Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Undesirable effects are mainly associated with prolonged use or high doses. The most commonly observed effects include nausea, abnormal taste sensations and the risk of neuropathy in case of long term treatment.
In the following listing, for the description of the frequencies of undesirable effects the following terms are used:
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) 

Infections and infestations
Common:                  Superinfections with candida (e.g. genital infections).
.Rare:                   Pseudomembranous colitis.
Details regarding emergency treatment - see section 4.4.
Blood and lymphatic system disorders
Very rare:                granulocytopenia, agranulocytosis, pancytopenia and thrombocytopenia.
Not known:               Leucopenia and aplastic anaemia.
Immune system disorders
Rare:                      Severe acute systemic hypersensitivity reactions: anaphylaxis, up to anaphylactic shock.
Not known:                 Angioedema.
Metabolism and nutrition disorders

Not known:                 Anorexia.

Psychiatric disorders
Very rare:              Psychotic disorders, including states of confusion and hallucination.
Not known:                    Depression.
Nervous system disorders


Very rare:                  Encephalopathy, headache, fever, drowsiness, dizziness, disturbances in sight and movement, vertigo,
ataxia, dysarthriaand convulsions.
Not known:                    Somnolence or insomnia, myoclonuis, seizures, peripheral neuropathy manifesting as paraesthesia,
pain, furry sensation and tingling in the extremities.
Aseptic meningitis.
Eye disorders
Very rare:                    Disturbance of vision, e.g. diplopia, myopia.
Not known:                    Oculogyric crisis, optic neuropathy/neuritis (isolated cases).
Cardiac disorders
Rare:                          ECG changes like flattening of T-wave.
Gastro-intestinal disorders
Very rare:                     Pancreatitis.
Not Known:                    Vomiting, nausea, diarrhoea, glossitis and stomatitis, eructation with bitter taste, epigastric pressure,
metallic taste, furred tongue Dysphagia (caused by central nervous effects of metronidazole).
Hepatobiliary disorders
Very rare:                     Abnormal values of hepatic enzymes and bilirubin, Hepatitis, jaundice.
Skin and subcutaneous tissue disorders
Very rare:                     Allergic skin reactions, e. g. pruritus, urticaria, STEVENS-JOHNSON syndrome and toxic epidermalnecrolysis.
Not known:                     Erythema multiforme.
.Musculoskeletal and connective tissue disorders
Very rare:                    Arthralgia and myalgia.
Renal and urinary disorders
Uncommon:                     Dark coloured urine (due to a metabolite of metronidazole).
General disorders and administration site conditions

Not known:                    Vein irritations (up to thrombophlebitis) after intravenous administration.
States of weakness and fever.
Paediatric population
Frequency, type and severity of adverse reactions in children are the same as in adults.


Reporting 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.