Patient leaflet - FLOXAPEN CAPSULES 250 MG
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.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Floxapen capsules are and what they are used for
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2. Before you take Floxapen capsules
3. How to take Floxapen capsules
4. Possible side effects
5. How to store Floxapen capsules
6. Contents of the pack and other information
1. What Floxapen capsules are and what they are 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”.
Floxapen capsules are used to treat:
- chest infections
- throat or nose infections
- ear infections
- skin and soft tissue infections
- heart infections
- bones and joints infections
- meningitis
- digestive system infections
- blood infections
- kidney, bladder or urethra (the tube which carries urine from the bladder) infections.
Floxapen capsules can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.
2. Before you take Floxapen capsules
you are allergic to flucloxacillin or any other penicillin antibiotics (see symptoms in section 4).- you are allergic to any of the other ingredients of this medicine (listed in section 6).
- you have suffered previously from liver problems (e.g. jaundice) after taking flucloxacillin.
- you have had an allergic reaction to P-lactam antibiotics (e.g. penicillins, cephalosporins).
Warnings and precautions
Talk to your doctor or pharmacist before taking Floxapen capsules if:
- you suffer from kidney problems, as you may require a lower dose than normal (convulsions may occur very rarely in patients with kidney problems who take high doses)
- you suffer from liver problems, as this medicine could cause them to worsen
- you are 50 years of age or older
- you have other serious illnesses (apart from the infection this medicine is treating)
- you are taking this medicine for a long time as regular tests of liver and kidney function are advised
- you are on a sodium-restricted diet.
- you 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 capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:
- probenecid or sulfinpyrazone (used to treat gout)
- 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)
- paracetamol
- other antibiotics (used to treat infections)
Pregnancy, breast feeding and fertility
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 capsules.
Tell your doctor that you are taking Floxapen if you are having urine tests or blood tests because Floxapen may affect the results.
Floxapen capsules contain sodium
Each 250mg capsule contains 13mg of sodium and each 500mg capsule contain 25mg of sodium. To be taken into consideration by patients on a controlled sodium diet.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure
Take this medicine when your stomach is empty. This means an 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. However, the usual doses for each age group are:
Adults (including the elderly) – one 250mg capsule four times a day, your doctor may prescribe a different dose for severe infections.
- 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.
Use in children and adolescents
- Children aged 10–18 years – 250mg four times daily
- Children aged 2–10 years: 125mg four times daily.
- Children under 2 years: 62.5mg four times daily.
- Premature or babies less than 4 weeks old: Not recommended.
- Severe kidney disease: your doctor may reduce your dose.
If you still feel unwell after finishing the treatment, speak to your doctor.
If you take more Floxapen capsules than you should
If you (or someone else) swallow a lot of capsules at the same time, or you think a 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 Floxapen capsules
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 Floxapen capsules
Do not stop treatment early because some bacteria may survive and cause the infection to come back.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Floxapen capsules 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).
- jaundice (yellow colour in 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).
- changes in numbers of blood cells (causing unexplained bleeding, bruising or skin discolouration),
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, anaemia, skin rash with circular, red patches (Erythema multiforme). Joint or muscle pain or fever, may develop after 2 days or more from the start of treatment with Floxapen capsules. 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).
Some of these reactions can be delayed for up to two months after finishing the treatment.
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.
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.
5. how to store floxapen capsules
Keep out of the sight and reach of children.
Store in a dry place in the original package.
Do not use Floxapen capsules 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.
6. contents of the pack and other information
- The active substance (the ingredient that makes the capsules work) is flucloxacillin. Each capsule contains either 250mg or 500mg of the active ingredient.
- The capsule also contains: magnesium stearate.
- The capsule shell contains: gelatin, titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172), red iron oxide (E172).
- The printing ink contains: shellac (E904), propylene glycol (E1520), sodium hydroxide (E524), povidone, titanium dioxide (E171)
What Floxapen capsules look like and contents of the pack
Floxapen are caramel hard gelatin capsules (body) fitted with black caps. acraws is printed on the black cap. The 250mg capsule has ‘250’ on the body and the 500mg capsule has ‘500’ on the body.
Pack sizes of 28
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer
Actavis B.V.,Baarnse Dijk 1, 3741 LN BAARN, The Netherlands
Actavis Group PTC ehf, Reykjav^kurvegur 76–78, 220 Hafnarfjordur, Iceland
This leaflet was last revised in September 2018
Floxapen is a registered trademark of Accord Healthcare Limited