PRADAXA (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

PRADAXA 75 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted with “R75”. The color of the imprinting is black. The capsules are supplied in the packages listed:

  • NDC 0597-0107-54 Unit of use bottle of 60 capsules
  • NDC 0597-0107-60 Blister package containing 60 capsules (10 x 6 capsule blister cards)

PRADAXA 150 mg capsules have a light blue opaque cap imprinted with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted with “R150”. The color of the imprinting is black. The capsules are supplied in the packages listed:

  • 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 Medication Guide before you start taking PRADAXA and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about PRADAXA?

  • PRADAXA can cause bleeding which can be serious, and sometimes lead to death. This is because PRADAXA is a blood thinner medicine that lowers the chance of blood clots forming in your body.
  • You may have a higher risk of bleeding if you take PRADAXA and:
    • are over 75 years old
    • have kidney problems
    • have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer
    • take other medicines that increase your risk of bleeding, including: Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
      • aspirin or aspirin containing products
      • long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
      • warfarin sodium (Coumadin®, Jantoven®)
      • a medicine that contains heparin
      • clopidogrel (Plavix®)
      • prasugrel (Effient®)
  • PRADAXA can increase your risk of bleeding because it lessens the ability of your blood to clot. While you take PRADAXA:
    Call your doctor or get medical help right away if you have any of these signs or symptoms of bleeding:
    Take PRADAXA exactly as prescribed. Do not stop taking PRADAXA without first talking to the doctor who prescribes it for you. Stopping PRADAXA may increase your risk of a stroke.
    PRADAXA may need to be stopped, if possible, for one or more days before any surgery, or medical or dental procedure. If you need to stop taking PRADAXA for any reason, talk to the doctor who prescribed PRADAXA for you to find out when you should stop taking it. Your doctor will tell you when to start taking PRADAXA again after your surgery or procedure.
    See “What are the possible side effects of PRADAXA?” for more information about side effects.
    • you may bruise more easily
    • it may take longer for any bleeding to stop

What is PRADAXA?

PRADAXA is a prescription medicine used to reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of a stroke. PRADAXA is a blood thinner medicine that lowers the chance of blood clots forming in your body.

It is not known if PRADAXA is safe and works in children.

Who should not take PRADAXA?

Do not take PRADAXA if you:

  • currently have certain types of abnormal bleeding. Talk to your doctor, before taking PRADAXA if you currently have unusual bleeding.
  • have had a serious allergic reaction to PRADAXA. Ask your doctor if you are not sure.

What should I tell my doctor before taking PRADAXA?

Before you take PRADAXA, tell your doctor if you:

  • have kidney problems
  • have ever had bleeding problems
  • have ever had stomach ulcers
  • have any other medical condition
  • are pregnant or plan to become pregnant. It is not known if PRADAXA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your breast milk.
    Tell all of your doctors and dentists that you are taking PRADAXA. They should talk to the doctor who prescribed PRADAXA for you, before you have any surgery, or medical or dental procedure.
    Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way PRADAXA works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about PRADAXA?”
    Especially tell your doctor if you take:
    Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
    • rifampin (Rifater, Rifamate, Rimactane, Rifadin)

How should I take PRADAXA?

  • Take PRADAXA exactly as prescribed by your doctor.
  • Do not take PRADAXA more often than your doctor tells you to.
  • You can take PRADAXA with or without food.
  • Swallow PRADAXA capsules whole. Do not break, chew, or empty the pellets from the capsule.
  • If you miss a dose of PRADAXA, take it as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose. Do not take two doses of PRADAXA at the same time.
  • Your doctor will decide how long you should take PRADAXA. Do not stop taking PRADAXA without first talking with your doctor. Stopping PRADAXA may increase your risk of stroke.
  • Do not run out of PRADAXA. Refill your prescription before you run out. If you plan to have surgery, or a medical or a dental procedure, tell your doctor and dentist that you are taking PRADAXA. You may have to stop taking PRADAXA for a short time. See “What is the most important information I should know about PRADAXA?”
  • If you take too much PRADAXA, go to the nearest hospital emergency room or call your doctor or the Poison Control Center right away.

What are the possible side effects of PRADAXA?

PRADAXA can cause serious side effects.

  • See “What is the most important information I should know about PRADAXA?”
  • Allergic Reactions. In some people, PRADAXA can cause symptoms of an allergic reaction, including hives, rash, and itching. Tell your doctor or get medical help right away if you get any of the following symptoms of a serious allergic reaction with PRADAXA:
    • chest pain or chest tightness
    • swelling of your face or tongue
    • trouble breathing or wheezing
    • feeling dizzy or faint

Common side effects of PRADAXA include:

  • indigestion, upset stomach, or burning
  • stomach pain

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of PRADAXA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store PRADAXA?

  • Store PRADAXA at room temperature between 59°F to 86°F (15°C to 30°C). After opening the bottle, use PRADAXA within 30 days. Safely throw away any unused PRADAXA after 30 days.
  • Store PRADAXA in the original package to keep it dry. Keep the bottle tightly closed.

Keep PRADAXA and all medicines out of the reach of children.

General information about PRADAXA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PRADAXA for a condition for which it was not prescribed. Do not give your PRADAXA to other people, even if they have the same symptoms. It may harm them.

This Medication Guide summarizes the most important information about PRADAXA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about PRADAXA that is written for health professionals.

For more information, go to www.PRADAXA.com or call 1-800-542-6257 or (TTY) 1-800-459-9906.

What are the ingredients in PRADAXA?

Active ingredient: dabigatran etexilate mesylate

Inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, potassium chloride, titanium dioxide, and black edible ink.

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

Revised: March 2011
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Copyright 2011 Boehringer Ingelheim Pharmaceuticals, Inc.
ALL RIGHTS RESERVED

75461-02
IT5060BC072011

75457-02
IT5400B

Repackaged by

Rebel Distributors Corp

Thousand Oaks, CA 91320

Coumadin® is a registered trademark for Bristol-Myers Squibb
Jantoven® is a registered trademark for USL Pharma
Plavix® is a registered trademark of sanofi aventis Effient® is a registered trademark of Eli Lilly and Company

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.