FLONOX

Ciprofloxacin is indicated for the treatment of the following infections (see sections 4.4 and 5.1). Particular attention should be paid to the available information on bacterial resistance to ciprofloxacin before initiating treatment.

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

In adults

· Lower respiratory tract infections due to Gram-negative bacteria

o exacerbations of chronic obstructive pulmonary disease. In the exacerbation of chronic obstructive pulmonary disease, CIPROFLOXACINE BENTA 500 mg, film-coated tablet must be used only when the antibiotics usually recommended for the treatment of these infections are deemed inappropriate

o broncho-pulmonary infections in cases of cystic fibrosis or bronchiectasis

o pneumonias

· Chronic purulent otitis media

· Acute exacerbations of chronic sinusitis, particularly due to Gram-negative bacteria

· Urinary tract infections

o Uncomplicated acute cystitis. In uncomplicated acute cystitis, CIPROFLOXACINE BENTA 500 mg, film-coated tablet must be used only when the antibiotics usually recommended for the treatment of these infections are deemed inappropriate.

o Acute pyelonephritis

o Complicated urinary tract infections

o Bacterial prostatitis

· Genital tract infections

o gonococcal urethritis and cervicitis due to sensitive strains of Neisseria gonorrhoeae

o orchiepididymitis, including infections due to sensitive strains of Neisseria gonorrhoeae

o upper gynecological infections, including infections due to sensitive strains of Neisseria gonorrhoeae

· Gastrointestinal infections (e.g. traveler's diarrhea)

· Intra-abdominal infections

· Skin and soft tissue infections due to Gram-negative bacteria

· Malignant external otitis

· Osteoarticular infections

· Prophylaxis of invasive Neisseria meningitidis infections

· Anthrax (post-exposure prophylaxis and curative treatment)

Ciprofloxacin can be used for the treatment of febrile neutropenic patients where a bacterial origin is suspected.

In children and adolescents

· Broncho-pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis

· Complicated urinary tract infections and acute pyelonephritis

· Anthrax (post-exposure prophylaxis and curative treatment)

Ciprofloxacin can also be used to treat severe infections in children and adolescents, if necessary.

Treatment should be initiated exclusively by physicians experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).

Pregnancy

Available data on the administration of ciprofloxacine in pregnant women show no malformation or fetal/neonatal toxicity from ciprofloxacine. Animal studies reveal no direct or indirect toxic effect on reproduction. In the prenatal phase and in young animals, effects on immature cartilage have been observed during exposure to quinolones. Therefore, the occurrence of joint damage caused by the drug on the cartilage of the immature human body/fetus cannot be excluded (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of ciprofloxacine during pregnancy.

Breastfeeding

Ciprofloxacine is excreted in breast milk. Given the potential risk of joint damage, ciprofloxacine must not be used during breastfeeding.

Due to its neurological effects, ciprofloxacine may affect reaction time. The ability to drive vehicles or use machines may therefore be impaired.

The most frequently reported treatment-related adverse effects are nausea and diarrhoea.

Adverse effects reported during clinical trials and post-marketing of ciprofloxacine (oral, intravenous, and sequential treatment) are listed below by frequency. The frequency analysis takes into account both oral and intravenous administration data for ciprofloxacine.

*Very rare cases of serious, persistent (lasting several months or years), disabling and potentially irreversible adverse reactions, affecting various, sometimes multiple, sensory organ systems (notably effects such as tendonitis, tendon rupture, arthralgia, pain in the extremities, gait disturbance, neuropathies associated with paraesthesia and neuralgia, fatigue, psychiatric disorders (including sleep disorders, anxiety, panic attacks, depression, suicidal ideation), memory and concentration disorders, 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 of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.4).

Paediatric population

The incidence of arthropathy (arthralgia, arthritis) mentioned above refers to data collected in studies in adults. In children, arthropathy is reported frequently (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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 reaction 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/ .