AXIMYCINE

AMOXICILLINE EVOLUGEN is indicated in the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):

· Acute bacterial sinusitis

· Acute otitis media

· Documented streptococcal tonsillitis/pharyngitis

· Acute exacerbations of chronic bronchitis

· Community-acquired pneumonia

· Acute cystitis

· Asymptomatic bacteriuria during pregnancy

· Acute pyelonephritis

· Typhoid and paratyphoid fever

· Dental abscess with cellulitis

· Joint infections on prostheses

· Eradication of Helicobacter pylori

· Lyme disease.

AMOXICILLINE EVOLUGEN is also indicated in the prophylaxis of endocarditis.

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

Pregnancy

Studies conducted in animals have not demonstrated direct or indirect deleterious effects on reproduction. Limited data on the use of amoxicillin in pregnant women do not indicate an increase in the risk of congenital malformations. Amoxicillin can be used in pregnant women if the potential benefits outweigh the potential risks associated with treatment.

Breastfeeding

Amoxicillin is excreted in breast milk in small quantities with a possible risk of sensitization. Consequently, diarrhea and fungal infection of the mucous membranes are possible in the breastfed infant and could necessitate stopping breastfeeding. Amoxicillin can only be used during breastfeeding after assessment of the benefit/risk ratio by the treating physician.

Fertility

There is no data relating to the effects of amoxicillin on human fertility. Reproduction studies conducted in animals have shown no effect on fertility.

No study has been conducted regarding the ability to drive vehicles and use machines. 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 diarrhoea, nausea and skin rashes.

The adverse effects identified in clinical studies and since the marketing of amoxicillin 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 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 .