FLOTROS

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

TROSPIUM CHLORIDE

থেকে পাওয়া:

Galen Limited

এটিসি কোড:

G04BD09

INN (আন্তর্জাতিক নাম):

TROSPIUM CHLORIDE

ডোজ:

20 Milligram

ফার্মাসিউটিকাল ফর্ম:

Film Coated Tablet

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

থেরাপিউটিক এলাকা:

trospium

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2009-05-01

তথ্য লিফলেট

1.3.1.3 Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLOTROS 20MG FILM-COATED TABLETS
Trospium chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE 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 only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT FLOTROS 20MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLOTROS 20MG FILM-COATED TABLETS
3.
HOW TO TAKE FLOTROS 20MG FILM-COATED TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FLOTROS 20MG FILM-COATED TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT FLOTROS 20MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED
FOR
Flotros 20mg film-coated tablets are a medicine that relaxes the
muscles of the bladder.
Flotros 20mg film-coated tablets are used in patients with a
compelling need to urinate (urgency)
accompanied by involuntary urine loss (urge incontinence) and/or
frequent urination and need to
urinate in patients with an overactive bladder (due to unknown causes
or neurological disease).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLOTROS 20MG FILM-COATED
TABLETS
DO NOT TAKE FLOTROS 20MG FILM-COATED TABLETS:
-
if you are allergic to trospium chloride or any of the other
ingredients of this medicine (listed in
section 6)
-
if you suffer from urinary retention, i.e. blockage of the urinary
tract
-
if you have raised pressure in the eye (narrow angle glaucoma)
-
if you have a fast, irregular heartbeat (tachycardic arrhythmia)
-
if you have myasthenia gravis, a disorder that causes muscle fatigue
-
if you suffer from severe inflammation of the gut (intestines), e.g.
sever

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flotros 20mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 20 mg of trospium chloride.
Excipients with known effect: 1 film-coated tablet contains 93.333 mg
lactose-monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, white film-coated tablet
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
1 film-coated tablet twice a day (corresponding to 40 mg of trospium
chloride daily).
The film-coated tablet should be taken whole on an empty stomach with
a glass of water before meals.
In patients with severe kidney dysfunction (creatinine clearance
between 10 and 30 mL/min/1.73 m
2
) 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.
Paediatric Population
As no sufficient data is available, the use of this product in
children under the age of 12 is not recommended.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Flotros 20 mg is contraindicated in patients with urinary retention,
severe gastrointestinal dysfunctions (including
toxic megacolon and severe colitis ulcerosa), myasthenia gravis,
narrow-angle glaucoma and tachyarrhythmias.
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