CURAM

AMOXICILLINE/ACIDE CLAVULANIQUE ALMUS 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,

· Infections of the bones and joints, in particular osteomyelitis.

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

Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Limited data on the use of amoxicillin/clavulanic acid during pregnancy in humans do not indicate an increased risk of congenital malformations. In a single study in women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with amoxicillin/clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates. Use should be avoided during pregnancy, unless considered essential by the physician.

Breastfeeding

Both substances are excreted in breast milk (the effects of clavulanic acid on the breast-fed infant are not known). Consequently, diarrhoea and a fungal infection of the mucous membranes are possible in the breast-fed infant and might require the cessation of breast-feeding.

Amoxicillin/clavulanic acid should only be used during breast-feeding after benefit/risk assessment by the physician in charge.

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 common adverse effects are diarrhoea, nausea and vomiting.

Adverse effects identified in clinical studies and since the marketing of AMOXICILLINE/ACIDE CLAVULANIQUE products are mentioned below according to the MedDRA system organ class.

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

Very common ( ³ 1/10)

Common ( ³ 1/100 to < 1/10)

Uncommon ( ³ 1/1 000 to < 1/100)

Rare ( ³ 1/10 000 to < 1/1 000)

Very rare (< 1/10 000)

Not known (cannot be estimated from the available data)

Declaration 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/