Flucloxacillin 125mg/5ml Oral Suspension
Floxapen® 125mg/5ml Oral Suspension
(flucloxacillin magnesium)
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.
The name of your medicine is Floxapen 125mg/5ml Oral Suspension but it will be referred to as Floxapen Oral Suspension or Oral Suspension throughout this leaflet.
Index
Q What Floxapen Oral Suspension is and what it is used for 3 Before you take Q How to take Q Poss ible side effects Q How to store 0 Further information
Q 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.
0 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.
Taking other medicines
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) 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.
Tests
Regular monitoring of liver and kidney function should be performed whilst 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.
0 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.
Doses:
• 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: 2.5ml 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.
Q Poss ible 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.
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 any side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
U How to store
• Keep out of the sight and reach of children.
• Before reconstitution do not store above 25°C.
• After reconstitution store in a refrigerator (2-8°C).
• Do not freeze.
• After 14 days any unused suspension should be returned to your pharmacist (chemist).
• Do not take suspension after the expiry date which is stated on the carton and bottle label after 'Exp'. The expiry date refers to the last day of that month.
• If the suspension becomes discoloured or shows any signs of deterioration, seek the advice of your 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 to protect the environment.
0 Further information
What Floxapen Oral Suspension contains
• The active ingredient in Floxapen Oral Suspension is flucloxacillin.
• Each 5ml contains 125mg flucloxacillin as flucloxacillin magnesium.
• The other ingredients are saccharin sodium, sucrose, xanthan gum (E415), citric acid anhydrous, sodium citrate, sodium benzoate (E211), blood orange, tutti frutti and menthol flavours.
What Floxapen Oral Suspension looks like and contents of the pack
Clear glass bottle containing white to off-white powder with a tamper-evident metal screw cap and a plastic measuring cup.
It is available in the pack size of 100ml suspension.
Manufactured by: Mitim S.R.L., Via Cacciamali, 34-38, 25125-Brescia, Italy. or
Actavis B.V., Baarnse Dijk 1, 3741 LN Baarn, The Netherlands. or
Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
Floxapen® 125mg/5ml Oral Suspension;
PL 18799/2966 ._.
POM I
Leaflet date: 03.10.2016 lPOMJ
Floxapen is the registered trademark of Actavis Group PTC ehf.
Flucloxacillin 125mg/5ml Oral Suspension
(flucloxacillin magnesium)
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.
The name of your medicine is Flucloxacillin 125mg/5ml Oral Suspension but it will be referred to as Flucloxacillin Oral Suspension or Oral Suspension throughout this leaflet.
Index
Q What Flucloxacillin Oral Suspension is and what it is used for 3 Before you take Q How to take Q Poss ible side effects Q How to store 0 Further information
Q 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 joints 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.
0 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.
Taking other medicines
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) 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.
Tests
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.
0 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.
Doses:
• 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: 2.5ml 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.
Q Poss ible 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.
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 any side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
U How to store
• Keep out of the sight and reach of children.
• Before reconstitution do not store above 25°C.
• After reconstitution store in a refrigerator (2-8°C).
• Do not freeze.
• After 14 days any unused suspension should be returned to your pharmacist (chemist).
• Do not take suspension after the expiry date which is stated on the carton and bottle label after 'Exp'. The expiry date refers to the last day of that month.
• If the suspension becomes discoloured or shows any signs of deterioration, seek the advice of your 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 to protect the environment.
0 Further information
What Flucloxacillin Oral Suspension contains
• The active ingredient in Flucloxacillin Oral Suspension is flucloxacillin.
• Each 5ml contains 125mg flucloxacillin as flucloxacillin magnesium.
• The other ingredients are saccharin sodium, sucrose, xanthan gum (E415), citric acid anhydrous, sodium citrate, sodium benzoate (E211), blood orange, tutti frutti and menthol flavours.
What Flucloxacillin Oral Suspension looks like and contents of the pack
Clear glass bottle containing white to off-white powder with a tamper-evident metal screw cap and a plastic measuring cup.
It is available in the pack size of 100ml suspension.
Manufactured by: Mitim S.R.L., Via Cacciamali, 34-38, 25125-Brescia, Italy. or
Actavis B.V., Baarnse Dijk 1, 3741 LN Baarn, The Netherlands. or
Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
Flucloxacillin 125mg/5ml Oral Suspension; PL 18799/2966 ._.
POM I
Leaflet date: 03.10.2016 lPOMJ
By reporting side effects, you can help provide
more information on the safety of this medicine.