17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
DETROL®LA (DE-trol el-ay)
(tolterodine tartrate extended release capsules)
Read the Patient Information that comes with DETROL LA before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or your treatment. Only your doctor can determine if treatment with DETROL LA is right for you.
DETROL LA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:
- Having a strong need to urinate with leaking or wetting accidents (urge urinary incontinence).
- Having a strong need to urinate right away (urgency).
- Having to urinate often (frequency).
DETROL LA did not help the symptoms of overactive bladder when studied in children.
Overactive bladder happens when you cannot control your bladder muscle. When the muscle contracts too often or cannot be controlled, you get symptoms of overactive bladder, which are leakage of urine (urge urinary incontinence), needing to urinate right away (urgency), and needing to urinate often (frequency).
Do not take DETROL LA if:
- You have trouble emptying your bladder (also called "urinary retention").
- Your stomach empties slowly (also called "gastric retention").
- You have an eye problem called "uncontrolled narrow-angle glaucoma".
- You are allergic to DETROL LA or to any of its ingredients. See the end of this leaflet for a complete list of ingredients.
- You are allergic to TOVIAZ, which contains fesoterodine.
Before starting DETROL LA, tell your doctor about all of your medical conditions, including if you:
- Have any stomach or intestinal problems.
- Have trouble emptying your bladder or you have a weak urine stream.
- Have an eye problem called narrow-angle glaucoma.
- Have liver problems.
- Have kidney problems.
- Have a condition called myasthenia gravis.
- Or any family members have a rare heart condition called QT prolongation (long QT syndrome).
- Are pregnant or trying to become pregnant. It is not known if DETROL LA could harm your unborn baby.
- Are breastfeeding. It is not known if DETROL LA passes into your milk and if it can harm your child.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Other drugs can affect how your body handles DETROL LA. Your doctor may use a lower dose of DETROL LA if you are taking:
- Certain medicines for fungus or yeast infections such as Nizoral® (ketoconazole), Sporanox® (itraconazole), or Monistat® (miconazole).
- Certain medicines for bacteria infections such as Biaxin® (clarithromycin).
- Certain medicines for treatment of HIV infection such as Norvir® (ritonavir), Invirase® (saquinavir), Reyataz® (atazanavir).
- Sandimmune® (cyclosporine) or Velban® (vinblastine).
Know the medicines you take. Keep a list of them with you to show your doctor or pharmacist each time you get a new medicine.
- Take DETROL LA exactly as prescribed. Your doctor will prescribe the dose that is right for you. Do not change your dose unless told to do so by your doctor.
- Take DETROL LA capsules once a day with liquid. Swallow the whole capsule. Tell your doctor if you cannot swallow a capsule.
- DETROL LA can be taken with or without food.
- Take DETROL LA the same time each day.
- If you miss a dose of DETROL LA, begin taking DETROL LA again the next day. Do not take 2 doses of DETROL LA in the same day.
- If you took more than your prescribed dose of DETROL LA, call your doctor or poison control center, or go to the hospital emergency room.
DETROL LA may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat, or tongue. If you experience these symptoms, you should stop taking DETROL LA and get emergency medical help right away.
The most common side effects with DETROL LA are:
Medicines like DETROL LA can cause blurred vision, dizziness, and drowsiness.
Do not drive, operate machinery, or do other dangerous activities until you know how DETROL LA affects you.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
These are not all the side effects with DETROL LA. For a complete list, ask your doctor or pharmacist.
- Store DETROL LA at room temperature, 68° – 77°F (20° – 25°C); brief periods permitted between 59° – 86°F (15° – 30°C). Protect from light. Keep in a dry place.
- Keep DETROL LA and all medicines out of the reach of children.
General Information about DETROL LA
Medicines are sometimes prescribed for conditions that are not in the patient information leaflet. Only use DETROL LA the way your doctor tells you. Do not share it with other people even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about DETROL LA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DETROL LA that is written for health professionals. You can also visit www.DETROLLA.com on the Internet, or call 1-888-4-DETROL (1-888-433-8765).
Active ingredients: tolterodine tartrate
Inactive ingredients: sucrose, starch, hypromellose, ethylcellulose, medium chain triglycerides, oleic acid, gelatin, and FD&C Blue #2. 2 mg capsule also contains yellow iron oxide. Capsules have pharmaceutical grade printing ink that contains shellac glaze, titanium dioxide, propylene glycol, and simethicone.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
Revised July 2018