Safe Use, Storage and Disposal of FENTORA
Click on the links below for important information about safe use, storage and disposal of FENTORA:
Safe use
What to tell your doctor before starting FENTORA
Tell your doctor about all medical and mental health issues, especially the ones listed below.
- Trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
- A head injury or brain problem
- Seizures (convulsions or fits)
- Liver or kidney problems
- Slow heart rate or other heart problems
- Low blood pressure
- Mental health issues including major depression or hallucinations (seeing or hearing things that are not there)
- A past or present drinking problem or alcoholism, or family history
- A past or present drug abuse or addiction problem, or family history
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 regularly using 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
- Do not let anyone else take the FENTORA that has been prescribed for you
What to do if someone else takes your FENTORA
Call 9-1-1 or call emergency help immediately.
What is addiction?
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 does not often occur when you take medicine under your doctor’s supervision.
Are opioid pain medicines addictive?
There is a chance you could get addicted to opioid pain medicines including 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 health issues. 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 the same as addiction.
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Storage
How should I store FENTORA?
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.
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Disposal
How should I dispose of unopened FENTORA tablets when they are no longer needed?
Dispose of any unopened FENTORA tablets remaining from a prescription as soon as they are no longer needed.
If you need help with disposal of FENTORA or information on how to return unused tablets, call Cephalon at 1-800-896-5855.
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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.