Flucloxacillin Capsules Bp 500mg
Front of leaflet -148.5mm
Package leaflet: Information for the user
Flucloxacillin Capsules BP 250 mg and 500 mg
Flucloxacillin as Flucloxacillin Sodium
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
• 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 have any further questions, please ask your doctor or pharmacist
• 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 Capsule is and what it is used for
2. What you need to know before you take Flucloxacillin Capsules
3. How to take Flucloxacillin Capsules
4. Possible side effects
5. Howto store Flucloxacillin Capsules
6. Contents of the pack and other information
1. What Flucloxacillin Capsules are and what they are used for
These capsules are available in two different strengths containing either 250mg or 500mg of the active ingredient, flucloxacillin (as flucloxacillin sodium).
Flucloxacillin is one of a group of antibiotics called penicillinase-resistant penicillins. It is used to kill bacteria which cause infections in your body.
Flucloxacillin Capsules are used to treat a wide range of bacterial infections which may include those affecting the chest and lungs, the pharynx, tonsils, sinuses and ears.
They are also used to treat skin and soft tissue infections such as boils, carbuncles, skin ulcers, abscesses, eczema, acne, infected wounds and burns, and also for skin-graft protection. They are also used to treat infections affecting the intestines, heart (i.e. endocarditis), membranes of the brain (i.e. meningitis), blood, bones, joints and urinary tract (kidney, bladder, urethra).
Flucloxacillin can also be used to prevent an infection occurring during major surgery, particularly in heart or orthopaedic surgery.
2. What you need to know before you take Flucloxacillin Capsules
Do not take Flucloxacillin capsules:
• If you know you are allergic to flucloxacillin or to any of the other ingredients (listed in section 6)
• If you have ever had an allergic reaction (e.g. rash, itching, shortness of breath) to another penicillin or cephalosporin antibiotic in the past
• If you have a previous history of jaundice or liver problems associated with taking 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
• 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
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.
• Probenecid (used to treat gout)
• Oral contraceptive pill (as it may not work properly and you will need to use other means of contraception e.g. a condom)
• 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)
Always tell your doctor or pharmacist about all the medicines you are taking. Some medicines may affect the way others work. This means medicines you have bought yourself as well as those you have on prescription from your doctor.
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
This medicinal product contains approximately 46.6mg sodium per g. To be taken into consideration by patients on a controlled sodium diet.
Other special warnings
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.
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 capsules should be swallowed whole with a drink of water.
The capsules should be taken half to one 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.
Always take the capsules exactly as the doctor has told you. The dose will be on the pharmacist's label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.
The recommended dose for:
Adults:
• Take one 250mg capsule four times a day. In more severe infections your doctor may prescribe a larger dose of 500mg four times a day
• Surgical prophylaxis: 1 to 2g IV at induction of anaesthesia followed by 500mg every six hours for up to 72 hours.
For infections of the joints or of the heart: Up to 8g daily, in divided doses every six to eight hours.
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It is important that you take your medicine at the right times of day. Space the doses out as evenly as possible throughout the day. Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may reoccur or get worse. Children under 10 years of age: Flucloxacillin Capsules are not suitable for use in children under 10 years, who are usually given a liquid preparation of flucloxacillin instead.
The usual liquid dose is as follows:
Children under 2 years of age: 62.5 mg four times a day. Children 2-10 years of age: 125 mg four times a day.
In serious infections the dosage may be doubled.
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 capsule than you should
You should contact your doctor or go to your nearest hospital casualty department immediately. Take your capsules or the pack with you so that the doctor knows what you have taken.
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.
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:
• Allergy or hypersensitivity including itchy rash, itching, hives, nettle rash or bleeding under the skin
• Sudden wheeziness: difficulty breathing: sore mouth or eyes ; swelling of the mouth, face, eyes, lips, throat, tongue or genitals
• Severe, possibly bloody, diarrhoea
• 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)
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 up to 1 in 10,000 people
• Redness, peeling or blistering of the skin (erythema multiforme)
• Difficulty passing water or blood in the urine (may be a sign of inflammation of the kidney)
• Joint or muscle pains or fever (may develop 2 days after starting treatment)
• Severe diarrhoea with bleeding, fever and abdominal pain (pseudomembranous colitis).
• Unexplained bleeding, bruising or skin discolouration, light-headedness, tiredness, weak pulse or palpitations (neutropenia (including agranulocytosis), thrombocytopenia, haemolytic anaemia).
Some of these reactions can be delayed for up to two months after finishing the treatment. Check with your doctor if you have any problems while taking this medicine, even if you think the problems are not connected with the medicine or are not listed in this leaflet.
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. 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. 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
What Flucloxacillin capsule contains
Each capsule contains either 250mg or 500mg of the active ingredient, flucloxacillin (as flucloxacillin sodium). The other ingredient 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 “flue 250" and the 500 mg capsules are printed with “flue 500". They are supplied to your pharmacist in packs of 28, 100, 250, 500 or 1000 capsules. Not all pack sizes may be available. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Special Concept Development (UK) Ltd, Units 1-7 Colonial Way, Watford, Hertfordshire WD24 4YR. Manufacturer: RX Farma Ltd, Unit 3 Colonial Way,
Watford, WD24 4YR.
Product licence numbers
PL 36722/0010
PL 36722/0011
For any information about this
medicine, please contact the
Marketing Authorisation Holder
The Leaflet was last reviewed in March 2016
If you would like this leaflet in a different format, please contact the licence holder at the above address.