TOLTERODINE TARTRATE 2MG FILM COATED TABLETS

Active substance: TOLTERODINE TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Detrusitol® 2mg
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 2mg Film-coated Tablets but it will be referred
to as Detrusitol throughout this leaflet. This medicine is also available in other
strengths.

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.
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.
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 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 reach and sight 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 storage conditions.
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
The active ingredient in Detrusitol 2mg Film-coated tablet is tolterodine tartrate
Each film-coated tablet contains 2mg tolterodine tartrate equivalent to 1.37mg
tolterodine.
The other ingredients are:
Core: Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch
glycollate, 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 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 2mg film-coated tablets are available in the blister packs containing 28
tablets (2 strips of 14).
Manufactured by: Pfizer Italia S.r.l., 63046 Marino del Tronto, Ascoli Piceno, Italy.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Detrusitol® 2mg Film-coated Tablets – PL No: 18799/2160
Leaflet date: 21.01.2014
Detrusitol is a registered trademark of Pfizer group of companies.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tolterodine tartrate 2mg
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 2mg Film-coated Tablets but it will
be referred to as Tolterodine tablet throughout this leaflet. This medicine is also
available in other strengths.

In this leaflet:
1. What Tolterodine tablet is and what it is used for
2. Before you take Tolterodine tablet
3. How to take Tolterodine tablet
4. Possible side effects
5. How to store Tolterodine tablet
6. Further information
1. What Tolterodine tablet is and what it is used for
The active substance in Tolterodine tablet is tolterodine. Tolterodine belongs to a
class of medicinal products called antimuscarinics.
Tolterodine tablet 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 tablet
Do not take Tolterodine tablet if you:
are allergic (hypersensitive) to tolterodine or any of the other ingredients in
Tolterodine tablet
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 tablet
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 tablet, 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 tablet 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 tablet (antimuscarinic
properties) or medicines with an opposite mode of action to Tolterodine tablet
(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 tablet with food and drink
Tolterodine tablet can be taken before, after or during a meal.
Pregnancy and breast-feeding
Pregnancy
You should not use Tolterodine tablet 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 tablet, is excreted in
the mother’s breast milk. Breast-feeding is not recommended during administration of
Tolterodine tablet.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Tolterodine tablet 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 tablet
Dosage
Always take Tolterodine tablet 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 tablet 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 tablet 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 Tolterodine tablet than you should:
If you or somebody else takes too many tablets, contact your doctor or pharmacist
immediately.
If you forget to take Tolterodine tablet
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 tablet 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 tablet 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.
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 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 tablet
Keep Tolterodine tablet out of the reach and sight of children.
Do not use Tolterodine tablet 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.
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 tablet contains
The active ingredient in Tolterodine 2mg Film-coated tablet is tolterodine tartrate.
Each film-coated tablet contains 2mg tolterodine tartrate equivalent to 1.37mg
tolterodine.
The other ingredients are:
Core: Microcrystalline cellulose, calcium hydrogen phosphate dehydrate, sodium
starch glycollate, magnesium stearate and colloidal anhydrous silica.
Film coating: Hypromellose, microcrystalline cellulose, stearic acid and titanium
dioxide (E171).
What Tolterodine tablet looks like and contents of the pack
Tolterodine 2mg film-coated tablets are white, round, biconvex and marked with arcs
above and below the lettering DT and plain on the other side.
Tolterodine 2mg film-coated tablets are available in the blister packs containing 28
tablets (2 strips of 14).
Manufactured by: Pfizer Italia S.r.l., 63046 Marino del Tronto, Ascoli Piceno, Italy.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Tolterodine tartrate 2mg Film-coated Tablets - PL No: 18799/2160 POM
Leaflet date: 21.01.2014

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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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