ABSTRAL- fentanyl tablet 
ProStrakan, Inc.


Medication Guide

Sublingual tablets

100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, 800 mcg


Do not use ABSTRAL unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant).

Keep ABSTRAL in a safe place away from children.

Get emergency medical help right away if:

  • a child takes ABSTRAL. ABSTRAL can cause an overdose and death in any child who takes it.
  • an adult who has not been prescribed ABSTRAL takes it
  • an adult who is not already taking opioids around-the-clock, takes ABSTRAL

These are medical emergencies that can cause death. If possible, try to remove ABSTRAL from the mouth.

Read this Medication Guide completely before you start taking ABSTRAL, and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Be sure to share this important information with members of your household and other caregivers.

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

ABSTRAL can cause life-threatening breathing problems which can lead to death.

  1. Do not take ABSTRAL if you are not opioid tolerant.
  2. If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop taking ABSTRAL. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
  3. Take ABSTRAL exactly as prescribed by your healthcare provider.
    • You must not take more than 2 doses of ABSTRAL for each episode of breakthrough cancer pain.
    • You must wait two hours before treating a new episode of breakthrough pain with ABSTRAL. See the Medication Guide section "How should I take ABSTRAL?" and the Patient Instructions for Use at the end of this Medication Guide for detailed information about how to take ABSTRAL the right way.
  4. Do not switch from ABSTRAL to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of ABSTRAL is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of ABSTRAL that may be different than other fentanyl containing medicines you may have been taking.
  5. Do not take ABSTRAL for short-term pain that you would expect to go away in a few days, such as:
    • pain after surgery
    • headache or migraine
    • dental pain
  6. Never give ABSTRAL to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.

ABSTRAL is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.

7. ABSTRAL is available only through a program called the TIRF (Transmucosal Immediate-Release Fentanyl) REMS (Risk Evaluation and Mitigation Strategy) Access program. To receive ABSTRAL, you must:

What is ABSTRAL?

It is not known if ABSTRAL is safe and effective in children under 18 years of age.

Who should not take ABSTRAL?

Do not take ABSTRAL:

What should I tell my healthcare provider before taking ABSTRAL?

Before taking ABSTRAL, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening side effects when taken with ABSTRAL. Sometimes, the doses of certain medicines and ABSTRAL may need to be changed if used together.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take ABSTRAL?

Before you can begin to take ABSTRAL:


What should I avoid while taking ABSTRAL?

What are the possible side effects of ABSTRAL?

ABSTRAL can cause serious side effects, including:

  1. Breathing problems that can become life-threatening. See "What is the most important information I should know about ABSTRAL?"
    • Call your healthcare provider or get emergency medical help right away if you:
      • have trouble breathing
      • have drowsiness with slowed breathing
      • have shallow breathing (little chest movement with breathing)
      • feel faint, very dizzy, confused, or have other unusual symptoms
      These symptoms can be a sign that you have taken too much ABSTRAL or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not take any more ABSTRAL until you have talked to your healthcare provider.
  2. Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
  3. Physical dependence. Do not stop taking ABSTRAL or any other opioid, without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction.
  4. A chance of abuse or addiction. This chance is higher if you are or have ever been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental health problems.

The most common side effects of ABSTRAL are:

Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including ABSTRAL and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking ABSTRAL.

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

These are not all the possible side effects of ABSTRAL. For more information, ask your healthcare provider or pharmacist.

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

How should I store ABSTRAL?

How should I dispose of unopened ABSTRAL tablets when they are no longer needed?

General information about ABSTRAL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use ABSTRAL only for the purpose for which it was prescribed. Do not give ABSTRAL to other people, even if they have the same symptoms you have. ABSTRAL can harm other people and even cause death. Sharing ABSTRAL is against the law.

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

For more information about the TIRF REMS Access program, go to www.TIRFREMSAccess.com or call 1-866-822-1483.

What are the ingredients in ABSTRAL?

Active Ingredient: fentanyl citrate

Inactive Ingredients: croscarmellose sodium, magnesium stearate, mannitol, and silicified microcrystalline cellulose.

Patient Instructions for Use

Before you take ABSTRAL, it is important that you read the Medication Guide and these Patient Instructions for Use. Be sure that you read, understand, and follow these Patient Instructions for Use so that you take ABSTRAL the right way. Ask your healthcare provider or pharmacist if you have questions about the right way to take ABSTRAL.

When you get an episode of breakthrough pain, take the dose prescribed by your healthcare provider as follows:

Manufactured by:
Novartis Consumer Health, Inc.,
Lincoln, NE 68517

Manufactured for:
ProStrakan Inc.,
Bridgewater, NJ 08807

Issued: February 2012

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Copyright © 2012, ProStrakan Inc. All rights reserved.

ABSTRAL and ProStrakan are trademarks owned by the ProStrakan group of companies.

Revised: 2/2012
ProStrakan, Inc.