Flotros 20mg film-coated tablets (Trospium chloride) - New SPC

Source: eMC (electronic Medicines Compendium)

Date published: 30/07/2010 17:23

Type of SPC Change: New SPC

Generic drug name: Trospium chloride

Drug brand name: Flotros

Legal status: POM - Prescription Only Medicine

Pharmaceutical manufacturer: Galen

Summary
by: Vinty Amin

Indicated for 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).

 

In patients with severe kidney dysfunction (creatinine clearance between 10 and 30 mL/min/1.73 m2) the recommended dose is 1 film-coated tablet once a day or every second day (corresponding to 20 mg of trospium chloride every day or every second day).

 

The necessity of continuing the treatment should be reassessed at regular intervals of 3 - 6 months.

 

As no corresponding data is available, the use of this product in children under the age of 12 is not recommended.

 

Flotros 20mg is contraindicated in patients with urinary retention, severe gastrointestinal dysfunctions (including toxic megacolon and severe colitis ulcerosa), myasthenia gravis, narrow-angle glaucoma and tachyarrhythmias.

 

For further information, please read the full text SPC.

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Related evidence
7.4.2 Drugs for urinary frequency, enuresis, and incontinence