Tolterodine L-Tartrate 2mg Tablets
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699 LEAFLET Detrusitol 20130509
PACKAGE LEAFLET: INFORMATION FOR THE USER
DETRUSITOL 2mg TABLETS (tolterodine L-tartrate)
Your medicines can be called by the names given above and will usually be referred to as Detrusitol in this leaflet.
Information for other strengths i.e. Detrusitol 1mg Tablets also may be available in this leaflet.
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please 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 Detrusitol is and what it is used for
2. Before you take Detrusitol
3. How to take Detrusitol
4. Possible side effects
5. How to store Detrusitol
6. Further information
The active substance in Detrusitol is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics.
Detrusitol is used for the treatment of the symptoms of overactive bladder syndrome.
If you have overactive bladder syndrome, you may find that:
• you are unable to control urination,
• you need to rush to the toilet with no advance warning and/or go to the toilet frequently.
Tolterodine, the active substance of Detrusitol, may interact with other medicinal products.
It is not recommended to use tolterodine in combination with:
• some antibiotics (containing e.g. erythromycin, clarithromycin)
• medicinal products used for the treatment of fungal infections (containing e.g. ketoconazole, itraconazole)
• medicinal products used for the treatment of HIV.
Detrusitol should be used with caution when taken in combination with:
• medicines that affect the passage of food (containing e.g. metoclopramide and cisapride)
• medicines for the treatment of irregular heartbeat (containing e.g. amiodarone, sotalol, quinidine, procainamide)
• other medicines with a similar mode of action to Detrusitol (antimuscarinic properties) or medicines with an opposite mode of action to Detrusitol (cholinergic properties). Ask your doctor if you are unsure.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Detrusitol with food and drink Detrusitol can be taken before, after or during a meal.
Pregnancy and Breast-feeding Pregnancy
You should not use Detrusitol when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant or are planning to become pregnant.
Breast-feeding
It is not known if tolterodine, the active substance of Detrusitol, is excreted in the mother's breast milk. Breast-feeding is not recommended during administration of Detrusitol.
Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines
Detrusitol may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.
Do not take Detrusitol if you:
• are allergic (hypersensitive) to tolterodine or any of the other ingredients in Detrusitol
• are unable to pass urine from the bladder (urinary retention)
• have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated)
• suffer from myasthenia gravis (excessive weakness of the muscles)
• suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
• suffer from a toxic megacolon (acute dilatation of the colon).
Take special care with DETRUSITOL
• If you have difficulties in passing urine and/or a poor stream of urine
• If you have a gastro-intestinal disease that affects the passage and/or digestion of food
• If you suffer from kidney problems (renal insufficiency)
• If you have a liver condition
• If you suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)
• If you have a hiatal hernia (herniation of an abdominal organ)
• If you ever experience decreased bowel movements or suffer from severe constipation (decreased gastro-intestinal motility)
• If you have a heart condition such as:
• an abnormal heart tracing (ECG);
• a slow heart rate (bradycardia);
• relevant pre-existing cardiac diseases such as:
- cardiomyopathy (weak heart muscle)
- myocardial ischaemia (reduced blood flow to the heart)
- arrhythmia (irregular heartbeat)
- and heart failure
• If you have abnormally low levels of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia) in your blood.
Talk to your doctor or pharmacist before starting your treatment with
Detrusitol if you think any of these might apply to you.
Dosage
Always take Detrusitol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is one 2 mg tablet twice daily, except for patients who have a kidney or a liver condition or troublesome side effects in which case your doctor may reduce your dose to one 1 mg tablet twice daily.
Detrusitol is not recommended for children.
The tablets are for oral use and should be swallowed whole. Duration of treatment
Your doctor will tell you how long your treatment with Detrusitol will last. Do not stop treatment early because you do not see an immediate effect. Your bladder will need some time to adapt. Finish the course of tablets prescribed by your doctor. If you have not noticed any effect by then, talk to your doctor.
The benefit of the treatment should be re-evaluated after 2 or 3 months.
Always consult your doctor if you are thinking of stopping the treatment.
If you have taken more Detrusitol than you should:
If you or somebody else takes too many tablets, contact your doctor or pharmacist immediately.
If you forget to take Detrusitol
If you forget to take a dose at the usual time, take it as soon as you remember unless it is almost time for your next dose. In that case, omit the forgotten dose and follow the normal dose schedule.
Do not take a double dose to make up for a forgotten one.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines Detrusitol can cause side effects, although not everybody gets them.
You should see your doctor immediately or go to the casualty department if you experience symptoms of angioedema such as:
• swollen face, tongue or throat
• difficulty to swallow
• hives and difficulty in breathing
You should also seek medical attention if you experience a hypersensitivity reaction (for example itching, rash, hives, difficulty breathing). This occurs uncommonly (occurs in less than 1 in 100 patients).
Tell your doctor immediately or go to the casualty department if you notice any of the following:
• chest pain, difficulty breathing or getting tired easily (even at rest), difficulty breathing at night, swelling of the legs.
The following side effects have been observed in Detrusitol with the following frequencies.
Very common side effects (occurs in more than 1 in 10 patients) are:
• Dry mouth
• Headache
Common side effects (occurs in less than 1 in 10 patients) are:
• Bronchitis
• Dizziness, sleepiness, sensation of pins and needles in the fingers and toes
• Dry eyes, blurred vision
• Vertigo
• Palpitations
• Difficulty with digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine, vomiting
• Dry skin
• Painful or difficult urination, inability to empty the bladder
• Tiredness, chest pain, extra fluid in the body causing swelling (e.g. in the ankles)
• Increased weight
• Diarrhoea
Uncommon side effects (occurs in less than 1 in 100 patients) are:
• Allergic reactions
• Nervousness
• Increased heart rate, heart failure, irregular heartbeat
• Heart burn
• Memory impairment
Additional reactions reported include severe allergic reactions, confusion, hallucinations, flushed skin angioedema, and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for dementia.
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.
Further information
How common are bladder problems?
Almost 5 million people in Britain suffer with bladder problems of one kind or another.
What else can you do?
Bladder training - this helps you regain control of your bladder so that you can extend the length of time before passing water. You can do this by holding on for as long as possible before passing water.
Pelvic floor exercises - these strengthen the muscles which can help you to 'hold on' longer before passing water. This will help if you leak when you cough, laugh or sneeze.
If you require details of these contact your doctor or the organisation below.
Where else can you get information?
Incontact:
Incontact is a charity that provides information and support for people with bladder and bowel problems and their carers. They produce a regular newsletter, as well as offering a pen pal service to put people in touch with each other.
If you would like more information about Incontact write to;
Incontact
FREEPOST RRKK-CCHG-HBBB
Kettering, NN16 9JH
Or call 0870 770 3246 or 01536 533255
-K---------------------------------------------------------------------------------------
5. HOW TO STORE DETRUSITOL
• Keep out of the sight and reach of children.
• Store below 25°C.
• Do not take the tablets after the expiry date stated on the pack.
• If the medicine becomes discoloured or shows any other signs of deterioration, check with your pharmacist who will tell you what to do.
• 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 Detrusitol contains
• Detrusitol 2mg Tablets: each tablet contains 2mg of the active ingredient tolterodine L-tartrate corresponding to 1.37mg tolterodine.
• The tablets also contain microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycollate, magnesium stearate, colloidal anhydrous silica, hypromellose, stearic acid and titanium dioxide (E171).
What Detrusitol looks like and contents of the pack
Detrusitol 2mg Tablets are round white, film-coated tablets coded with arcs above and below the letters ‘DT' on one side and plain on the reverse.
Detrusitol are available in blister packs containing 56 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Pfizer Italia S.r.L, Ascoli Piceno,
Italy
| POM | PL 08747/0699 Detrusitol 2mg Tablets
Leaflet revision date: 9th May 2013
Detrusitol is a registered trademark of Pharmacia AG, Sweden.
699 LEAFLET Detrusitol 20130509
Free Personal Support Programme
Pfizer can offer you support with your condition through their ‘Pride and Prejudice' programme. If you would like to learn more about your treatment, or for further support from Pfizer, please fill in your details below in order for you to gain access to the programme, where you will find information and resources to help you manage your condition. You can find out more about how your treatment works and what to expect from it, as well as learn about exercises that can strengthen your bladder muscles. Interactive resources are available to help you monitor your symptoms, track your progress and keep track of doctor's appointments.
The magazine ‘Pride & Prejudice Me' provides hints and tips for an easier day-to-day life, interviews and advice from people talking about their experience of overactive bladder, as well as expert information about how you can control your bladder symptoms, enabling you to go about your daily activities, enabling you to live your life as you want. This is available online, but you can also get a copy by emailing your name and address, including postcode, to prideandprejudice@hhealth.com.
If you wish to enrol in the programme, please complete the details below and return in an envelope to the following freepost address -No stamp required, or call us freephone on 0800 018 6400
FREEPOST RLYK-CBGS-ETXE
Pride and Prejudice, Olympic House, Birches Industrial Estate, East Grinstead RH19 1EH
I wish to subscribe to Pride and Prejudice:
Your Name:_Title:_
Your Address:_
Your postcode:_DOB:
Signature:_Date:
Your email address:_
Please send me my Pride and Prejudice joining email / letter (please delete as appropriate)
By requesting to join Pride and Prejudice (whether by post, email or phone), you agree that your information will be held on a database within or outside of the EEA controlled by Pfizer Ltd, Walton Oaks, Dorking Road, Walton-on-the-Hill, Tadworth, Surrey, KT20 7NS. The information will be used to provide you with materials and communications/information about overactive bladder syndrome to be sent to you as part of Pride and Prejudice and for administering your membership. Pfizer respects the confidentiality of your personal information and only it, other Pfizer group companies or
organisations working under Pfizer's control will have access to your personal information.
Pfizer would also like to use your information to send you information on other health issues. Please tick this box if you are happy for Pfizer to use your personal details for this purpose:
□ I wish to receive information about other health issues.
All the information you provide us will be held in the strictest confidence and will NOT be passed to other companies or organisations.
699 LEAFLET Tolterodine 20130509
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOLTERODINE L-TARTRATE 2mg TABLETS
Your medicines can be called by the names given above and will usually be referred to as Tolterodine in this leaflet.
Information for other strengths i.e. Tolterodine 1mg Tablets also may be available in this leaflet.
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please 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 Tolterodine is and what it is used for
2. Before you take Tolterodine
3. How to take Tolterodine
4. Possible side effects
5. How to store Tolterodine
6. Further information
The active substance in Tolterodine is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics.
Tolterodine is used for the treatment of the symptoms of overactive bladder syndrome.
If you have overactive bladder syndrome, you may find that:
• you are unable to control urination,
• you need to rush to the toilet with no advance warning and/or go to the toilet frequently.
Tolterodine, the active substance of Tolterodine, may interact with other medicinal products.
It is not recommended to use tolterodine in combination with:
• some antibiotics (containing e.g. erythromycin, clarithromycin)
• medicinal products used for the treatment of fungal infections (containing e.g. ketoconazole, itraconazole)
• medicinal products used for the treatment of HIV.
Tolterodine should be used with caution when taken in combination with:
• medicines that affect the passage of food (containing e.g. metoclopramide and cisapride)
• medicines for the treatment of irregular heartbeat (containing e.g. amiodarone, sotalol, quinidine, procainamide)
• other medicines with a similar mode of action to Tolterodine (antimuscarinic properties) or medicines with an opposite mode of action to Tolterodine (cholinergic properties). Ask your doctor if you are unsure.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Tolterodine with food and drink Tolterodine can be taken before, after or during a meal.
Pregnancy and Breast-feeding Pregnancy
You should not use Tolterodine when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant or are planning to become pregnant.
Breast-feeding
It is not known if tolterodine, the active substance of Tolterodine, is excreted in the mother's breast milk. Breast-feeding is not recommended during administration of Tolterodine.
Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines
Tolterodine may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.
Do not take Tolterodine if you:
• are allergic (hypersensitive) to tolterodine or any of the other ingredients in Tolterodine
• are unable to pass urine from the bladder (urinary retention)
• have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated)
• suffer from myasthenia gravis (excessive weakness of the muscles)
• suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
• suffer from a toxic megacolon (acute dilatation of the colon).
Take special care with TOLTERODINE
• If you have difficulties in passing urine and/or a poor stream of urine
• If you have a gastro-intestinal disease that affects the passage and/or digestion of food
• If you suffer from kidney problems (renal insufficiency)
• If you have a liver condition
• If you suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)
• If you have a hiatal hernia (herniation of an abdominal organ)
• If you ever experience decreased bowel movements or suffer from severe constipation (decreased gastro-intestinal motility)
• If you have a heart condition such as:
• an abnormal heart tracing (ECG);
• a slow heart rate (bradycardia);
• relevant pre-existing cardiac diseases such as:
- cardiomyopathy (weak heart muscle)
- myocardial ischaemia (reduced blood flow to the heart)
- arrhythmia (irregular heartbeat)
- and heart failure
• If you have abnormally low levels of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia) in your blood.
Talk to your doctor or pharmacist before starting your treatment with
Tolterodine if you think any of these might apply to you.
Dosage
Always take Tolterodine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is one 2 mg tablet twice daily, except for patients who have a kidney or a liver condition or troublesome side effects in which case your doctor may reduce your dose to one 1 mg tablet twice daily.
Tolterodine is not recommended for children.
The tablets are for oral use and should be swallowed whole. Duration of treatment
Your doctor will tell you how long your treatment with Tolterodine will last. Do not stop treatment early because you do not see an immediate effect. Your bladder will need some time to adapt. Finish the course of tablets prescribed by your doctor. If you have not noticed any effect by then, talk to your doctor.
The benefit of the treatment should be re-evaluated after 2 or 3 months.
Always consult your doctor if you are thinking of stopping the treatment.
If you have taken more Tolterodine than you should:
If you or somebody else takes too many tablets, contact your doctor or pharmacist immediately.
If you forget to take Tolterodine
If you forget to take a dose at the usual time, take it as soon as you remember unless it is almost time for your next dose. In that case, omit the forgotten dose and follow the normal dose schedule.
Do not take a double dose to make up for a forgotten one.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines Tolterodine can cause side effects, although not everybody gets them.
You should see your doctor immediately or go to the casualty department if you experience symptoms of angioedema such as:
• swollen face, tongue or throat
• difficulty to swallow
• hives and difficulty in breathing
You should also seek medical attention if you experience a hypersensitivity reaction (for example itching, rash, hives, difficulty breathing). This occurs uncommonly (occurs in less than 1 in 100 patients).
Tell your doctor immediately or go to the casualty department if you notice any of the following:
• chest pain, difficulty breathing or getting tired easily (even at rest), difficulty breathing at night, swelling of the legs.
The following side effects have been observed in Tolterodine with the following frequencies.
Very common side effects (occurs in more than 1 in 10 patients) are:
• Dry mouth
• Headache
Common side effects (occurs in less than 1 in 10 patients) are:
• Bronchitis
• Dizziness, sleepiness, sensation of pins and needles in the fingers and toes
• Dry eyes, blurred vision
• Vertigo
• Palpitations
• Difficulty with digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine, vomiting
• Dry skin
• Painful or difficult urination, inability to empty the bladder
• Tiredness, chest pain, extra fluid in the body causing swelling (e.g. in the ankles)
• Increased weight
• Diarrhoea
Uncommon side effects (occurs in less than 1 in 100 patients) are:
• Allergic reactions
• Nervousness
• Increased heart rate, heart failure, irregular heartbeat
• Heart burn
• Memory impairment
Additional reactions reported include severe allergic reactions, confusion, hallucinations, flushed skin angioedema, and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for dementia.
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.
Further information
How common are bladder problems?
Almost 5 million people in Britain suffer with bladder problems of one kind or another.
What else can you do?
Bladder training - this helps you regain control of your bladder so that you can extend the length of time before passing water. You can do this by holding on for as long as possible before passing water.
Pelvic floor exercises - these strengthen the muscles which can help you to 'hold on' longer before passing water. This will help if you leak when you cough, laugh or sneeze.
If you require details of these contact your doctor or the organisation below.
Where else can you get information?
Incontact:
Incontact is a charity that provides information and support for people with bladder and bowel problems and their carers. They produce a regular newsletter, as well as offering a pen pal service to put people in touch with each other.
If you would like more information about Incontact write to;
Incontact
FREEPOST RRKK-CCHG-HBBB
Kettering, NN16 9JH
Or call 0870 770 3246 or 01536 533255
-K---------------------------------------------------------------------------------------
5. HOW TO STORE TOLTERODINE
• Keep out of the sight and reach of children.
• Store below 25°C.
• Do not take the tablets after the expiry date stated on the pack.
• If the medicine becomes discoloured or shows any other signs of deterioration, check with your pharmacist who will tell you what to do.
• 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 Tolterodine contains
• Tolterodine L-tartrate 2mg Tablets: each tablet contains 2mg of the active ingredient tolterodine L-tartrate corresponding to 1.37mg tolterodine.
• The tablets also contain microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycollate, magnesium stearate, colloidal anhydrous silica, hypromellose, stearic acid and titanium dioxide (E171).
What Tolterodine looks like and contents of the pack
Tolterodine L-tartrate 2mg Tablets are round white, film-coated tablets coded with arcs above and below the letters ‘DT' on one side and plain on the reverse.
Tolterodine are available in blister packs containing 56 tablets. Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Pfizer Italia S.r.L, Ascoli Piceno,
Italy
| POM | PL 08747/0699 Tolterodine L-tartrate 2mg Tablets Leaflet revision date: 9th May 2013
699 LEAFLET Tolterodine 20130509
Free Personal Support Programme
Pfizer can offer you support with your condition through their ‘Pride and Prejudice' programme. If you would like to learn more about your treatment, or for further support from Pfizer, please fill in your details below in order for you to gain access to the programme, where you will find information and resources to help you manage your condition. You can find out more about how your treatment works and what to expect from it, as well as learn about exercises that can strengthen your bladder muscles. Interactive resources are available to help you monitor your symptoms, track your progress and keep track of doctor's appointments.
The magazine ‘Pride & Prejudice Me' provides hints and tips for an easier day-to-day life, interviews and advice from people talking about their experience of overactive bladder, as well as expert information about how you can control your bladder symptoms, enabling you to go about your daily activities, enabling you to live your life as you want. This is available online, but you can also get a copy by emailing your name and address, including postcode, to prideandprejudice@hhealth.com.
If you wish to enrol in the programme, please complete the details below and return in an envelope to the following freepost address -No stamp required, or call us freephone on 0800 018 6400
FREEPOST RLYK-CBGS-ETXE
Pride and Prejudice, Olympic House, Birches Industrial Estate, East Grinstead RH19 1EH
I wish to subscribe to Pride and Prejudice:
Your Name:_Title:_
Your Address:_
Your postcode:_DOB:
Signature:_Date:
Your email address:_
Please send me my Pride and Prejudice joining email / letter (please delete as appropriate)
By requesting to join Pride and Prejudice (whether by post, email or phone), you agree that your information will be held on a database within or outside of the EEA controlled by Pfizer Ltd, Walton Oaks, Dorking Road, Walton-on-the-Hill, Tadworth, Surrey, KT20 7NS. The information will be used to provide you with materials and communications/information about overactive bladder syndrome to be sent to you as part of Pride and Prejudice and for administering your membership. Pfizer respects the confidentiality of your personal information and only it, other Pfizer group companies or
organisations working under Pfizer's control will have access to your personal information.
Pfizer would also like to use your information to send you information on other health issues. Please tick this box if you are happy for Pfizer to use your personal details for this purpose:
□ I wish to receive information about other health issues.
All the information you provide us will be held in the strictest confidence and will NOT be passed to other companies or organisations.