Flucloxacillin 125mg/5ml Oral Suspension
Ref: LTT099/290616/1/F
Assessed against the UK PIL dated Feb 2016
MOCKUP
Floxapen ® 125mg/5ml Oral suspension
(flucloxacillin)
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Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* 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 symptoms are the same as yours.
Your medicine is called Floxapen 125mg/5ml Oral Suspension but will be called Floxapen Oral suspension throughout this leaflet.
™ What Floxapen Oral suspension is and what it is used for 3 Before you take How to take
.4 Possible side effects .4 How to store [4 Further information
/UPPROVflDEfSE S
By Caroline McDermott at
a
taking Floxapen Oral Suspension.
Tell your doctor that you are taking Floxapen Oral Suspension if you are having liver function tests as Floxapen may affect the results.
Important information about some of the ingredients in the Oral
Suspension
* Each 5ml spoonful of Oral Suspension contains 10mg of sodium, this is particularly important if you are on a reduced salt diet.
* If you, or your child have been told by your doctor that you have an intolerance to some sugars, contact them before taking this medicine, as it contains sucrose.
* This medicine also contains sodium benzoate which is a mild irritant to the skin, eyes and mucous membrane. It may increase the risk of jaundice in newborn babies.
^ What Floxapen Oral Suspension is and what it is used for
Floxapen is an antibiotic used to treat infections by killing the bacteria that can cause them. It belongs to a group of antibiotics called "penicillins”.
Floxapen Oral Suspension is used to treat:
* chest infections
* throat or nose infections
* ear infections
* skin and soft tissue infections
* heart infections
* bones and joints infection
* meningitis
* digestive system infections
* blood infections
* kidney, bladder or the urethra (the tube which carries urine from the bladder) infections.
Floxapen Oral Suspension can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.
[2) Before you take
Do not take Floxapen Oral Suspension and tell your doctor if you or your child:
* are allergic (hypersensitive) to flucloxacillin, penicillin, any other antibiotic or any of the other ingredients (see section 6)
* have ever had liver problems after taking flucloxacillin.
Check with your doctor or pharmacist before taking Floxapen Oral Suspension if you or your child:
* has liver or kidney problems
* have any serious illness, other than this infection
* are 50 years old or over
* are giving this medicine to a newborn child.
[4 How to take
Always take Floxapen Oral Suspension exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow the Oral Suspension half to one hour before meals. Never take more than the recommended dose each day.
* Adults and children over 10 years: 10ml four times a day.
* 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.
* Children 2 to 10 years: one 5ml spoonful four times a day.
* Children under 2 years: 2.5 ml four times a day, your pharmacist will explain how to give this to your child.
* Premature or babies less than 4 weeks old - Not recommended.
* Severe kidney disease: your doctor may reduce the dose, maximum dose in adults is 1g every 8-12 hours.
If you still feel unwell after finishing the treatment, speak to your doctor.
If you take more than you should
If you (or someone else) swallow a lot of Oral Suspension at the same time, or you think another child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick and diarrhoea.
If you forget to take the Oral Suspension
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 the Oral Suspension
Do not stop treatment early because some bacteria may survive and cause the infection to come back
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
* probenecid (to treat gout)
* other antibiotics (used to treat infections)
(flucloxacillin)
Patient Information Leaflet (continued)
[4 Possible side effects
Like all medicines, Floxapen Oral Suspension can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.
Stop taking Floxapen Oral Suspension and contact your doctor at once
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).
* blisters or ulcers (Stevens-Johnson syndrome) or a severe rash with reddening, peeling and swelling of the skin that resembles burns (toxic epidermal necrolysis).
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common (occurs in less than 1 in 10 users): minor stomach disturbances e.g. stomach upset or diarrhoea.
Very rare (occurs in less than 1 in 10,000 users): inflammation of the kidney or liver, jaundice (skin or the white of your eyes turning yellow), changes in numbers of blood cells (causing unexplained bleeding, bruising or skin discolouration), anaemia, skin rash with circular, red patches (Erythema multiforme), severe skin rash with flushing, fever. Joint or muscle pain or fever, may develop after 2 days or more from the start of treatment with Floxapen Oral Suspension.
Some of these reactions can be delayed for up to two months after finishing the treatment.
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.
What Floxapen Oral Suspension contains
* The active substance (the ingredient that makes the Oral Suspension work) is flucloxacillin. Each 5ml contains 125mg flucloxacillin as flucloxacillin magnesium.
* The other ingredients are saccharin sodium, sucrose, xanthan gum (E415), sodium citrate, citric acid anhydrous, sodium benzoate (E211), blood orange, tutti frutti flavour and menthol flavours.
What Floxapen Oral Suspension looks like and contents of the pack
100ml glass bottle containing white powder for the preperation of a white to off white oral suspension. Reconstituted volume of 100ml.
Manufacturer and Licence Holder
This medicine is manufactured by MITIM s.r.l. Via Cacciamali, 34-36-38, 25125 Brescia, Italy and procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road East Moons Moat, Redditch, Worcestershire B98 0RE. Repackaged by Lexon (UK) Limited,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 33723/0099
Floxapen is a registered trademark of Actavis Group PTC ehf Revision date: 29/06/16
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
>4 How to store
If any medicine is left after two weeks (14 days), return it to your pharmacist. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in a refrigerator.
Do not use Floxapen Oral Suspension 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.
If your medicine becomes discoloured or shows any other signs of deterioration consult your pharmacist who will tell you what to do.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* 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 symptoms are the same as yours.
Your medicine is called Flucloxacillin 125mg/5ml Oral Suspension but will be called Flucloxacillin Oral suspension throughout this leaflet.
3 What Flucloxacillin Oral Suspension is and what it is used for 3 Before you take 3 How to take 3 Possible side effects 3 How to store 3 Further information
If you are pregnant, planning to become pregnant or are breast feeding ask your doctor or pharmacist for advice before taking this medicine.
Regular monitoring of liver and kidney function should be performed whilst taking Flucloxacillin Oral Suspension.
Tell your doctor that you are taking Flucloxacillin Oral Suspension if you are having liver function tests as Flucloxacillin may affect the results.
Important information about some of the ingredients in the Oral Suspension
* Each 5ml spoonful of Oral Suspension contains 10mg of sodium, this is particularly important if you are on a reduced salt diet.
* If you, or your child have been told by your doctor that you have an intolerance to some sugars, contact them before taking this medicine, as it contains sucrose.
* This medicine also contains sodium benzoate which is a mild irritant to the skin, eyes and mucous membrane. It may increase the risk of jaundice in newborn babies.
3 What Flucloxacillin Oral Suspension is and what it is 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 Oral Suspension is used to treat:
* chest infections
* throat or nose infections
* ear infections
* skin and soft tissue infections
* heart infections
* bones and joint infection
* meningitis
* digestive system infections
* blood infections
* kidney, bladder or the urethra (the tube which carries urine from the bladder) infections.
Flucloxacillin Oral Suspension can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.
3 Before you take
Do not take Flucloxacillin Oral Suspension and tell your doctor if you or your child:
* are allergic (hypersensitive) to flucloxacillin, penicillin, any other antibiotic or any of the other ingredients (see section 6)
* have ever had liver problems after taking flucloxacillin.
Check with your doctor or pharmacist before taking Flucloxacillin Oral Suspension if you or your child:
* has liver or kidney problems
* have any serious illness, other than this infection
* are 50 years old or over
* are giving this medicine to a newborn child.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
* probenecid (to treat gout)
* other antibiotics (used to treat infections)
3 How to take
Always take Flucloxacillin Oral Suspension exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow the Oral Suspension half to one hour before meals. Never take more than the recommended dose each day.
* Adults and children over 10 years: 10ml four times a day.
* 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.
* Children 2 to 10 years: one 5ml spoonful four times a day.
* Children under 2 years: 2.5 ml four times a day, your pharmacist will explain how to give this to your child.
* Premature or babies less than 4 weeks old - Not recommended.
* Severe kidney disease: your doctor may reduce the dose, maximum dose in adults is 1g every 8-12 hours.
If you still feel unwell after finishing the treatment, speak to your doctor.
If you take more than you should
If you (or someone else) swallow a lot of Oral Suspension at the same time, or you think another child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick and diarrhoea.
If you forget to take the Oral Suspension
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 the Oral Suspension
Do not stop treatment early because some bacteria may survive and cause the infection to come back
Patient Information Leaflet (continued)
[4 Possible side effects
Like all medicines, Flucloxacillin Oral Suspension can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.
Stop taking Flucloxacillin Oral Suspension and contact your doctor at once 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).
* blisters or ulcers (Stevens-Johnson syndrome) or a severe rash with reddening, peeling and swelling of the skin that resembles burns (toxic epidermal necrolysis).
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common (occurs in less than 1 in 10 users): minor stomach disturbances e.g. stomach upset or diarrhoea.
Very rare (occurs in less than 1 in 10,000 users): inflammation of the kidney or liver, jaundice (skin or the white of your eyes turning yellow), changes in numbers of blood cells (causing unexplained bleeding, bruising or skin discolouration), anaemia, skin rash with circular, red patches (Erythema multiforme), severe skin rash with flushing, fever. Joint or muscle pain or fever, may develop after 2 days or more from the start of treatment with Flucloxacillin Oral Suspension.
Some of these reactions can be delayed for up to two months after finishing the treatment.
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.
What Flucloxacillin Oral Suspension contains
* The active substance (the ingredient that makes the Oral Suspension work) is flucloxacillin. Each 5ml contains 125mg flucloxacillin as flucloxacillin magnesium.
* The other ingredients are saccharin sodium, sucrose, xanthan gum (E415), sodium citrate, citric acid anhydrous, sodium benzoate (E211), blood orange, tutti frutti flavour and menthol flavours.
What Flucloxacillin Oral Suspension looks like and contents of the pack
100ml glass bottle containing white powder for the preperation of a white to off white oral suspension. Reconstituted volume of 100ml.
Manufacturer and Licence Holder
This medicine is manufactured by MITIM s.r.l. Via Cacciamali, 34-36-38, 25125 Brescia, Italy and procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
|PQM PL 33723/0099 Revision date: 29/06/16
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
How to store
If any medicine is left after two weeks (14 days), return it to your pharmacist. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in a refrigerator.
Do not use Flucloxacillin Oral Suspension 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.
If your medicine becomes discoloured or shows any other signs of deterioration consult your pharmacist who will tell you what to do.