Flucloxacillin 125 mg/5 ml Oral Solution

(flucloxacillin sodium)

PATIENT INFORMATION LEAFLET

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, please ask your doctor or pharmacist (chemist).

-    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

2.    What you need to know before you take your medicine

3.    How to take your medicine

4.    Possible side effects

5.    How to store your medicine

6.    Contents of the pack and other information

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

-    ear infections

-    heart infections

-    meningitis

-    blood infections

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

-    throat or nose infections

-    skin and soft tissue infections

-    bone and joint infections

-    digestive system 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 Do not take this medicine if:

-    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.

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

-    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 is advised

Other medicines and Flucloxacillin 125mg/5ml Oral Solution BP

Check with 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)

-    The contraceptive pill as antibiotics can make these less effective (you will need to use extra precautions such as condoms while taking flucloxacillin and for a full 7 days after you finish taking it)

-    Oral typhoid vaccine (antibiotics can make this less effective)

-    Sugammadex (used with general anaesthetics)

-    Piperacillin (an antibiotic taken by injection)

-    Warfarin (medicine used 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.

Tests

Regular monitoring of liver and kidney function should be performed whilst taking flucloxacillin for a long period of time. Tell your doctor that you are taking Flucloxacillin if you are having urine tests or blood tests because it may affect the results.

Your medicine contains sucrose and sodium

This medicine contains up to 3.09g of sucrose (sugar) per 5ml dose. Check with your doctor before taking this medicine if you are a diabetic. Do not use this medicine if you have been told by your doctor that you have an intolerance to some sugars.

This medicine contains 18.05mg sodium per 5ml dose. To be taken into consideration by patients on a sodium controlled 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 your medicine on an empty stomach, at least thirty minutes to one hour before meals/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

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.

How long to take your medicine for:

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 take more of your medicine than you should

If you (or somebody else) take 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 the dose you have missed.

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 and contact your doctor 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, 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 the treatment

-    severe skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome) or a 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. If severe or lasting longer, tell your doctor.

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)

-    skin rash with circular red patches (Erythema Multiforme).

-    joint or muscle pains or fever (may develop 2 days after starting 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: www.mhra.gov.uk/yellowcard.

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 in a safe place where children cannot see or reach it.

Dry powder: Do not store above 25°C.

Store in the original container in order to protect from light and moisture.

Do not open the foil pouch until ready to reconstitute the product.

Once opened the foil pouch may be discarded.

Store the solution at 2°C to 8°C in a refrigerator, and use within 7 days.

Do not freeze.

Store in the original container.

Do not use this medicine after the expiry date shown on the label.

Return any left-over medicine to the 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.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Flucloxacillin 125mg/5ml Oral Solution contains

Active ingredient: flucloxacillin as flucloxacillin sodium Other ingredients: sodium benzoate (E211), disodium edetate, saccharin sodium, ammonium glycyrhizate, sodium citrate anhydrous, pineapple flavour, menthol flavour, erythrosine (E127) and sucrose.

Please see further information on sucrose in section 2.

What Flucloxacillin 125mg/5ml Oral Solution looks like

Unconstituted powder: a pink granular powder with a characteristic odour of pineapple.

Reconstituted solution: a pink coloured solution with a characteristic odour of pineapple.

Flucloxacillin 125mg/5ml Oral Solution is available in size 100ml on reconstitution.

5ml measuring spoon included in package.

Manufacturer and Product Licence Holder

Manufactured by Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland. Procured from within the EU by the Product Licence holder

Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref.) 29.05.14[4]