FLUCLOXACILLIN 500 MG CAPSULES - patient leaflet, side effects, dosage

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 or pharmacist.

• – 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 or pharmacist. this includes any possible side effects

not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

|1. What your medicine 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 is used to treat:

• – chest infections – throat or nose infections

• – ear infections – skin and soft tissue infections

• – heart infections – bone and joint infections

• – meningitis – digestive system infections

• – blood infections

• – kidney, bladder or urethra (the tube which carries urine from the bladder) infections.

Flucloxacillin can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.

2. what you need to know before you take your medicine)- 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 this medicine 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 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 Flucloxacillin Capsules

Tell your doctor or pharmacist before taking this medicine if you are taking 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)

Some medicines may affect the way others work. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This means medicines you have bought yourself as well as medicines on prescription from a doctor.

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.

Your medicine contains sodium

This medicinal product contains approximately 52.3mg sodium per g. To be taken into consideration by patients on a controlled sodium diet.

3. how to take your medicine |

Always take this medicine exactly as your doctor or pharmacist has told you. Their directions may differ from the information contained in this leaflet. The pharmacist’s label should tell you how much to take and how often. 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)

• – The usual dose is 250mg four times a day

• – Bone or heart infection: Up to 8g daily, in divided doses at six to eight hours apart.

• – Surgical prophylaxis: 1 to 2g IV at induction of anaesthesia followed by 500mg every six hours for

up to 72 hours.

Use in children and adolescents

Children (10–18 years of age): 250mg four times daily

Children (2–10 years of age): 125mg four times daily

Children under 2 years of age: 62.5mg four times daily

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 a forgotten dose.

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.

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. If they occur, they are likely to be temporary, and not serious. However, some may be serious and need medical attention.

STOP taking Flucloxacillin Capsules and contact your doctor immediately if you experience:

• – allergy or hypersensitivity including itchy rash, itching, sore mouth or eyes, swelling of the face,

lips, throat or tongue or breathing problems

• – severe, possibly bloody, diarrhoea

• – 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).

Tell your doctor if you notice any of the following effects:

Common (may affect up to 1 in 10 people):

• – diarrhoea, stomach upset and feeling sick – should be mild and wear off after a few days.

Very rare (may affect up to 1 in 10,000 people):

• – difficulty passing water or blood in the urine (may be a sign of inflammation of the kidney)

• – unusual bleeding or bruising, anaemia (may be caused by changes in the numbers of blood cells)

• – joint or muscle pains or fever (may develop 2 days after starting treatment)

• – increase in the number of white blood cells in the blood (eosinophilia)

• – 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).

Other side effects (frequency not known)

• – Serious skin reactions

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme atr 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 your medicine |

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Securitainers: Store below 25oC. Store in the original package. Keep the container tightly closed in order 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 in order to protect from light and moisture.

Return any left-over medicine to the pharmacist. Do not 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 informationthe active substance is flucloxacillin as flucloxacillin sodium.

The other ingredients are 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.

What Flucloxacillin Capsules look like and contents of the pack

The 250mg capsules are opaque caramel and grey, printed with ‘FXN 250’ in black ink. The capsules contain a granular off-white powder.

The 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.

Marketing Authorisation Holder and Manufacturer

Kent Pharmaceuticals Limited, connect 38, 1, Dover Place, Ashford, Kent, united kingdom, TN23 1FB.

Distributed by: Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, UK

PL08215/0189

PL08215/0190

This leaflet was last revised in February 2022

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