AVELOX

MOXIFLOXACINE SANDOZ is indicated in patients aged 18 years and older in the treatment of the following bacterial infections caused by bacteria sensitive to moxifloxacin (see sections 4.4, 4.8 and 5.1).

In the following indications, moxifloxacin should be used only when other antibiotics usually recommended for the treatment of these infections are deemed inappropriate:

· acute bacterial sinusitis (correctly diagnosed),

· acute exacerbation of chronic obstructive pulmonary disease, including bronchitis.

In the following indications, moxifloxacin should be used only when antibiotics usually recommended for the initial treatment of these infections are deemed inappropriate or when these antibiotics have not been effective in the treatment of the infection:

· community-acquired acute pneumonias (CAP), except for severe forms,

· upper gynecological infections of mild to moderate intensity (i.e. upper gynecological infections, including salpingitis and endometritis), not associated with a tubo-ovarian or pelvic abscess.

MOXIFLOXACINE SANDOZ is not recommended as monotherapy in the treatment of upper gynecological infections of mild to moderate intensity but must be administered in association with another appropriate antibiotic (for example a cephalosporin) due to the increased resistance rate of Neisseria gonorrhoeae to moxifloxacin, unless such resistance can be excluded (see sections 4.4 and 5.1).

MOXIFLOXACINE SANDOZ can also be used as follow-up to an initial intravenous treatment of moxifloxacin in patients who have shown improvement in their condition in the following indications:

· community-acquired acute pneumonias,

· complicated skin and soft tissue infections.

MOXIFLOXACINE SANDOZ must not be used in the initial treatment of severe community-acquired acute pneumonias or of all types of complicated skin and soft tissue infections.

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

Pregnancy

The safety of moxifloxacine use in pregnant women has not been evaluated. Studies conducted in animals have shown reproductive toxicity (see section 5.3). The potential risk in humans is unknown.

Due to the risk of damage to the cartilage of weight-bearing joints in immature animals by fluoroquinolones and reversible joint damage described in children receiving fluoroquinolones, moxifloxacine must not be used in pregnant women (see section 4.3).

Breastfeeding

There is no data available in breastfeeding women. Based on preclinical data, small amounts of moxifloxacine are excreted in breast milk. In the absence of clinical data and due to the risk of damage to the cartilage of weight-bearing joints by fluoroquinolones observed in immature animals, breastfeeding is contraindicated during treatment with moxifloxacine (see section 4.3).

Fertility

Studies conducted in animals have not shown deleterious effects on fertility (see section 5.3).

Effects on the ability to drive vehicles or use machines have not been studied. However, fluoroquinolones, including moxifloxacin, may have an impact on the ability to drive vehicles or use machines due to neurological manifestations (example: sensations of dizziness, sudden and transient loss of vision, see section 4.8) or brief loss of consciousness (syncope, see section 4.8). Patients must be informed of these potential risks and must know their reactions to this medicine before driving a vehicle or using machines.

The adverse events observed in clinical trials and from post-marketing reports with moxifloxacin administered at 400 mg (oral administration, sequential treatment), are listed below classified according to frequency categories:

Apart from nausea and diarrhoea, all adverse events were observed at a frequency of less than 3 %.

In each frequency category, adverse effects are presented in descending order of severity. Frequencies are defined as follows:

· 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),

· undetermined (cannot be estimated on the basis of available data).

* Very rare cases of serious, persistent (lasting several months or years), disabling and potentially irreversible adverse effects, affecting various sensory organ systems, sometimes multiple (notably effects of the tendinitis type, tendon rupture, arthralgia, pain in the extremities, walking disorders, neuropathies associated with paresthesia and neuralgia, fatigue, psychiatric disorders (including sleep disorders, anxiety, panic attacks, depression, suicidal ideation), memory and concentration disorders, and hearing, vision, taste and smell disorders), have been reported in association with the use of quinolones and fluoroquinolones, sometimes independently of pre-existing risk factors (see section 4.4).

** Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal), and regurgitation/incompetence of one of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.4).

The following side effects have been reported in very rare cases during treatment with other fluoroquinolones. They are therefore likely to occur also during treatment with moxifloxacin: increased intracranial pressure (including pseudotumor cerebri), hypernatremia, hypercalcemia, hemolytic anemia.

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance 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/ .