2 mg and 4 mg prolonged-release capsules, hard
Tolterodine
1. WHAT DETRUSITOL SR IS AND WHAT IT IS USED FOR
The active substance in Detrusitol SR is tolterodine. Tolterodine belongs to a class of medicines called antimuscarinic medicines.
Detrusitol SR is used to treat 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 SR
Do not use Detrusitol SR
- if you are allergic (hypersensitive) to tolterodine or any of the other ingredients of Detrusitol SR
- 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 SR
- 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 have 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 suffered from severe 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 SR, 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 SR, 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 concomitantly
- medicines that affect the passage of food (eg metoclopramide and cisapride)
- drugs for the treatment of irregular heartbeat (eg amiodarone, sotalol, quinidine, procainamide )
- other drugs with a similar mechanism of action as Detrusitol SR (antimuscarinic properties) or drugs with the opposite mechanism of action as Detrusitol SR (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 SR with food and drink
Detrusitol SR can be taken before, after, or during a meal.
Pregnancy and breastfeeding
Pregnancy
You should not use Detrusitol SR if you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby.
Breast-feeding
It is unknown whether tolterodine, the active substance in Detrusitol SR, passes into breast milk. Breast-feeding is not recommended when using Detrusitol SR.
Talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
Detrusitol SR 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.
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 using this medicine. Patients with rare hereditary problems of fructose intolerance, glucose-galactose intolerance, or glucose-isomaltase insufficiency should not take this medicine.
3. HOW TO USE DETRUSITOL SR
Dosage
Always take Detrusitol SR exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose is one 4 mg prolonged-release capsule daily, except for patients with kidney or liver problems or troublesome side effects. Then the doctor may reduce the dose one to one 2 mg prolonged-release capsule daily.
Detrusitol SR is not recommended for use in children.
Swallow the prolonged-release capsules whole. Do not chew.
Treatment time
Your doctor will tell you how long Detrusitol SR 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 prolonged-release capsules prescribed by your doctor. If you do not get any effect after stopping 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 SR then 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 SR
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 all medicines, Detrusitol SR 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, 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 SR 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):
- sinusitis
- dizziness, drowsiness, headache
- dry eyes, blurred vision
- digestive problems ( dyspepsia ), constipation, abdominal pain, flatulence
- pain or difficulty throwing water
- fatigue
- fluid accumulation in the body that causes swelling (taxi ankles)
- diarrhea
Less common side effects are (less than 1 in 100):
- allergic reactions
- concern
- an ant crawls in fingers and toes
- dizziness
- palpitations, heart failure, irregular heart rate
- inability to empty the bladder
- chest pain
- memory impairment
Other side effects that have been reported include severe allergic reactions, confusion, hallucinations, increased heart rate, reddening of the skin, heartburn, vomiting, angioedema, dry skin, 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 SR
Keep out of sight and reach of children.
Do not use Detrusitol SR after the expiry date which is stated on the label/carton.
The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Jar: Store in the original package.
Blister: Store blister in the outer carton.
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
Content declaration
The active substance in Detrusitol SR 2 mg prolonged-release capsule is 2 mg tolterodine tartrate, equivalent to 1.37 mg tolterodine.
The active substance in Detrusitol SR 4 mg prolonged-release capsule is 4 mg tolterodine tartrate, equivalent to 2.74 mg tolterodine.
Other ingredients are:
Capsule contents: Sugar spheres (sucrose and maize starch), hypromellose, and Surelease E-7-19010 (ethylcellulose, medium-chain triglycerides, and oleic acid).
Capsule shell: Gelatin and dyes.
Dyes:
Teal 2 mg prolonged-release capsule: Indigo carmine (E 132), titanium dioxide (E 171), and yellow iron oxide (E 172).
Blue 4 mg prolonged-release capsule: Indigo carmine (E 132) and titanium dioxide (E 171).
Pressure: Shellac, titanium dioxide (E 171), propylene glycol, and simethicone
What the medicine looks like and the contents of the pack
Detrusitol SR is a hard prolonged-release capsule, developed to be dosed once a day.
Detrusitol SR 2 mg prolonged-release capsules are blue-green and marked with white print (symbol and ‘2’).
Detrusitol SR 4 mg prolonged-release capsules are blue and marked with white print (symbol and ‘4’).
Detrusitol SR 2 mg and 4 mg prolonged-release capsules are available in the following pack sizes:
Blister packs containing:
- 7 prolonged-release capsules
- 14 depot capsules
- 28 prolonged-release capsules
- 49 prolonged-release capsules
- 84 prolonged-release capsules
- 98 prolonged-release capsules
- 280 prolonged-release capsules
Jars containing 30, 100, and 200 capsules. Hospital packs are available containing 80, 160, and 320 capsules. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
In Finland:
Pfizer Oy
Datagränden 4
00330 Helsinki
Tel: (09) 430 040
Manufacturer
Pfizer Italia Srl
Located in Marino del Tronto, 63100 Ascoli Piceno
Italy
This medicinal product is authorized in the following Member States within the European Economic Area under the names:
Detrusitol retard: Belgium, Denmark, Iceland, Italy, Luxembourg, Portugal, Germany, and Austria
Detrusitol SR: Finland, Greece, Ireland, the Netherlands, Norway
Detrusitol LP: France
Detrusitol Neo: Spain
Detrusitol XL: United Kingdom