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DETRUSITOL XL 4MG CAPSULES

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

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

DETRUSITOL® XL 4mg CAPSULES
(tolterodine L-tartrate)
Patient Information Leaflet
This product is known by the above name but will be referred to as Detrusitol XL in this leaflet.

1. What Detrusitol XL is and what it is used for
The active substance in Detrusitol XL is tolterodine. Tolterodine belongs to a class of medicinal products
called antimuscarinics.
Detrusitol XL 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.

WARNING!

Taking other medicines
Tolterodine, the active substance of Detrusitol XL, 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.

TO UK PIL DATED MARCH 2012
REPORTING OF SIDE EFFECTS

TVT CHECKED
6464/2388 2389D

04/02/14
CODE:

DATE:
DATE:

DT

DATE OF PROOF:

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

Detrusitol XL 4mg caps

ARTWORKER:

Take special care with Detrusitol XL
• 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.

PRODUCT:

CUSTOMER
APPROVED:
Q.A.
APPROVED:
04-1957
CUSTOMER: Waymade

PRE-PRESS NO.:

2. Before you take Detrusitol XL
Do not take Detrusitol XL if you:
• are allergic (hypersensitive) to tolterodine or any of the other ingredients in Detrusitol XL
• 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).

Detrusitol XL 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 XL (antimuscarinic properties) or
medicines with an opposite mode of action to Detrusitol XL (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 XL with food and drink
Detrusitol XL can be taken before, after or during a meal.
Pregnancy and breast-feeding
Pregnancy
You should not use Detrusitol XL 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 XL, is excreted in the mother's breast milk.
Breast-feeding is not recommended during administration of Detrusitol XL.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Detrusitol XL may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery
may be affected.
Important information about some of the ingredients of Detrusitol XL
This medicine contains sucrose (a type of sugar). If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine. Patients with rare hereditary
problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
should not take this medicine.

Colour
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Black

WARNING!

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BRIDGED TO
CRESTOR 6464/2069 2070

«PAdBì

In this leaflet:
1. What Detrusitol XL is and what it is used for
2. Before you take Detrusitol XL
3. How to take Detrusitol XL
4. Possible side effects
5. How to store Detrusitol XL
6. Further information

PROOF HISTORY:
v.1 - waymade - 04/02/14

Leaflet Flat Size = 148 x 432

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

3. How to take Detrusitol XL
Dosage
Always take Detrusitol XL 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 4 mg prolonged-release capsule 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 2 mg Detrusitol
daily.
Detrusitol XL is not recommended for children.
The prolonged-release capsules are for oral use and should be swallowed whole. Do not chew the capsules.

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Always consult your doctor if you are thinking of stopping the treatment.
If you have taken more Detrusitol XL than you should
If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist
immediately.
If you forget to take Detrusitol XL
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 XL 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

WARNING!

Tell your doctor immediately or got 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).
DATE:

The following side effects have been observed during treatment with Detrusitol XL with the following
frequencies.
Very common side effects (occurs in more than 1 in 10 patients) are:
• Dry mouth

DT

04/02/14

ARTWORKER:

DATE OF PROOF:

Uncommon side effects (occurs in less than 1 in 100 patients) are:
• Allergic reactions
• Nervousness
• Sensation of pins and needles in the fingers and toes
• Vertigo
• Palpitations, heart failure, irregular heartbeat
• Inability to empty the bladder
• Chest pain
• Memory impairment
Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart
rate, flushed skin, heart burn, vomiting, angioedema dry skin, and disorientation. There have also been
reports of worsening symptoms of dementia in patients being treated for dementia.

TO UK PIL DATED MARCH 2012
REPORTING OF SIDE EFFECTS

6464/2388 2389D
CODE:

Detrusitol XL 4mg caps
PRODUCT:

CUSTOMER: Waymade

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 XL
Keep out of the sight and reach of children.
Detrusitol XL 4mg capsules should not be stored above 30°C. Store in the original package
Do not use after the expiry date printed on the carton, label or blister strip. The expiry date refers to
the last day of that month.
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 the environment.
If your capsules become discoloured or show any other signs of deterioration, consult your doctor or
pharmacist who will tell you what to do.

6. Further information
Each prolonged release capsule contains 4mg of the active ingredient tolterodine L-tartrate (corresponding to
2.74mg tolterodine).
Each blue capsule is marked with a symbol on the cap and ‘4’ on the body.
Detrusitol XL 4mg capsules also contain the following ingredients:
sucrose, maize starch, ethyl cellulose, medium chain triglycerides, oleic acid, hypromellose, gelatin, shellac,
simethicone, propylene glycol, titanium dioxide (E171) and indigo carmine (E132).
Detrusitol XL 4mg capsules are available as blister packs of 28 capsules.
POM

PL No: 6464/2388
PL No: 6464/2389

These products are manufactured by Pfizer Italia S.r.l., Marino Del Tronto, Ascoli Piceno, Italy and
procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 04.02.2014
Detrusitol® is a registered trademark of Pfizer Enterprises Sarl

Colour
Swatch

Black

WARNING!

04-1957

DATE:

Common side effects (occurs in less than 1 in 10 patients) are:
• Sinusitis
• Dizziness, sleepiness, headache
• Dry eyes, blurred vision
• Difficulty with digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or
gases in the stomach or the intestine
• Painful or difficult urination
• Tiredness
• Extra fluid in the body causing swelling (e.g. in the ankles)
• Diarrhoea

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

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).

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

«PAdBì

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

PROOF HISTORY:
v.1 - waymade - 04/02/14

Leaflet Flat Size = 148 x 432

Duration of treatment
Your doctor will tell you how long your treatment with Detrusitol XL 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
prolonged-release capsules prescribed by your doctor. If you have not noticed any effect by then, talk to your
doctor.

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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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