Patient leaflet - Flucloxacillin 250 mg capsules BP
1. What Flucloxacillin Capsules are and what they are used for
Flucloxacillin is an antibiotic used to treat infections by killing the bacteria that can cause them. It belongs to a group of antibiotics called "penicillins".
Flucloxacillin capsules are used to treat:
- chest infections
- throat or nose infections
- ear infections
- skin and soft tissue infections
- heart infections
- bones and joints infections
- meningitis
- digestive system infections
- blood infections
kidney, bladder or urethra (the tube which carries
urine from the bladder) infections.
Flucloxacillin capsules can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.
2. What you need to know before you take Flucloxacillin Capsules
Do not take Flucloxacillin capsules if:
you are allergic to flucloxacillin or any other
penicillin antibiotics (see symptoms in section 4). • you are allergic to any of the other ingredients of
this medicine (listed in section 6).
you have suffered previously from liver problems
(e.g. jaundice) after taking flucloxacillin. • you have had an allergic reaction to β-lactam
antibiotics (e.g. penicillins, cephalosporins).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
- are 50 years of age or older
have other serious illness (apart from the infection
this medicine is treating).
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).
suffer from liver problems, as this medicine could
cause them to worsen.
are taking this medicine for a long time as regular
tests of liver and kidney function are advised • are taking or will be taking paracetamol • are on a sodium-restricted diet.
- are giving this medicine to a newborn child
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.
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 in the treatment of 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
- voriconazole (used against fungal infections) • Other antibiotics (used to treat infections)
Flucloxacillin Capsules with food and drink
Take your flucloxacillin capsules at least 1 hour before or 2 hours after meals.
Pregnancy, breast feeding and fertility
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.
Tests
Regular monitoring of liver and kidney function should be performed whilst taking flucloxacillin capsules for a long period of time. Tell your doctor that you are taking flucloxacillin capsules if you are having urine tests or blood tests because it may affect the results
Driving and using machines
Flucloxacillin Capsules are not expected to affect your ability to drive or operate machinery.
Flucloxacillin Capsule contains Sodium
This medicine contains less than 1mmol sodium (23mg) per capsule, that is to say essentially 'sodium free’.
3. How to take Flucloxacillin Capsules
Always take the capsules exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For oral use only.
Take this medicine when your stomach is empty. It is important that you take your medicine at the right times.
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 capsules with a full glass of water (250 ml) and do not lie down immediately after taking your capsules.
Take this medicine when your stomach is empty. This means an hour before food or 2 hours after food. 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. However, the usual doses for each age group are:
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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Flucloxacillin 250mg Capsules BP Flucloxacillin 500mg Capsules BP
(flucloxacillin sodium)
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.
Use in children and adolescents
Children aged 10-18 years – 250mg four
times daily
Children aged 2-10 years: 125mg four times
daily.
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.
If you still feel unwell after finishing the treatment, speak to your doctor.
If you take more Flucloxacillin Capsules than you should
Contact your doctor or nearest hospital casualty department if you or a child have swallowed too much medicine. Take this leaflet and any remaining capsules with you, if possible. Symptoms of overdose include nausea, vomiting, diarrhoea.
If you forget to take Flucloxacillin capsules
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and carry on as before, try to wait about four hours before taking the next dose.
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, Flucloxacillin Capsules can cause side effects, although not everybody gets them.
STOP taking Flucloxacillin Capsules and contact your doctor if you experience any of the following:
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 in 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 if you notice any of the following side effects or notice any other effects not listed:
COMMON: (may affect up to 1 in 10 people) • Minor stomach disturbances e.g. stomach upset
or diarrhoea gastrointestinal disturbances (e.g. diarrhoea, nausea & vomiting)
VERY RARE: (may affect up to 1 in 10,000 people) • Inflammation of the kidney
- Anaemia
Erythema multiforme (skin rash with circular, red
patches)
Arthralgia (pain in a joint) and myalgia (pain in the
muscles).
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 reaction - A red, scaly rash with
bumps under the skin and blisters (exanthematous pustulosis). Contact your 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:
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.
Do not store above 25°C. Store in the original pack and keep tightly closed.
Do not use the capsules after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Flucloxacillin Capsules contains
The active substance is flucloxacillin sodium, 250mg or 500mg per capsule.
The other ingredients are:
- Magnesium stearate (E572), Colloidal anhydrous silica.
Body- red iron oxide (E172), yellow iron oxide
(E172), titanium dioxide (E171), gelatin. • Cap - black iron oxide (E172), titanium dioxide
(E171), gelatin.
Ink components - titanium dioxide (E171), shellac
(E904), industrial methylated spirits, soya lecithin, dimethyl siloxane, mono- and di-glycerides of fatty acids (E471), methyl cellulose, polyethylene glycol stearate, xanthan gum, benzoic acid, polyethylene glycol, sorbic acid.
See Section 2 'Important information about some of the ingredients of Flucloxacillin Capsules'.
What Flucloxacillin Capsules look like and contents of the pack
The capsules are hard gelatin, elongated with caramel body and black cap printed with 'FLU250MIL' for the 250mg strength, or 'FLU500MIL' for the 500mg strength. They are available in white plastic containers containing 14, 28, 100, 250, 500 and 1000 capsules, or blister strips of 14, 28 and 100 capsules (not all pack sizes may be marketed).
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD,
United Kingdom
Manufacturer
Milpharm Limited
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD,
United Kingdom
APL Swift Services (Malta) Ltd.,
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia BBG 3000, Malta