Adverse reactions : תופעות לוואי

4.8     Undesirable effects

The most common adverse reactions are Candida overgrowth, eosinophilia, headache, dizziness, gastrointestinal disturbances and transient rise in liver enzymes.

The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data (for example from placebo-controlled studies) for calculating incidence were not available. In addition the incidence of adverse reactions associated with cefuroxime axetil may vary according to the indication.

Data from large clinical studies were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e. those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than true frequency. Placebo-controlled trial data were not available.
Where incidences have been calculated from clinical trial data, these were based on drug- related (investigator assessed) data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Treatment related adverse reactions, all grades, are listed below by MedDRA body system organ class, frequency and grade of severity. The following convention has been utilised for the classification of frequency: 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 and not known (cannot be estimated from the available data).

System organ        Common              Uncommon                    Not known class
Infections and     Candida                                   Clostridium difficile infestations       overgrowth                                overgrowth 
Blood and          eosinophilia      positive Coomb’s        haemolytic anaemia lymphatic                            test,
system disorders                     thrombocytopenia,
leukopenia
(sometimes profound)
Immune system                                                drug fever, serum sickness, disorders                                                    anaphylaxis, Jarisch- Herxheimer reaction
Nervous system     headache,
disorders          dizziness

Gastrointestinal   diarrhoea,        vomiting                pseudomembranous colitis disorders          nausea,                                   (see section 4.4) abdominal pain
Hepatobiliary      transient                                 jaundice (predominantly disorders          increases of                              cholestatic), hepatitis hepatic enzyme levels
Skin and                             skin rashes             urticaria, pruritus, erythema subcutaneous                                                 multiforme, Stevens- tissue disorders                                             Johnson syndrome, toxic epidermal necrolysis
(exanthematic necrolysis)
(see Immune system disorders), angioneurotic oedema
Description of selected adverse reactions
Cephalosporins as a class tend to be absorbed onto the surface of red cells membranes and react with antibodies directed against the drug to produce a positive Coombs’ test (which can interfere with cross-matching of blood) and very rarely haemolytic anaemia.

Transient rises in serum liver enzymes have been observed which are usually reversible.

Paediatric population
The safety profile for cefuroxime axetil in children is consistent with the profile in adults.

Reporting 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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@m oh.gov.il
Additionally, you should also report to GSK Israel (il.safety@gsk.com)