Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Trospium chloride should be used with caution by patients:
- with obstructive conditions of the gastrointestinal tract such as pyloric stenosis
- with obstruction of the urinary flow with the risk of formation of urinary retention
- with autonomic neuropathy
- with hiatus hernia associated with reflux oesophagitis
- in whom fast heart rates are undesirable e.g. those with hyperthyroidism, coronary artery disease and congestive heart failure.

As there are no data in patients with severe hepatic impairment, treatment of these patients with trospium chloride is not recommended. In patients with mild to moderate liver impairment caution should be exercised.
Trospium chloride is mainly eliminated by renal excretion. Marked elevations in the plasma levels have been observed in patients with severe renal impairment. Therefore, in this population but also in patients with mild to moderate renal impairment caution should be exercised (see section 4.2).
Before commencing therapy organic causes of urinary frequency, urgency, and urge incontinence, such as heart diseases, diseases of the kidneys, polydipsia, or infections, or tumours of urinary organs should be excluded.
This medicinal product contains less than 1 mmol sodium (23 mg) per coated tablet, that is to say it is essentially ‘sodium-free’.

Effects on Driving

4.7   Effects on ability to drive and use machines
Principally, disorders of accommodation can lower the ability to actively participate in road traffic and to use machines.

However, examinations of parameters characterising the ability to participate in road traffic (visual orientation, general ability to react, reaction under stress, concentration and motor coordination) have not revealed any effects of trospium chloride.