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Information leaflet

                                                    Irish Medicines Board

                                                         Part II
                                Summary of Product Characteristics

 Flucillin 125mg/5ml Powder for Oral Solution.


 Each 5 ml contains flucloxacillin 125 mg as flucloxacillin sodium.

 Excipients: also includes sucrose 3.1g per 5ml, sodium 0.534mmol per 5ml and trace amounts of sulphur dioxide
 For a full list of excipients, see section 6.1.


 Powder for oral solution.
 A pink, pineapple-flavoured granular powder for oral solution.


 4.1 Therapeutic Indications

 Flucloxacillin is recommended for the treatment of infections due to pencillinase-producing Staphylococci and other
 gram-positive organisms susceptible to Flucloxacillin.

 4.2 Posology and method of administration

 750 mg to 1500 mg daily in divided doses. The dosage may be increased if necessary.

 Aged over 12 years: 750 mg to 1500 mg daily in divided doses. The dosage may be increased if necessary.

 Aged 2 – 12 years:
 The usual daily dose is 50 mg/kg bodyweight in divided doses.

 Special Groups:
 In the presence of severe renal failure (creatinine clearance < 10 ml/min) a reduction in dose or extension of dose
 interval should be considered.

 Oral doses should be administered one hour before meals or on an empty stomach.

 4.3 Contraindications

 Flucloxacillin should not be given to patients with a history of hypersensitivity to -lactam antibiotics (e.g. penicillins,
 cephalosporins) or any of the excipients.

 Flucloxacillin is contraindicated in patients with a previous history of flucloxacillin-associated janudice/hepatic

Date Printed 23/07/2008                               CRN 2053972                                         page number: 1
                                                     Irish Medicines Board

 4.4 Special warnings and precautions for use

 Before initiating therapy with flucloxacillin, careful inquiry should be made concerning previous hypersensitivity
 reactions to beta-lactams.Cross-sensitivity between penicillins and cephalosporins is well documented.

 Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-
 lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on
 oral therapy. These reactions are more likely to occur in indivduals with a history of beta-lactam hypersensitivity. If an
 allergic reaction occurs, flucloxacillin should be discontinued and the appropriate therapy instituted. Serious
 anaphylactoid reactions may require immediate emergency treatment with adrenaline. Oxygen, i.v. steroids, and airway
 management, including intubation, may also be required.

 Flucloxacillin has been associated with cholestatic jaundice which may occur several weeks after stopping therapy (risk
 increased in those treated for longer than 2 weeks or who are over 55 years of age).

 Flucloxacillin is excreted in a manner similar to that for benzyl penicillin i.e. by glomerular filtration and tubular
 secretion. This should be borne in mind when prescribing therapy.

 Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction, those with serious
 underlying disease, and the elderly. In these patients, hepatic events may be severe, and in extremely rare
 circumstances, deaths have been reported (See section 4.8, Undesirable effects).

 Dosage should be adjusted in renal impairment (see section 4.2, Posology and method of administration).

 Special caution is essential in the newborn because of the risk of hyperbilirubinemia. Studies have shown that, at high
 dose following parenteral administration, flucloxacillin can displace bilirubin from plasma protein binding sites, and
 may therefore predispose to kernicterus in a jaundiced baby. In addition, special caution is essential in the newborn
 because of the potential for high serum levels of flucloxacillin due to a reduced rate of renal excretion.

 During prolonged treatments (e.g. osteomyelitis, endocarditis), regular monitoring of hepatic and renal functions is

 Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

 Contains sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or
 sucrose-isomaltase insufficiency should not take this medicine.

 Sodium content: This medicinal product contains approximately 38.5 mg sodium per 10ml (250mg) dose. To be taken
 into consideration by patients on a controlled sodium diet.

 4.5 Interaction with other medicinal products and other forms of interaction

 Probenecid reduces the excretion of flucloxacillin.

 4.6 Pregnancy and lactation

 Flucloxacillin should not be used during pregnancy unless the physician considers the expected benefits to the patient
 outweigh the potential risks to the foetus.

 Flucloxacillin is excreted in breast milk, presenting the risk of candidiasis and also of central nervous system toxicity
 due to immaturity of the blood brain barrier. There is a theoretical possibility of later sensitisation.

 4.7 Effects on ability to drive and use machines

 Not applicable.

Date Printed 23/07/2008                               CRN 2053972                                         page number: 2
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