ZINNAT

CEFUROXIME CRISTERS is indicated in the treatment of the following infections in adults and in children from 3 months (see sections 4.4 and 5.1):

· Acute streptococcal tonsillitis and pharyngitis

· Acute bacterial sinusitis

· Acute otitis media

· Acute exacerbations of chronic obstructive pulmonary disease

· Cystitis

· Pyelonephritis

· Uncomplicated skin and soft tissue infections

· Treatment of early stage Lyme disease

Official recommendations regarding the appropriate use of antibacterials should be taken into account.

Medicines reducing gastric acidity may lead to a decrease in the bioavailability of céfuroxime axétil, compared to that observed in the fasting state, and tend to cancel the improvement in absorption obtained after food intake.

Céfuroxime is eliminated by glomerular filtration and tubular secretion. Concomitant use of probenecid is not recommended. Concomitant administration of probenecid significantly increases the peak concentration, the area under the curve of serum concentrations against time, and the elimination half-life of céfuroxime.

Concomitant use of oral anticoagulants may lead to an increase in the « International Normalized Ratio » - Rapport international normalisé (INR).

Pregnancy

Data on the use of céfuroxime in pregnant women are limited. Animal studies have not demonstrated deleterious effects on gestation, embryonic or fetal development, parturition or post-natal development. CEFUROXIME CRISTERS should be prescribed in pregnant women only if the benefit is greater than the risk.

Breastfeeding

Céfuroxime is weakly excreted in breast milk. The occurrence of adverse effects at therapeutic doses is not expected, although a risk of diarrhea and fungal infection of the mucous membranes cannot be excluded. These adverse effects may necessitate stopping breastfeeding. The possibility of sensitization must be taken into account. The use of céfuroxime during breastfeeding should only be considered after evaluation of the benefit/risk ratio by a physician.

Fertility

No data are available regarding the effects of céfuroxime axétil on fertility in humans. Animal reproduction studies have not shown an effect on fertility.

No study on the effects of céfuroxime on the ability to drive vehicles and use machines has been carried out. However, as this medicine can cause sensations of dizziness, it is advisable to recommend that patients be cautious when driving vehicles or using machines.

The most frequent adverse effects are Candida proliferation, eosinophilia, headache, dizzy sensations, gastrointestinal disorders and transient elevation of hepatic enzymes.

The frequency categories assigned to the adverse effects below are, for most effects, estimates due to the absence of appropriate data (for example, from placebo-controlled clinical studies) for calculating incidences. In addition, the incidence of adverse effects associated with céfuroxime axétil may vary depending on the indication.

Data from large-scale clinical trials have been used to determine the frequency of adverse effects from very frequent to rare. The frequencies assigned to all other adverse effects (i.e. those occurring at a frequency < 1/10 000) have been mainly determined on the basis of post-marketing data and correspond to a reporting rate rather than an actual frequency. Data from placebo-controlled trials were not available. When incidences were calculated from clinical trial data, they were based on adverse effects judged to be related to treatment (on the basis of investigator assessment). Within each frequency group, adverse effects are presented in descending order of severity.

Treatment-related adverse effects, regardless of their grade, are listed below by organ system class, by frequency and by severity. The following convention has been used for the classification of frequencies: very frequent ≥ 1/10; frequent ≥ 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 undetermined frequency (cannot be estimated on the basis of available data).

Pediatric population

The safety profile of cefuroxime axetil in children is consistent with that in adults.

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorization of the medicinal product is important. It allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/ .