FLUCLOXACILLIN 500MG CAPSULES
Active substance: FLUCLOXACILLIN SODIUM
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Patient Information Leaflet
FLUCLOXACILLIN 250MG CAPSULES FLUCLOXACILLIN 500MG CAPSULES
Read all of this leaflet carefully before you start taking your medicine. eep this leaflet. You may need to read K it again. f you have further questions, please I ask your doctor or pharmacist (chemist). his medicine has been prescribed for T you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. f any of the side effects gets serious, I or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
You are 50 years of age or older ou have other serious illnesses (apart Y from the infection this medicine is treating) ou are taking this medicine for a long Y time as regular tests of liver and kidney function is advised You are on a sodium restricted diet. Check with your doctor or pharmacist before taking this medicine if you are taking any other medicines, especially: robenecid or sulfinpyrazone (used to P treat gout) Methotrexate (a chemotherapy drug) he contraceptive pill as antibiotics can T make these less effective (you will need to use extra precautions such as condoms while taking flucloxacillin and for a full 7 days after you finish taking it) ral typhoid vaccine (antibiotics can O make this less effective) ugammadex (used with general S anaesthetics) iperacillin (an antibiotic taken by P injection) Some medicines may affect the way others work. Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from a doctor.
Pharmacode Position
Taking other medicines
IN THIS LEAFLET 1 hat your medicine is and what W it is used for 2 Before you take your medicine 3 How to take your medicine 4 ossible side effects of your P medicine 5 How to store your medicine 6 Further information
1 HAT YOUR MEDICINE IS AND W
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 is used to treat: hest infections c throat or nose infections ar infections e skin and soft tissue infections eart infections h bone and joint infections meningitis igestive system infections d blood infections idney, bladder or urethra (the tube which k carries urine from the bladder) infections. Flucloxacillin can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.
WHAT IT IS USED FOR
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Important information about some of the ingredients in your medicine
This medicine contains approximately 52.3mg sodium per g. Check with your doctor before taking this medicine if you are on a sodium restricted diet.
2 EFORE YOU TAKE YOUR B
Do not take this medicine if:
MEDICINE
ou have ever had an allergic reaction Y to flucloxacillin or any other penicillin antibiotics (see symptoms section 4). ou have ever had an allergic reaction Y to any of the other ingredients of this medicine see list of ingredients in section 6, Further information. ou have suffered previously from liver Y problems (e.g. jaundice) after taking flucloxacillin.
3 HOW TO TAKE YOUR MEDICINE Follow all directions given to you by your doctor or pharmacist. Their directions may differ from the information contained in this leaflet. The pharmacists label should tell you how much to take and how often. If it does not, or you are not sure, check with your doctor or pharmacist. Take this medicine when your stomach is empty. This means an hour before food or 2 hours after food. 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)
Take special care with your medicine
Check with your doctor or pharmacist before taking this medicine if: ou suffer from kidney problems, as you Y may require a lower dose than normal ou suffer from liver problems, as this Y medicine could cause them to worsen
Continued top of next column AAAE3614
The usual dose is 250mg four times a day one or heart infection: Up to 8g daily, in B divided doses at six to eight hours apart. urgical prophylaxis: 1 to 2g IV at S induction of anaesthesia followed by 500mg every six hours for up to 72 hours.
Continued over page
Children
Children (10-18 years of age): Same as adult dose Children (2-10 years of age): Half the adult dose Children under 2 years of age: Quarter the adult dose
Patients with kidney problems
If you suffer from severe kidney failure your doctor will give you lower or fewer doses.
If you take more of your medicine than you should
If you (or somebody else) accidentally takes too much of your medicine, speak to your doctor or pharmacist immediately.
If you forget to take your medicine
If you forget to take a dose, take it as soon as you remember, then carry on as before. Do not take a double dose to make up for the dose you have missed.
5 HOW TO STORE YOUR MEDICINE Do not use this medicine after the expiry date shown on the label. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Securitainers: Store below 25oC. Store in the original package. Keep the container tightly closed to protect from light and moisture. Blister Packs: Store below 25oC. Do not open the foil pouch until ready to use the product. Once opened the foil pouch may be discarded. Store the product in the outer carton to protect from light and moisture. Return any left-over medicine to the pharmacist. 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 protect the environment. 6 FURTHER INFORMATION
If you stop taking your medicine
Keep taking your 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 infection may return or get worse. If you are still unwell after taking all the medicine, go and see your doctor.
What Flucloxacillin Capsules contain
Active ingredient: flucloxacillin as flucloxacillin sodium Other ingredients: sodium starch glycolate, magnesium stearate, red iron oxide (E172), yellow iron oxide (E172),black iron oxide (E172), titanium dioxide (E171) and gelatin. Please see further information on sodium in section 2.
4 OSSIBLE SIDE EFFECTS OF P
Like all medicines, Flucloxacillin Capsules may cause unwanted side effects. If they occur, they are likely to be temporary, and not serious. However, some may be serious and need medical attention.
YOUR MEDICINE
What Flucloxacillin Capsules look like and contents of the pack
llergy or hypersensitivity including itchy a rash, itching, sore mouth or eyes, swelling of the face, lips, throat or tongue or breathing problems severe, possibly bloody, diarrhoea aundice (yellow colour in the skin and j whites of the eyes) (Can be delayed for up to 2 months after finishing treatment.) evere skin rash with flushing, fever, s blisters or ulcers (Stevens-Johnson syndrome) evere rash with reddening, peeling and s swelling of the skin that looks like a burn (toxic epidermal necrolysis).
STOP taking Flucloxacillin Capsules and contact your doctor if you experience:
250mg Capsules are opaque caramel and grey, printed with FXN 250 in black ink. The capsules contain a granular off-white powder. 500mg Capsules are opaque caramel and grey, printed with FXN 500 in black ink. The capsules contain a granular off-white powder. Both strengths are available in the following pack sizes: Securitainers are available in pack sizes of 15, 18, 20, 21, 28, 30, 50, 100, 250 & 500 capsules. Blister packs are available in pack sizes of 15, 18, 20, 21, 28, 30, 50, 100, 250 & 500 capsules. Not all pack sizes may be marketed.
The licence holder and manufacturer is:
Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.
Tell your doctor if you notice any of the following effects:
Common (occurs in less than 1 in 10 users but more than 1 in 100 users): iarrhoea, stomach upset and feeling sick d - hould be mild and wear off after a few s days. Very rare (occurs in less than 1 in 10,000 users): ifficulty passing water or blood in the d urine (may be a sign of inflammation of the kidney) nusual bleeding or bruising, anaemia u (may be caused by changes in the numbers of blood cells) oint or muscle pains or fever (may j develop 2 days after starting 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.
Continued top of next column AAAE3614
Distributed by:
PL06453/0015 PL06453/0016
Actavis Barnstaple, EX32 8NS, UK
This leaflet was revised September 2012.
Actavis, Barnstaple, EX32 8NS, UK
FLUCLOXACILLIN 250MG CAPSULES FLUCLOXACILLIN 500MG CAPSULES
Read all of this leaflet carefully before you start taking your medicine. eep this leaflet. You may need to read K it again. f you have further questions, please I ask your doctor or pharmacist (chemist). his medicine has been prescribed for T you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. f any of the side effects gets serious, I or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
You are 50 years of age or older ou have other serious illnesses (apart Y from the infection this medicine is treating) ou are taking this medicine for a long Y time as regular tests of liver and kidney function is advised You are on a sodium restricted diet. Check with your doctor or pharmacist before taking this medicine if you are taking any other medicines, especially: robenecid or sulfinpyrazone (used to P treat gout) Methotrexate (a chemotherapy drug) he contraceptive pill as antibiotics can T make these less effective (you will need to use extra precautions such as condoms while taking flucloxacillin and for a full 7 days after you finish taking it) ral typhoid vaccine (antibiotics can O make this less effective) ugammadex (used with general S anaesthetics) iperacillin (an antibiotic taken by P injection) Some medicines may affect the way others work. Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from a doctor.
Pharmacode Position
Taking other medicines
IN THIS LEAFLET 1 hat your medicine is and what W it is used for 2 Before you take your medicine 3 How to take your medicine 4 ossible side effects of your P medicine 5 How to store your medicine 6 Further information
1 HAT YOUR MEDICINE IS AND W
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 is used to treat: hest infections c throat or nose infections ar infections e skin and soft tissue infections eart infections h bone and joint infections meningitis igestive system infections d blood infections idney, bladder or urethra (the tube which k carries urine from the bladder) infections. Flucloxacillin can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.
WHAT IT IS USED FOR
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Important information about some of the ingredients in your medicine
This medicine contains approximately 52.3mg sodium per g. Check with your doctor before taking this medicine if you are on a sodium restricted diet.
2 EFORE YOU TAKE YOUR B
Do not take this medicine if:
MEDICINE
ou have ever had an allergic reaction Y to flucloxacillin or any other penicillin antibiotics (see symptoms section 4). ou have ever had an allergic reaction Y to any of the other ingredients of this medicine see list of ingredients in section 6, Further information. ou have suffered previously from liver Y problems (e.g. jaundice) after taking flucloxacillin.
3 HOW TO TAKE YOUR MEDICINE Follow all directions given to you by your doctor or pharmacist. Their directions may differ from the information contained in this leaflet. The pharmacists label should tell you how much to take and how often. If it does not, or you are not sure, check with your doctor or pharmacist. Take this medicine when your stomach is empty. This means an hour before food or 2 hours after food. 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)
Take special care with your medicine
Check with your doctor or pharmacist before taking this medicine if: ou suffer from kidney problems, as you Y may require a lower dose than normal ou suffer from liver problems, as this Y medicine could cause them to worsen
Continued top of next column AAAE3614
The usual dose is 250mg four times a day one or heart infection: Up to 8g daily, in B divided doses at six to eight hours apart. urgical prophylaxis: 1 to 2g IV at S induction of anaesthesia followed by 500mg every six hours for up to 72 hours.
Continued over page
Children
Children (10-18 years of age): Same as adult dose Children (2-10 years of age): Half the adult dose Children under 2 years of age: Quarter the adult dose
Patients with kidney problems
If you suffer from severe kidney failure your doctor will give you lower or fewer doses.
If you take more of your medicine than you should
If you (or somebody else) accidentally takes too much of your medicine, speak to your doctor or pharmacist immediately.
If you forget to take your medicine
If you forget to take a dose, take it as soon as you remember, then carry on as before. Do not take a double dose to make up for the dose you have missed.
5 HOW TO STORE YOUR MEDICINE Do not use this medicine after the expiry date shown on the label. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Securitainers: Store below 25oC. Store in the original package. Keep the container tightly closed to protect from light and moisture. Blister Packs: Store below 25oC. Do not open the foil pouch until ready to use the product. Once opened the foil pouch may be discarded. Store the product in the outer carton to protect from light and moisture. Return any left-over medicine to the pharmacist. 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 protect the environment. 6 FURTHER INFORMATION
If you stop taking your medicine
Keep taking your 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 infection may return or get worse. If you are still unwell after taking all the medicine, go and see your doctor.
What Flucloxacillin Capsules contain
Active ingredient: flucloxacillin as flucloxacillin sodium Other ingredients: sodium starch glycolate, magnesium stearate, red iron oxide (E172), yellow iron oxide (E172),black iron oxide (E172), titanium dioxide (E171) and gelatin. Please see further information on sodium in section 2.
4 OSSIBLE SIDE EFFECTS OF P
Like all medicines, Flucloxacillin Capsules may cause unwanted side effects. If they occur, they are likely to be temporary, and not serious. However, some may be serious and need medical attention.
YOUR MEDICINE
What Flucloxacillin Capsules look like and contents of the pack
llergy or hypersensitivity including itchy a rash, itching, sore mouth or eyes, swelling of the face, lips, throat or tongue or breathing problems severe, possibly bloody, diarrhoea aundice (yellow colour in the skin and j whites of the eyes) (Can be delayed for up to 2 months after finishing treatment.) evere skin rash with flushing, fever, s blisters or ulcers (Stevens-Johnson syndrome) evere rash with reddening, peeling and s swelling of the skin that looks like a burn (toxic epidermal necrolysis).
STOP taking Flucloxacillin Capsules and contact your doctor if you experience:
250mg Capsules are opaque caramel and grey, printed with FXN 250 in black ink. The capsules contain a granular off-white powder. 500mg Capsules are opaque caramel and grey, printed with FXN 500 in black ink. The capsules contain a granular off-white powder. Both strengths are available in the following pack sizes: Securitainers are available in pack sizes of 15, 18, 20, 21, 28, 30, 50, 100, 250 & 500 capsules. Blister packs are available in pack sizes of 15, 18, 20, 21, 28, 30, 50, 100, 250 & 500 capsules. Not all pack sizes may be marketed.
The licence holder and manufacturer is:
Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.
Tell your doctor if you notice any of the following effects:
Common (occurs in less than 1 in 10 users but more than 1 in 100 users): iarrhoea, stomach upset and feeling sick d - hould be mild and wear off after a few s days. Very rare (occurs in less than 1 in 10,000 users): ifficulty passing water or blood in the d urine (may be a sign of inflammation of the kidney) nusual bleeding or bruising, anaemia u (may be caused by changes in the numbers of blood cells) oint or muscle pains or fever (may j develop 2 days after starting 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.
Continued top of next column AAAE3614
Distributed by:
PL06453/0015 PL06453/0016
Actavis Barnstaple, EX32 8NS, UK
This leaflet was revised September 2012.
Actavis, Barnstaple, EX32 8NS, UK
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
