Tolterodine L-Tartrate 2mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Detrusitol™ 2mg
Film-coated Tablets (tolterodine L-tartrate)
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, 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your product is Detrusitol 2mg Film-coated Tablets but it will be referred to as Detrusitol throughout the leaflet. This medicine is also available in another strength as Detrusitol 1mg Film-coated Tablets.
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
1. What Detrusitol is and what it is used for
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.
2. Before you take Detrusitol 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.
Taking other medicines
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.
3. How to take DETRUSITOL 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.
4. Possible side effects
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 pharynx
• 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.
These may be symptoms of heart failure. This occurs uncommonly (occurs in less than 1 in 100 patients).
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.
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 Detrusitol
Keep Detrusitol out of the reach and sight of children.
Do not use Detrusitol after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month.
No special precautions for storage.
If your tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.
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
Each film-coated tablet contains 2mg tolterodine L-tartrate equivalent to 1.37mg tolterodine.
The other ingredients are:
Core: Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycollate, magnesium stearate and colloidal anhydrous silica.
Film coating: Hypromellose, microcrystalline cellulose, stearic acid and titanium dioxide (E171).
What Detrusitol looks like and contents of the pack
Detrusitol 2mg film-coated tablets are white, round, biconvex and marked with arcs above and below the lettering DT on one side and plain on the other side.
Detrusitol 2mg film-coated tablets are available in the blister packs containing 56 tablets.
Manufactured by: Pfizer Italia S.r.l., 63046 Marino del Tronto, Ascoli Piceno, Italy.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
POM
Detrusitol 2mg Film-coated Tablets - PL No: 18799/2135
Leaflet date: 21.01.2014 Detrusitol® is a registered trademark.
Tolterodine L-tartrate 2mg
Film-coated Tablets
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, 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your product is Tolterodine L-tartrate 2mg Film-coated Tablets but it will be referred to as Tolterodine tablet throughout the leaflet. This medicine is also available in another strength as Tolterodine L-tartrate 1mg Film-coated Tablets
In this leaflet:
1. What Tolterodine tablet is and what it is used for
2. Before you take Tolterodine tablet
3. How to take Tolterodine tablet
4. Possible side effects
5. How to store Tolterodine tablet
6. Further information
1. What Tolterodine tablet is and what it is used for
The active substance in Tolterodine tablet is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics.
Tolterodine tablet 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.
2. Before you take Tolterodine tablet Do not take Tolterodine tablet if you:
• are allergic (hypersensitive) to tolterodine or any of the other ingredients in Tolterodine tablet
• 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 tablet
• 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.
Taking other medicines
Tolterodine, the active substance of Tolterodine tablet, 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 tablet 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 tablet (antimuscarinic properties) or medicines with an opposite mode of action to Tolterodine tablet (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 tablet with food and drink
Tolterodine tablet can be taken before, after or during a meal.
Pregnancy and breast-feeding Pregnancy
You should not use Tolterodine tablet 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 tablet, is excreted in the mother's breast milk. Breast-feeding is not recommended during administration of Tolterodine tablet.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Tolterodine tablet may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.
3. How to take Tolterodine tablet Dosage
Always take Tolterodine tablet 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 tablet 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 tablet 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 tablet than you should:
If you or somebody else takes too many tablets, contact your doctor or pharmacist immediately.
If you forget to take Tolterodine tablet
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.
4. Possible side effects
Like all medicines, Tolterodine tablet 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 pharynx
• 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.
These may be symptoms of heart failure. This occurs uncommonly (occurs in less than 1 in 100 patients).
The following side effects have been observed in Tolterodine tablet 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.
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 Tolterodine tablet
Keep T olterodine tablet out of the reach and sight of children.
Do not use Tolterodine tablet after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month.
No special precautions for storage.
If your tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.
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 tablet contains
Each film-coated tablet contains 2mg tolterodine L-tartrate equivalent to 1.37mg tolterodine.
The other ingredients are:
Core: Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycollate, magnesium stearate and colloidal anhydrous silica.
Film coating: Hypromellose, microcrystalline cellulose, stearic acid and titanium dioxide (E171).
What Tolterodine tablet looks like and contents of the pack
Tolterodine 2mg film-coated tablets are white, round, biconvex and marked with arcs above and below the lettering DT and plain on the other side.
Tolterodine 2mg film-coated tablets are available in the blister packs containing 56 tablets.
Manufactured by: Pfizer Italia S.r.l., 63046 Marino del Tronto, Ascoli Piceno, Italy. Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
POM
Tolterodine L-tartrate 2mg Film-coated Tablets - PL No: 18799/2135
Leaflet date: 21.01.2014