ng of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
4.9 Overdose
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.
Co-fluampicil contains flucloxacillin. Haemodialysis does not lower the serum levels of flucloxacillin.
Co-fluampicil contains ampicillin, which may be removed from the circulation by haemodialysis.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Infections encountered in medical practice can involve mixed strains of bacteria and may include β-lactamase-producing strains. Co-fluampicil provides broad spectrum activity.
5.2 Pharmacokinetic properties
Co-fluampicil is excreted via the kidneys with a plasma half-life of approximately one hour.
5.3 Preclinical safety data
Not relevant
6. Pharmaceutical particulars
6.1 List of excipients
Capsules: Magnesium Stearate:
Capsule Shells: Gelatin, Black Iron Oxide (E172), Titanium Dioxide (E171), Patent Blue V (E131), Quinoline Yellow (E104).
6.2 Incompatibilities
None known
6.3 Shelf life
Two years
6.4 Special precautions for storage
Do not store above 25°C
Store in the original package
6.5 Nature and contents of container
Capsules: Standard polypropylene tube with a polythene closure or standard aluminium canisters or glass bottles fitted with a screw cap with a waxed pulpboard wad. Pack sizes of 20, 50, 100 or 500.
Aluminium foil pack. Pack size 12 capsules.
Aluminium/PVDC blister pack with aluminium overseal. Pack size 20, 28 and 100 capsules.
6.6 Special precautions for disposal and other handling
None
7. Marketing authorisation holder
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
United Kingdom.
8. Marketing authorisation number(s)
PL 29831/0052
9. Date of first authorisation/renewal of the authorisation
18th June 2007
10. Date of revision of the text
10/03/2016
