Flotros 20mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Trospium chloride

Dostupno od:

Galen Ltd

ATC koda:

G04BD09

INN (International ime):

Trospium chloride

Doziranje:

20mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 07040200; GTIN: 5016298021417

Uputa o lijeku

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

Svojstava lijeka

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 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 insufficient 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 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.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Flotros 20mg should only be used with caution in patients:
-
with obstructions to the gastrointestinal tract, such as pyloric
stenosis
-
with urinary obstructions, with the risk of formation of residual
urine
-
with autonomous neuropathy
-
with hiatus hernia
-
with reflux oesophagitis
-
in