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 to <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 organ     Common       Uncommon       Rare (≥1/10,000 to           Not known (cannot be class            (≥1/100 to   (≥1/1,000 to   <1/1,000)                    estimated from available <1/10 )      <1/100)                                     data)

Infections and                Fungal infestations                  infection including
Candida infection
Pathogen resistance
Blood and the                 Leukopenia     Thrombocytopenia             Pancytopenia lymphatic                     Eosinophilia   Neutropenia                  Agranulocytosis system                                                                    Haemolytic anaemia disorders

Immune system                                Angioedema                   Anaphylactic shock a disorders                                    Hypersensitivity (see        Anaphylactoid shock a (see section 4.4)                 section 4.4)

Endocrine                                    Syndrome of disorders                                    inappropriate secretion of antidiuretic hormone
(SIADH)

Metabolism and                Anorexia       Hypoglycaemia            Hyperglycaemia (see nutrition                                    particularly in diabetic section 4.4) disorders                                    patients, Hypoglycaemic coma (see section 4.4)

Psychiatric      Insomnia     Anxiety        Psychotic reactions (with    Psychotic disorders with *                   Confusional    e.g. hallucination,          self-endangering behaviour disorders state          paranoia)                    including suicidal ideation Nervousness    Depression                   or suicide attempt (see
Agitation                    section 4.4)
Abnormal dreams
Nightmares, Delirium
Nervous system Headache       Somnolence     Convulsion (see sections     Peripheral sensory *    Dizziness      Tremor         4.3 and 4.4)                 neuropathy (see section disorders
Dysgeusia      Paraesthesia                 4.4)
Memory impairment            Peripheral sensory motor neuropathy (see section
4.4)
Parosmia including anosmia
Dyskinesia
Extrapyramidal disorder
Ageusia
Syncope


Benign intracranial hypertension


Eye disorders *                                  Visual disturbances such Transient vision loss (see as blurred vision (see   section 4.4) section 4.4)


Ear and                           Vertigo        Tinnitus                   Hearing loss Labyrinth                                                                   Hearing impaired disorders *


Cardiac                                          Tachycardia, Palpitation   Ventricular tachycardia, **                                                             which may result in cardiac disorders 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 iv                  Hypotension
**   form only: disorders
Phlebitis

Respiratory,                      Dyspnoea                                  Bronchospasm thoracic and                                                                Pneumonitis allergic mediastinal disorders

Gastro-           Diarrhoea       Abdominal                                 Diarrhoea – haemorrhagic intestinal        Vomiting        pain                                      which in very rare cases disorders         Nausea          Dyspepsia                                 may be indicative of Flatulence                                enterocolitis, including
Constipation                              pseudomembranous colitis
(see section 4.4)
Pancreatitis (see section
4.4)
Hepatobiliary     Hepatic         Blood                                     Jaundice and severe liver disorders         enzyme          bilirubin                                 injury, including fatal cases increased       increased                                 with acute liver failure, (ALT/AST,                                                 primarily in patients with alkaline                                                  severe underlying diseases phosphatase,                                              (see section 4.4) GGT)                                                      Hepatitis

Skin and                               Rash              Drug Reaction with            Toxic epidermal necrolysis subcutaneous                           Pruritus          Eosinophilia and              Stevens-Johnson syndrome tissue disorders                       Urticaria         Systemic Symptoms             Erythema multiforme b
Hyperhidrosis     (DRESS) (see section          Photosensitivity reaction 4.4), Fixed drug eruption     (see section 4.4)
Leukocytoclastic vasculitis
Stomatitis
Musculoskeletal                        Arthralgia        Tendon disorders (see         Rhabdomyolysis and connective                         Myalgia           sections 4.3 and 4.4)         Tendon rupture (e.g.
tissue disorders                                         including tendinitis (e.g.    Achilles tendon) (see *                                                        Achilles tendon)              sections 4.3 and 4.4) Muscular weakness             Ligament rupture which may be of special       Muscle rupture importance in patients        Arthritis with myasthenia gravis
(see section 4.4)
Renal and                              Blood             Renal failure acute (e.g.
Urinary                                creatinine        due to interstitial disorders                              increased         nephritis)

General           Applies to iv   Asthenia               Pyrexia                       Pain (including pain in disorders and     form only:                                                           back, chest, and administration    Infusion site                                                        extremities) * reaction (pain,
site conditions 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 *
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/ and emailed to the Registration Holder’s Patient Safety Unit at: drugsafety@neopharmgroup.com.