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Onsolis

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Onsolis Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FENTANYL DISSOLVING FILM - BUCCAL

(FEN-ta-nil)

COMMON BRAND NAME(S): Onsolis

WARNING: See also Uses and How To Use sections.

Fentanyl has a high risk for abuse and severe, possibly fatal, breathing problems. Do not use fentanyl dissolving film unless you have been regularly taking moderate to large amounts of narcotic pain medication. Otherwise, it may cause overdose (even death). The risk for harm is higher if you take the wrong dose/strength, or if you take it along with other drugs that might also affect breathing. It might also be higher when you start this medication and after a dose increase. Get medical help right away if you notice unusual slow/shallow breathing.

Carefully follow the specific directions for using fentanyl buccal films. Since they are not taken the same way, different forms of fentanyl (including lozenges, buccal tablets, patches) do not have the same effects at equal strengths and should not be substituted for each other. Tell your doctor or pharmacist of all medications that you use, especially of drugs that can affect how fentanyl works (see also Drug Interactions section). Do not start, stop, or change the dosage of any medicines you are using without your doctor's approval.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If a child accidentally swallows this drug, get medical help right away.

Because of the risk of misuse, abuse, and overdose, you will need to register with a special distribution program (FOCUS) before receiving your prescription. Only doctors and pharmacies enrolled in FOCUS may prescribe or dispense this medication. Ask your doctor or pharmacist for details.

USES: This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of narcotic pain medication. Fentanyl belongs to a class of drugs known as narcotic (opiate) analgesics. It works in the brain to change how your body feels and responds to pain.

This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using fentanyl and each time you get a refill. Learn all usage and disposal instructions. If you have any questions, ask your doctor or pharmacist.

Use fentanyl buccal films as directed by your doctor. Before using, rinse your mouth with water or use your tongue to wet the inside of your cheek. With dry hands, open the blister pack just before using. Use the tip of a dry finger to place one film inside your mouth with the pink side facing against one cheek. Press and hold the film in place for 5 seconds, then remove your finger. The film should stay in place on its own after this. Leave it in place until it is dissolved (usually 15 to 30 minutes). You may drink liquids after the film has been in place for 5 minutes but do not move the strip with your tongue/finger or eat any food until the film has completely dissolved. If your doctor directs you to use more than one film at the same time for your breakthrough cancer pain, do not place one on top of the other. Place the films on either side of your mouth.

Do not cut, tear, bite, chew, or swallow the film whole.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

If you start to have side effects (such as dizziness, feeling sick to your stomach, severe drowsiness) before finishing a dose, your doctor may need to adjust your dose. Remove any remaining film and discard into a sink or toilet. Rinse your mouth with water and spit into a sink or toilet. Rinse the sink or flush the toilet afterward to finish proper disposal. Tell your doctor promptly if this happens.

The dosage is based on your medical condition and response to treatment. Wait at least 2 hours before using fentanyl buccal films again for another episode of sudden (breakthrough) pain. To avoid any confusion and chance of overdose, you should only keep a supply of one strength of this medication. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed.

Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

You should continue to also take your long-acting narcotic medication as directed by your doctor. Other non-narcotic pain relievers (such as acetaminophen, ibuprofen) may also be prescribed with this medication. Ask your doctor or pharmacist if you have any questions about using fentanyl safely with other drugs.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens or if you have more than 4 episodes of breakthrough pain daily.

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