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Regurin 20mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER Regurin® 20mg Tablets / Trospium Chloride® 20mg Tablets (trospium chloride)


Children under the age of 12 years

Do not give Trospium Chloride to children under the age of 12 years.


This product is available in the above names but will be referred to

as Trospium Chloride throughout this leaflet

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 is and what it is used for

2.    Before you take Trospium Chloride

3.    How to take Trospium Chloride

4.    Possible side effects

5.    How to store Trospium Chloride

6.    Further information


Taking 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.


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


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 (such as those used to treat Parkinson's disease, asthma and stomach cramps)

-    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.

Please note that this information may also apply to medicines that

you have used recently.


Trospium Chloride is a medicine used for the relaxation of the bladder. It is used for the treatment of symptoms associated with involuntary loss of urine (wetting) and/or increased frequency of urination and imperative urge of urination in patients with hyperactive bladder (involuntary urge of urination and voiding problems of unknown origin or due to nervous system disorders).


2. Before you take Trospium Chloride


Do not take Trospium Chloride

-    If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of Trospium Chloride (An allergic reaction can be a rash, itchiness or shortness of breath). For the list of ingredients in Trospium Chloride, please see section 6.

-    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.

Take special care with Trospium Chloride

If you suffer from any of the following:

-    any type of stomach or bowel obstruction,

-    difficulties in passing urine and/or poor stream of urine (male prostate disorders),

-    neuropathy i.e., nerve damage,

-    a hernia of the diaphragm with inflammation of the oesophagus due to reflux of gastric acid (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 any of the above apply to you, it is important that you speak to your doctor or pharmacist before taking Trospium Chloride and they will decide what to do.

Patients with liver disorders

You should not take Trospium Chloride 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.

Patients with kidney disorders

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 'For patients with kidney disorders).


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

Please tell your doctor if you are pregnant, think you might be pregnant, or are breastfeeding. Your doctor will decide if this medicine is suitable for you.

Driving and using machines

Trospium Chloride can cause blurred vision. If you experience this, do not drive or use any tools or machines.

Important information about some of the ingredients of Trospium Chloride

This product contains lactose (milk sugar) and sucrose (sugar). If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.

This product also contains wheat starch. If you suffer from wheat allergy (different from coeliac disease) you should not take this product. Trospium Chloride is suitable for patients with coeliac disease.


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3. How to take Trospium Chloride


Always take Trospium Chloride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Usual dose unless otherwise prescribed by your doctor

Unless otherwise prescribed by your doctor, the usual daily dose for adults and children over the age of 12 years is one Trospium Chloride tablet taken twice daily (equivalent to 40 mg of trospium chloride daily).

Method of administration

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

Duration of treatment

Your doctor will determine the duration of treatment.

The need for continued treatment should be checked by your doctor at regular intervals of 3-6 months.

For patients with kidney disorders

If your kidney function is slightly to moderately impaired, no dose adjustment of Trospium Chloride 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.