TROSPIUM CHLORIDE Film-coated tablet Ref.[9719] Active ingredients: Trospium

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.

Hepatic impairment

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.

Renal impairment

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 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.

Trospium chloride 20mg film-coated tablets contain lactose monohydrate and sucrose.

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 sucrose-isomaltase insufficiency should not take this medicine.

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 β-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 medicinal products may be altered.

Pharmacokinetic interactions

An inhibition of the absorption of trospium chloride with drugs like guar, cholestyramine 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 active substance 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.

Though trospium chloride was shown not to affect pharmakinetics of digoxin, an interaction with other active substances eliminated by active tubular secretion cannot be excluded.

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.

For Trospium chloride 20mg film-coated tablets, no clinical data on exposed pregnancies are available.

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

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.

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 trospium chloride 20 mg film-coated tablets:

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very Rare (<1/10,000)
Not known (cannot be estimated from the available data)

Cardiac disorders

Uncommon: Tachycardia

Not known: Tachyarrhythmia

Nervous system disorders

Uncommon: Headache

Rare: Dizziness

Not known: Hallucination*, Confusion*, Agitation*

Eye disorders

Rare: Vision disorders

Respiratory, thoracic and mediastinal disorders

Not known: Dyspnoea

Gastrointestinal disorders

Very common: Dry mouth

Common: Dyspepsia, Constipation, Abdominal pain, Nausea

Uncommon: Flatulence, Diarrhoea

Renal and urinary disorders

Rare: Micturition disorders, Urinary retention

Skin and subcutaneous disorders

Rare: Rash

Very Rare: Angio-oedema

Not known: Pruritus, Urticaria, Stevens-Johnson Syndrome (SJS) / Toxic Epidermal Necrolysis (TEN)

Muscoskeletal and connective tissue disorders

Rare: Myalgia, Arthralgia

General disorders and administration site conditions

Uncommon: Chest pain

Not known: Asthenia

Immune system disorders

Not known: Anaphylaxis

Investigations

Not known: 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system Yellow Card Scheme www.mhra.gov.uk/yellowcard.

Not applicable.