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FLOTROS 20MG FILM-COATED TABLETS

Active substance(s): TROSPIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

f lotros
Trospium chloride

Read all of this leaflet carefully before you start taking this medicine.
• 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Flotros 20mg film-coated tablets are and
what they are used for
2. 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. Further 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. BEFORE YOU TAKE FLOTROS 20MG FILM-COATED
TABLETS
Do not take Flotros 20mg film-coated tablets:
- if you are allergic (hypersensitive) to trospium chloride or
any of the other ingredients of the tablets
- 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. severe ulcerative colitis or Crohn’s
disease
- if you have a severe gastro-intestinal condition, such as
toxic megacolon
Take special care with Flotros 20mg film-coated
tablets:
- if you have an obstruction in your gut, e.g. a narrowing of
the exit from your stomach (pyloric stenosis)
- if you have difficulties in passing urine and/or a poor
stream of urine
- if you suffer from neuropathy, i.e. nerve damage
- if you have any heart conditions, such as coronary artery
disease or congestive heart failure
- if you have a hiatus hernia or heartburn
- if you have an overactive thyroid gland

Patients with liver problems:
If you have severe liver disease, you should not take Flotros
20mg film-coated tablets.
If you have mild to moderate liver disease, please talk to
your doctor.
Patients with kidney problems:
If you have kidney problems, please talk to your doctor.
Your doctor may have to adjust the dose of Flotros 20mg
film-coated tablets (see Section 3: “How to take Flotros
20mg film-coated tablets”).
Taking Flotros 20mg film-coated tablets with other
medicines:
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Especially talk to your doctor if you are taking one of the
following medicines:
- amantadine (used for the treatment of Parkinson’s
disease)
- certain medicines used to treat depression called tricyclic
antidepressants (e.g. imipramine or amitriptyline)
- medicines to treat asthma, which may accelerate your
heart beat (e.g. salbutamol)
- medicines used to treat nausea and vomiting (e.g.
metoclopramide or domperidone)
- medicines that contain guar, colestyramine or colestipol
- medicines that contain quinidine or disopyramide (used to
treat heart rhythm problems)
- medicines used to treat allergies (antihistamines)
Please note that this information may also apply to
medicines that you have used recently.
Pregnancy and breast-feeding:
Your doctor will decide whether you should take this
medicine if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines:
This medicine may cause blurred vision. If you experience
this, do not drive or use any tools or machines.
Important information about some of the
ingredients of Flotros 20mg film-coated tablets:
This medicinal product contains lactose. If you have been
told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal
product.

3. HOW TO TAKE FLOTROS 20MG FILM-COATED
TABLETS
Always take Flotros 20mg film-coated tablets exactly as
your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
Unless otherwise prescribed by the doctor, the usual dose is:
1 film-coated tablet twice daily (equal to a daily total of
40mg trospium chloride).
The maximum daily dose is 40mg trospium chloride.
In patients with severe kidney problems, the recommended
dosage is 1 film-coated tablet daily or 1 film-coated tablet
every other day (equal to a total of 20mg trospium chloride
either daily or every other day).
The tablet should be swallowed whole with a glass of water.
It should be taken before meals, on an empty stomach.
The length of your treatment is determined by your doctor.
The need to continue treatment should be evaluated every
3 to 6 months.
Do not give Flotros 20mg film-coated tablets to children of
less than 12 years of age.
If you take more Flotros 20mg film-coated tablets
than you should:
If you have taken too many Flotros 20mg film-coated tablets
you should contact your doctor or go to the nearest hospital
emergency department immediately.
If you forget to take Flotros 20mg film-coated
tablets:
If you forget to take a tablet, take your next tablet as soon
as you remember. Do not take a double dose to make up
for a forgotten dose.
If you stop taking Flotros 20mg film-coated tablets:
Your symptoms may return if you stop taking Flotros 20mg
film-coated tablets before told to do so by your doctor.
Therefore, you should take Flotros 20mg film-coated tablets
for as long as prescribed by your doctor. Please consult your
doctor if you wish to stop treatment.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Flotros 20mg film-coated tablets can
cause side effects, although not everybody gets them.
The following very rare side effects are important
and will require immediate action if you experience
them. You should stop taking Flotros 20mg
film-coated tablets and see your doctor
immediately if the following symptoms occur:
Very rare side effects, affecting fewer than 1 in
10,000 patients:
• swelling of the face, tongue and windpipe, which
can cause difficulty in breathing
• a sudden allergic reaction with shortness of
breath, rash, wheezing and sudden dizziness
The following side effects have also been reported:
Very common side effects, affecting more than 1 in
10 people:
dry mouth
Common side effects, affecting fewer than 1 in 10
people:
indigestion, constipation, abdominal pain, nausea
Uncommon side effects, affecting fewer than 1 in
100 people:
wind (flatulence), diarrhoea

Rare side effects, affecting fewer than 1 in 1000
people:
inability to (completely) empty the bladder
fast heart beat
blurred vision
breathing difficulties (dyspnoea)
skin rash
chest pain
weakness
Very rare side effects (including isolated reports),
affecting fewer than 1 in 10,000 people:
fast and irregular heart beat
muscle pain, joint pain
changes in blood test results used to monitor the liver
(measured by your doctor)
headache
dizziness
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
5. HOW TO STORE FLOTROS 20MG FILM-COATED
TABLETS
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the
blister and on the carton after “EXP”. The expiry date refers
to the last day of that month.
This medicinal product does not require any special storage
conditions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Flotros 20mg film-coated tablets contain:
The active substance is: trospium chloride 20mg
The other ingredients are:
Tablet core: silica, colloidal anhydrous; lactose monohydrate;
cellulose, microcrystalline; sodium starch glycolate (Type A);
povidone K25; magnesium stearate;
Tablet film: hypromellose; macrogol 6000; talc; titanium
dioxide (E171); saccharin sodium.
What Flotros 20mg film-coated tablets look like
and contents of the pack:
Flotros 20mg film-coated tablets are round, white-coloured,
film-coated tablets available in packs of 10, 20, 30, 50, 60
and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Galen Limited, Seagoe Industrial Estate, Craigavon, BT63
5UA, UK
Manufacturer:
Dr. R. Pfleger Chemische Fabrik GmbH, Dr.-Robert-PflegerStraße 12, D-96052 Bamberg

This medicinal product is authorised in the member
states of the EEA under the following names:
Austria:
Denmark:
Finland:

Germany:
Ireland:
Italy:
United Kingdom:

Trospiumchlorid Pfleger 20mg
Trospiumchlorid Alternova
Trospium Verman 20mg
tabletti, kalvopäällysteinen
Spasmex 20mg Filmtabletten
Flotros 20mg Film-Coated Tablets
Trospio cloruro Pfleger 20mg
Flotros 20mg Film-Coated Tablets
This leaflet was last approved in 02/2011

207800 002
301709

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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