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

Do not take Detrusitol XL:

• If you are allergic (hypersensitive) to tolterodine or any of the other ingredients in the medicine
• If you are unable to pass urine from the bladder (urinary retention)
• If you have uncontrolled narrow angle glaucoma (increase in intraocular pressure)
• If you suffer from myasthenia gravis (excessive weakness of the muscles)
• If you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)
• If you 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 (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 are taking any medicine for the treatment of an irregular heartbeat (arrhythmia) (see ‘taking other medicines’).

Ask your doctor or pharmacist before starting this treatment 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

Tolterodine 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) (see ‘Take special care with Detrusitol XL’)
• other medicinal products with antimuscarinic (medicines with a similar mode of action to Detrusitol XL) or cholinergic (medicines with an opposite mode of action to Detrusitol XL) properties.

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.

Lactation

It is not known if tolterodine 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. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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 one 2 mg prolonged-release capsule 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.

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, discuss it with 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 take more Detrusitol XL than you should:

If you or somebody else take too many prolonged-release capsules, contact your doctor or pharmacist at once.

If you forget to take Detrusitol XL

Do not take a double dose to make up for a forgotten one. If you have forgotten to take a dose at the usual time, you can take it as soon as you remember unless it is almost time for your next dose. In that case follow the normal dose schedule.

If you have any further questions on the use of this product, ask your doctor or pharmacist

Common (less than 1 per 10 but more than 1 per 100 patients) side effects are:

• Nervousness
• Dizziness
• Sleepiness
• Sensation of pins and needles in the fingers and toes
• Dry eyes
• Blurred vision
• Bad digestion (dyspepsia)
• Constipation
• Abdominal pain
• Excessive amounts of air or gases in the stomach or the intestine
• Being sick (vomiting)
• Dry skin
• Tiredness
• Headache
• Chest pain

Uncommon (less than 1 per 100 but more than 1 per 1000 patients) side effects are:

• allergic reactions
• confusion
• inability to empty the bladder
• extra fluid in the body causing swelling (e.g. in the ankles)

Rare (less than 1 per 1000 but more than 1 per 10,000 patients) side effects are:

• hallucinations (seeing, hearing, feeling, tasting or smelling things that are not there)
• increased heart rate
• palpitations and irregular heartbeat.

How common are bladder problems?

Over 3 million people in Britain suffer with bladder problems of one kind or another.

What else can you do?

Bladder training - this helps you regain control of your bladder so that you can extend the length of time before passing water. You can do this by holding on for as long as possible before passing water.

Pelvic floor exercises - these strengthen the muscles which can help you to 'hold on' longer before passing water. This will help if you leak when you cough, laugh or sneeze..