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DETRUSITOL 1MG TABLETS

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

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T05928

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DETRUSITOL® 1 mg Tablets
DETRUSITOL® 2 mg Tablets
(tolterodine L-tartrate)

Patient Information Leaflet

This product is available using any of the above
names but will be referred as Detrusitol
throughout the Patient Information 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:
• 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:

antibiotics
(containing
e.g.
• Some
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
1mg 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.

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4. Possible side effects

6. Further information

Like all medicines, Detrusitol can cause side
effects, although not everybody gets them.

What Detrusitol contains
The active substance in Detrusitol 1mg tablets
is 1mg of tolterodine L-tartrate, corresponding
to 0.68mg of tolterodine.

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 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.

The active substance in Detrusitol 2mg tablets
is 2mg of tolterodine L-tartrate, corresponding
to 1.37mg of tolterodine.
The other ingredients are:
microcrystalline cellulose, calcium hydrogen
phosphate dihydrate, magnesium stearate,
colloidal anhydrous silica, sodium starch
glycollate, hypromellose, stearic acid and
titanium dioxide (E171).
What Detrusitol looks like and contents of
the pack
Detrusitol 1mg tablets are white, round and
film-coated and coded on one side with arcs
above and below the letters ‘TO’ and plain on
the reverse.
Detrusitol 2mg tablets are white, round,
biconvex and marked with arcs above and
below the letters ‘DT’ and plain on the reverse.
Detrusitol tablets are available as blister packs
of 50 and 56 tablets.
Manufacturer and Product Licence Holder
This medicine is manufactured by Pfizer Italia
S.r.l, Ascoli Piceno, Italy. It is procured from with
in the EU by the PL Holder: Swinghope Ltd,
Brandon House, Marlowe Way, Croydon
CR0 4XS UK and repackaged by Interport
Limited, Brandon house, Marlowe Way,
Croydon CR0 4XS UK.
POM
PL No: 10380/0912
PL No: 10380/0913

Detrusitol 1 mg tablets
Detrusitol 2 mg tablets

Leaflet revision date: 03/08/2015.
Detrusitol® is a registered
Pharmacia AB, Sweden.

trademark

of

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
No special precautions for storage.
Keep all the medicines out of the sight and
reach and of children.
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 the tablets become discoloured or show signs
of any deterioration, you should seek the advice
of your pharmacist who will advise you what to
do.

T05928

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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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