NEOMOX

AMOXICILLINE EG 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;

· prosthetic joint infections;

· eradication of Helicobacter pylori;

· Lyme disease.

AMOXICILLINE EG is also indicated in the prophylaxis of endocarditis.

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

Probenecid

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may lead to increased and prolonged blood levels of amoxicillin.

Allopurinol

Concomitant administration of allopurinol during treatment with amoxicillin may increase the likelihood of allergic skin reactions.

Tetracyclines

Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

Oral anticoagulants

Oral anticoagulants are often administered concomitantly with antibiotics of the penicillin family and no interaction has been reported. However, cases of increased INR have been reported in the literature in patients maintained on acenocoumarol or warfarin during the administration of amoxicillin. If co-administration is necessary, the Quick time or INR should be closely monitored upon the addition or withdrawal of amoxicillin. Furthermore, a dosage adjustment of oral anticoagulants may be necessary (see sections 4.4 and 4.8).

Methotrexate

Penicillins may reduce the excretion of methotrexate and thereby increase its toxicity.

Pregnancy

Animal studies have not shown evidence of direct or indirect 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 the treatment.

Breastfeeding

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

Fertility

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

No studies have been conducted on the ability to drive vehicles and use machines. However, adverse effects (e.g. allergic reactions, dizziness, convulsions) that may affect the ability to drive vehicles or use machines may occur (see section 4.8).

The most frequent undesirable effects are diarrhoea, nausea and cutaneous eruptions. The undesirable 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 the undesirable effects according to their frequency:

Very frequent (≥ 1/10)

Frequent (≥ 1/100 to < 1/10)

Uncommon (≥ 1/1000 to < 1/100)

Rare (≥ 1/10 000 to < 1/1000)

Very rare (< 1/10 000)

Undetermined frequency (cannot be estimated on the basis of available data)

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions following authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reaction 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/.