DETRUSITOL SR 4 mg. 28 capsules
The active substance in DETRUSITOL SR is tolterodine (tolterodine). Tolterodine belongs to a class of medicines called antimuscarinic.
DETRUSITOL SR is used to treat the symptoms of the symptoms of overactive bladder.
If you have overactive bladder, you may find that:
can not control urination;
you need to go quickly to the bathroom without you experienced prior notice and / or feel a need to frequently go to the bathroom.
2. BEFORE YOU TAKE DETRUSITOL SR
Do not take DETRUSITOL SR:
if you are allergic (hypersensitive) to tolterodine or any of the other ingredients of DETRUSITOL SR;
if you have impaired emptying of the bladder (urinary retention);
if you have uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of vision, which is not treated adequately);
if you suffer from myasthenia gravis (excessive muscle weakness);
if you have severe ulcerative colitis (ulceration and inflammation of the colon);
if you have toxic megacolon (acute dilation of the colon).
Take special care with DETRUSITOL SR:
if you have difficulty emptying the urine and / or distortion of the urine stream;
if you have a gastrointestinal disease that affects the passage and / or digestion of food;
if you have kidney problems (renal failure);
if you have liver disease;
if you suffer from a neurological disorder affecting your blood pressure, bowel or sexual function (autonomic neuropathy);
if you have a hiatus hernia (hernia of the abdominal organs);
If you have suffered or are suffering from severe constipation (decreased gastro-intestinal activity);
if you have heart disease, such as:
violation heart recording (ECG);
slow heart rate (bradycardia);
prior cardiac diseases, such as:
cardiomyopathy (weak heart muscle);
myocardial ischemia (reduced blood flow to the heart);
arrhythmia (irregular heartbeat);
you have abnormally low levels of potassium (hypokalemia), calcium (hypocalcaemia) or magnesium (hypomagnesemia) in the blood.
Ask your doctor or pharmacist before starting treatment with DETRUSITOL SR, if you think any of the above may apply to you.
Taking other medicines
Tolterodine, the active substance of DETRUSITOL SR, may interact with other medications.
It is not recommended to take tolterodine in combination with:
certain antibiotics (containing eg. erythromycin, clarithromycin);
drugs used to treat fungal infections (containing eg. ketoconazole);
drugs used to treat HIV.
DETRUSITOL SR should be used with caution when taken in combination with:
medicines that affect the passage of food through the stomach and intestines (containing eg. metoclopramide and cisapride);
medicines to treat irregular heartbeat (containing eg. amiodarone, sotalol, quinidine, procainamide);
other medicines with a mechanism of action similar to DETRUSITOL SR (antimuscarinic properties) or medicines with a mechanism of action opposite DETRUSITOL SR (cholinergic properties). If you are unsure, consult your doctor.
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 meals.
Pregnancy and lactation
You should not take DETRUSITOL SR, while you are pregnant. Tell your doctor if you are pregnant, think you are pregnant or planning to become pregnant.
It is not known whether tolterodine, the active substance of DETRUSITOL SR, is excreted in human milk. Breastfeeding is not recommended while taking DETRUSITOL SR.
Ask your doctor or pharmacist 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 DETRUSITOL SR
This medicine contains sucrose (a sugar). If your doctor has told you 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.
3. HOW TO TAKE DETRUSITOL SR
Always take DETRUSITOL SR exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
The usual dose is one capsule extended release 4 mg twice a day, except in patients with impaired renal or hepatic function or troublesome side effects in which case your doctor may reduce your dose to one capsule with the prolonged release of 2 mg twice daily.
DETRUSITOL SR is not recommended for children.
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. Do not stop treatment early because you do not see an immediate effect. Your bladder will need some time to adapt. Finish the course prolonged-release capsules prescribed by your doctor. If you have not found an effect then discuss this with your doctor.
The benefit of treatment should be re-evaluated after 2 or 3 months.
Always consult your doctor if you plan to stop treatment.
If you take more dose DETRUSITOL SR
If you or someone else takes too many prolonged-release capsules DETRUSITOL SR, immediately contact your doctor or pharmacist.
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 hardly the time has come to take the next dose. If skip the missed dose, follow the usual dose regimen. Do not take a double dose to make up.
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 immediately meet with your doctor or go to casualty if you have symptoms of angioedema, such as:
swollen face, tongue or pharynx;
hives and difficulty breathing.
You should also seek medical care if you get a hypersensitivity reaction (eg. Itching, rash, hives, difficulty breathing). It occurs infrequently (occurring in more than 1 out of 100 patients).
Consult your doctor immediately or go to casualty if you notice any of the following:
chest pain, shortness of breath and fatigue (even at rest), difficulty breathing at night, swelling of the legs.
These may be symptoms of heart failure. It occurs infrequently (occurring in more than 1 out of 100 patients).
The following adverse reactions have been reported during treatment with DETRUSITOL SR with the following frequencies:
Very common side effects (occurring in more than 1 patient in 10) are:
Common side effects (occurring in less than 1 in 10 patients) are:
dizziness, drowsiness, headache;
dry eyes, blurred vision;
difficulty in eating (dyspepsia), constipation, abdominal pain, excessive amounts of air or gas in the stomach or intestines, vomiting;
painful or difficult urination;
accumulation of extra fluid in the body causing a swelling (eg. of the ankle);
Uncommon side effects (occurring in less than 1 in 100 patients) are:
feeling of pins and needles in the fingers and toes;
palpitations, heart failure, irregular heartbeat;
inability to empty the bladder;
Additional reactions that have been reported include severe allergic reactions, confusion, hallucinations, increased heart rate, flushed skin, burning in chest, vomiting, swollen dry skin and disorientation. There are also reports of worsening symptoms of dementia in patients being treated for dementia.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DETRUSITOL SR
Keep out of reach of children.
Do not use DETRUSITOL SR after the expiry date stated on the label / carton.
Store at room temperature (below 25 ° C).
Bottles: Store in the original package.
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.
6. FURTHER INFORMATION
What DETRUSITOL SR
The active substance in DETRUSITOL SR 2 mg prolonged-release capsules is 2 mg tolterodinov tartrate (tolterodine tartrate), equivalent to 1,37 mg tolterodine.
The active substance in DETRUSITOL SR 4 mg prolonged-release capsules is 4 mg tolterodinov tartrate equivalent to 2,74 mg tolterodine.
Other ingredients are:
Capsule contents: Sugar spheres (containing sucrose and maize starch), hypromellose and Surelease E-7-9010 (containing ethylcellulose, medium chain triglycerides and oleic acid).
Capsule shell: Gelatin and colorants.
Cyan prolonged-release capsule of 2 mg:
Indigo carmine (E 132), titanium dioxide (E 171) and iron oxide yellow (E172).
Blue capsule extended release 4 mg:
Indigo carmine (E 132) and titanium dioxide (E171).
Printing ink: shellac glaze, titanium dioxide (E 171), propylene glycol and simethicone.
Looks DETRUSITOL SR and contents of the pack
DETRUSITOL SR is a time release capsule designed for once daily dosing.
DETRUSITOL SR prolonged-release capsules 2 mg tablets are blue-green with white lettering (symbol and 2).
DETRUSITOL SR prolonged-release capsules of 4 mg are blue with white lettering (symbol and 4).