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).

The following table lists possibly related drug reactions reported for patients treated with Spasmo-lyt  20 mg:

Very       Common           Un-           Rare           Very Rare          Not known common                      common                                          (cannot be estimated from
(>1/10)    (1/100,<1/10) (1/1000, (1/10.000,          (<1/10.000)        the available <1/100)    <1/1000)                               data)
Cardiac                                      Tachycardi                                        Tach- disorders                                    a                                                 yarrhythmia Nervous system                               Headache Dizziness                                Hallucination* disorders                                                                                      confusion* agitation*
Eye disorders                                                Vision disorders
Respiratory,                                                                                   Dyspnoea thoracic and mediastinal disorders
Gastrointestinal Dry mouth Dyspepsia           Flatulence disorders                  Constipation        Diarrhoea
Abdominal pain
Nausea
Renal and                                                    Micturition urinary                                                      disorders disorders                                                    Urinary retention
Skin and                                                     Rash           Angio-oedema       Pruritus subcutaneous                                                                                   Urticaria disorders                                                                                      Stevens-Johnson Syndrome (SJS)
/ Toxic
Epidermal
Necrolysis
(TEN)
Muscoskeletal                                                Myalgia and connective                                               Arthralgia tissue disorders
General                                        Chest pain                                      Asthenia 
Very       Common           Un-           Rare           Very Rare          Not known common                      common                                          (cannot be estimated from
(>1/10)    (1/100,<1/10) (1/1000,       (1/10.000,    (<1/10.000)        the available <1/100)         <1/1000)                          data) disorders 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).