Flotros 20mg film-coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Trospium chloride

Tilgængelig fra:

Pfleger Arzneimittel GmbH

ATC-kode:

G04BD; G04BD09

INN (International Name):

Trospium chloride

Dosering:

20 milligram(s)

Lægemiddelform:

Film-coated tablet

Terapeutisk område:

Drugs for urinary frequency and incontinence; trospium

Autorisation status:

Marketed

Autorisation dato:

2009-05-01

Indlægsseddel

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

Produktets egenskaber

HealthProductsRegulatoryAuthority
28May2019
CRN008Y7W
Page1of6
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dy