Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Following administration of cefradine, a false positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solution or with reagent tablets such as Clinitest. This does not occur with enzyme based tests such as Clinistix or Diastix.
Prolonged use of antibiotics may result in overgrowth of non-susceptible organisms.
Dosage should be reduced in renal failure (see section 4.2).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Loop diuretics may increase nephrotoxicity of cephalosporins.
Probenecid has been seen to raise serum concentrations of cefradine, by reducing renal clearance of the cephalosporins.
There is evidence of partial allergenicity between the penicillins and the cephalosporins. Therefore, cefradine should be used with caution in those patients with known hypersensitivity to penicillins. There have been instances of patients who have had reactions to both drug classes (including anaphylaxis).
Although animal studies have shown no teratogenic effects, safety in pregnancy has not been established.
As with all medicines, use should be avoided in pregnancy especially in the first trimester, unless considered essential by the physician.
Cefradine is excreted in breast milk and therefore should be used with caution in lactating mothers.
Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.
Undesirable effects are uncommon and mainly mild in nature. They are limited essentially to gastrointestinal disturbances and on occasion to hypersensitivity phenomena.
Rarely: Antibiotic-associated colitis
Frequency unknown: Vaginitis, candidal overgrowth, candidiasis
Frequency unknown: Eosinophilia, blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
Frequency unknown: Fever, athralgia, serum sickness-like reactions, anaphylaxis
Frequency unknown: Confusion, sleep disturbances
Frequency unknown: Hypersensitivity, hyperactivity, hypertonia, dizziness, nervousness
Rarely: Headache
Frequency unknown: Diarrhoea, nausea, glossitis, heartburn
Rarely: Vomiting, abdominal discomfort,
Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
Frequency unknown: Rashes, toxic epidermal necrolysis, pruritis, urticaria, erythema multiforme, Stevens-Johnson syndrome, oedema
Frequency unknown: Reversible interstitial nephritis
Frequency unknown: Tightness in the chest
Frequency unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphates, positive direct Coombs' test
Frequency unknown: joint pain
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
None.
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