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

Posology

One film-coated tablet twice daily (equivalent to 40 mg of trospium chloride per day).

The need for continued treatment should be reassessed at regular intervals of 3-6 months.

Patients with renal impairment

In patients with severe renal impairment (creatinine clearance between 10 and 30 ml/min.1.73 m²), the recommended dosage is one film-coated tablet per day or every second day (equivalent to 20 mg of trospium chloride per day or every second day).

Paediatric population

The safety and efficacy of Trospium chloride 20mg film-coated tablets in children under 12 years of age has not been established. No data are available.

Method of administration

The film-coated tablet should be swallowed whole with a glass of water before meals on an empty stomach.

After administration of a maximum single dose of 360 mg trospium chloride to healthy volunteers, dryness of the mouth, tachycardia and disorders of micturition were observed to an increased extent. No manifestations of severe overdose or intoxication in humans have been reported to date. Increased anticholinergic symptoms are to be expected as signs of intoxication.

In the case of intoxication the following measures should be taken:

• gastric lavage and reduction of absorption (e.g. activated charcoal)
• local administration of pilocarpine to glaucoma patients
• catheterisation in patients with urinary retention
• treatment with a parasympathomimetic agent (e.g. neostigmine) in the case of severe symptoms
• administration of beta blockers in the case of insufficient response, pronounced tachycardia and/or circulatory instability (e.g. initially 1 mg propranolol intravenously along with monitoring of ECG and blood pressure).

Shelf life: 30 months.

This medicinal product does not require any special storage conditions.

PVC/PVDC-Aluminium blisters in cartons of 30, 50, 60, 100 film-coated tablets per carton.

Not all pack sizes may be marketed.

No special requirements.