Package Leaflet: Information for the user

Package Leaflet: Information for the user
Trospium chloride 20 mg film-coated tablets
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 Trospium chloride 20 mg film-coated tablets is and what it is used for.
2. Before you take Trospium chloride 20 mg film-coated tablets
3. How to take Trospium chloride 20 mg film-coated tablets
4. Possible side effects
5. How to store Trospium chloride 20 mg film-coated tablets
6. Further information
1. WHAT TROSPIUM CHLORIDE 20 mg FILM-COATED TABLETS IS AND WHAT IT IS
USED FOR
Trospium chloride 20 mg film-coated tablets is a medicine that relaxes the muscles of the bladder.
Trospium chloride 20 mg film-coated tablets is used: in urgency (compelling need to urinate) with
involuntary urine loss (urge incontinence) and / or frequent urination and urgency in patients with
overactive bladder (due to unknown causes or to neurological disease).
2. BEFORE YOU TAKE TROSPIUM CHLORIDE 20 mg FILM-COATED TABLETS
Do not take Trospium chloride 20 mg film-coated tablets:
- if you are hypersensitive (allergic) to trospium chloride or any of the other ingredients of
the tablets
- if you are unable to empty the filled urinary bladder spontaneously due to a mechanical
obstruction of the urinary flow from the bladder (e.g. enlargement of the prostate gland)
- if you have increased intraocular pressure caused by narrowing of the angle of the eyes;
so-called glaucoma (narrow angle glaucoma)
- if you have an accelerated, irregular heartbeat (tachycardic arrhythmias)
- if you have myasthenia gravis, a disease characterised by weakness of muscles after use
- if you have severe, chronic inflammatory intestinal disease (severe ulcerative colitis or
severe Crohn’s disease)
- if you have toxic megacolon, a condition associated with dilatation of the colon and
constipation
Take special care with Trospium chloride 20 mg film-coated tablets
- if you suffer from an obstruction of the gastrointestinal tract, e.g. narrowing of the exit of
your stomach (pyloric stenosis)
- if you suffer from an obstruction of the urinary flow from the bladder, with urinary
retention (incomplete ability to empty the bladder).

- if you have a disorder of the autonomic nervous system (the part of the body’s nervous
system that controls the activities of the heart, blood vessels, glands and other parts of the
body)
- if you have an hiatus hernia or heartburn
- if you have an overactive thyroid gland or heart disease (trospium chloride may make your
heart beat faster than you can tolerate)
Patients with impairment of liver function:
If you have severe liver disease, you should not take Trospium chloride 20 mg film-coated tablets.
If you have mild to moderateliver disease, please talk to your doctor.
Patients with impairment of kidney function:
If you have impaired kidney function, please talk to your doctor. Your doctor may have to adjust the
dose of Trospium chloride 20 mg film coated tablets (see section 3: “How to take Trospium chloride
20 mg film-coated tablets”).
Children:
Do not give Trospium chloride 20 mg film-coated tablets to children under the age of 12.
Taking Trospium chloride 20 mg 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 ( e.g. imipramine or amitryptiline)
- medicines to treat asthma, which may accelerate your heart beat (e.g. salbutamol)
- medicines used to increase gut movement (e.g. metoclopramide or cisapride)
- medicines used to affect secretion of digestive juices
- medicines that contain guar, colestyramine, or colestipol
- medicines that contain chinidine
- medicines used to treat allergies (antihistaminics)
Please note that these data could also apply to recently used medicines.
Pregnancy and Breast-feeding:
Ask your doctor or pharmacist for advice before taking / using any medicine.
There is insufficient data on the use of trospium chloride in humans during pregnancy and
breastfeeding.
It is unknown whether trospium chloride is excreted in human breast milk. Your doctor will decide
whether or not you should stop breast feeding while taking Trospium chloride 20 mg film-coated
tablets.
Driving and using machines:
Do not drive or operate machinery, because trospium chloride may have such an impact on the driver’s
vision that the ability to participate actively in road traffic or to operate machinery is affected.
Important information about some of the ingredients of Trospium chloride 20 mg film-coated
tablets

This medicinal product contains lactose (sugar). 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 TROSPIUM CHLORIDE 20 mg FILM-COATED TABLETS
Always take Trospium chloride 20 mg 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 40 mg trospium chloride)
The maximum daily dose is 40 mg trospium chloride.
In patients with severe kidney function disorder, the recommended dosage: 1 film-coated tablet daily
or 1 film-coated tablet every other day (equal to a total of 20 mg trospium chloride either daily or
every other day).
The tablet is taken unchewed with a glass of water, fasting and before meals.
The duration of intake is determined by your doctor. The need to continue treatment should be
evaluated every 3 to 6 months.
Do not give Trospium chloride 20 mg film-coated tablets to children of less than 12 years of age.
Please tell your doctor or pharmacist if you have the feeling that the effect of Trospium chloride 20 mg
film-coated tablets is too strong or too weak for you.
If you take more Trospium chloride 20 mg film-coated tablets than you should:
If you have taken too much of trospium chloride or symptoms of overdose occur, you should
immediately see a doctor.
Indications of overdose may occur in the form of visual disturbances, accelerated heartbeat, dryness of
the mouth and erythema (anti-cholinergic symptoms).
If you forget to take Trospium chloride 20 mg film-coated tablets:
Do not take a double dose to make up for a forgotten dose. Take the next tablet as usual.
If you stop taking / using Trospium chloride 20 mg film-coated tablets:
Discuss what to do with your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Trospium chloride 20 mg film-coated tablets can cause side effects, although not
everybody gets them.
The following side effects are important and will require immediate action if you experience
them. You should stop taking Trospium chloride 20 mg film-coated tablets and see your doctor
immediately if the following symptoms occur:
Very rare side effects affect fewer than 1 in 10,000 patients
swelling of the face, tongue and windpipe which can cause great difficulty in breathing
a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood
pressure
Inability to empty the filled urinary bladder
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 up to 1 in 10 people:
indigestion, constipation, abdominal pain, nausea
Uncommon side effects, affecting fewer than 1 in 100 people:
flatulence (wind), 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 10000 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 TROSPIUM CHLORIDE 20 mg 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 Trospium chloride 20 mg film-coated tablets contains:
The active substance is: trospium chloride 20 mg
The other ingredients are:
Tablet core: silica, colloidal anhydrous; lactose monohydrate 93 mg; cellulose, microcrystalline ;
sodium starch glycolate (Type A) ; povidone K 25; magnesium stearate;
Tablet film: hypromellose; macrogol 6000; talc; titanium dioxide (E171); saccharin sodium.
What Trospium chloride 20 mg film-coated tablets looks like and contents of the pack:
Trospium chloride 20 mg 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 and Manufacturer

To be completed nationally
This medicinal product is authorised in the member states of the EEA under the following
names:
Austria:
Denmark:
Finland:
Germany:
Ireland:
Italy:
Portugal:
United Kingdom :
Trospasyt 20 mg
Trospiumchlorid TAD 20 mg
Trospiumkloridi TAD Pharma 20 mg
Trospasyt 20 mg
Trostad 20 mg
Trospio cloruro TAD 20 mg
Cloreto de tróspio 20 mg
Trospium chloride 20 mg
This leaflet was last approved in {MM/YYYY}

Labelling Carton

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Cardboard folding box
1. NAME OF THE MEDICINAL PRODUCT
Trospium chloride 20 mg film-coated tablets
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Trospium chloride
3. LIST OF EXCIPIENTS
Contains lactose.
See leaflet for further information
4. PHARMACEUTICAL FORM AND CONTENTS
Film-coated tablets
1 film-coated tablet contains 20 mg trospium chloride
10, 20, 30, 50,60, 100 film-coated tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
oral use
The tablet should be taken on an empty stomach with a glass of water.
Read the package leaflet before use.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
-
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
-
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
12. MARKETING AUTHORISATION NUMBER(S)
13. BATCH NUMBER
BN
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Trospium chloride 20 mg

Module 1.3.1.2
Labelling Blister – proposed version

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
PVC/PVDC-Aluminium blisters
1. NAME OF THE MEDICINAL PRODUCT
Trospium chloride 20 mg film-coated tablets
Trospium chloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
to be completed nationally
3. EXPIRY DATE
[For terms on Batch number and Expiry date see Appendix IV]
BN
4. BATCH NUMBER
[For terms on Batch number and Expiry date see Appendix IV]
EXP
5. OTHER