Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Clinical Trials
During double-blind controlled clinical trials or clinical pharmacology studies, LORMYX 200 mg effects have been compared to placebo and other antibiotics, therefore quantitative safety data are available.
Note: The majority of adverse reactions listed (in particular for gastrointestinal disorders) may also be attributable to the underlying diseases being treated and have been reported during clinical trials at the same frequency as the one reported in placebo-treated patients.

Post-marketing experience
During post-approval use of LORMYX 200 mg further undesirable effects have been reported, whose frequency is not known.
Frequency categories are defined using the following convention:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000), Not known (frequency cannot be estimated from the available data).
Frequency of undesirable effects

MedDRA System           Common       Uncommon                    Unknown Organ Class

Infections and                       Candidiasis,                Clostridial infection infestations                         Herpes simplex,
Nasopharyngitis,
Pharyngitis,
Upper respiratory tract infection


Blood and                            Lymphocytosis,              Thrombocytopenia lymphatic system                     Monocytosis,
disorder                             Neutropenia


Immune                                                           Anaphylactic reaction, system                                                           Hypersensitivity disorders

Metabolism and                       Decreased appetite,
nutrition                            Dehydration disorders

Psychiatric disorders                Abnormal dreams,
Depressed mood,
Insomnia,
Nervousness
Nervous                 Dizziness,   Hypoesthesia,               Presyncope system                  Headache     Migraine,
disorders                            Paraesthesia,
Sinus headache,
Somnolence

Eye disorders                        Diplopia

Ear and labyrinth                    Ear pain,
disorders                            Vertigo

Cardiac disorders                    Palpitations

Vascular disorders                   Blood pressure increased,
Hot flush
Respiratory,                                Cough,
thoracic, and                               Dry throat,
mediastinal                                 Dyspnoea,
disorders                                   Nasal congestion,
Oropharyngeal pain,
Rhinorrhea
Gastrointestinal          Abdominal pain,   Abdominal pain upper,
disorders                 Constipation,     Ascites,
Defecation        Dry lip,
urgency,          Dyspepsia,
Diarrhoea,        Gastrointestinal motility
Flatulence,       disorder,
Abdominal         Faeces hard,
distension,       Haematochezia,
Nausea,           Mucous stools,
Vomiting,         Taste disorders
Rectal tenesmus


Hepatobiliary disorders                     Aspartate                   Liver function tests aminotransferase            abnormalities increased

Skin and                                    Rashes,                     Stevens-Johnson syndrome* subcutaneous tissue                         Eruptions and               Toxic Epidermal Necrolysis* disorders                                   exanthemas,                 Angioedema, (partially as signs of                      Sunburn 1                   Dermatitis, hypersensitivity                                                        Dermatitis exfoliative, reactions)                                                              Eczema, Erythemas,
Pruritus,



Musculoskeletal                             Back pain, Muscle and Connective                              spasms, Muscular tissue disorders                            weakness, Myalgia,
Neck pain

Renal and urinary                           Blood in urine,
disorders                                   Glycosuria,
Pollakiuria,
Polyuria,
Proteinuria
Reproductive                                Polymenorrhoea system and breast disorders
General disorders          Pyrexia             Asthenic conditions,
and administration                             Chills,
site conditions                                Cold sweat,
Hyperhidrosis,
Influenza like illness,
Oedema peripheral,
Pain and discomfort

Investigations                                                               International normalised ratio abnormal


*Severe Cutaneous Adverse Reactions have been observed in patients with cirrhosis.
1
As the investigator reported “sunburn” this is not be considered as generally referring to photosensitivity but actually to “sunburn”

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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