Flucloxacillin 500 Mg Capsules
24 mm
10 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCLOXACILLIN 250MG CAPSULES FLUCLOXACILLIN 500MG CAPSULES
(Flucloxacillin)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Flucloxacillin Capsules are and what are they used for
2. What do you need to know before you take Flucloxacillin Capsules
3. How to take Flucloxacillin Capsules
4. Possible side effects
5. How to store Flucloxacillin Capsules
6. Contents of the pack and other information
1. What Flucloxacillin Capsules are and what are they used for
The name of the medicine is Flucloxacillin 250mg or 500mg Capsules which will be referred to as Flucloxacillin Capsules throughout this leaflet.
The active ingredient is flucloxacillin.
Flucloxacillin belongs to a group of medicines called Beta-lactamase resistant penicillins. It is an antibiotic used to treat infections by killing the bacteria that cause them.
Flucloxacillin is used to treat the following infections in adults, and children aged 2-10 years. It can also be used in children less than 2 years of age. Your doctor will adjust the dose depending on the age of the patient
• skin and soft tissue infections (including boils, abcesses, carbuncles, ulcers, infected eczema and acne, wounds
and burns.
• chest infections (including pneumonia and lung abcess)
• ear, nose and throat infections including tonsils (tonsillitis), sinuses (sinusitis), pharynx (pharyngitis) and ear infections (otitis media and otitis externa).
• heart infections (endocarditis)
• bones and joint infections (osteomyelitis)
• infections of the membranes of the brain (meningitis)
• gut infection (enteritis)
• blood infections (septicaemia)
• infections of kidney, bladder and urethra (the tube that carries urine from the bladder)
• Flucloxacillin can also be used to prevent infections during major surgical procedures, particularly in heart or orthopaedic surgery.
2. What you need to know before you take Flucloxacillin Capsules
Do not take Flucloxacillin Capsules if you:
• have ever been told you are allergic to flucloxacillin, any other antibiotics (especially penicillin) or any other ingredients (these are listed in Section 6.)
• have a previous history of jaundice (yellowing of the skin) or liver problems related to flucloxacillin
Warnings and Precautions:
Tell your doctor before taking Flucloxacillin Capsules if you have or have had any medical conditions, and especially if you:
• have had a skin rash, swelling of the face or neck, or any serious complaint when taking any antibiotic
• are 50 years of age or older
• are suffering from any serious illness
• have liver problems
• are on a low-sodium diet
• are being treated for kidney problems or gout
• are taking this medicine for a long time as regular tests of liver and kidney function is advised.
New-borns receiving flucloxacillin treatment should be regularly monitored by the doctor.
Tell your doctor that you are taking Flucloxacillin if you are having urine tests or blood tests because Flucloxacillin may affect the results.
Other medicines and Flucloxacillin Capsules
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or might take any other medicines. This is because Flucloxacillin Capsules can affect the way some medicines work. Also some other medicines can affect the way Flucloxacillin Capsules work.
Especially:
• probenecid or sulfinpyrazone (to treat gout)
• methotrexate (a chemotherapy drug)
• oral typhoid vaccine (antibiotics can make it less effective)
• sugammadex (used with general anaesthetics)
• piperacillin (an antibiotic taken by injection)
• warfarin (medicine to prevent blood clotting)
Pregnant, 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 advise before taking this medicine.
Flucloxacillin capsules contain Sodium and Benzoates Each 250mg capsule contains approximately 13mg of sodium and each 500mg capsule contains approximately 25mg of sodium. Check with your doctor before taking this medicine if you are on a sodium restricted diet.
This medicine also contains methyl hydroxy benzoate and propyl hydroxy benzoate which may cause allergic reactions.
3. How to take Flucloxacillin Capsules
• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• The dosage and duration of treatment will depend on the type and severity of the infection.
• Take each capsule with a full glass of water
• 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.
Adults:
• The usual dose is one 250 mg capsule four times a day.
• The dose may be doubled in case of severe infections.
• For infections of the joints (osteomyelitis) or heart (endocarditis), the usual dose is up to 8 g daily in divided doses six to eight hourly.
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• For surgical prophylaxis, 1 to 2g is given intravenously at induction of anaesthesia followed by 500mg every six hours for upto 72 hours.
Use in children:
• The usual dose for children aged 2-10 years is half the adult dose.
• The dose for children under 2 years old is quarter of the adult dose.
• Your doctor may prescribe a different dose depending on the age, weight and severity of infection.
• If a dose of less than 250mg is required your doctor will prescribe flucloxacillin in a dosage form that is suitable for your needs.
Patients with kidney problems
If you suffer from severe kidney failure your doctor will give you lower or fewer doses.
If you take more Flucloxacillin Capsules than you should
It is important to stick to the dose on the label. Taking more than this can make you ill.
If you accidently take too many capsules, tell your doctor immediately or contact your nearest Hospital Casualty/Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
If you forget to take Flucloxacillin Capsules If you forget to take a dose, take it as soon as you remember, however, if it is almost time for your next dose then, skip the missed dose and then take your next dose when it is due.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE
If you stop taking Flucloxacillin Capsules
Take all the capsules that have been prescribed for you, even if you start to feel better. Your symptoms may start to improve before the infection is completely treated. If you stop taking the capsules too soon, your symptoms may return.
| 4. Possible side effects |
Like all medicines, this medicine cause side effects, although not everybody gets them.
STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following:
• hypersensitivity or severe allergic reaction including swollen face or breathing problems. An unexpected skin reaction, e.g. a rash and/or a sore mouth or eyes
• blisters or ulcers (Stevens-Johnson syndrome)
• peeling and swelling of the skin that resembles burns (toxic epidermal necrolysis)
• allergic skin reactions e.g. 'hives' or 'nettle' rash
• severe diarrhoea with bleeding
• notice your urine becoming darker or your faeces (otherwise known as poo) becoming paler
• hepatitis (inflammation of the liver)
• cholestatic jaundice (skin or white of your eyes turning yellow)
• changes in numbers of blood cells (causing unexplained bleeding, bruising or skin discolouration)
• inflammation of the kidney (nephritis), bowel and/or liver
• joint or muscle pain, this may develop after 2 days or more from the start of treatment with Flucloxacillin
• fever, this may develop after two days or more from the start of treatment with flucloxacillin
Common side effects: (effects less than 1 in 10 people but more than 1 in 100 people)
• diarrhoea, stomach upset and feeling sick - should be mild and wear off after a few days.
Very rare side effects: (effects less than 1 in 10,000 people)
• difficulty passing water or blood in urine (may be a sign of inflammation of kidney)
Inflammation of kidney (interstitial nephritis) is usually reversible when treatment is discontinued, but in rare situations can lead to kidney failure
Some of these reactions can be delayed for up to two months after finishing the treatment.
Reporting of side effects
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 at: www.mhra.gov.uk/yellowcard. 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.
• Blisters : Do not store above 250C. Store in the original packing.
• Do not use this medicine after the expiry date shown on the pack.
• 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 enviroment.
6. Contents of the pack and other information What Flucloxacillin Capsules contain:
• The active ingredient is flucloxacillin (as flucloxacillin sodium).
• Flucloxacillin Capsules come in two strengths, 250mg and 500mg. Each capsule contains either 250mg or 500mg of the active ingredient.
• The other ingredients are magnesium stearate, gelatin, indigo carmine (E132), titanium dioxide (E171), shellac, methyl hydroxybenzoate and propyl hydroxybenzoate.
What Flucloxacillin Capsules look like and contents of the pack:
• The 250 mg capsules are blue coloured printed with ”F 250”.
• The 500 mg capsules are blue coloured printed with ”F 500”.
• The capsules are supplied to the pharmacist in packs containing 28 and 56 capsules; your pharmacist will provide you with the required number of capsules as prescribed by your doctor.
• Not all packs may be marketed.
Marketing Authorisation Holder and Manufacturer:
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
E-mail: info@bristol-labs.co.uk
Flucloxacillin 250mg Capsules: PL 17907/0052 Flucloxacillin 500mg Capsules: PL 17907/0053 This leaflet was last revised in August 2015
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
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V4 12-08-15 D0 B
150 mm
240 mm
SAME SIZE ARTWORK
240 x 150 mm
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10 mm