URAPLEX Coated tablet Ref.[27636] Active ingredients: Trospium

Uraplex should be used with caution by patients:

• with obstructive conditions of the gastrointestinal tract such as pyloric stenosis
• with obstruction of 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 Uraplex 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 and 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.

Uraplex 20mg Coated Tablets contain lactose-monohydrate, sucrose and wheat starch.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency should not take this medicine.

Patients with wheat allergy (different from coeliac disease) should not take this medicine. Apart from that, trospium chloride is suitable for people with coeliac disease.

Pharmacodynamic interactions

The following potential pharmacodynamic interactions may occur: potentiation of the effect of drugs with anticholinergic action (such as amantadine, tricyclic antidepressants), enhancement of the tachycardic action of ß-sympathomimetics, decrease in efficacy of pro-kinetic agents (e.g. metoclopramide).

Since trospium chloride may influence gastro-intestinal motility and secretion, the possibility cannot be excluded that the absorption of other concurrently administered drugs may be altered.

Pharmacokinetic interactions

An inhibition of the absorption of trospium chloride with drugs like guar, colestyramine and colestipol cannot be excluded. Therefore the simultaneous administration of these drugs with trospium chloride is not recommended.

Metabolic interactions of trospium chloride have been investigated in vitro on cytochrome P450 enzymes involved in drug metabolism (P450 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4). No influence on their metabolic activities was observed. Since trospium chloride is metabolised only to a low extent and since ester hydrolysis is the only relevant metabolic pathway, no metabolic interactions are expected.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). In rats, placental transfer and passage into the maternal milk of trospium chloride occurs.

There are no clinical data on exposed pregnancies available.

Caution should be exercised when prescribing to pregnant or breastfeeding women.

Principally, disorders of accommodation can lower the ability to drive and to use machines.

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

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

In 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 trospium chloride:

Not applicable.