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TOLTERODINE TARTRATE 2MG TABLETS

Active substance(s): TOLTERODINE L-TARTRATE

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Ref:1305/120115/1/F

®

Detrusitol 2mg Tablets
(tolterodine tartrate)
Patient Information 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Detrusitol 2mg Tablets but will be referred to as
Detrusitol throughout this Patient Information Leaflet.
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.

Ref:1305/120115/1/B

Detrusitol ® 2mg Tablets
(tolterodine tartrate)
Patient Information Leaflet (continued)
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

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

*
*
*

Like all medicines, Detrusitol can cause side effects, although not everybody
gets them.
You should see your doctor immediately or go 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 during treatment with
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.

*

6

How to store this medicine
Keep this medicine out of the reach and sight of children.
Do not take your tablets out of the blister strip until it is time to take your
dose.
Do not use this medicine after the expiry date shown on the carton label
or blister strip. If your doctor tells you to stop taking this medicine, return
any unused tablets to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your tablets become discoloured or
show any other signs of deterioration, consult your pharmacist who will
tell you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. This
leaflet does not tell you everything about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist.
He/she will have additional information about this medicine and will be
able to advise you.

Further information

What Detrusitol contains
Each film-coated tablet contains 2mg tolterodine L-tartrate as the active
ingredient.
Your medicine also contains the following inactive ingredients:
microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium
starch glycollate, colloidal anhydrous silica, hypromellose, stearic acid,
titanium dioxide (E171), and magnesium stearate.
What Detrusitol looks like and contents of the pack
They are white, round, biconvex, film coated tablets. Engraved with arcs
above and below the letters 'DT' one one side.
Each pack contains 28 or 56 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Pfizer Italia S.r.l, Localita Marino del Tronto,
63100 Ascoli Piceno, Italy and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1305 - Detrusitol 2mg Tablets

Detrusitol is a registered trademark of Pfizer Health AB.
Leaflet revision date: 12/01/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref:1305/120115/2/F

Tolterodine tartrate 2mg Tablets
Patient Information 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Tolterodine tartrate tartrate 2mg Tablets but will be
referred to as Tolterodine tartrate tartrate throughout this Patient Information
Leaflet.
In this leaflet:
1 What Tolterodine tartrate is and what it is used for
2. Before you take Tolterodine tartrate
3

How to take Tolterodine tartrate

4

Possible side effects

5

How to store Tolterodine tartrate

6

1

Further information

What Tolterodine tartrate is and what it is used for

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

Do not take Tolterodine tartrate if you:
* Are allergic (hypersensitive) to tolterodine tartrate or any of the other
ingredients in Tolterodine tartrate;
* 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).

Talk to your doctor or pharmacist before starting your treatment with
Tolterodine tartrate if you think any of these might apply to you.
Taking other medicines
Tolterodine tartrate, the active substance of Tolterodine tartrate, may interact
with other medicinal products.
It is not recommended to use tolterodine tartrate 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 tartrate 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 tartrate
(antimus carinic properties) or medicines with an opposite mode of action
to Tolterodine tartrate (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 tartrate with food and drink
Tolterodine tartrate can be taken before, after or during a meal.
Pregnancy and breast-feeding
Pregnancy
You should not use Tolterodine tartrate 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 tartrate, the active substance of Tolterodine
tartrate, is excreted in the mother’s breast milk. Breast-feeding is not
recommended during administration of Tolterodine tartrate.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Tolterodine tartrate may make you feel dizzy, tired or affect your sight; your
ability to drive or operate machinery may be affected.

3
Take special care with Tolterodine tartrate:
* 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.

How to take Tolterodine tartrate

Dosage
Always take Tolterodine tartrate 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 tartrate 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 tartrate 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.

Ref:1305/120115/2/B

Tolterodine tartrate 2mg Tablets
Patient Information Leaflet (continued)
Always consult your doctor if you are thinking of stopping the
treatment.
If you have taken more Tolterodine tartrate than you should:
If you or somebody else takes too many tablets, contact your doctor or
pharmacist immediately.
If you forget to take Tolterodine tartrate
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 tartrate can cause side effects, although not
everybody gets them.
You should see your doctor immediately or got the casualty department if
you experience symptoms of angioedema, such as:
* Swollen face, tongue or pharynx;
* difficulty to swallow;
* hives and difficulty in breathing.

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.
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

*
*
*

*

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 during treatment with
Tolterodine tartrate 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

6

How to store Tolterodine tartrate
Keep this medicine out of the reach and sight of children.
Do not take your tablets out of the blister strip until it is time to take your
dose.
Do not use this medicine after the expiry date shown on the carton label
or blister strip. If your doctor tells you to stop taking this medicine, return
any unused tablets to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your tablets become discoloured or
show any other signs of deterioration, consult your pharmacist who will tell
you what to do.
Remember this medicine is for you. Only a doctor can prescribe it. This
leaflet does not tell you everything about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist.
He/she will have additional information about this medicine and will be
able to advise you.

Further information

What Tolterodine tartrate contains
Each film-coated tablet contains 2mg tolterodine L-tartrate as the active
ingredient.
Your medicine also contains the following inactive ingredients:
microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium
starch glycollate, colloidal anhydrous silica, hypromellose, stearic acid,
titanium dioxide (E171), and magnesium stearate.
What Tolterodine tartrate looks like and contents of the pack
They are white, round, biconvex, film coated tablets. Engraved with arcs
above and below the letters 'DT' one one side.
Each pack contains 28 or 56 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Pfizer Italia S.r.l, Localita Marino del Tronto,
63100 Ascoli Piceno, Italy and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1305 - Tolterodine tartrate 2mg Tablets

Leaflet revision date: 12/01/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

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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