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.



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Table of adverse reactions

System organ          Common       Uncommon            Rare                   Not known (cannot class                 (≥1/100 to   (≥1/1,000 to        (≥1/10,000 to          be estimated from <1/10)       <1/100)             <1/1,000)              available data) Infections and                     Fungal infection infestations                       including Candida infection
Pathogen resistance
Blood and                          Leukopenia          Thrombocytopenia Bone marrow failure lymphatic system                   Eosinophilia        Neutropenia       including aplastic disorders                                                                anaemia, pancytopenia,
agranulocytosis,
haemolytic anaemia
Immune system                                          Angioedema        Anaphylactic shock 1 disorders                                              Hypersensitivity  Anaphylactoid shock 1 (see section 4.4) (see section 4.4)
Endocrine                                              Syndrome of disorders                                              inappropriate secretion of antidiuretic hormone (SIADH)
Metabolism and                     Anorexia            Hypoglycaemia          Hyperglycaemia nutrition disorders                                    particularly in diabetic patients,     (see section 4.4)
Hypoglycaemic coma
(see section 4.4)
Psychiatric           Insomnia     Anxiety             Psychotic              Psychotic disorders disorders                          Confusional state   reactions (with e.g.   with self-endangering Nervousness         hallucination,         behaviour including paranoia)              suicidal ideation or
Depression             suicide attempt
Agitation              (see section 4.4)
Abnormal dreams        Mania
Nightmares,
Delirium.


Nervous system        Headache     Somnolence          Convulsion (see        Peripheral sensory disorders             Dizziness    Tremor              sections 4.3 and       neuropathy (see Dysgeusia           4.4)                   section 4.4)
Paraesthesia,          Peripheral sensory
Memory                 motor neuropathy (see impairement            section 4.4)
Parosmia including anosmia
Dyskinesia
Extrapyramidal disorder
Ageusia
Syncope
Benign intracranial hypertension
Myoclonus


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Eye disorders                                       Visual              Transient vision loss disturbances such   (see section 4.4),
as blurred vision   uveitis
(see section 4.4)
Ear and Labyrinth                Vertigo            Tinnitus disorders                                                               Hearing loss Hearing impaired
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                                            Hypotension disorders**
Respiratory,                     Dyspnoea                               Bronchospasm thoracic and                                                            Pneumonitis allergic mediastinal disorders
Gastro-intestinal   Diarrhoea    Abdominal pain                         Diarrhoea – disorders           Vomiting     Dyspepsia                              haemorrhagic which Nausea       Flatulence                             in very rare cases may Constipation                           be indicative of enterocolitis,
including pseudomembranous colitis (see section
4.4)
Pancreatitis (see section 4.4)
Hepatobiliary       Hepatic      Blood bilirubin                        Jaundice and severe disorders           enzyme       increased                              liver injury, including increased                                           cases with fatal acute (ALT/AST,                                           liver failure, primarily alkaline                                            in patients with severe phosphatase,                                        underlying diseases GGT)                                                (see section 4.4) Hepatitis



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Skin and                         Rash                 Drug Reaction        Toxic epidermal subcutaneous                     Pruritus             with Eosinophilia    necrolysis tissue disordersb                Urticaria            and Systemic         Stevens-Johnson Hyperhidrosis        Symptoms             syndrome
(DRESS) (see         Erythema multiforme section 4.4),        Photosensitivity
Fixed drug           reaction (see section eruption             4.4)
Leukocytoclastic vasculitis
Stomatitis
Skin hyperpigmentation

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

Renal and Urinary                Blood creatinine     Renal failure acute disorders                        increased            (e.g. due to interstitial nephritis)
General disorders                Asthenia             Pyrexia             Pain (including pain in and administration                                                        back, chest, and site conditions                                                           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.
* 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


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