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DETRUSITOL 2 MG FILM-COATED TABLETS

Active substance(s): TOLTERODINE L-TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

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

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.

(tolterodine tartrate)

The benefit of the treatment should be re-evaluated after 2 or 3 months.

The name of this product is Detrusitol 1 mg film-coated tablets or Detrusitol 2 mg
film-coated tablet but will be referred to Detrusitol throughout this leaflet. Other
strengths are available.

Always consult your doctor if you are thinking of stopping the treatment.

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:
• 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

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 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.

Talk to your doctor or pharmacist before starting your treatment with Detrusitol if you
think any of these might apply to you.

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.

Taking other medicines
Tolterodine, the active substance of Detrusitol, may interact with other medicinal
products.

5. How to store DETRUSITOL

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.

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.
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.
If your medicine shows signs of discolouration or deterioration, please contact your
doctor or pharmacist who will tell you what to do.
6. Further information
What Detrusitol contains
Each tablet contains 1mg of tolterodine tartrate, equivalent to 0.68mg of tolteradine.
Each tablet contains 2mg of tolterodine tartrate, equivalent to 1.37mg of tolteradine.
The other ingredients are:
Core: Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch
glycolate, 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 1 mg tablets are white, round, biconvex and marked with arcs above and
below the lettering TO.
Detrusitol 2 mg tablets are white, round, biconvex and marked with arcs above and
below the lettering DT
Detrusitol 1 mg and 2 mg tablets are available in the following pack sizes:
Blister packs containing; - 56 tablets
Manufacturer:
Pfizer Italia S.r.l, Località Marino del Tronto, 63100 Ascoli Piceno (AP), Italy
Procured from within the EU by PL holder PilsCo Ltd, 9-15 Springburn Place, East
Kilbride, G74 5NU.
PL 39467/0118 Detrusitol 1 mg film-coated tablets
PL 39467/0119 Detrusitol 2 mg film-coated tablets
This leaflet was last revised in 20/08/2013
®Pfizer Health AB

POM

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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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