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

For oral administration.

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

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

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

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

Since no data are available, the use in children under 12 years of age is contraindicated.

After the 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 overdosage 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).

5 years.

This medicinal product does not require any special storage conditions.

PVC foiled aluminium blister.

Pack sizes approved: 2, 20, 28, 30, 40, 50, 56, 60, 90, 100, 120, 150, 200, 500, 600, 1000, 1200, 2000.

Not all pack sizes may be marketed.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.