1 mg and 2 mg film-coated tablets
1. WHAT DETRUSITOL IS AND WHAT IT IS USED FOR
The active substance in Detrusitol is tolterodine. Tolterodine belongs to a class of medicines called antimuscarinic medicines. Detrusitol is used to treat the symptoms of overactive bladder. If you have an overactive bladder, you may find that:
- you have difficulty controlling urination,
- you need to rush to the toilet without any warning and/or go to the toilet often.
2. BEFORE YOU USE DETRUSITOL
Do not use Detrusitol
- if you are allergic (hypersensitive) to tolterodine or any of the other ingredients of Detrusitol
- if you have bladder emptying difficulties ( urinary retention )
- if you have uncontrolled glaucoma with a narrow ventricular angle (increased pressure in the eye leading to impaired vision, which is not under optimal control)
- if you suffer from myasthenia gravis (severe muscle weakness)
- if you suffer from severe ulcerative colitis (ulcers and inflammation of the colon)
- if you suffer from toxic megacolon ( acute pronounced enlargement of the colon)
Take special care with Detrusitol
- If you have difficulty throwing water and/or the weak urine stream
- If you have gastrointestinal problems that affect the passage of food and/or digestion
- If you suffer from any kidney disease (impaired kidney function)
- If you suffer from any liver disease
- If you suffer from any nerve disorder that affects your blood pressure, bowel, or sexual function ( neuropathy in the autonomic nervous system )
- If you have a hiatus hernia (diaphragmatic hernia)
- If you have ever had problems with emptying the bowel or suffering from constipation (decreased gastrointestinal movements)
- If you have any heart disease such as:
- an abnormal electrocardiogram ( ECG )
- slow heart rate ( bradycardia )
- or have previously had heart problems such as:
- – cardiomyopathy (weak heart muscle)
- – myocardial ischemia (decreased blood flow to the heart)
- – arrhythmia (irregular heartbeat)
- – heart failure
- If you have abnormally low levels of potassium ( hypokalaemia ), calcium ( hypocalcemia ), or magnesium (hypomagnesemia) in your blood.
Before starting treatment with Detrusitol, ask your doctor or pharmacist if you think any of the above may apply to you.
Use of other medicines
Tolterodine, the active substance in Detrusitol, may be affected by and/or affect other medicines.
Therefore, concomitant use of tolterodine with:
- certain antibiotics (eg erythromycin, clarithromycin)
- medicines used to treat fungal infections (eg ketoconazole, itraconazole)
- medicines used to treat HIV.
Tolterodine should be used with caution when taken at the same time as:
- medicines that affect the passage of food (eg metoclopramide and cisapride)
- drugs for the treatment of irregular heartbeat (eg amiodarone, sotalol, quinidine, procainamide )
- other medicines with a similar mechanism of action as Detrusitol (antimuscarinic properties) or medicines with the opposite mechanism of action to Detrusitol (cholinergic properties). Ask your doctor if you are unsure.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Detrusitol with food and drink
Detrusitol can be taken before, after, or during a meal.
Pregnancy and breastfeeding
You should not use Detrusitol if you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby.
It is unknown whether tolterodine, the active substance in Detrusitol, passes into breast milk. Breast-feeding is not recommended when using Detrusitol.
Talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
Detrusitol may make you feel dizzy, tired, or affect your vision. Your ability to drive or use machines may be affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. The description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. HOW TO USE DETRUSITOL
Always take Detrusitol exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose is one 2 mg tablet twice a day, except for patients with a kidney or liver condition or troublesome side effects. Then your doctor may reduce your dose to one 1 mg tablet twice a day.
Detrusitol is not recommended for children.
Swallow the tablets whole.
Your doctor will tell you how long Detrusitol treatment will last. Do not stop treatment earlier because you do not see any immediate effect. Your bladder needs some time to adjust. Therefore, you should complete your treatment with tablets prescribed by your doctor. If you have not experienced any effect after treatment, talk to your doctor.
The benefit of treatment should be re-evaluated after 2 or 3 months.
Always consult your doctor if you are considering stopping treatment.
If you take more Detrusitol than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Detrusitol
Do not take a double dose to make up for a forgotten dose. If you have missed a dose as you usually take it, you can take it as soon as you remember if it is not soon for the next dose. In that case, follow the usual dosing schedule instead.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like other medicines, Detrusitol can cause side effects, although not everybody gets them.
You should contact a doctor immediately or see an emergency department if you experience signs of angioedema such as
- swollen face, tongue, and throat
- difficulty swallowing
- hives and difficulty breathing
You should also see a doctor if you experience hypersensitivity (such as itching, skin rash, hives, difficulty breathing). Such reactions are less common (occurring in less than 1 in 100 patients).
Contact a doctor immediately or see an emergency department if you experience the following symptoms:
- chest pain, difficulty breathing or pronounced fatigue (even at rest), difficulty breathing at night, swollen legs.
These symptoms may be signs of heart failure, which is less common (occurring in less than 1 in 100 patients).
The following side effects have been observed during treatment with Detrusitol with the following frequency:
A very common side effect is (in more than 1 in 10):
- dry mouth
Common adverse s (less than 1 in 10):
- tracheal catarrh
- dizziness, drowsiness, and crawling in fingers and toes
- dry eyes, blurred vision
- digestive problems ( dyspepsia ), constipation, abdominal pain, flatulence, vomiting
- dry skin
- pain or difficulty throwing water, inability to empty the bladder
- fatigue, chest pain, fluid accumulation in the body that causes swelling (taxi ankles)
- weight gain
Less common side effects are (less than 1 in 100):
- allergic reactions
- increased heart rate, heart failure, irregular heart rate
- memory impairment
Other side effects that have been reported include severe allergic reactions, confusion, hallucinations, reddening of the skin, angioedema, and disorientation. There have also been reports of worsening dementia symptoms 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.
5. HOW TO STORE DETRUSITOL
Keep out of sight and reach of children
Do not use Detrusitol after the expiry date which is stated on the label/carton.
The expiration date is the last day of the specified month.
No special storage instructions.
The medicine 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
The active substance in Detrusitol 1 mg tablets is 1 mg tolterodine tartrate, equivalent to 0.68 mg tolterodine.
The active substance in Detrusitol 2 mg tablets is 2 mg tolterodine tartrate, equivalent to 1.37 mg tolterodine.
Other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycolate, magnesium stearate, colloidal anhydrous silica
Film coating: hypromellose, microcrystalline cellulose, stearic acid, and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Detrusitol 1 mg tablets are white, round, biconvex, and marked with arcs above and below the letters too.
Detrusitol 2 mg tablets are white, round, biconvex, and marked with circles above and below the letters DT.
Detrusitol 1 mg and 2 mg tablets are available in the following pack sizes:
Blister packs containing:
– 20 tablets (2 blister cards of 10 tablets)
– 30 tablets (3 blister cards of 10 tablets)
– 50 tablets (5 blister cards 10 tablets)
– 100 tablets (10 blister cards of 10 tablets)
– 14 tablets (1 blister card of 14 tablets)
– 28 tablets (2 blister cards of 14 tablets)
– 56 tablets (4 blister cards of 14 tablets)
– 280 tablets
– 560 tablets
Jars containing 60 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Tel: (09) 430 040
Pfizer Italia Srl
Located in Marino del Tronto, 63100 Ascoli Piceno
This medicinal product is authorized in the following Member States within the European Economic Area under the name Detrusitol:
Belgium, France, Finland, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, the United Kingdom, Germany, and Austria