Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The information given below is based on data from clinical studies in more than 8300 patients and on extensive post-marketing experience.
Frequencies in this table are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System          Common       Uncommon        Rare                               Not known (cannot Very rare organ           (≥1/100 to   (≥1/1000 to     (≥1/10000 to                       be estimated from (<1/10000) class           <1/10 )      <1/100)         <1/1000)                           available data) Infections                   Fungal and                          infection infestations                 including
Candida infection
Pathogen resistance
Blood and                    Leukopenia      Thrombocytopenia                   Pancytopenia the                          Eosinophilia    Neutropenia                        Agranulocytosis lymphatic                                                                       Haemolytic system                                                                          anaemia disorders
Immune                                       Angioedema                         Anaphylactic shocka system                                       Hypersensitivity                   Anaphylactoid disorders                                    (see section 4.4)                  shocka (see section 4.4)
Endocrine                                    Symptoms of disorders                                    inappropriate secretion of antidiuretic hormone (SIADH)
Metabolism                   Anorexia        Hypoglycaemia                      Hyperglycaemia and nutrition                                particularly in disorders                                    diabetic patients,                 (see section 4.4) Hypoglycaemic coma

(see section 4.4)
System         Common       Uncommon      Rare                               Not known (cannot Very rare organ          (≥1/100 to   (≥1/1000 to   (≥1/10000 to                       be estimated from (<1/10000) class          <1/10 )      <1/100)       <1/1000)                            available data) Psychiatric    Insomnia     Anxiety       Psychotic reactions                Psychotic disorders Disorders*                  Confusional   (with e.g.                         with self‑ state         hallucination,                     endangering
Nervousness   paranoia)                          behaviour including
Depression                         suicidal ideation or
Agitation                          suicide attempt (see
Abnormal dreams                    section 4.4)
Nightmares,
Delirium
Nervous        Headache     Somnolence    Convulsion (see                    Peripheral sensory system         Dizziness    Tremor        sections 4.3 and                   neuropathy (see Disorders*                  Dysgeusia     4.4)                               section 4.4) Paraesthesia                       Peripheral sensory
Memory                             motor neuropathy impairment                         (see section 4.4)
Parosmia including anosmia
Dyskinesia
Extrapyramidal disorder
Ageusia
Syncope
Benign intracranial hypertension
Eye                                       Visual                             Transient vision disorders*                                disturbances such                  loss as blurred vision                  (see section 4.4)
(see section 4.4)
Ear and                     Vertigo       Tinnitus                           Hearing loss labyrinth                                                                    Hearing impaired disorders*
Cardiac                                   Tachycardia                        Ventricular Disorders**                               Palpitation                        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 (see sections
4.4 and 4.9)
Vascular       Phlebitis                  Hypotension
Disorders**
Respiratory,                Dyspnoea                                         Bronchospasm thoracic and                                                                 Pneumonitis allergic mediastinal disorders
System             Common            Uncommon          Rare                                      Not known (cannot Very rare organ              (≥1/100 to        (≥1/1000 to       (≥1/10000 to                              be estimated from (<1/10000) class              <1/10 )           <1/100)           <1/1000)                                   available data) Gastrointesti      Diarrhoea         Abdominal                                                   Diarrhoea- nal                Vomiting          pain                                                        haemorrhagic disorders          Nausea            Dyspepsia                                                   which Flatulence                                                  in very rare cases Constipation                                                may be indicative of enterocolitis,
including pseudo- membranous colitis (see section
4.4)
Pancreatitis (see section 4.4)
Hepatobiliary      Hepatic           Blood                                                       Jaundice and disorders          enzyme            bilirubin                                                   severe increased         increased                                                   liver injury, including (ALT/AST,                                                                     fatal cases with alkaline                                                                      acute phosphatase                                                                   liver failure, ,GGT)                                                                         primarily in patients with severe underlying diseases
(see section 4.4)
Hepatitis
Skin and                             Rash               Drug Reaction with                       Toxic epidermal subcutaneou                          Pruritus            Eosinophilia and                        necrolysis s                                    Urticaria               Systemic                            Stevens‑Johnson tissue                               Hyperhidrosis          Symptoms                             syndrome disorders b                                               (DRESS) (see                           Erythema section 4.4), Fixed                      multiforme drug eruption                         Photosensitivity reaction (see section
)4.4
Leukocytoclastic vasculitis
Stomatitis
Musculoskel                          Arthralgia        Tendon disorders                          Rhabdomyolysis etal                                 Myalgia           (see sections 4.3                         Tendon rupture and                                                    and 4.4) including                        (e.g., connective                                             tendinitis (e.g.,                         Achilles tendon) tissue                                                 Achilles tendon)                          (see disorders*                                             Muscular                                  sections 4.3 and weakness                                  4.4) which may be of                           Ligament rupture special importance                        Muscle rupture in patients with                          Arthritis myasthenia gravis
(see section 4.4)
Renal and                            Blood             Renal failure urinary                              creatinine        acute (e.g., due disorders                            increased         to interstitial nephritis)
General            Infusion          Asthenia          Pyrexia                                   Pain (including pain disorders          site reaction                                                                 in back, chest, and and                (pain,                                                                        extremities) administratio      reddening) n site conditions* a
Anaphylactic and anaphylactoid reactions may sometimes occur even after the first dose.
b
Mucocutaneous reactions may sometimes occur even after the first dose.
*
Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors(see section 4.4).

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

Other undesirable effects which have been associated with fluoroquinolone administration include: attacks of porphyria in patients with porphyria.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/.