DETRUSITOL 1MG FILM-COATED TABLETS

Active substance: TOLTERODINE L-TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DETRUSITOL® 1mg film-coated tablets
DETRUSITOL® 2mg film-coated tablets
(tolterodine L-tartrate)
Your medicine is available as either of the above names but will be
referred to as Detrusitol throughout 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.
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:
ο an abnormal heart tracing (ECG);
ο a slow heart rate (bradycardia);
ο 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 the 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 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.
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 out of the sight and reach of children.
Do not use them after the expiry date that is printed on the carton
label or blister label after ‘EXP’.
The expiry date refers to the last day of that month.
No special precautions for storage.
If your Detrusitol tablets become discoloured or show any other signs
of deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via waste water 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
The active substance in Detrusitol is tolterodine L-tartrate.
Detrusitol 1mg tablets: each film-coated tablet contains 1mg
tolterodine L-tartrate, equivalent to 0.68mg of tolterodine.
Detrusitol 2mg tablets: each film-coated tablet contains 2mg
tolterodine L-tartrate, equivalent to 1.37mg of 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
Detrusitol 1mg film-coated tablets are white, round, biconvex and
marked with arcs above and below the lettering ‘TO’ on one side and
plain on the other side.
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 1mg and 2mg film-coated tablets are available in the
following pack sizes:
Blister packs containing: 56 tablets (4 strips of 14).
Manufacturer and Product Licence holder
Detrusitol is manufactured by Pfizer Italia S.r.l., Localita Marino del
Tronto, 63100 Ascoli Piceno, Italy.
Procured from within the EU and repackaged by the Product Licence
holder: G-Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1438
PL 16369/1439

Detrusitol 1mg film-coated tablets
Detrusitol 2mg film-coated tablets

Date of revision of this leaflet: 21/02/2014
Detrusitol is a registered trademark of the
Pfizer group of companies

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER
DETRUSITOL® 1mg film-coated tablets
DETRUSITOL® 2mg film-coated tablets
(tolterodine L-tartrate)
Your medicine is available as either of the above names but will be
referred to as Detrusitol throughout 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.
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:
ο an abnormal heart tracing (ECG);
ο a slow heart rate (bradycardia);
ο 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 the 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 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.
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 out of the sight and reach of children.
Do not use them after the expiry date that is printed on the carton
label or blister label after ‘EXP’.
The expiry date refers to the last day of that month.
No special precautions for storage.
If your Detrusitol tablets become discoloured or show any other signs
of deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via waste water 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
The active substance in Detrusitol is tolterodine L-tartrate.
Detrusitol 1mg tablets: each film-coated tablet contains 1mg
tolterodine L-tartrate, equivalent to 0.68mg of tolterodine.
Detrusitol 2mg tablets: each film-coated tablet contains 2mg
tolterodine L-tartrate, equivalent to 1.37mg of 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
Detrusitol 1mg film-coated tablets are white, round, biconvex and
marked with arcs above and below the lettering ‘TO’ on one side and
plain on the other side.
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 1mg and 2mg film-coated tablets are available in the
following pack sizes:
Blister packs containing: 56 tablets (4 strips of 14).
Manufacturer and Product Licence holder
Detrusitol is manufactured by Pfizer Italia S.r.l., Localita Marino del
Tronto, 63100 Ascoli Piceno, Italy.
Procured from within the EU and repackaged by the Product Licence
holder: G-Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1438
PL 16369/1439

Detrusitol 1mg film-coated tablets
Detrusitol 2mg film-coated tablets

Date of revision of this leaflet: 21/02/2014
Detrusitol is a registered trademark of the
Pfizer group of companies

POM

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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