Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In patients with a history of penicillin allergy, Amben should be used with caution. There is evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Should an allergic reaction to Amben occur, the drug should be discontinued and the patient treated with the usual agents (pressor amines, corticosteroids and/or antihistamines), depending on the severity of the reaction.
As experience in premature infants and neonates is limited, the use of Amben in these patients should only be undertaken with caution.
As with all antibiotics, prolonged use may result in overgrowth of non-susceptible organisms.
As with other broad spectrum antibiotics, pseudomembranous colitis has been reported. It is important to consider its diagnosis in patients who develop diarrhoea in association with Amben therapy.
Amben contains azorubine which may cause allergic reactions.
There are not sufficient data available to indicate whether the concurrent use of Amben and potential nephrotoxic agents such as aminoglycosides causes any alteration in their nephrotoxic effects.
The concomitant administration of probenecid reduces the renal elimination of cefadroxil; therefore, plasma concentrations of cefadroxil may be increased when given in combination with probenecid.
A false-positive Coombs' reaction may occur in some patients receiving Amben.
Urine from patients treated with Amben may give a false-positive glycosuria reaction when tested with Benedict’s or Fehling’s solutions. This does not occur with enzyme based tests.
Although animal studies and clinical experience have not shown any evidence of teratogenicity, the safe use of cefadroxil during pregnancy has not been established.
Amben is excreted in breast milk and should be used with caution in lactating mothers.
None known.
The adverse events are ranked under headings of frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Not known: genital moniliasis
Rare: Reversible neutropenia, leucopenia, thrombocytopenia, agranulocytosis
Common: hypersensitivity phenomena.
Rare: serum sickness, anaphylaxis.
Not known: dizziness, headache
Common: The most commonly reported side-effects are gastrointestinal disturbances.
Rare: pseudo-membraneous colitis.
Not known: nausea, vomiting, diarrhoea, dyspepsia, abdominal discomfort, colitis
Rare: and minor elevations in serum transaminase
Rare: Rash, pruritus, urticaria, angioneurotic oedema, erythema multiforme, Stevens-Johnson syndrome.
Not known: arthralgia
Not known: fever
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
None known.
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