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PACKAGE LEAFLET: INFORMATION FOR THE USER

Flucloxacillin 125mg/5ml Powder For Oral Solution

Read all of this leaflet carefully before you start taking this medicine.

-    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

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 sodium belongs to a class of antibiotics called “penicillinase-

resistant penicillins” and is used to treat bacterial infections including:

•    Skinandsoft tissue infections

•    Boils,abscesses, carbuncles ( A painful localized bacterial infection of the skin and subcutaneous tissue that usually has several openings through which pus is discharged)

•    Cellulitis(inflammation of tissue below the skin)

•    Infectedwounds, infected burns

•    Protectionfor skin grafts

•    Infectedskin condition E.g.ulcer, eczema and acne

•    Furunculosis,( A skin condition characterized by the development of recurring boils)

•    Impetigo(a contagious skin disease, esp. of children, usually caused by streptococcal bacteria, marked by a superficial pustular eruption, particularly on the face)

•    Respiratory tract infections

•    Pneumonia (inflammation of the lungs with congestion), lung abscess, empyema (a collection of pus in a body cavity, especially in the lung cavity)

•    Sinusitis(inflammation of a sinus or the sinuses)

•    Pharyngitis (inflammation of the mucous membrane of the pharynx; sore throat)

•    Tonsillitis(inflammation of the tonsils).

•    Otitismedia (inflammation of the middle ear)

•    OtitisExterna (Inflammation of the external auditory canal)

•    Quinsy(tonsillar abscess)

•    Other infections

•    Osteomyelitis (affecting the bone and bone marrow)

•    Enteritis(affecting the intestinal tract, especially the small intestine)

•    Endocarditic (inflammation of the lining of the heart and its valves),

•    Urinarytract infections

•    Meningitis (a serious disease characterised by inflammation of the membranes around the brain or spinal cord)

•    Septicaemia (blood poisoning).

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:

•    Areallergic (hypersensitive) to penicillins/flucloxacillin sodium or any of the other ingredients in the product (see Section 6 and end of Section 2).

•    Haveprevious history of liver problems from taking flucloxacillin.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

•    ageover 50 years old

•    anyserious illness other than infection

•    Impaired kidney function

•    Liverproblems

Other medicines and Flucloxacillin Powder For Oral Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

•    Probenecid (used in the treatment of gout)

•    Otherantibiotics (used to treat infections)

•    Methotrexate (a chemotherapy drug)

•    Oraltyphoid vaccine (antibiotics can make this less effective),

•    Sugammadex (used with general anaesthetics),

•    Piperacillin (an antibiotic taken by injection)

•    Warfarin (medicine to prevent blood clotting)

•    Sulfinpyrazone (used in the treatment of gout)

Taking this medicine with food and drink

The solution should be taken half to one hour before meals.

Pregnancy and breast-feeding

This medicine should only be used by pregnant women if considered essential by the doctor. Flucloxacillin passes into breast milk, so ask your doctor for advice before taking any 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.

Driving and using machines

This medicine is not expected to affect your ability to drive or operate machinery.

Your medicine contains:

•    Sodium- Each 5ml spoonful of solution contains approximately 10.72mg of sodium, this is particularly important if you are on a reduced salt diet.

•    Sucrose - if you know you have an intolerance to some sugars, contact your doctor before use.

•    Sodium benzoate (E211) - may increase the risk of jaundice in newborn babies

E

Always take your medicine exactly as your doctor has told you. The pharmacist's label should tell you how much to take and how often.

For oral use only.

Take this medicine half to one hour BEFORE meals

Adults and children over 10 years: 10ml four times a day Children 2-10 years: 5ml four times a day.

Children under 2 years: 2.5ml four times a day.

Endocarditis or Osteomyelitis: up to 320ml daily in divided doses six to eight hourly

Severe kidney disease: your doctor may reduce the dose.

Make sure you complete your prescribed course; do not stop taking this medicine if you feel better.

If you take more of your medicine than you should

Contact your doctor or nearest hospital casualty department if you or a child have swallowed too much medicine. Take this leaflet and any remaining solution with you, if possible.

Symptoms of overdose include nausea, vomiting, diarrhoea If you forget to take your medicine

If you miss a dose, take the solution as soon as you remember and carry on as before. If it is almost time for your next dose, skip the forgotten dose and continue as usual.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody

gets them.

STOP taking flucloxacillin and contact your doctor if you experience:

•    Allergic reaction, symptoms of which includes rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue

•    Jaundice (yellow colour in the skin and whites of the eyes)

•    Severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome) ora 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 SIDE EFFECTS: (occurs in less than 1 in 10 users)

•    Minor gastrointestinal disturbances (e.g. diarrhoea, nausea & vomiting)

UNCOMMON SIDE EFFECTS: (occurs less than 1 in 1000 users)

•    Urticaria (itchy skin eruption)

•    Purpura (brownish-red spots on the skin)

VERY RARE SIDE EFFECTS: (occurs in lesst than 1 in 10,000 users)

•    Blood abnormalities i.e. neutropenia and thrombocytopenia Haemolytic anaemia

•    Anaphylactic Shock (severe allergic reaction)

•    Angioneurotic Oedema (rapid swelling)

•    Pseudomembranous colitis (inflammation of the colon with abdominal cramps, diarrhoea, bloody stools)

•    Hepatitis (inflammation of the liver)

•    Changes in liver function tests

•    Erythema multiforme (a red rash caused by hypersensitivity to a drug or disease or other allergen),

•    Arthralgia (pain in a joint) and myalgia (pain in the muscles).

•    Interstitial nephritis (Nephritis in which the interstitial connective tissue is chiefly affected)

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.

How to store your medicine

Keep this medicine out of the sight and reach of children.

Unopened bottle: Do not store above 25°C. Store in the original container and keep tightly closed. Do not use after the expiry date is stated on the label. Reconstituted solution: Store at 2 - 8°C and use within 7 days.

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.

Contents of the pack and other information

What Flucloxacillin oral solution contains

The active substance is flucloxacillin sodium, 125mg in a 5ml spoonful.

The other ingredients are sodium benzoate (E211), disodium edetate, saccharin sodium, mono-ammonium-glycyrrhizinate, sodium citrate anhydrous (E331), flavour pineapple, flavour menthol, erythrosine (E127), sucrose (see Section 2 'Important information about some of the ingredients of Flucloxacillin oral solution').

What your medicine looks like and contents of the pack

Unconstituted powder is a pinkish colour free flowing granular powder which on reconstitution becomes clear red colour solution supplied in a 150ml bottle. Marketing Authorisation Holder Milpharm Limited Ares, Odyssey Business Park,

West End Road,

South Ruislip, HA4 6QD,

United Kingdom

Manufacturer

Milpharm Limited Ares, Odyssey Business Park,

West End Road,

South Ruislip, HA4 6QD,

United Kingdom

APL Swift Services (Malta) Ltd.,

HF26, Hal Far Industrial Estate,

Hal Far, Birzebbugia BBG 3000, Malta

This leaflet was last revised in 12/2015.