Patient leaflet - Trospium Chloride 20 mg film-coated tablets

1. What Trospium Chloride is and what it is used for

The name of this medicine is Trospium Chloride

20 mg Film-Coated Tablets. Trospium Chloride

20 mg Film-Coated Tablets are used to treat the

symptoms of overactive bladder conditions. For

example, needing to go to the toilet frequently,

needing to suddenly rush to the toilet and/or

having difficulty getting there in time and wetting

yourself.

2. What you need to know before you take Trospium Chloride

Do not take Trospium Chloride if your doctor has told you that you have:

An allergic reaction to Trospium Chloride or
any of the ingredients listed in section 6. (An
allergic reaction can be a rash, itchiness or
shortness of breath).
Urinary retention i.e. urination occurs less
frequently than normal.
The eye condition glaucoma.
Abnormal/faster than normal heartbeats.
Myasthenia gravis (a disorder which causes
muscle fatigue).
A severe gastro-intestinal condition, such as
toxic megacolon.

Do NOT give this product to children under

12 years of age.

Warnings and precautions

Check with your doctor or pharmacist before

taking your medicine if you suffer from any of the

following:

Any type of stomach or bowel obstruction.
Blockage of the urinary tract.
Neuropathy i.e. nerve damage.
A hiatus hernia associated with reflux
oesophagitis. This is usually associated with
heartburn which worsens on bending or lying
down.
An overactive thyroid.
Any heart conditions, such as coronary artery
disease or congestive heart failure.
Any liver problems.
Any kidney problems.

If you are not sure if any of the above apply to

you, talk to your doctor or pharmacist before

taking this medicine.

Other medicines and Trospium Chloride

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines, including medicines obtained without

a prescription. Taking some medicines together

can be harmful.

In particular, tell your doctor or pharmacist if you

are taking any of the following medicines:

Amantadine (used in the treatment of
Parkinson’s disease or as protection against
influenza).
- Tricyclic antidepressants.
- A ‘sympathomimetic’ (one of a class of drugs which can increase the heart rate).
- Metoclopramide (a drug which increases the rate of movement of digested food through your gastrointestinal system).
- Guar gum (sometimes used in a type of diabetes).
- Cholestyramine or colestipol (drugs used to reduce the levels of certain fats in your bloodstream).

If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.

Taking Trospium Chloride with food and drink

As high fat diets can affect the action of Trospium Chloride, the medicine should be taken before meals on an empty stomach.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Trospium Chloride.

Driving and using machines

Trospium Chloride does not affect your ability to drive or use machines.

Trospium Chloride 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.

Information on sodium content

This medicine contains less than 1 mmol (23mg) sodium per tablet, that is to say essentially ‘sodium-free’.

3. How to take Trospium Chloride

Always take this medicine exactly as your doctor or pharmacist has told you. You should check with them if you are not sure. Trospium Chloride should be taken orally.

Adults and children 12 years or over:

The usual dose for adults is one tablet twice a day. Doctors may prescribe different doses to this. For example, patients with kidney problems may take a reduced dose of one tablet per day or one tablet every second day. Read the pharmacist’s label as it will tell you exactly how many you should take.

The tablets should be swallowed whole with a glass of water, before meals on an empty stomach.

If symptoms persist, contact your doctor or pharmacist. Your doctor will want to assess your treatment every 3 to 6 months, to decide whether this medicine is the best one for you. 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.
Package leaflet: Information for the patient
Trospium Chloride 20 mg Film-Coated Tablets
What is in this leaflet:
1. 1. What Trospium Chloride is and what it is used for
2. 2. What you need to know before you take Trospium Chloride
3. 3. How to take Trospium Chloride
4. 4. Possible side effects
5. 5. How to store Trospium Chloride
6. 6.
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Children under 12 years of age:

This product should not be taken by children under 12 years of age.

If you take more Trospium Chloride than you should:

It is always important to follow the recommended dose on the label. If too many tablets are taken by accident, contact your doctor or hospital immediately.

If you forget to take Trospium Chloride:

Take the dose as soon as you remember to take it and then continue on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Trospium Chloride

Your symptoms may return if you stop taking Trospium Chloride Tablets before recommended by your doctor. Therefore, you should take Trospium Chloride Tablets for as long as prescribed by your doctor. Please consult 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, Trospium Chloride can cause side effects, although not everybody gets them.

The side effects occurring most frequently are typical for this kind of medicine and comprise of dry mouth, dyspepsia and constipation.

The following side effects below are serious and will require immediate action if you experience them. You should stop taking Trospium Chloride and see your doctor immediately if the following symptoms occur:

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
Serious reactions with severe blistering and
peeling of the skin and/or mucous membranes like for example in the lips, eyes, mouth, nose and genitals. This may be accompanied by a fever and chills, aching muscles and generally feeling unwell

Other side effects include:

Very Common (may affect more than 1 in 10 people):

Dry mouth

Common (may affect up to 1 in 10 people):

Constipation
Nausea
Abdominal pain
Indigestion (dyspepsia)

Uncommon (may affect up to 1 in 100 people):

Fast heart rate (tachycardia)
Headache
Flatulence
Diarrhoea
Chest pain

Rare (may affect up to 1 in 1,000 people):

Dizziness
Difficulty emptying the bladder
Urinary retention
Difficulty seeing objects close-up
Rash
Joint and muscle pains

Other Side Effects include:

Accelerated and irregular heart rate
(tachyarrhythmia)
Difficulty in breathing
Itchiness
Nettle rash (hives)
General feeling of weakness (asthenia)
Slight to moderate increase of certain liver
enzyme levels
- Sporadic cases of hallucination, confusion and agitation have occurred mostly in elderly patients and can be facilitated by neurological diseases and/or other drugs with a similar mechanism of action taken at the same time

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Trospium Chloride

Keep all medicines out of the sight and reach of children.

Do not take Trospium Chloride after the expiry date on the carton and blister. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Trospium Chloride contains:

Each coated tablet contains 20 mg of trospium chloride as the active ingredient.

The tablets also contain maize starch, lactose monohydrate, microcrystalline cellulose, povidone K30, sodium starch glycolate, magnesium stearate, macrogol 400, hypromellose and iron oxide yellow (E172).

What Trospium Chloride looks like and contents of the pack:

Trospium Chloride tablets are round yellow tablets.

Trospium Chloride tablets are available in boxes of 20 or 60 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Manufacturers:

Tiofarma B.V.,

Benjamin Franklinstraat 5-10, 3261 LW, Oud-Beijerland, The Netherlands