TROSPIUM CHLORIDE 20 Milligram Film Coated Tablet

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

TROSPIUM CHLORIDE

Saadav alates:

Auden Mckenzie (Pharma Division) Ltd

ATC kood:

G04BD09

INN (Rahvusvaheline Nimetus):

TROSPIUM CHLORIDE

Annus:

20 Milligram

Ravimvorm:

Film Coated Tablet

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Drugs for urinary frequency and incontinence

Volitamisolek:

Transfer Pending

Loa andmise kuupäev:

2011-06-17

Infovoldik

continued... please turn over
PATIENT INFORMATION LEAFLET
PACKAGE LEAFLET 
A1000167/2
Back of leaflet 
TROSPIUM CHLORIDE 20MG FILM-COATED TABLETS
IN THIS LEAFLET
1. What is Trospium Chloride and what is it used for? 
2. Before you take Trospium Chloride 
3. How to take Trospium Chloride 
4. Possible side effects 
5. Storing Trospium Chloride 
6. Further information 
1. WHAT IS TROSPIUM CHLORIDE AND 
    WHAT IS IT USED FOR? 
2. BEFORE YOU TAKE TROSPIUM CHLORIDE
3.

HOW TO TAKE TROSPIUM CHLORIDE
4. POSSIBLE SIDE EFFECTS 
5. STORING TROSPIUM CHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or
pharmacist. 
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,  even if their 
  symptoms are the same as yours. 
• If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, 
   please tell your doctor or pharmacist. 
DO NOT TAKE TROSPIUM CHLORIDE IF YOUR 
DOCTOR HAS TOLD YOU THAT YOU HAVE: 

   • An allergic reaction to Trospium Chloride
     or any of the ingredients listed in section 6. 
     (An allergic reaction can be a rash, itchiness 
     or shortness of breath).  
   • Urinary retention i.e. urination occurs less 
     frequently than normal. 
   • The eye condition glaucoma. 
   • Abnormal/faster than normal heart beats. 
   • Myasthenia gravis (a disorder which causes 
     muscle fatigue). 
   • A severe gastro-intestinal condition, such as 
     toxic megacolon. 
DO NOT GIVE THIS PRODUCT TO CHILDREN UNDER 12 
YEARS OF AGE. 
SPECIAL PRECAUTIONS
Check with your doctor or pharmacist before 
taking your medicine if you suffer from any of the 
following: 
   • Any type of stomach or bowel obstruction. 
   • Blockage of the urinary tract. 
   • Neuropathy i

Toote omadused

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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Trospium chloride should be used with caution by patients:
with obstructive conditions of the gastro-intestinal tract such as pyloric