Detrol LA (Page 6 of 6)

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LAB-0256-10.0

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.

What is DETROL LA?

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.

What is overactive bladder?

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).

Who should not take DETROL LA?

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.

What should I tell my doctor before starting DETROL LA?

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.

How should I take DETROL LA?

  • 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.

What are possible side effects of DETROL LA?

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:

  • Dry mouth
  • Headache
  • Constipation
  • Stomach pain

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.

How do I store DETROL LA?

  • 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).

What are the ingredients in DETROL LA?

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.

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LAB-0312-7.0August 2012

Principal Display Panel

Tolterodine Tartrate XR 2 mg capsule
(click image for full-size original)

Tolterodine Tartrate XR 2 mg capsule
(click image for full-size original)
DETROL LA tolterodine tartrate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-5190(NDC:0009-5190)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLTERODINE TARTRATE (TOLTERODINE) TOLTERODINE TARTRATE 2 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
HYPROMELLOSES
ETHYLCELLULOSES
MEDIUM-CHAIN TRIGLYCERIDES
OLEIC ACID
GELATIN
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW
Product Characteristics
Color BLUE (Blue-green) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-5190-1 1 CAPSULE, EXTENDED RELEASE in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021228 03/16/2016
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-5190), repack (69189-5190)

Revised: 03/2017 Avera McKennan Hospital

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