Patient leaflet - FLUCLOXACILLIN ORAL SUSPENSION 250 MG / 5ML, FLOXAPEN ORAL SUSPENSION 250 MG / 5ML
1. What Floxapen Oral Suspension is and what it is used for
2. What you need to know before you take Floxapen Oral Suspension
3. How to take Floxapen Oral Suspension
4. Possible side effects
5. How to store Floxapen Oral Suspension
6. Contents of the pack and other information
1. what floxapen oral suspension is and what it is used for
Floxapen 250mg in 5ml Oral Suspension contains the active substance flucloxacillin. 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.
Do not take Floxapen Oral Suspension and tell your doctor if you or your child:
- are allergic to flucloxacillin, penicillin, any other antibiotic or any of the other ingredients of this medicine (listed in section 6)
- have ever had liver problems after taking flucloxacillin.
Warnings and precautions
Talk to 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.
- are taking or will be taking paracetamol.
There is a risk of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, particularly in certain groups of patients at risk, e.g. patients with severe renal impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used. High anion gap metabolic acidosis is a serious disease that must have urgent treatment.
Other medicines and Floxapen Oral Suspension
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:
- probenecid (to treat gout)
- other antibiotics (used to treat infections)
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.
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.
- Floxapen Oral Suspension contains sodium, sucrose and sodium benzoateEach 5ml 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. how to take floxapen oral suspension
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the Oral Suspension half to one hour before meals. Never take more than the recommended dose each day.
The recommended dose is
- Adults and children over 10 years: 5ml 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: 2.5ml four times a day, your pharmacist will explain how to give this to your child.
- Children under 2 years: 1.25ml 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.
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. 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. Very rare cases of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors (see section 2).
- Not known (frequency cannot be estimated from the available data): Serious skin reactions – A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). Contact a doctor immediately if you get any of these symptoms.
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: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
If any medicine is left after two weeks (14 days), return it to your pharmacist. Keep the medicine in its original bottle and store it in the fridge (5°C). Do not freeze the medicine.
Do not use this medicine after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.
Do nto 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 Floxapen Oral Suspension contains
- The active substance (the ingredient that makes the oral suspension work) is flucloxacillin. 5ml contains 250mg of the active ingredient.
- The other ingredients are saccharin sodium, sucrose, xanthan gum (E415), citric acid, sodium citrate, sodium benzoate (E211), orange, tutti frutti and menthol flavours.
What Floxapen Oral Suspension looks like and contents of the pack
Floxapen Oral Suspension comes in a bottle containing 100ml of a white to off-white liquid mixture, called a suspension.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer
Actavis Group PTC ehf, Reykjav'kurvegur 76–78,
220 Hafnarfjordur, Iceland
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600,
Bulgaria
This leaflet was last revised in December 2017
Floxapen® is a registered trademark of Accord Healthcare Limited
Accord Healthcare Ltd, North Harrow, HA1 4HF, UK