Safe use, storage, and disposal

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Continue to use your around-the-clock opioid while you are using FENTORA

FENTORA must only be used if you are regularly using other opioid pain medicines and your body is used to these medicines (your body is "opioid tolerant")

Never stop using your around-the-clock opioid pain medicine while you are using FENTORA without talking to your doctor

Never use FENTORA for the treatment of short-term pain from injuries, surgery, or headaches/migraines

Safe use

What to tell your doctor before starting FENTORA

Tell your doctor about all medical and mental problems, especially the following:

Trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
A head injury or brain problem
Liver or kidney problems
Seizures (convulsions or fits)
Slow heart rate or other heart problems
Low blood pressure
Mental problems including major depression or hallucinations (seeing or hearing things that are not there)
A past or present drinking problem or alcoholism, or a family history of this problem
A past or present drug abuse or addiction problem, or a family history of this problem

Tell your doctor if you are

Pregnant or planning to become pregnant. FENTORA may harm your unborn baby
Breast-feeding. Fentanyl passes through breast milk, and it may cause serious harm to your baby. Therefore, you should not use FENTORA while breast-feeding

Using medicines other than your pain medicine, and herbal products while taking FENTORA

Do not start any new prescription medicine, nonprescription medicine, vitamins, or herbal supplements while using FENTORA until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines while you are using FENTORA.

Tell your doctor about all the medicines you take, including

Prescription and nonprescription medicines
Vitamins
Herbal supplements

Avoid alcohol

You should avoid alcoholic beverages while using FENTORA. Drinking alcohol can produce dangerous side effects, resulting in serious injury or death.

Do not take FENTORA if you

Are not already taking other opioid pain medicines for your persistent cancer pain
Only have short-term pain from injuries, surgery, or headaches/migraines
Are allergic to anything in FENTORA. The active ingredient in FENTORA is fentanyl. The other ingredients are mannitol, sodium starch glycolate, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate
Have not been prescribed FENTORA

What to do if someone else takes your FENTORA

Call 911 or call emergency help immediately.

Are pain medicines addictive?

Addiction is a chronic disease that is characterized by one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving of a medicine. Addiction rarely occurs when you take medicine under your doctor's supervision.

There is a chance you could get addicted to FENTORA. The chance is higher if you are or were ever addicted to other medicines, street drugs, or alcohol, or if you abused them. The chance is also higher if you have a history of mental problems. Talk with your doctor about the risk of addiction.

You can develop "physical dependence" on an opioid. This means that stopping the opioid suddenly makes you feel sick because your body has become used to it. Physical dependence is not unusual and is different from addiction.

Storage

Keep FENTORA in a safe place away from children and from anyone for whom it has not been prescribed. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes FENTORA, get emergency help right away.

FENTORA is supplied in single sealed child-resistant blister packages. Keep tablets in their blister packages until you are ready to take FENTORA. Do not store FENTORA in pillboxes. Once a blister is opened, the tablet must be taken immediately.

Store FENTORA at room temperature, 59°F to 86°F (15°C 30°C) until ready to use.

Always keep FENTORA in a secure place to protect from theft.

Disposal

Dispose of any unopened FENTORA tablets remaining from a prescription as soon as they are no longer needed.

To dispose of unused FENTORA, remove FENTORA tablets from blister packages and flush down the toilet. Do not flush the FENTORA blister packages or cartons down the toilet.

If you need help with disposal of FENTORA, call Cephalon Medical Services at 1-800-896-5855.

IMPORTANT:

Do not use FENTORA unless you are regularly using other opioid pain medicines around-the-clock for your constant cancer pain and your body is used to these medicines.
Keep FENTORA in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes FENTORA, get emergency help right away.

Read the Medication Guide that comes with FENTORA before you start taking it 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 doctor about your medical condition or your treatment. Share this important information with members of your household.

The most important information you should know about FENTORA is:

FENTORA can cause life-threatening breathing problems which can lead to death:
- If you are not regularly using other opioid pain medicines around-the-clock for your constant cancer pain and your body is not used to these medicines. This means that you are not opioid tolerant
- If you do not use it exactly as prescribed by your doctor
Your doctor will prescribe a starting dose of FENTORA that is different than other fentanyl containing medicines you may have been taking. Do not substitute FENTORA for other fentanyl medicines, including Actiq^®, without talking with your doctor.