FLUCLOXACILLIN 125MG/5ML POWDER FOR ORAL SOLUTION
Active substance(s): FLUCLOXACILLIN SODIUM / FLUCLOXACILLIN SODIUM / FLUCLOXACILLIN SODIUM
PACKAGE LEAFLET: INFORMATION FOR THE USER
powder for oral solution
Read all of this leaflet carefully before you start taking this
- 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
- 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
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
• 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
• endocarditis (inflammation of the lining of the heart and its
• 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
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
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
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
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.
• 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
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.
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
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:
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : firstname.lastname@example.org
This leaflet was last approved in 10/2013
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
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
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.