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» Detrusitol SR
Brand Name: Detrusitol SR
Generic name: Tolterodine tartrate
What DETRUSITOL SR is and what it is used for
The active substance in Detrusitol SR is tolterodine. Tolterodine belongs to a class of
medicinal products called antimuscarinics.
Detrusitol SR 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
Before you take DETRUSITOL SR
Do not take Detrusitol SR if you:
• are allergic (hypersensitive) to tolterodine or any of the other ingredients in
• 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
• suffer from a toxic megacolon (acute dilatation of the colon).
Take special care with DETRUSITOL SR
• 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 SR if
you think any of these might apply to you.
Taking other medicines
Tolterodine, the active substance of Detrusitol SR, may interact with other medicinal
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 SR should be used with caution when taken in combination with:
• medicines that affect the passage of food (containing e.g. metoclopramide
• medicines for the treatment of irregular heartbeat (containing e.g.
amiodarone, sotalol, quinidine, procainamide)
• other medicines with a similar mode of action to Detrusitol SR
(antimuscarinic properties) or medicines with an opposite mode of action to
Detrusitol SR (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 SR with food and drink
Detrusitol SR can be taken before, after or during a meal.
Pregnancy and breast-feeding
You should not use Detrusitol SR when you are pregnant. Tell your doctor
immediately if you are pregnant, think you are pregnant or are planning to become
It is not known if tolterodine, the active substance of Detrusitol SR, is excreted in the
mother’s breast milk. Breast-feeding is not recommended during administration of
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Detrusitol SR 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 SR
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, glucosegalactose
malabsorption or sucrase-isomaltase insufficiency should not take this
How to take DETRUSITOL SR
Always take Detrusitol SR 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 SR 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 SR 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
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 SR 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 SR
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
Possible side effects
Like all medicines, Detrusitol SR can cause side effects, although not everybody gets
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
• 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 SR
with the following frequencies.
The most common reported side effect (occurs in more than 1 in 10 patients) is a dry
Common side effects (occurs in less than 1 in 10 patients) are:
• Dizziness, sleepiness, headache
• Dry eyes, blurred vision
• Difficulty in 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 swelling (e.g. in the ankles)
Uncommon side effects (occurs in less than 1 in 100 patients) are:
• Allergic reactions
• Sensation of pins and needles in the fingers and toes
• 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 desorientation. 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.
How to store DETRUSITOL SR
Keep Detrusitol SR out of the reach and sight of children.
Do not use Detrusitol SR after the expiry date which is stated on the label/carton.
The expiry date refers to the last day of that month.
Do not store above 30oC.
Bottle: Store in the original container.
Blisters: Keep the blister in the outer carton.
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.
What Detrusitol SR contains
The active substance in Detrusitol SR 2 mg prolonged-release capsules is 2 mg of
tolterodine tartrate, equivalent to 1.37 mg of tolterodine.
The active substance in Detrusitol SR 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
Capsule shell: Gelatine and colourants.
Blue-green 2 mg prolonged-release capsule: Indigo carmine (E132), titanium dioxide
(E171) and yellow iron oxide (E172).
Blue 4 mg prolonged-release capsule: Indigo carmine (E132) and titanium dioxide
Printing ink: Shellac glaze, titanium dioxide (E171), propylene glycol and simeticone.