NDC 0597-0135-54 Unit of use bottle of 60 capsules
NDC 0597-0135-60 Blister package containing 60 capsules (10 x 6 capsule blister cards)
Bottles

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Once opened, the product must be used within 30 days. Keep the bottle tightly closed. Store in the original package to protect from moisture.

Blisters

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Store in the original package to protect from moisture.

Keep out of the reach of children.

17 PATIENT COUNSELING INFORMATION
See Medication Guide

17.1  Instructions for Patients
Tell patients to take PRADAXA exactly as prescribed.
Remind patients not to discontinue PRADAXA without talking to the health care provider who prescribed it.
Advise patients not to chew or break the capsules before swallowing them and not to open the capsules and take the pellets alone (e.g., sprinkled over food or into beverages).
17.2  Bleeding
Inform patients that they may bleed more easily, may bleed longer, and should call their health care provider for any signs or symptoms of bleeding.

Instruct patients to seek emergency care right away if they have any of the following, which may be a sign or symptom of serious bleeding:

Unusual bruising (bruises that appear without known cause or that get bigger)
Pink or brown urine
Red or black, tarry stools
Coughing up blood
Vomiting blood, or vomit that looks like coffee grounds
Instruct patients to call their health care provider or to get prompt medical attention if they experience any signs or symptoms of bleeding:

Pain, swelling or discomfort in a joint
Headaches, dizziness, or weakness
Reoccurring nose bleeds
Unusual bleeding from gums
Bleeding from a cut that takes a long time to stop
Menstrual bleeding or vaginal bleeding that is heavier than normal
17.3  Gastrointestinal Adverse Reactions
Instruct patients to call their health care provider if they experience any signs or symptoms of dyspepsia or gastritis:

Dyspepsia (upset stomach), burning, or nausea
Abdominal pain or discomfort
Epigastric discomfort, GERD (gastric indigestion)
17.4  Invasive or Surgical Procedures
Instruct patients to inform their health care provider that they are taking PRADAXA before any invasive procedure (including dental procedures) is scheduled.

17.5  Concomitant Medications
Ask patients to list all prescription medications, over-the-counter medications, or dietary supplements they are taking or plan to take so their health care provider knows about other treatments that may affect bleeding risk (e.g., aspirin or NSAIDs) or dabigatran exposure.

Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Copyright 2011 Boehringer Ingelheim Pharmaceuticals, Inc.
ALL RIGHTS RESERVED

75461-02
IT5060BC072011

75457-02
IT5400B

MEDICATION GUIDE
PRADAXA (pra dax´ a)
(dabigatran etexilate mesylate)
capsules

Read this Medicat