PC 2810

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What Flucloxacillin Powder for Oral Solution is and what it is used for

2.    Before you take Flucloxacillin Powder for Oral Solution

3.    How to take Flucloxacillin Powder for Oral Solution

4.    Possible side effects

5.    How to store Flucloxacillin Powder for Oral Solution

6.    Further information

1. WHAT FLUCLOXACILLIN POWDER FOR ORAL SOLUTION 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:

•    Skin and soft tissue infections

•    boils, abscesses, carbuncles (multiple boils)

•    cellulitis (inflammation of tissue below the skin)

•    infected wounds, infected burns

•    protection for skin grafts

•    otitis (ear infection).

•    Respiratory tract infections

•    pneumonia (chest infection), lung abscess, empyema (a collection of pus in a body cavity, especially in the lung cavity)

•    sinusitis (sinus infection)

•    pharyngitis (throat infection)

•    tonsillitis (inflammation of the tonsils).

•    Other infections

•    osteomyelitis (affecting the bone and bone marrow)

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

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

•    urinary tract infections

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

•    septicaemia (blood poisoning).

2. BEFORE YOU TAKE FLUCLOXACILLIN POWDER FOR ORAL SOLUTION

Do not take Flucloxacillin Powder for Oral Solution if you:

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

Take special care with Flucloxacillin Powder for Oral Solution

Speak to your doctor if you have:

•    impaired kidney function

•    congestive heart failure.

Taking other medicines

Please inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription, particularly probenecid (used in the treatment of gout).

Taking Flucloxacillin Powder for Oral Solution with food and drink

The solution should be taken 1 hour before meals, or on an empty stomach.

Pregnancy and breast-feeding

Flucloxacillin Powder for Oral Solution 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.

Driving and using machines

Flucloxacillin Powder for Oral Solution is not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Flucloxacillin Powder for Oral Solution

•    Sodium- Each 5ml spoonful of syrup contains approximately 10.75mg 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.

3. HOW TO TAKE FLUCLOXACILLIN POWDER FOR ORAL SOLUTION

Always take Flucloxacillin Powder for Oral Solution 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 Flucloxacillin Powder for Oral Solution one hour BEFORE meals or on an empty stomach.

Adults:

•    For all infections except osteomyelitis, endocarditis and surgical prophylaxis: take 10ml, four times a day.

•    Osteomyelitis and endocarditis: take up to 320ml (8g) a day, in divided doses (every 6-8 hours).

• Surgical prophylaxis (preventing infection after operation):

following injection of the injectable form of flucloxacillin, take 20ml flucloxacillin Powder for Oral Solution (containing 500mg flucloxacillin) every six hours for up to 72 hours.

In serious infections, dosages may be doubled. Treatment for over 2 weeks should be considered with caution, due to the risk of cholestatic jaundice after prolonged treatment.

Children 2-10 years: 5ml four times a day.

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

Make sure you complete your prescribed course; do not stop taking Flucloxacillin Powder for Oral Solution if you feel better.

If you take more Flucloxacillin Powder for Oral Solution 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 suspension with you, if possible.

If you forget to take Flucloxacillin Powder for Oral Solution If you miss a dose, take the suspension 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Flucloxacillin Powder for Oral Solution can cause side effects, although not everybody gets them.

You may suffer an allergic reaction, symptoms of which include rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue. If this happens to you, stop taking the suspension immediately and seek medical help.

The following have also been reported:

•    hepatitis (inflammation of the liver) and cholestatic jaundice (yellowing of the skin and whites of the eyes)

•    convulsions with very high doses of flucloxacillin, particularly in infants, the elderly, and those patients with renal failure

•    diarrhoea, nausea, heartburn

•    pruritus ani (itching)

•    skin rashes; treatment should be discontinued if this is experienced. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE FLUCLOXACILLIN POWDER FOR ORAL SOLUTION

Keep out of the reach and sight 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

stated on the pack.

Made-up 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.

6. FURTHER INFORMATION

What Flucloxacillin Powder for Oral Solution contains

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

spoonful.

The other ingredients are sodium benzoate (E211), Disodium Edetate, saccharin sodium, mono-ammonium-glycyrrhizate, sodium citrate (dried) (E331), flavour pineapple, flavour menthol, erythrosine (E127), sucrose (see Section 2 ‘Important information about some of the ingredients of Flucloxacillin Powder for Oral Solution’).

What Flucloxacillin Powder for Oral Solution looks like and contents of the pack

The medicine is a pink colour free-flowing Powder for Oral Solution, supplied in a 150ml bottle.

Marketing Authorisation Holder and Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK E-mail : info@medreich.co.uk

This leaflet was last approved in 10/2013

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