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DETRUSITOL XL 4 MG CAPSULES

Active substance(s): TOLTERODINE TARTRATE

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Detrusitol® XL 4 mg Capsules

2626
25.11.14[2]

(tolterodine tartrate)
Your medicine is available using the above name but will be referred to as
Detrusitol XL 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 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
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.
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).
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.
Talk to your doctor or pharmacist before starting your treatment with
Detrusitol XL if you think any of these might apply to you.
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.

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 sucraseisomaltase insufficiency should not take this medicine.
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.
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 prolongedrelease capsules 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 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
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 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).
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
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
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.
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 Detrusitol XL out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to protect
from light.
Do not use Detrusitol XL after the expiry date which is stated on the
label/carton. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking this medicine, return any unused
capsules to your doctor for safe disposal. Only keep the capsules if your
doctor tells you to.
If your capsules become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to do.
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 XL contains
Each capsule contains 4mg tolterodine tartrate.
The other ingredients are sucrose, maize starch, ethylcellulose, medium
chain triglycerides, oleic acid, hypromellose 2910, gelatin, shellac, indigo
carmine (E132), simeticone, propylene glycol, titanium dioxide (E171).
What Detrusitol XL looks like and contents of the pack
Detrusitol XL are blue, prolonged-release hard capsule printed with a
symbol on the cap and ‘4’ on the body in white.
Detrusitol XL are available in the blister packs containing 28 prolonged
release capsules.
Manufacturer and Product Licence Holder
Manufactured by Pfizer Italia S.r.L., Ascoli Piceno, Italy and is procured
from within the EU by Product Licence holder Star Pharmaceuticals Ltd.,
5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PL 20636/2626

Leaflet revision and issue date (Ref) 25.11.14[2]
Detrusitol is a trademark of Pfizer Enterprises Sarl.

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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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