Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.


The most frequently reported undesirable effects of Fucidin Leo administered orally are gastrointestinal disorders like abdominal discomfort and pain, diarrhoea, dyspepsia, nausea and vomiting. Anaphylactic shock has been reported.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency group, adverse reactions are presented in the order of decreasing seriousness.


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 (cannot be estimated from available data)
Blood and lymphatic system disorders

Uncommon                   Pancytopenia
Leukopeniaa)
Thrombocytopenia
Anaemia

Immune system disorders
Uncommon                   Anaphylactic shock/anaphylactic reaction

Rare                       Hypersensitivity

Nervous system disorders
Uncommon                   Headache
Somnolence

Gastrointestinal disorders

Common                     Vomiting
Diarrhoea
Abdominal pain
Dyspepsia
Nausea
Abdominal discomfort
Hepatobiliary disorders

Uncommon                   Hepatic failure
Cholestasis
Hepatitisb)
Jaundicec)
Hyperbilirubinaemia
Liver function test abnormald)

Rare                         Hepatic function abnormal
Skin and subcutaneous tissue disorders

Uncommon                     Acute generalised exanthematous pustulosis Urticaria
Pruritus
Rashe)
Erythema

Rare                         Angioedema

Not known                    Toxic epidermal necrolysis (Lyell´s syndrome)f) Stevens-Johnson syndrome f)
Drug Reaction with Eosinophilia and Systemic Symptoms
(DRESS) syndrome f)

Musculoskeletal and connective tissue disorders

Uncommon                     Rhabdomyolysisg)
Renal and urinary disorders

Uncommon                     Renal failureh)

General disorders and administration site conditions
Common                       Lethargy/Fatigue/Asthenia
 a) Haematological disorders affecting the white cell line (neutropenia, granulocytopenia and agranulocytosis) have been reported.
b) Hepatitis also includes hepatitis cholestatic /cytolytic hepatitis c) Jaundice also includes jaundice cholestatic d) Including alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased and gamma glutamyltransferase increased e) Rash includes various types of rash reactions such as drug eruption, erythematous and maculo- papular rash f) These adverse reactions were identified through post-marketing surveillance. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see section 4.4) g) Rhabdomyolysis may be fatal h) Renal failure also includes renal failure acute.


Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults, based on limited data.


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