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|Fentora

Fentora

Fentora is used for:

Managing breakthrough pain in cancer patients who are already using and are tolerant to narcotic pain medicines.

Fentora is a narcotic (opioid) analgesic. It works in the brain to decrease pain.

Do NOT use Fentora if:

• you are allergic to any ingredient in Fentora or any similar medicine (eg, sufentanil)
• you have not been taking other narcotic pain medicines (eg, morphine, codeine) on a regular schedule
• you have mild or short-term pain, including pain from injuries or surgery
• you have diarrhea caused by food poisoning
• you also take sibutramine or sodium oxybate (GHB)
• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fentora :

Some medical conditions may interact with Fentora . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of mental or mood problems; suicidal thoughts or actions; or alcohol, narcotic, or other substance abuse or dependence
• if you have severe drowsiness; lesions, growths, or increased pressure in the brain; or a recent head injury
• if you have lung or breathing problems (eg, asthma, slow or difficult breathing, chronic obstructive pulmonary disease [COPD]), urinary blockage, diabetes, heart problems (eg, slow or irregular heartbeat, ventricle problems), liver or kidney disease, inflammation in the mouth, an enlarged prostate, stomach or bowel problems (eg, recent stomach surgery, inflammatory bowel disease), an underactive thyroid, or seizures
• if you have been very ill, have a fever, or have had recent surgery

Some MEDICINES MAY INTERACT with Fentora . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antihistamines (eg, diphenhydramine), aprepitant, azole antifungals (eg, ketoconazole), benzodiazepines (eg, diazepam), cimetidine, diltiazem, HIV protease inhibitors (eg, ritonavir), macrolides (eg, erythromycin, clarithromycin), MAOIs (eg, phenelzine), nelfinavir, nefazodone, phenothiazines (eg, chlorpromazine), skeletal muscle relaxants (eg, cyclobenzaprine), sodium oxybate (GHB), troleandomycin, or verapamil because they may increase the risk of Fentora "s side effects, including serious breathing problems, severe lightheadedness or dizziness, or severe drowsiness
• Sibutramine because a severe reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma may occur
• Mixed agonist/antagonist analgesics (eg, pentazocine, butorphanol), nalmefene, naloxone, or naltrexone because they may decrease Fentora "s effectiveness and withdrawal symptoms may occur
• Rifampin because it may decrease Fentora "s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fentora may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fentora :

Use Fentora as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fentora comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fentora refilled.
• Do not use Fentora if the blister pack is damaged in any way.
• Do not chew, suck, or swallow the tablet whole. Do not try to split the tablet in half.
• Do not remove the tablet from the blister unit until you are ready to take Fentora . Make sure that your hands are dry when you open the blister pack. Do NOT push the tablet through the foil. Peel back the foil on the blister unit to expose the tablet. Use the tablet right away after opening the blister unit. Do not store the removed tablet for future use.
• Place the tablet between the upper cheek and gum above the back tooth. Leave the tablet in place and allow it to dissolve. Do not eat, drink, or smoke while the tablet is dissolving.
• Fentora usually takes 14 to 25 minutes to dissolve. If any pieces of the tablet remain after 30 minutes, swallow them with a glass of water.
• Check with your doctor before including grapefruit or grapefruit juice in your diet while you use Fentora .
• If Fentora is no longer needed, dispose of it as soon as possible. Remove the tablets from the blister pack and flush them down the toilet. Do not flush the blister pack or cartons down the toilet.
• If you miss a dose of Fentora and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fentora .

Important safety information:

• Fentora may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fentora with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fentora ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Fentora may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do NOT take more than the recommended dose, use more often than prescribed, or suddenly stop taking Fentora without checking with your doctor.
• Tell your doctor or dentist that you take Fentora before you receive any medical or dental care, emergency care, or surgery.
• Contact your doctor if your pain is not relieved or if it worsens after you use Fentora . Contact your doctor if your usual dose stops providing pain relief. Be sure to tell your doctor or health care provider how your pain is responding to Fentora so that your dose can be adjusted if needed.
• Fentora can be harmful, even fatal, to a child. Keep Fentora out of the reach of children.
• If Fentora is no longer needed, dispose of it as soon as possible. If you have questions about how to dispose of Fentora properly, check with your doctor or other health care provider.
• Diabetes patients - Fentora may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Use Fentora with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, stomach pain, constipation, and vomiting.
• Use Fentora with extreme in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Fentora may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fentora while you are pregnant. Fentora is found in breast milk. Do not breast-feed while taking Fentora .

When used for long periods of time or at high doses, Fentora may not work as well and may require higher doses to obtain the same effect as when first taken. This is known as TOLERANCE. Talk with your doctor if Fentora stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Fentora . This is known as DEPENDENCE or "addiction." If you suddenly stop taking Fentora , you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Fentora :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; headache; mouth pain or irritation; nausea; numbness or tingling at the site where the tablet is used; stomach pain; vomiting; weakness or tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes (eg, depression); mouth sores, ulcers, bleeding, or inflammation; numbness or tingling in the hands, legs, or feet; severe drowsiness; severe dry eyes, mouth, or skin; severe or persistent dizziness; shortness of breath; slowed breathing; swelling of the hands, feet, or ankles; unusual bruising or bleeding; unusual or severe weakness or tiredness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm ), or emergency room immediately. Symptoms may include loss of consciousness; muscle rigidity; pinpoint pupils; severe drowsiness or dizziness; slow or shallow breathing; very slow or weak heartbeat.

Store Fentora at 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original package away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate or freeze. Do not use if the foil pouch has been opened. Keep Fentora out of the reach of children and away from pets.

General information:

• If you have any questions about Fentora , please talk with your doctor, pharmacist, or other health care provider.
• Fentora is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fentora . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.