Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Side effects observed during treatment with trospium chloride are mainly caused by the typical anticholinergic effect such as dry mouth dyspepsia or constipation.


Following market launch of trospium chloride containing medicines, the side effects in the following table were observed according to the shown frequencies and system organ classes: System organ class                Common              Uncommon                   Rare               Not known (≥1/100 to <1/10)   (≥ 1/1,000 to <1/100)                         (cannot be estimated from the
Very available data)
Immune system                                                                    Anaphylaxis        StevensJohnson disorders.                                                                                          Syndrome (SJS), toxic epidermal necrolyses
(TEN)

Eye disorders                                         Accommodation disorders (especially in patients who       are hyperopic          and not sufficiently corrected)
Cardiac disorders                                     Tachycardia                Tachyarrhythmia 

Respiratory,                                                                     Dyspnoea thoracic and mediastinal disorders
Gastrointestinal      Dry mouth, Dyspepsia,       Diarrhoea, flatulence disorders                        constipation,
stomach ache and nausea
Skin and                                          Skin rashes                    Angioedema subcutaneous tissue disorders
Renal and urinary                                     Disturbance in urination Urinary retention tract disorders                                       (e.g. formation of residual urine)
General disorders                                     Weakness or chest pains and administration site conditions
Investigations                                                                   Mild to moderate increase of transaminases


The following undesirable effects have additionally been observed in other products containing trospium chloride: dry eyes, disturbed vision, dry nose, urinary tract infection, myalgia and arthralgia.

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/