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TOLTERODINE L-TARTRATE 1MG TABLETS

Active substance(s): TOLTERODINE L-TARTRATE

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S466 LEAFLET Detrusitol 20150413





an abnormal heart tracing (ECG);

DETRUSITOL 1mg TABLETS
(tolterodine L-tartrate)



a slow heart rate (bradycardia);



relevant pre-existing cardiac diseases such as:
 cardiomyopathy (weak heart muscle)

Your medicine is known as the Detrusitol 1mg Tablets but will be
referred to as Detrusitol throughout the following patient information
leaflet.

 myocardial ischaemia (reduced blood flow to the heart)
 arrhythmia (irregular heartbeat)

Information for other strengths of Detrusitol (Detrusitol 2mg Tablets)
also may be present 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, 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 you have a heart condition such as:

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

 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:

In this leaflet:



some antibiotics (containing e.g. erythromycin, clarithromycin)

1. What Detrusitol is and what it is used for



medicinal products used for the treatment of fungal infections
(containing e.g. ketoconazole, itraconazole)



medicinal products used for the treatment of HIV.

2. Before you take Detrusitol
3. How to take Detrusitol
4. Possible side effects

Detrusitol should be used with caution when taken in combination
with:

5. How to store Detrusitol
6. Further information



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.

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.

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.

2 BEFORE YOU TAKE DETRUSITOL
Do not take Detrusitol if you:

Pregnancy and breast-feeding



are allergic (hypersensitive) to tolterodine or any of the other
ingredients in Detrusitol

Pregnancy



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)

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



suffer from myasthenia gravis (excessive weakness of the
muscles)

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.



suffer from severe ulcerative colitis (ulceration and inflammation
of the colon)

Ask your doctor or pharmacist for advice before taking any
medicine.



suffer from a toxic megacolon (acute dilatation of the colon).
Driving and using machines

Take special care with Detrusitol

Detrusitol may make you feel dizzy, tired or affect your sight; your
ability to drive or operate machinery may be affected.



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

3 HOW TO TAKE DETRUSITOL



If you suffer from kidney problems (renal insufficiency)



If you have a liver condition

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



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)

Dosage

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.

Uncommon side effects (occurs in less than 1 in 100 patients)
are:


Allergic reactions



Nervousness



Increased heart rate, heart failure, irregular heartbeat

The benefit of the treatment should be re-evaluated after 2 or 3
months.



Heart burn



Memory impairment

Always consult your doctor if you are thinking of stopping the
treatment.
If you have taken more Detrusitol than you should:

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 you or somebody else takes too many tablets, contact your doctor
or pharmacist immediately.

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 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:

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 OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not take the tablets after the date shown on the pack.



If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.



If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of 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


Each film-coated tablet contains 1mg of the active ingredient
tolterodine L-tartrate equivalent to 0.68mg tolterodine.



The tablets also contain microcrystalline cellulose, calcium
hydrogen phosphate dihydrate, sodium starch glycollate (Type
B), magnesium stearate, colloidal anhydrous silica,
hypromellose, stearic acid and titanium dioxide (E171).

What Detrusitol looks like and contents of the pack
Detrusitol Tablets are round white film-coated tablets marked with
arcs above and below ‘TO’ on one side and plain on the other.
Detrusitol Tablets are available in blister packs containing 20, 50,
56 or 60 tablets.



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

And



Painful or difficult urination, inability to empty the bladder

Pfizer Italia S.r.I., Ascoli Piceno, Italy.



Tiredness, chest pain, extra fluid in the body causing swelling
(e.g. in the ankles)

Leaflet revision date: 13 April 2015



Increased weight



Diarrhoea

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
These Capsules are manufactured by Pharmacia Italia SpA, Ascoli
Piceno, Italy.

POM

PL No. 19488/0466

S466 LEAFLET Detrusitol 20150413

S466 LEAFLET Tolterodine 20150413



If you have a heart condition such as:

PACKAGE LEAFLET: INFORMATION FOR THE USER



an abnormal heart tracing (ECG);

TOLTERODINE L-TARTRATE 1mg TABLETS



a slow heart rate (bradycardia);



relevant pre-existing cardiac diseases such as:

Your medicine is known as the Tolterodine L-Tartrate 1mg Tablets
but will be referred to as Tolterodine throughout the following
patient information leaflet.

 cardiomyopathy (weak heart muscle)
 myocardial ischaemia (reduced blood flow to the heart)

Information for other strengths of Tolterodine (Tolterodine L-Tartrate
2mg Tablets) also may be present 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, 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.

 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, may interact with
other medicinal products.

In this leaflet:

It is not recommended to use tolterodine in combination with:

1. What Tolterodine is and what it is used for



some antibiotics (containing e.g. erythromycin, clarithromycin)

2. Before you take Tolterodine



medicinal products used for the treatment of fungal infections
(containing e.g. ketoconazole, itraconazole)



medicinal products used for the treatment of HIV.

3. How to take Tolterodine
4. Possible side effects
5. How to store Tolterodine
6. Further information

Tolterodine should be used with caution when taken in combination
with:


medicines that affect the passage of food (containing e.g.
metoclopramide and cisapride)

1 WHAT TOLTERODINE IS AND WHAT IT IS USED FOR



The active substance in Tolterodine is tolterodine. Tolterodine
belongs to a class of medicinal products called antimuscarinics.

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.

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.

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

2 BEFORE YOU TAKE TOLTERODINE

Tolterodine can be taken before, after or during a meal.

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).

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.

Take special care with Tolterodine

Driving and using machines



If you have difficulties in passing urine and/or a poor stream of
urine

Tolterodine may make you feel dizzy, tired or affect your sight; your
ability to drive or operate machinery may be affected.



If you have a gastro-intestinal disease that affects the passage
and/or digestion of food



3 HOW TO TAKE TOLTERODINE

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)

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.

Uncommon side effects (occurs in less than 1 in 100 patients)
are:


Allergic reactions



Nervousness



Increased heart rate, heart failure, irregular heartbeat

The benefit of the treatment should be re-evaluated after 2 or 3
months.



Heart burn



Memory impairment

Always consult your doctor if you are thinking of stopping the
treatment.
If you have taken more Tolterodine than you should:

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 you or somebody else takes too many tablets, contact your doctor
or pharmacist immediately.

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 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.
4 POSSIBLE SIDE EFFECTS
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 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 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:

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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not take the tablets after the date shown on the pack.



If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.



If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of 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


Each film-coated tablet contains 1mg of the active ingredient
tolterodine L-tartrate equivalent to 0.68mg tolterodine.



The tablets also contain microcrystalline cellulose, calcium
hydrogen phosphate dihydrate, sodium starch glycollate (Type
B), magnesium stearate, colloidal anhydrous silica,
hypromellose, stearic acid and titanium dioxide (E171).

What Tolterodine looks like and contents of the pack
Tolterodine Tablets are round white film-coated tablets marked with
arcs above and below ‘TO’ on one side and plain on the other.
Tolterodine Tablets are available in blister packs containing 20, 50,
56 or 60 tablets.



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

And



Painful or difficult urination, inability to empty the bladder

Pfizer Italia S.r.I., Ascoli Piceno, Italy.



Tiredness, chest pain, extra fluid in the body causing swelling
(e.g. in the ankles)

Leaflet revision date: 13 April 2015



Increased weight



Diarrhoea

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
These Capsules are manufactured by Pharmacia Italia SpA, Ascoli
Piceno, Italy.

POM

PL No. 19488/0466
S466 LEAFLET Tolterodine 20150413

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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