TROSPIUM CHLORIDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TROSPIUM CHLORIDE

Available from:

Teva B.V.

ATC code:

G04BD09

INN (International Name):

TROSPIUM CHLORIDE

Dosage:

20 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

trospium

Authorization status:

Marketed

Authorization date:

2011-06-17

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trospium Chloride 20mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 20 mg trospium chloride.
Excipient:
Each tablet contains 71 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated Tablet.
Yellow, round tablets.
4 CLINICAL PARTICULARS
4.1 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).
4.2 POSOLOGY AND METHOD OF 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 m
2
) 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, use in children under 12 years of age is
contra-indicated.
4.3 CONTRAINDICATIONS
Trospium chloride is contra-indicated in patients with urinary
retention, severe gastro-intestinal condition (including
toxic megacolon), myasthenia gravis, narrow-angle glaucoma and
tachyarrhythmia.
Trospium chloride is also contra-indicated in patients who have
demonstrated hypersensitivity to the active substance
or to any of the excipients.
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