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 postmarketing 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.


Table of adverse reactions
System organ Common               Uncommon          Rare                Not known (cannot class           (≥1/100 to <1/10) (≥1/1,000 to      (≥1/10,000 to       be estimated from <1/100)           <1/1,000)           available data)
Infections and                    Fungal infestations                      infection including
Candida infection
Pathogen resistance
Blood and the                     Leukopenia        Thrombocytopen Pancytopenia lymphatic                         Eosinophilia      ia             Agranulocytosis system                                              Neutropenia    Hemolytic disorders                                                          anaemia 

System organ Common            Uncommon       Rare                Not known (cannot class        (≥1/100 to <1/10) (≥1/1,000 to   (≥1/10,000 to       be estimated from <1/100)        <1/1,000)           available data)
Immune                                        Angioedema          Anaphylactic system                                        Hypersensitivity shock a disorders                                     (see section 4.4) Anaphylactoid shock a
(see section 4.4)
Endocrine                                      Syndrome 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)
Psychiatric      Insomnia       Anxiety        Psychotic           Psychotic disorders                       Confusional    reactions (with     disorders with state          e.g.,               self-endangering
Nervousness    hallucination,      behaviour paranoia)           including suicidal
Depression          ideation or suicide
Agitation           attempt
Abnormal            (see section 4.4) dreams
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 impairement         (see section 4.4)
Parosmia including anosmia
Dyskinesia
Extrapyramidal disorder
Ageusia
Syncope
Benign intracranial hypertension


System organ Common              Uncommon         Rare                 Not known (cannot class          (≥1/100 to <1/10) (≥1/1,000 to     (≥1/10,000 to        be estimated from <1/100)          <1/1,000)            available data)
Eye disorders                                     Visual               Transient vision disturbances such    loss (see section as blurred vision    4.4),
(see section 4.4)    uveitis
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         Applies to i.v.                  Hypotension disorders**      form only:
Phlebitis
Respiratory,                       Dyspnoea                            Bronchospasm thoracic and                                                           Pneumonitis mediastinal                                                            allergic disorders
Gastrointestina Diarrhoea          Abdominal                           Diarrhoea – l disorders     Vomiting           pain                                haemorrhagic Nausea             Dyspepsia                           which in very rare Flatulence                          cases may be
Constipation                        indicative of enterocolitis,
including pseudomembranou s colitis (see section 4.4)
Pancreatitis


System organ Common              Uncommon       Rare              Not known (cannot class          (≥1/100 to <1/10) (≥1/1,000 to   (≥1/10,000 to     be estimated from <1/100)        <1/1,000)         available data)
Hepatobiliary Hepatic enzyme Blood                                Jaundice and disorders      increased         bilirubin                        severe liver injury, (ALT/AST,         increased                        including fatal alkaline                                           cases with acute phosphatase,                                       liver failure,
GGT)                                               primarily in patients with severe underlying diseases (see section 4.4)
Hepatitis
Skin and                          Rash          Drug Reaction      Toxic epidermal subcutaneous                      Pruritus      with Eosinophilia necrolysis tissue                            Urticaria     and Systemic       Stevens-Johnson disordersb                        Hyperhidrosis Symptoms           syndrome (DRESS) (see       Erythema section 4.4),      multiforme
Fixed drug         Photosensitivity eruption           reaction (see section 4.4)
Leukocytoclastic vasculitis
Stomatitis



Musculoskelet                     Arthralgia     Tendon disorders    Rhabdomyolysis al and                            Myalgia        (see sections 4.3   Tendon rupture connective                                       and 4.4)            (e.g., Achilles tissue                                           including           tendon) (see disorders                                        tendinitis (e.g.,   sections 4.3 and Achilles tendon)    4.4)
Muscular            Ligament rupture weakness which      Muscle rupture may be of special   Arthritis importance in patients with myasthenia gravis (see section 4.4)

Renal and                         Blood          Renal failure
Urinary                           creatinine     acute (e.g., due disorders                         increased      to interstitial nephritis)

System organ Common                 Uncommon Rare                     Not known (cannot class            (≥1/100 to <1/10) (≥1/1,000 to (≥1/10,000 to         be estimated from <1/100)        <1/1,000)          available data)
General          Applies to i.v.   Asthenia       Pyrexia             Pain (including disorders and form only:                                              pain in back, administration Infusion site                                          chest, and site conditions reaction (pain,                                       extremities) reddening) 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.
* 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)

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