1WHAT 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

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) 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.

Check with your doctor if you have any problems while taking this medicine, even if you think the problems are not connected with the medicine, or are not listed in this leaflet.

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 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 out of the sight and reach of children.

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

Dry powder: Store below 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 may be discarded.

Reconstituted mixture: Store for 7 days at 2°C-8°C in a refrigerator.

Once reconstituted (mixed) by the pharmacist, this medicine must be used within 7 days.

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.

4. POSSIBLE SIDE EFFECTS

6 CONTENTS OF THE PACK AND ■ OTHER INFORMATION

Like all medicines, this medicine may 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 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).

What Flucloxacillin Oral Solution contains

The active substance is flucloxacillin as flucloxacillin sodium.

The other ingredients are sodium benzoate (E211), disodium edetate, saccharin sodium, monoammonium-glycyrrhizinate, sodium citrate, flavour pineapple, flavour menthol, RED FD&C No. 3 (E127) and sucrose.

Please refer to information on sucrose in section 2.

What Flucloxacillin Oral Solution looks like and contents of the pack

Unconstituted powder: a pink granular powder with a characteristic odour of pineapple. Reconstituted solution: a pink coloured solution with a characteristic flavour and odour of pineapple.

Flucloxacillin Solution is available in a size of 100ml on reconstitution.

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited,

Ballymurray, Co. Roscommon, Ireland.

Manufacturer

Athlone Laboratories Limited,

Ballymurray, Co. Roscommon, Ireland.

Distributed by

Kent Pharmaceuticals Limited,

Repton Road, Measham, DE12 7DT, U.K.

PL 30464/0167

This leaflet was last revised in April 2016.

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