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DETRUSITOL 2 MG FILM-COATED TABLETS

Active substance(s): TOLTERODINE L-TARTRATE

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Detrusitol® 2 mg
film-coated tablets
(tolterodine 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 medicine is Detrusitol 2 mg film-coated tablets but will be referred to
as Detrusitol throughout this leaflet.
Please note that the leaflet also contains information about another strength, Detrusitol
1 mg 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 L-tartrate 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.

xxxxx-xx-xx

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Yellow Card Scheme at: www.mhra.gov.uklyellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. 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 sight and reach 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 this medicine becomes discoloured or shows any other signs of deterioration, please
contact your pharmacist who will advise you on 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 tablet contains tolterodine tartrate 2 mg corresponding to 1.37 mg tolterodine.
The other ingredients are:
Core: Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch
glycollate (type B), 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
The film-coated tablet is white, round and biconvex. The tablet is engraved with arcs
above and below the lettering DT on one side and plain on the other side.
Detrusitol 2 mg film-coated tablets are available in the following pack size: Blister pack
containing 56 tablets.
Product Licence Holder and Manufacturer
Procured from within the EU by the Product License holder Orifarm A/S, Energivej 15,
5260 Odense S, Denmark
Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, Czech Republic
Manufactured by Pfizer Italia S.r.l., Italy
Detrusitol 2 mg film-coated tablets
PL 46927/0023

POM

Leaflet revision date: 22/12/2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call +45 63 95 27 00
to obtain the leaflet in a format suitable for you.

Tolterodine Tartrate 2 mg
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 medicine is Tolterodine Tartrate 2 mg film-coated tablets but will be
referred to as Tolterodine throughout this leaflet.
Please note that the leaflet also contains information about another strength,
Tolterodine Tartrate 1 mg film-coated tablets.
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
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.
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.
2. Before you take Tolterodine
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.
Taking other medicines
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.
3. How to take Tolterodine
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.

xxxxx-xx-xx

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.
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:

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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Yellow Card Scheme at: www.mhra.gov.uklyellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store Tolterodine
Keep Tolterodine out of the sight and reach of children.
Do not use Tolterodine 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 this medicine becomes discoloured or shows any other signs of deterioration, please
contact your pharmacist who will advise you on 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 tablet contains tolterodine tartrate 2 mg corresponding to 1.37 mg tolterodine.
The other ingredients are:
Core: Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch
glycollate (type B), magnesium stearate and colloidal anhydrous silica.
Film coating: Hypromellose, microcrystalline cellulose, stearic acid and titanium dioxide
(E171).
What Tolterodine looks like and contents of the pack
The film-coated tablet is white, round and biconvex. The tablet is engraved with arcs
above and below the lettering DT on one side and plain on the other side.
Tolterodine Tartrate 2 mg film-coated tablets are available in the following pack size:
Blister pack containing 56 tablets.
Product Licence Holder and Manufacturer
Procured from within the EU by the Product License holder Orifarm A/S, Energivej 15,
5260 Odense S, Denmark
Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, Czech Republic
Manufactured by Pfizer Italia S.r.l., Italy
Tolterodine Tartrate 2 mg film-coated tablets
PL 46927/0023

POM

Leaflet revision date: 22/12/2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call +45 63 95 27 00
to obtain the leaflet in a format suitable for you.

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