paracetamol
- other antibiotics (used to treat infections)
- Voriconazole (used against fungal infections)
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Flucloxacillin Capsules should not affect your ability to drive or operate machinery.
Flucloxacillin Capsules contains sodium
Each 250mg capsule contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
Each 500mg capsule contain 25mg of sodium. To be taken into consideration by patients on a controlled sodium diet.
Other special warnings
Regular monitoring of liver and kidney function should be performed whilst taking Flucloxacillin capsules.
If you are having urine tests or blood tests, tell your doctor that you are taking Flucloxacillin Capsules as they may affect the results of these tests.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
Take your flucloxacillin capsules at least 1 hour before or 2 hours after meals.
To reduce the risk of pain in your oesophagus
(the tube that connects your mouth with your stomach) swallow flucloxacillin capsules with a full glass of water (250 ml) and do not lie down immediately after taking your flucloxacillin capsules.
It is important that you take your medicine at the right times. The dose will depend on the patient and will be decided by your doctor.
The recommended dose for:
Adults (including the elderly): one 250mg capsule four times a day, your doctor may prescribe a different dose for severe infections.
- Joint infections (osteomyelitis) or heart infections (endocarditis) up to 8g daily in divided doses, six to eight hourly.
- To prevent infection due to surgery- 1 to 2g by injection into a vein, at the same time as the anaesthetic, followed by 500mg six hourly either by mouth or injection into a vein or muscle for up to 72 hours.
3. HOW TO TAKE FLUCLOXACILLIN CAPSULES
Use in children and adolescents
- Children aged 10-18 years – 250mg four times daily
Children aged 2-10 years: 125mg four times daily.
If you still feel unwell after finishing the treatment, speak to your doctor.
If you take more Flucloxacillin capsule than you should
You should contact your doctor or go to your nearest hospital casualty department immediately, if you or a child have swallowed too much medicine. Take your capsules or the pack with you so that the doctor knows what you have taken. Symptoms of overdose include feeling sick and diarrhoea.
If you forget to take Flucloxacillin Capsules
If you miss a dose don't worry. Do not take a double dose to make up for a forgotten dose, just carry on with the normal routine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you stop taking Flucloxacillin capsules Do not stop treatment early because some bacteria may survive and cause the infection to come back.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Flucloxacillin Capsules and tell your doctor immediately if you experience the following effects:
- hypersensitivity or severe allergic reaction including itchy rash, itching, sore mouth or eyes, swelling of the face, lips, throat or tongue or breathing problems.
Severe bloody diarrhoea
(pseudomembranous colitis).
- Jaundice (yellow colour of the skin and whites of the eyes), hepatitis (liver inflammation) - sometimes these effects on the liver can be delayed for up to 2 months after finishing treatment
- Severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome)
- Severe rash with reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis)
- changes in numbers of blood cells (causing unexplained bleeding, bruising or skin discolouration),
Tell your doctor immediately if you experience the following:
Common: may affect up to 1 in 10 people
- Diarrhoea, stomach upset and feeling sick - should be mild and wear off after a few days
Uncommon: may affect up to 1 in 100 people:
- Rash, urticaria and purpura
Very rare: may affect to 1 in 10,000 people
- Inflammation of the kidney
- Blood disorders (neutropenia (including agranulocytosis), thrombocytopenia, haemolytic anaemia).
- Anaphylactic Shock (severe allergic reaction)
- Angioneurotic Oedema (rapid swelling)
- Severe diarrhoea with bleeding, fever and abdominal pain (pseudomembranous colitis).
- Changes in liver function test
- Redness, peeling or blistering of the skin (erythema multiforme)
- Joint or muscle pains or fever (may develop 2 days after starting treatment)
- 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).
Some of these reactions can be delayed for up to two months after finishing the treatment.
Not known (frequency cannot be estimated from the available data)
- Serious skin reactions - A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). Contact a doctor immediately if you get any of these symptoms.
- Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythm.
Pain in oesophagus (the tube that connects mouth with stomach) and other related symptoms, such as difficulties in swallowing, heartburn, throat irritation or chest pain.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at 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.
5. HOW TO STORE FLUCLOXACILLIN CAPSULES
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
Store this medicine in a dry place, below 25°C.
Store in the original pack. Keep it in the pack in which it was given to you. Do not transfer your medicine to another container.
Do not use your medicine after the expiry date shown on the label or carton.
The expiry date refers to the last day of that month.
If your doctor tells you to stop taking the capsules, please take any unused medicine back to your pharmacist to be destroyed.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Marketing Authorization Holder Flamingo Pharma (UK) Ltd.
st1 Floor, Kirkland House,
11-15 Peterborough Road, Harrow, Middlesex, HA1 2AX, United Kingdom.
Manufacturer
Flamingo Pharma (UK) Limited,
The Bloc, 38 Springfield Way,
Anlaby, Hull, HU10 6RJ,
United Kingdom
Product licence numbers
PL 43461/0070
PL 43461/0071
For any information about this medicine, please contact the Marketing Authorisation Holder
The Leaflet was last reviewed in April 2023.
If you would like this leaflet in a different format, please contact the licence holder at the above address.
MPLLFLU0500CPCOM
FPLXXX237V02 What Flucloxacillin capsule contains
Each capsule contains either 250mg or 500mg of the active ingredient, flucloxacillin (as flucloxacillin sodium). The other ingredien
t is magnesium stearate. The capsule shells contain gelatin and the colours indigo carmine
(E132) and titanium dioxide (E171). The printing ink contains titanium dioxide (E171), shellac and polysorbate 80.
What Flucloxacillin Capsules look like and contents of the pack
The capsule shells are blue. The 250 mg capsules are printed with “fluc 250” and the 500 mg capsules are printed with “fluc 500”. They are supplied to your pharmacist in packs of 28, 100, 250, 500 or 1000 capsules.
Not all pack sizes may be available.
POM
- Children under 2 years: 62.5mg four times daily.
- Premature or babies less than 4 weeks old: Not recommended.
- Severe kidney disease: your doctor may reduce your dose.