Regulatory Information
PHARMLINE MARKETING PTE. LTD.
PHARMLINE MARKETING PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, COATED
**Posology and method of administration** One coated tablet twice daily (equivalent to 40 mg of trospium chloride per day). The coated tablet should be swallowed whole with a glass of water before the meals on empty stomach. 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 the meals on 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.
ORAL
Medical Information
**Therapeutic indications** Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity).
**Contra-indications** Trospium chloride is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis, narrowangle glaucoma, and tachyarrhythmia. Trospium chloride is also contraindicated in patients who have demonstrated hypersensitivity to the active substance or to any of the excipients.
G04BD09
trospium
Manufacturer Information
PHARMLINE MARKETING PTE. LTD.
Madaus GmbH
Active Ingredients
Documents
Package Inserts
Spasmolyt PI.pdf
Approved: March 19, 2018