Last Updated on eMC 12-01-2018 View medicine  | Wockhardt UK Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:10-01-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update sections 4.4, 4.5, 4.8 of the SmPC and 2, 4 of the PIL in line with PRAC recommendations published 23 October 2017

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:14-07-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

PRAC signal - Acute generalized exanthematous

Reasons for adding or updating:

  • Change from joint to individual SPC

Date of revision of text on the SPC:07-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Previous Combined SmPC

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Individual SPC superseded by joint SPC

Date of revision of text on the SPC:15-06-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 Special warnings and precautions for use - Update in line with PSUR covering the period 01/05/2008 to 30/04/2011

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities

Date of revision of text on the SPC:14-12-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 - Update in line with PSUR
Section 4.8 - Update in line with PSUR and MedDRA SOC
Section 4.9 - Update in line with MHRA recommendations during renewal (addition of symptoms/treatment subheadings)
Section 6.2 - Update in line with PSUR

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-10-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 - Product name updated in line with current guidance

Section 10 - Date of revision amended

Reasons for adding or updating:

  • Change of Marketing Authorisation Holder

Date of revision of text on the SPC:01-03-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

'CP Pharmaceuticals Ltd' amended to 'Wockhardt UK Ltd'
PL 04543/0402 amended to PL 29831/0092

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.2 - Incompatibilities

Date of revision of text on the SPC:01-12-2003

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

4.5            Interaction with other medicinal products and other forms of interaction

 

            Other antibacterials: Since bacteriostatic drugs such as chloramphenicol and tetracycline may interfere with the bactericidal effect of penicillins in the treatment of meningitis or in other situations in which a rapid bactericidal effect is necessary, it is best to avoid concurrent therapy.

 

           Immunosuppressants: There is reduced excretion of methotrexate (increased risk of toxicity).

 

            Oral contraceptives: Flucloxacillin may decrease the efficacy of oestrogen-containing oral contraceptives.   

 

            Uricosuric agents: Plasma concentrations of flucloxacillin are enhanced if probenecid is given concurrently.

 

            Interference with diagnostic tests: Penicillins may produce false-positive results with the direct antiglobulin (Coombs’) test, falsely high urinary glucose results with the copper sulphate test and falsely high urinary protein results, but glucose enzymatic tests (e.g. Clinistix) and bromophenol blue tests (e.g. Multistix or Albustix) are not affected.

 

 

4.6            Pregnancy and lactation

 

            There has been no evidence of a teratogenic effect in animals or untoward effect in humans.  However, use in pregnancy should be reserved for essential cases. 

 

Trace quantities of penicillin can be detected in breast milk with the potential for hypersensitivity reactions (e.g. drug rashes) in the breast-fed neonate or acute alterations in the neonatal bowel flora with resultant diarrhoea.

 

4.8            Undesirable effects

 

            The most common adverse effects are sensitivity reactions including urticaria, maculo-papular rashes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), pruritus,

fever, joint pains and angioedema.  Anaphylaxis occasionally occurs and has sometimes been fatal.  Late sensitivity reactions may include serum sickness-like reactions, haemolytic anaemia, nephropathy and acute interstitial nephritis, which is reversible when treatment is discontinued.

 

            Other adverse effects are generally associated with large intravenous doses of flucloxacillin or impaired renal function.  These include transient leucopenia and thrombocytopenia, haemolytic anaemia, agranulocytosis and neutropenia (which might have some immunological basis); prolongation of bleeding time and defective platelet function; convulsions and other signs of central nervous system toxicity (encephalopathy has been reported following intrathecal administration and can be fatal); electrolyte disturbances due to administration of large amounts of sodium (see Section 4.4). 

 

            Hepatic effects:  Changes in liver function test results may occur, but are reversible when treatment is discontinued.  Hepatitis and cholestatic jaundice have been reported.  These reactions are related neither to the dose nor to the route of administration; administration for more than two weeks and increasing age are risk factors.  The onset of these effects may be delayed for up to two months post-treatment; in several cases the course of the reactions has been protracted and lasted for some months.  In very rare cases, a fatal outcome has been reported, almost always in patients with serious underlying disease. 

 

            Some patients with syphilis may experience a Jarisch-Herxheimer reaction shortly after treatment is started.  Symptoms include fever, chills, headache and reaction at the site of lesions.  The reaction can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy.

 

             Gastrointestinal effects (diarrhoea, and nausea and vomiting) reported with flucloxacillin commonly occur after oral administration, not or parenteral administration.  Pseudomembranous colitis has been reported with most antibiotics.  Prolonged use of penicillins may lead to the development of oral candidiasis.

 

            Phlebitis has followed intravenous infusion.

 

6.2            Incompatibilities

 

            Flucloxacillin may be administered in combination with other antibiotics including ampicillin to produce a wider spectrum of antibacterial activity.  If used concurrently with an aminoglycoside the two antibiotics should not be mixed in the syringe, container or giving set as precipitation may occur.

 

            Flucloxacillin should not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions.

 

            The following drugs are incompatible with flucloxacillin: amiodarone, atropine sulphate, buprenorphine, calcium gluconate, chlorpromazine hydrochloride, ciprofloxacin, diazepam, dobutamine, hydrochloride, erythromycin lactobionate, gentamicin sulphate, metoclopramide hydrochloride, morphine sulphate, netilmicin sulphate, ofloxacin, papaveretum, pethidine hydrochloride, prochlorperazine edisylate, promethazine hydrochloride, tobramycin and verapamil hydrochloride.

 

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC