The adverse reactions are described according to the MedDRA system organ class as follows.
Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infections and infestations: Uncommon: Fungal infection including Candida infection, pathogen resistance.
Blood and lymphatic system disorders: Uncommon: Leukopenia, eosinophilia.
Rare: Thrombocytopenia, neutropenia.
Not known: Pancytopenia, agranulocytosis, haemolytic anaemia.
Immune system disorders: Rare: Angioedema, hypersensitivity.
Not known: Anaphylactic shock
a, anaphylactoid shock
a.
Metabolism and nutrition disorders: Uncommon: Anorexia.
Rare: Hypoglycaemia particularly in diabetic patients.
Not known: Hyperglycaemia, hypoglycaemic coma.
Psychiatric disorders: Common: Insomnia.
Uncommon: Anxiety, confusional state, nervousness.
Rare: Psychotic reactions (with e.g. hallucination, paranoia), depression, agitation, abnormal dreams, nightmares.
Not known: Psychotic disorders with self-endangering behaviour including suicidal ideation or suicide attempt.
Nervous system disorders: Common: Headache, dizziness.
Uncommon: Somnolence, tremor, dysgeusia.
Rare: Convulsion, paraesthesia.
Not known: Peripheral sensory neuropathy, peripheral sensory motor neuropathy, parosmia including anosmia, dyskinesia, extrapyramidal disorder, ageusia, syncope, benign intracranial hypertension.
Eye disorders: Rare: Visual disturbances such as blurred vision.
Not known: Transient vision loss.
Ear and labyrinth disorders: Uncommon: Vertigo.
Rare: Tinnitus.
Not known: Hearing loss, hearing impaired.
Cardiac disorders: Rare: Tachycardia, palpitation.
Not known: Ventricular tachycardia which may result in cardiac arrest, ventricular arrhythmia, and torsade de pointes (reported predominantly in patients with risk factors of QT prolongation), electrocardiogram QT prolonged.
Vascular disorders: Rare: Hypotension.
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnoea.
Not known: Bronchospasm, pneumonitis allergic.
Gastrointestinal disorders: Common: Diarrhoea, vomiting, nausea.
Uncommon: Abdominal pain, dyspepsia, flatulence, constipation.
Not known: Diarrhoea - haemorrhagic which in very rare cases may be indicative of enterocolitis, including pseudomembranous colitis, pancreatitis.
Hepatobiliary disorders: Common: Hepatic enzyme increased (ALT/AST, alkaline phosphatase, GGT).
Uncommon: Blood bilirubin increased.
Not known: Jaundice and severe liver injury, including cases with fatal acute liver failure, primarily in patients with severe underlying diseases, hepatitis.
Skin and subcutaneous tissue disordersb: Uncommon: Rash, pruritus, urticaria, hyperhidrosis.
Not known: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, photosensitivity reaction, leukocytoclastic vasculitis, stomatitis.
Musculoskeletal and connective tissue disorders: Uncommon: Arthralgia, myalgia.
Rare: Tendon disorder including tendinitis (e.g. Achilles tendon), muscular weakness which may be of importance in patients with myasthenia gravis.
Not known: Rhabdomyolysis, tendon rupture (e.g. Achilles tendon), ligament rupture, muscle rupture, arthritis.
Renal and urinary disorders: Uncommon: Blood creatinine increased.
Rare: Renal failure acute (e.g. due to interstitial nephritis).
General disorders and administration site conditions: Uncommon: Asthenia.
Rare: Pyrexia.
Not known: Pain (including pain in back, chest, and extremities).
a Anaphylactic and anaphylactoid reactions may sometimes occur even after the first dose.
b Mucocutaneous reactions may sometimes occur even after the first dose.
Other undesirable effects which have been associated with fluoroquinolone administration include: attacks of porphyria in patients with porphyria.
Please seek medical attention immediately at the first sign of any adverse drug reaction shall appear.