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DETRUSITOL 1MG FILM-COATED TABLETS

Active substance(s): TOLTERODINE L-TARTRATE / TOLTERODINE L-TARTRATE / TOLTERODINE L-TARTRATE

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(leaflet continued)
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:
x some antibiotics (containing e.g.
erythromycin, clarithromycin)
x medicinal products used for the treatment
of fungal infections (containing e.g.
ketoconazole, itraconazole)
x medicinal products used for the treatment
of HIV.
Detrusitol should be used with caution when
taken in combination with:
x medicines that affect the passage of food
(containing e.g. metoclopramide and
cisapride)
x medicines for the treatment of irregular
heartbeat (containing e.g. amiodarone,
sotalol, quinidine, procainamide)
x 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 reevaluated 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:
x swollen face, tongue or pharynx
x difficulty to swallow
x hives and difficulty in breathing

Uncommon side effects (occurs in less than
1 in 100 patients) are:
x Allergic reactions
x Nervousness
x Increased heart rate, heart failure, irregular
heartbeat
Heart burn
Memory impairment
x
x

5.
x
x

The following side effects have been observed
in Detrusitol with the following frequencies.

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.

Tell your doctor immediately or go to the
casualty department if you notice any of the
following:
x 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).

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.

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).

Very common side effects (occurs in more
than 1 in 10 patients) are:
Dry mouth
Headache
x
x

Common side effects (occurs in less than 1 in
10 patients) are:
x Bronchitis
x Dizziness, sleepiness, sensation of pins
and needles in the fingers and toes
x Dry eyes, blurred vision
x Vertigo
x Palpitations
x Difficulty with digestion (dyspepsia),
constipation, abdominal pain, excessive
amounts of air or gases in the stomach or
the intestine, vomiting
x Dry skin
x Painful or difficult urination, inability to
empty the bladder
x Tiredness, chest pain, extra fluid in the
body causing swelling (e.g. in the ankles)
Increased weight
Diarrhoea

x
x
x

How to store Detrusitol
Keep 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 the tablets show any signs of
discolouration or deterioration consult your
pharmacist for advice.
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.

x
x

(leaflet continued overleaf)

2. Before you take Detrusitol
Do not take Detrusitol if you:
x are allergic (hypersensitive) to tolterodine
or any of the other ingredients in Detrusitol
x are unable to pass urine from the bladder
(urinary retention)
x have an uncontrolled narrow-angle
glaucoma (high pressure in the eyes with
loss of eyesight that is not being adequately
treated)

PP4/1123/24/V1

Detrusitol is a registered trademark of
Pharmacia Aktiebolag
Date of preparation 29th April 2015
PL 20774/1124
Detrusitol 2mg Film-Coated Tablets

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:
x you are unable to control urination,
x you need to rush to the toilet with no
advance warning and/or go to the toilet
frequently.

POM

PL 20774/1123
Detrusitol 1mg Film-Coated Tablets
Manufactured by Pfizer Italia S.r.l, Localita
Marino del Tronto, 63100 Ascoli Piceno, Italy.
Procured from within the EU. Product Licence
Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock,
Bolton BL6 4SA. Repackaged by Maxearn Ltd,
Bolton BL6 4SA.

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

Detrusitol tablets are available in blister packs
of 56 tablets.
Detrusitol tablets also contain the following
inactive ingredients.
Microcrystalline cellulose, calcium hydrogen
phosphate dihydrate, magnesium stearate,
colloidal anhydrous silica, sodium starch
glycollate (type B), hypromellose, stearic acid
and titanium dioxide (E171).

Read all of this leaflet carefully before you
start using this medicine.
x Keep this leaflet. You may need to read it
again.
x If you have any further questions, ask your
doctor or pharmacist
x 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.
x 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.

Detrusitol 2mg Tablets are white, round filmcoated biconvex and marked with arcs above
and below the lettering DT and no marking on
the reverse.
Each tablet contains 2mg of the active
ingredient tolterodine L- tartrate equivalent to
1.37 mg tolterodine.

(leaflet continued overleaf)
Talk to your doctor or pharmacist before
starting your treatment with Detrusitol if you
think any of these might apply to you.
Take special care with Detrusitol
x If you have difficulties in passing urine
and/or a poor stream of urine
x If you have a gastro-intestinal disease that
affects the passage and/or digestion of food
x If you suffer from kidney problems (renal
insufficiency)
x If you have a liver condition
x If you suffer from neuronal disorders that
affect your blood pressure, bowel or sexual
function (any neuropathy of the autonomic
nervous system)
x If you have a hiatal hernia (herniation of an
abdominal organ)
x If you ever experience decreased bowel
movements or suffer from severe
constipation (decreased gastro-intestinal
motility)
x If you have a heart condition such as:
x an abnormal heart tracing (ECG);
x a slow heart rate (bradycardia);
x 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
x If you have abnormally low levels of
potassium (hypokalaemia), calcium
(hypocalcaemia) or magnesium
(hypomagnesaemia) in your blood.
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).

(leaflet continued)

PACKAGE LEAFLET: INFORMATION FOR THE USER

6. Further information
What Detrusitol contains
Detrusitol 1mg Tablets are white, round filmcoated biconvex and marked with arcs above
and below the lettering TO and no marking on
the reverse.
Each tablet contains 1mg of the active
ingredient tolterodine L- tartrate equivalent to
0.68 mg tolterodine.

®

x
The name of your medicine is Detrusitol 1mg
film-coated Tablets or Detrusitol 2mg film-coated
Tablets, but will be referred to as Detrusitol
throughout the leaflet.

x
x

Detrusitol 1mg film-coated Tablets / Detrusitol 2mg film-coated Tablets
(Tolterodine L-tartrate)
®

PP4/1123/24/V1

(leaflet continued)
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:
x some antibiotics (containing e.g.
erythromycin, clarithromycin)
x medicinal products used for the treatment
of fungal infections (containing e.g.
ketoconazole, itraconazole)
x medicinal products used for the treatment
of HIV.
Detrusitol should be used with caution when
taken in combination with:
x medicines that affect the passage of food
(containing e.g. metoclopramide and
cisapride)
x medicines for the treatment of irregular
heartbeat (containing e.g. amiodarone,
sotalol, quinidine, procainamide)
x 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.

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.

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.

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 reevaluated 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.

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.

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.

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.

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:
x swollen face, tongue or pharynx
x difficulty to swallow
x hives and difficulty in breathing

Uncommon side effects (occurs in less than
1 in 100 patients) are:
x Allergic reactions
x Nervousness
x Increased heart rate, heart failure, irregular
heartbeat
x Heart burn
x Memory impairment

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).

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.

Tell your doctor immediately or go to the
casualty department if you notice any of the
following:
x 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).

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.

The following side effects have been observed
in Detrusitol with the following frequencies.

5. How to store Detrusitol
x Keep out of the sight and reach of children.
x 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.
x No special precautions for storage.
x If the tablets show any signs of
discolouration or deterioration consult your
pharmacist for advice.
x 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.

Very common side effects (occurs in more
than 1 in 10 patients) are:
x Dry mouth
x Headache
Common side effects (occurs in less than 1 in
10 patients) are:
x Bronchitis
x Dizziness, sleepiness, sensation of pins
and needles in the fingers and toes
x Dry eyes, blurred vision
x Vertigo
x Palpitations
x Difficulty with digestion (dyspepsia),
constipation, abdominal pain, excessive
amounts of air or gases in the stomach or
the intestine, vomiting
x Dry skin
x Painful or difficult urination, inability to
empty the bladder
x Tiredness, chest pain, extra fluid in the
body causing swelling (e.g. in the ankles)
x Increased weight
x Diarrhoea

(leaflet continued overleaf)

PP4/1123/24/V1

Detrusitol is a registered trademark of
Pharmacia Aktiebolag
Date of preparation 29th April 2015
PL 20774/1124
Detrusitol 2mg Film-Coated Tablets

POM

PL 20774/1123
Detrusitol 1mg Film-Coated Tablets
Manufactured by Pfizer Italia S.r.l, Localita
Marino del Tronto, 63100 Ascoli Piceno, Italy.
Procured from within the EU. Product Licence
Holder: Quadrant Pharmaceuticals Ltd,
Lynstock House, Lynstock Way, Lostock,
Bolton BL6 4SA. Repackaged by Maxearn Ltd,
Bolton BL6 4SA.
Detrusitol tablets are available in blister packs
of 56 tablets.
Detrusitol tablets also contain the following
inactive ingredients.
Microcrystalline cellulose, calcium hydrogen
phosphate dihydrate, magnesium stearate,
colloidal anhydrous silica, sodium starch
glycollate (type B), hypromellose, stearic acid
and titanium dioxide (E171).
Detrusitol 2mg Tablets are white, round filmcoated biconvex and marked with arcs above
and below the lettering DT and no marking on
the reverse.
Each tablet contains 2mg of the active
ingredient tolterodine L- tartrate equivalent to
1.37 mg tolterodine.
6. Further information
What Detrusitol contains
Detrusitol 1mg Tablets are white, round filmcoated biconvex and marked with arcs above
and below the lettering TO and no marking on
the reverse.
Each tablet contains 1mg of the active
ingredient tolterodine L- tartrate equivalent to
0.68 mg tolterodine.
(leaflet continued)

2. Before you take Detrusitol
Do not take Detrusitol if you:
x are allergic (hypersensitive) to tolterodine
or any of the other ingredients in Detrusitol
x are unable to pass urine from the bladder
(urinary retention)
x have an uncontrolled narrow-angle
glaucoma (high pressure in the eyes with
loss of eyesight that is not being adequately
treated)
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:
x you are unable to control urination,
x you need to rush to the toilet with no
advance warning and/or go to the toilet
frequently.
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
Read all of this leaflet carefully before you
start using this medicine.
x Keep this leaflet. You may need to read it
again.
x If you have any further questions, ask your
doctor or pharmacist
x 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.
x 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.

(leaflet continued overleaf)
Talk to your doctor or pharmacist before
starting your treatment with Detrusitol if you
think any of these might apply to you.
Take special care with Detrusitol
x If you have difficulties in passing urine
and/or a poor stream of urine
x If you have a gastro-intestinal disease that
affects the passage and/or digestion of food
x If you suffer from kidney problems (renal
insufficiency)
x If you have a liver condition
x If you suffer from neuronal disorders that
affect your blood pressure, bowel or sexual
function (any neuropathy of the autonomic
nervous system)
x If you have a hiatal hernia (herniation of an
abdominal organ)
x If you ever experience decreased bowel
movements or suffer from severe
constipation (decreased gastro-intestinal
motility)
x If you have a heart condition such as:
x an abnormal heart tracing (ECG);
x a slow heart rate (bradycardia);
x 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
x If you have abnormally low levels of
potassium (hypokalaemia), calcium
(hypocalcaemia) or magnesium
(hypomagnesaemia) in your blood.
x

The name of your medicine is Detrusitol 1mg
film-coated Tablets or Detrusitol 2mg film-coated
Tablets, but will be referred to as Detrusitol
throughout the leaflet.

x
x

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).

Detrusitol® 1mg film-coated Tablets / Detrusitol® 2mg film-coated Tablets
(Tolterodine L-tartrate)
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP4/1123/24/V1

Expand Transcript

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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