Actiq

Not applicable.

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. A Child Safety Kit is available from the manufacturer. It contains important safety and educational materials and a safe storage container to keep this medication out of reach of children. If you have any questions about the materials in this kit, bring them to your doctor or pharmacist, or contact the manufacturer. Use fentanyl lozenges as directed by your doctor. Just before using, open the package with scissors. Remove the lozenge and place the medication end in your mouth between your cheeks and gums. Actively suck on the medication. Twirl the handle often and move the medication along the cheeks in your mouth, occasionally switching sides of the mouth. You should finish the medication in 15 minutes to get the most relief. Do not bite or chew the medication. You may drink some water before using this medication, but do not eat or drink anything while you are using it. 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 the rest of the lozenge from your mouth and store or dispose of it properly (see Medication Guide). Tell your doctor promptly if this happens. The dosage is based on your medical condition and response to treatment. If you need a second dose, wait 30 minutes after starting the first dose. Do not use more than 2 doses per episode of breakthrough pain. Wait at least 4 hours before using fentanyl lozenges again for another episode of 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, if you have more than 4 episodes of breakthrough pain daily, or if you need to use 2 units of medication for each episode of pain.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: certain pain medications (mixed narcotic agonist-antagonists such as pentazocine, nalbuphine, butorphanol), narcotic antagonists (such as naltrexone), sibutramine. Other medications can affect the removal of fentanyl from your body, which may affect how fentanyl works. Examples include cimetidine, nefazodone, St. John's wort, azole antifungals including itraconazole/ ketoconazole, calcium channel blockers such as diltiazem/verapamil, HIV drugs such as nelfinavir/ritonavir, macrolide antibiotics including erythromycin, rifamycins including rifampin, certain anti-seizure medicines including carbamazepine, among others. Avoid taking MAO inhibitors (isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, allergy or cough-and-cold products, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as codeine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Do not share this medication with others. It is against the law and the medication may cause harm to others. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, loss of consciousness.

Before taking fentanyl, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), diabetes, kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate). This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication contains sugar and may increase your chance of developing cavities or gum problems. Tell your dentist that you are using this medication. Brush and floss your teeth daily and have regular dental exams. Because this medication contains sugar, caution is advised if you have diabetes. Check your blood sugar levels regularly as directed by your doctor. Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, or urinary problems. During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of the potential for harm to the unborn baby. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor promptly. This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not refrigerate or freeze. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Throw away used medication handles in a secure trash can away from children and pets. Properly discard this product when it is expired or no longer needed. Read the Medication Guide for details. You may also consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Pain, sores, or irritation in the mouth (where the medication has been applied) may also occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener). To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating. Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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 lozenges 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. Get medical help right away if you notice unusual slow/shallow breathing. Carefully follow the specific directions for using fentanyl lozenges. 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. Properly throw away all opened units of this drug. If a child accidentally swallows this drug, get medical help right away.