UROCTAL

Pregnancy

It is preferable, as a precautionary measure, not to use norfloxacin during pregnancy.

Indeed, although studies conducted in animals have not demonstrated any teratogenic effect, clinical data are still insufficient.

Joint damage has been described in children treated with quinolones, but to date, no cases of arthropathy secondary to in utero exposure have been reported.

Breastfeeding

The administration of this medicine is contraindicated during breastfeeding, due to the passage of fluoroquinolones into breast milk and the joint risk.

As with any treatment likely to cause neurological manifestations, drivers of vehicles and users of machinery should be warned of this potential risk.

Gastrointestinal disorders

Retrosternal burning, abdominal pain and cramps, nausea, diarrhea, anorexia, pseudomembranous colitis, pancreatitis (rare), vomiting.

Skin and subcutaneous tissue disorders

Rash, pruritus, photosensitisation (see section 4.4), vascular purpura, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, exceptionally Lyell syndrome.

Musculoskeletal and connective tissue disorders *

Muscular and/or joint pain; rare tendinitis affecting, among others, the Achilles tendon, which can occur within the first 48 hours of treatment and become bilateral; exceptionally tendon ruptures (see sections 4.3, 4.4), elevation of creatine phosphokinase (CPK).

Nervous system disorders *

Convulsions (see section 4.4) headache, dizziness, sleep disorders, tinnitus, epiphora, paresthesias, tremors, myoclonus, polyneuropathy, worsening of myasthenia (see section 4.4).

Psychiatric disorders *

Psychotic reactions including hallucinations, mood disorders (depression, euphoria), confusion syndromes, anxiety, nervousness, irritability.

Immune system disorders

Urticaria, dyspnoea, exceptionally Quincke's edema and anaphylactic-type shock (see section 4.4).

Cardiac disorders**

Very rarely QT interval prolongation.

Hematological and lymphatic system disorders

Hemolytic anemia, particularly in patients with glucose-6-phosphate dehydrogenase deficiency, thrombocytopenia, rarely leucopenia, neutropenia, hypereosinophilia.

Renal and urinary disorders

Rarely elevations of blood urea and plasma creatinine: exceptionally nephropathy including interstitial and glomerular nephropathies (with nephrotic syndrome).

Hepatobiliary disorders

Elevation of transaminases, bilirubin and alkaline phosphatases, hepatitis with possibly jaundice.

Infections and infestations

Vaginal candidiasis.

* 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 type tendinitis, tendon rupture, arthralgia, pain in the extremities, walking disorders, neuropathies associated with paresthesias and neuralgias, fatigue, psychiatric disorders (including sleep disorders, anxiety, panic attacks, depression, suicidal ideation), memory and concentration disorders and disorders of hearing, sight, taste and smell), 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 cardiac valves have been reported in patients receiving fluoroquinolones (see section 4.4).

Reporting of suspected adverse effects

Reporting suspected adverse effects after medicinal product authorization is important. It allows for 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/