he 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
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 prolonged-release 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.
The active substance in Detrusitol XL 4 mg prolonged-release capsules is 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.
The other ingredients are:
Capsule contents: Sugar spheres (containing sucrose and maize starch), hypromellose and Surelease E-7-19010 (containing ethylcellulose, medium chain triglycerides and oleic acid).
Capsule shell: Gelatine and colourants.
Blue 4 mg prolonged-release capsule: Indigo carmine (E132) and titanium dioxide (E171).
Printing ink: Shellac glaze, titanium dioxide (E171), propylene glycol and simeticone.
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 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 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:
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
Extra fluid in the body causing swelli
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:
- 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
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
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.
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.
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