Trospium Chloride 20mg Tablets
0929
22.05.15[11]
Regurin® 20 mg Tablets Trospium Chloride 20 mg Tablets
(trospium chloride)
PATIENT INFORMATION LEAFLET
The name of your medicine is Regurin 20 mg Tablets / Trospium Chloride 20 mg Tablets but will be referred to as Regurin throughout the 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 Regurin is and what it is used for
2. Before you take Regurin
3. How to take Regurin
4. Possible side effects
5. How to store Regurin
6. Further information
1. WHAT REGURIN IS AND WHAT IT IS USED FOR
Regurin 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 REGURIN Do not take Regurin
- If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of Regurin (An allergic reaction can be a rash, itchiness or shortness of breath). For the list of ingredients in Regurin, 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 gastrointestinal condition, such as toxic megacolon.
Take special care with Regurin
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 Regurin and they will decide what to do.
Patients with liver disorders
You should not take Regurin 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).
Children under the age of 12 years
Do not give Regurin to children under the age of 12 years.
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 Regurin.
Please note that this information may also apply to medicines that you have used recently.
Taking Regurin with food and drink
As high fat diets can affect the action of Regurin, 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
Regurin 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 Regurin
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. Regurin is suitable for patients with coeliac disease.
3. HOW TO TAKE REGURIN
Always take Regurin 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 dairy dose for adults and children over the age of 12 years is one Regurin 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 Regurin 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.
If you take more Regurin than you should
If you have taken too much Regurin you should contact your doctor or go to the nearest hospital casualty department immediately.
If you forget to take Regurin
If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than two tablets in one day (unless prescribed otherwise).
If you stop taking Regurin
Your symptoms may return if you stop the intake of Regurin before recommended by your doctor. Therefore, you should take Regurin 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.
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.
POM
PL 20636/0929
4. POSSIBLE SIDE EFFECTS
Like all medicines, Regurin can cause side effects, although not everybody gets them.
The side effects occurring most frequently are typical for this kind of medicine and comprise 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 Regurin and see your doctor immediately if the following symptoms occur:
- swelling of the face, tongue and windpipe which can cause great difficulty in breathing (affects less than 1 user in 10,000)
- a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure (frequency unknown)
- 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 (frequency unknown).
PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by Madaus AG, 51109 Cologne, Germany and procured from the EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref) 22.05.15[11] Regurin is a registered trademark of Madaus AG.
The following side effects have been reported for Regurin:
Common side effects, affects 1 to 10 users in 100
- constipation, nausea, abdominal pain, indigestion (dyspepsia).
Uncommon side effects, affects 1 to 10 users in 1,000
- fast heart rate (tachycardia),
- headache,
- flatulence, diarrhoea,
- chest pain.
Rare side effects, affects 1 to 10 user in 10,000
- dizziness,
- difficulty emptying of the bladder, urinary retention,
- difficulty seeing objects close-up,
- rash,
- joint and muscle pains.
Other possible side effects, for which the frequency is not known
- 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 values (serum transaminases),
- 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 at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE REGURIN
Keep out of the sight and reach of children.
Do not use Regurin after the expiry date which is stated on the carton and the blister foil after EXP. The expiry date refers to the last day of that month.
Do not use Regurin if you notice that the pack or any of the tablets are damaged. If your tablets become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do. Only keep them if your doctor tells you to.
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 Regurin contains
The active substance is trospium chloride.
Each coated tablet contains 20 mg of trospium chloride as the active ingredient.
The other ingredients are sucrose, wheat starch, microcrystalline cellulose, talc, lactose monohydrate, calcium carbonate (E170), titanium dioxide (E171), stearic acid, croscarmellose sodium, povidone, macrogol 8000, silica colloidal anhydrous, yellow iron oxide hydrate (E172), carmellose sodium, white bees wax and carnauba wax
What Regurin looks like and contents of the pack
Regurin are yellow, round coated tablets.
This product is available in blister packs of 30 and 60 tablets.
Trospium Chloride 20 mg Tablets 22.05.15[11]
PATIENT INFORMATION LEAFLET
The name of your medicine is Trospium Chloride 20 mg Tablets but will be referred to as Trospium Chloride throughout the 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
1. WHAT TROSPIUM CHLORIDE IS AND WHAT IT IS USED FOR
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 gastrointestinal 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).
Children under the age of 12 years
Do not give Trospium Chloride to children under the age of 12 years.
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.
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.
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.
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 dairy 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.
If you take more Trospium Chloride than you should
If you have taken too much Trospium Chloride you should contact your doctor or go to the nearest hospital casualty department immediately.
If you forget to take Trospium Chloride
If you forget to take a tablet, take your tablet as soon as you remember, but do not take more than two tablets in one day (unless prescribed otherwise).
If you stop taking Trospium Chloride
Your symptoms may return if you stop the intake of Trospium Chloride before recommended by your doctor. Therefore, you should take Trospium Chloride 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, 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 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 (affects less than 1 user in 10,000)
- a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure (frequency unknown)
- 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 (frequency unknown).
The following side effects have been reported for Trospium Chloride:
Very common side effects, affects more than 1 user in 10
- dryness of the mouth.
Common side effects, affects 1 to 10 users in 100
- constipation, nausea, abdominal pain, indigestion (dyspepsia).
Uncommon side effects, affects 1 to 10 users in 1,000
- fast heart rate (tachycardia),
- headache,
- flatulence, diarrhoea,
- chest pain.
Rare side effects, affects 1 to 10 user in 10,000
- dizziness,
- difficulty emptying of the bladder, urinary retention,
- difficulty seeing objects close-up,
- rash,
- joint and muscle pains.
Other possible side effects, for which the frequency is not known
- 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 values (serum transaminases),
- 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 at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE TROSPIUM CHLORIDE
Keep out of the sight and reach of children.
Do not use Trospium Chloride after the expiry date which is stated on the carton and the blister foil after EXP. The expiry date refers to the last day of that month.
Do not use Trospium Chloride if you notice that the pack or any of the tablets are damaged. If your tablets become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.
Only keep them if your doctor tells you to.
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 contains
The active substance is trospium chloride.
Each coated tablet contains 20mg of trospium chloride as the active ingredient.
The other ingredients are sucrose, wheat starch, microcrystalline cellulose, talc, lactose monohydrate, calcium carbonate (E170), titanium dioxide (E171), stearic acid, croscarmellose sodium, povidone, macrogol 8000, silica colloidal anhydrous, yellow iron oxide hydrate (E172), carmellose sodium, white bees wax and carnauba wax
What Trospium Chloride looks like and contents of the pack
Trospium Chloride are yellow, round coated tablets.
This product is available in blister packs of 30 and 60 tablets.
PRODUCT LICENCE HOLDER AND MANUFACTURER
Manufactured by Madaus AG, 51109 Cologne, Germany and procured from the EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM
PL 20636/0929
Leaflet revision and issue date (Ref) 22.05.15[11]