IBERTIN

AMOXICILLINE/ACIDE CLAVULANIQUE ZENTIVA LAB is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):

· acute bacterial sinusitis (appropriately diagnosed),

· acute otitis media,

· exacerbation of chronic bronchitis (appropriately diagnosed),

· community-acquired acute pneumonia,

· cystitis,

· pyelonephritis,

· skin and soft tissue infections, in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis,

· bone and joint infections, in particular osteomyelitis.

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

Pregnancy

Animal studies have not shown direct or indirect deleterious effects on gestation and/or embryonic/fetal development and/or childbirth and/or post-natal development (see section 5.3). Limited data on the use of the amoxicilline/acide clavulanique combination in pregnant women do not indicate an increased risk of congenital malformations. A single study conducted in women presenting with premature rupture of fetal membranes before term indicated that prophylactic treatment with amoxicilline/acide clavulanique could be associated with an increased risk of necrotizing enterocolitis in newborns. Use should be avoided during pregnancy, unless the physician considers it necessary.

Breastfeeding

Both substances are excreted in breast milk (the effects of clavulanic acid on the breastfed infant are not known). Consequently, diarrhea and fungal infection of the mucous membranes are possible in the breastfed infant and could necessitate discontinuation of breastfeeding.

The amoxicilline-acide clavulanique combination can only be used during breastfeeding after evaluation of the benefit/risk ratio by the treating physician.

The effects on the ability to drive vehicles or use machines have not been studied.

However, the occurrence of adverse effects (e.g., allergic reactions, dizziness, convulsions) that may have an impact on the ability to drive vehicles or use machines is possible (see section 4.8).

The most frequent adverse effects are diarrhea, nausea and vomiting.

The adverse effects identified in clinical studies and since the marketing of AMOXICILLINE/ACIDE CLAVULANIQUE ZENTIVA LAB are mentioned below according to the MedDRA classification by system organ class.

The following terminology is used to classify adverse effects according to their frequency:

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)

Frequency unknown (cannot be estimated on the basis of available data)

Reporting of suspected adverse effects

Reporting suspected adverse effects after medicinal product authorization is important. It allows for continuous monitoring of the benefit/risk ratio of the medicine. 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 / .