Detrusitol Xl 4mg Prolonged Release Capsules
Out of date information, search anotherAssessed against UK PIL October 2006
Detrusitol® XL 4mg Prolonged Release Capsules
_(tolterodine-L-tartrate)_
PATIENT INFORMATION LEAFLET
Your medicine is available as 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
Each prolonged release capsule contains 4mg of the active ingredient tolterodine L-tartrate corresponding to 2.74mg tolterodine.
The capsules also contain the following inactive ingredients: sucrose, maize starch, ethylcellulose, medium chain triglycerides, oleic acid, hypromellose, gelatine, shellac glaze, titanium dioxide (E171), indigo carmine (E132), simeticone and propylene glycol.
Warning: Contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Detrusitol XL are hard, gelatin, blue, prolonged release capsule with a white 'freedom figure' printed in white on the cap and the number '4' printed in white on the body.
Your medicine is available in blister packs containing 14 and 28 capsules.
Manufactured by: International processing Corporation, Winchester, Kentucky, USA.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR. Product Licence holder: BR Lewis Pharmaceuticals Ltd,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0479 |POM|
The active substance in Detrusitol XL is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinic.
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, that 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 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 dilation 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 have kidney problems (renal insufficiency)
• If you have liver condition
• If you suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the automatic nervous system).
• If you have 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 abdominal 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 you 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 prescription.
Taking Detrusitol XL with food and drink
Detrusitol 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.
3. HOW TO TAKE DETRUSITOL XL
Dosage
Always take Detrusitol 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 4mg prolonged release capsule daily, except for patients who have a kidney or 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.
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, 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, consult 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 dose. 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 to take the next one. 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Detrusitol XL can have side effects although not everyone gets them
The following side effects have been observed during treatment with Detrusitol XL with the following frequencies.
The most common reported side effect is dry mouth.
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 side effects (less than 1 per 100 but more than 1 per 1000 patients) are:
- allergic reactions
- confusion
- inability to empty the bladder
- extra fluid in the body causing swelling (e. g. in the ankles)
Rare side effects (less than 1 per 1000 but more than 1 per 10,000 patients):
- hallucinations (seeing, hearing, feeling, tasting or smelling things that are not there)
- increased heart rate
- Palpitations and irregular heartbeat
Some severe allergic reactions (including angioedema) and heart failure have been very rarely observed.
You should see your doctor immediately if you experience symptoms of angioedema, such as
- Swollen face, tongue or pharynx
- Difficulty to swallow
- Hives and difficulty in breathing
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. STORING DETRUSITOL XL
■ Do not store above 30°C.
■ Store in the original package.
■ Keep out of the reach and sight of children.
■ You should not use your medicine after the 'expiry' date printed on the carton and blister label.
■ Return any unused medicine to the pharmacist for safe disposal.
■ If your capsules appear to be discoloured or show any other signs of deterioration, please return these to your pharmacist who will advise you what to do.
Leaflet revision and issue date (Ref): 22.08.07
Detrusitol XL® is a trademark of Pfizer Enterprises Sarl.
6. FURTHER INFORMATION
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. These will help if you leak when you cough, laugh or sneeze.
If you require details of these, contact your doctor or the organisations listed below.
Where else can you get information Incontact:
Incontact is a charity that provides information and support for people with bladder and bowel problems and their carers. They produce a regular newsletter, as well as offering a pen pal service to put people in touch with each other.
If you would like further information about Incontact, please write to:
Incontact
FREEPOST LON 12119
London
N7 9BR