Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Undesirable effects observed with trospium chloride such as dry mouth, dyspepsia and constipation mainly reflect the typical anticholinergic properties of the active ingredient.

In Phase- III clinical studies, dry mouth was very common and occurred in approximately 18% of patients treated with trospium chloride and in approximately 6% treated with placebo (total of 1931 patients of which 911 received placebo).

Adverse events are listed below by system organ class and frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000).
The following table lists possibly related drug reactions reported for patients treated with Trosmolyt 20mg film-coated tablets:

Very     Common        Uncommon         Rare        Very Rare     Not known (cannot be common                                                               estimated from the available data)

Cardiac disorders                                  Tachycardia                                  Tachyarrhythmia 
Nervous system                                      Headache     Dizziness                       Hallucination* disorders                                                                                     confusion* agitation* Eye disorders                                                     Vision disorders
Respiratory,                                                                                       Dyspnoea thoracic and mediastinal disorders
Gastrointestinal            Dry      Dyspepsia     Flatulence disorders                  mouth    Constipation   Diarrhoea
Abdominal pain
Nausea

Renal and urinary                                                Micturition disorders                                                         disorders Urinary retention

Skin and                                                            Rash       Angio-oedema        Pruritus subcutaneous                                                                                       Urticaria disorders                                                                                      Stevens-Johnson Syndrome (SJS) /
Toxic Epidermal
Necrolysis (TEN)

Muscoskeletal and                                                 Myalgia connective tissue                                                Arthralgia disorders

General disorders                                  Chest pain                                       Asthenia and administration site conditions

Immune system                                                                                     Anaphylaxis disorders

Investigations                                                                                  Mild to moderate increase in serum transaminase levels

*These   adverse effects occurred mostly in elderly patients and can be facilitated by neurological diseases and/or concomitant intake of other anticholinergic drugs (see section 4.5).
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