Trospium chloride 20mg film-coated tablets

• 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.

1. What Trospium chloride 20mg film-coated tablets are and what they are used for
2. What you need to know before you take Trospium chloride 20mg film-coated tablets
3. How to take Trospium chloride 20mg film-coated tablets
4. Possible side effects
5. How to store Trospium chloride 20mg film-coated tablets
6. Contents of the pack and other information

• if you are allergic to trospium chloride or any of the other ingredients of this medicine (listed in section 6). (An allergic reaction can be a rash, itchiness or shortness of breath).
• if you suffer from any of the following:
  • urinary retention, i.e. blockage of the urinary tract
  • the eye condition narrow-angle glaucoma
  • abnormal/faster than normal heart beats
  • myasthenia gravis (a disorder that causes muscle fatigue)
  • a severe gastro-intestinal condition, such as toxic megacolon.

Talk to your doctor or your pharmacist before taking Trospium chloride 20mg film-coated tablets if you suffer from any of the following :

• any type of stomach or bowel obstruction
• an impaired urine flow (e.g. in the case of benign tissue growth of the male prostate)
• 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 (see “Patients with liver disorders” below)
• any kidney problems (see “Patients with kidney disorders” below).

You should not take Trospium chloride 20mg film-coated tablets if you have a serious liver disorder. If you have a slight to moderate liver impairment, you should talk to your doctor before taking this medicine.

If you have a kidney disorder, you should talk to your doctor before taking this medicine. Your doctor will, if necessary, give you a lower dose (see dosage instructions in Section 3“How to take Trospium chloride 20mg film-coated tablets – Patients with kidney disorders”).

The safety and efficacy of [Name to be completed nationally] in children under 12 years of age has not been established. No data are available.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Inform your doctor in particular if you are taking any of the following medicines:

• certain medicines for the treatment of abnormal sadness (depression), e.g. amitriptyline or imipramine
• medicines for the treatment of asthma that may accelerate the heart rate (e.g. salbutamol)
• other medicines with anticholinergic action (e.g. amantadine)
• medicines for the stimulation of motility of the gastro-intestinal tract which are used to treat impaired gastric emptying or complaints due to reflux of gastric acid (reflux disease), e.g. metoclopramide
• medicines containing the substances guar, colestipol or cholestyramine which should not be taken simultaneously with Trospium chloride 20mg film-coated tablets.

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

As high fat diets can affect the action of Trospium chloride 20mg film-coated tablets, this medicine should be taken before meals on an empty stomach.

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

Since there is no experience with trospium chloride during pregnancy and breast-feeding, Trospium chloride 20mg film-coated tablets should be taken during pregnancy and breast-feeding only if your doctor considers it absolutely necessary.

This medicine can cause blurred vision. Do not drive motor vehicles, operate machines or perform other hazardous activities if you suffer from blurred vision after taking this medicine.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The recommended dose for adults and children over 12 years of age is one film-coated tablet twice a day (equivalent to 40 mg of trospium chloride per day), unless otherwise prescribed by your doctor.

Patients with kidney disorders

If your kidney function is slightly to moderately impaired, no dose adjustment is required.

In severely impaired kidney function, the dose should be reduced to one tablet once daily or every second day (equivalent to 20 mg of trospium chloride daily or every second day).

You should consult with your doctor about the correct dose for you.

Use in children

Do not give this medicine to children under 12 years of age.

Swallow one film-coated tablet whole with a glass of water. Take the tablet before a meal on an empty stomach.

Your doctor will want to assess your treatment every 3 to 6 months, to decide whether this medicine is still the best one for you.

No symptoms and signs of intoxication in humans have been reported to date.

If you have taken more Trospium chloride 20mg film-coated tablets than the amount prescribed, you should contact a doctor or pharmacist immediately.

If you miss a dose of Trospium chloride 20mg film-coated tablets, simply carry on with the next dose as usual. Do not take a double dose to make up for a forgotten dose.

Your symptoms may return if you stop the intake of Trospium chloride 20mg film-coated tablets before recommended by your doctor. Therefore, you should take this medicine for as long as prescribed by your doctor. Please consult your doctor if you wish to stop treatment.

• accelerated and irregular heart rate (tachyarrhythmia)
• difficulty in breathing (dyspnoea)
• itchiness, nettle rash (hives, urticaria)
• general feeling of weakness (asthenia)
• slight to moderate increase of certain liver values (serum transaminases)
• sporadic cases of hallucinations, 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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is trospium chloride. Each film-coated tablet contains 20 mg trospium chloride.
• The other ingredients are :

Core: Cellulose Microcrystalline, Lactose monohydrate, Maize starch, Povidone, Croscarmellose sodium, Silica Colloidal Anhydrous, Magnesium Stearate;

Coating: Sucrose, Copovidone, Titanium Dioxide (E171), Macrogol 6000, Macrogol 400, Talc, Hypromellose (E464), Iron Oxide Yellow (E172), Iron Oxide Red (E172).

Trospium chloride 20mg film-coated tablets are supplied as:

brownish yellow to light brown, round, biconvex film-coated tablets, debossed with “L” on one side and “l” on other side.

Trospium chloride 20mg film-coated tablets are available in PVC/PVDC-Aluminium blisters of 30, 50, 60, 100 tablets.

Not all pack sizes may be marketed.

This medicinal product is authorised in the Member States of the EEA under the following names:

France Trospipharm 20mg comprimé pelliculé

Germany: Trospiumchlorid Glenmark 20mg Filmtabletten

United Kingdom Trospium chloride 20mg film-coated tablets