ALFASPORINE

They derive from the antibacterial activity and the pharmacokinetic characteristics of cefaclor.

They take into account both the clinical studies conducted on the medicinal product and its place within the range of antibacterial products currently available.

They are limited to infections caused by sensitive germs when these infections allow for oral antibiotic therapy and exclude meningeal localizations, notably:

· ENT infections: documented beta-hemolytic streptococcus A tonsillitis, sinusitis, otitis;

· lower respiratory tract infections:

o superinfections of acute bronchitis,

o exacerbations of chronic bronchitis,

o community-acquired pneumonia in subjects:

§ without risk factors,

§ without signs of clinical severity,

§ in the absence of evidence suggesting a resistance of S. pneumoniae to penicillin,

§ in the absence of evidence suggestive of atypical pneumonia;

· uncomplicated urinary tract infections, except for prostatitis and pyelonephritis.

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

This medicine must never be used in case of allergy to cephalosporin group antibiotics.

Particular problems of INR imbalance:

Many cases of increased oral anticoagulant activity have been reported in patients receiving antibiotics. A marked infectious or inflammatory context, age, and the patient's general condition appear to be risk factors. In these circumstances, it appears difficult to distinguish between the infectious pathology and its treatment in the occurrence of INR imbalance. However, certain classes of antibiotics are more involved: notably fluoroquinolones, macrolides, tetracyclines, cotrimoxazole, and certain cephalosporins.

Pregnancy

Animal studies have not demonstrated any teratogenic effect. In the absence of a teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, substances responsible for malformations in the human species have proven to be teratogenic in animals during well-conducted studies on two species.

In clinical practice, the analysis of a high number of exposed pregnancies has apparently revealed no particular malformative or foetotoxic effect of this antibiotic. However, only epidemiological studies would allow for verifying the absence of risk.

Consequently, this medicine can be prescribed during pregnancy if necessary.

Breastfeeding

Passage into breast milk is low and the quantities ingested are much lower than therapeutic doses. Consequently, breastfeeding is possible in case of taking this antibiotic.

However, interrupt breastfeeding (or the medicine) in case of occurrence of diarrhoea, candidiasis, or skin rash in the infant.

This medicine may have a significant influence on the ability to drive vehicles and use machines, particularly due to the possible occurrence of encephalopathy (see sections 4.4, 4.8, 4.9).

Table of adverse effects

The table below presents the adverse effects of cefaclor, identified after marketing. The adverse effects listed below are classified according to their frequency and their organ system class.

The frequencies of adverse effects are classified according to the following convention: frequent (≥ 1/100, < 1/10); uncommon (≥ 1/1 000, < 1/100); rare (≥ 1/10 000, < 1/1 000); very rare (< 1/10 000); undetermined frequency (cannot be estimated on the basis of available data).

*Rare cases of serum sickness-type reactions have been reported. These are skin rashes most often urticarial, exceptionally of the polymorphous erythema type, associated with arthralgia / arthritis, with or without fever, occurring usually during or after a second administration (or more) of the drug. These symptoms, which have been described more frequently in young children, regress without sequelae a few days after stopping treatment. The efficacy of antihistamines and corticosteroid therapy has not been demonstrated. Short hospitalizations have sometimes been deemed necessary. This symptomatology, which could be related to a hypersensitivity reaction, differs from the typical picture of serum sickness by the fact that it is rarely related to lymphadenopathies and proteinuria and that circulating immune complexes were not found in the rare cases where they were sought.

As for any antibiotic, prolonged use of the drug can lead to a resistance phenomenon of the germs involved.

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 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: www.signalement-sante.gouv.fr .