Tapentadol Extended-Release Tablets

What is this medication?

TAPENTADOL (ta PEN ta dol) treats severe, chronic pain. It is prescribed when other pain medications have not worked or cannot be tolerated. It may also be used to treat nerve pain. It works by blocking pain signals in the brain. It belongs to a group of medications called opioids. This medication is long-acting. Do not use it to treat sudden pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Nucynta ER

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Brain tumor
• Drug abuse or addiction
• Head injury
• Heart disease
• If you often drink alcohol
• Low adrenal gland function
• Lung disease, asthma, or breathing problems
• Prostate disease
• Seizures
• Stomach or intestine problems
• Taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
• Thyroid disease
• An unusual or allergic reaction to tapentadol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Do not cut, crush, or chew this medication. Do not take a tablet that is not whole. A broken or crushed tablet can be very dangerous. You may get too much medication. Swallow only one tablet at a time. Do not wet, soak, or lick the tablet before you take it. You can take it with or without food. If it upsets your stomach, take it with food. Follow the directions on the prescription label. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Linezolid
• MAOIs like Marplan, Nardil, and Parnate
• Methylene blue
• Samidorphan
• Tedizolid

This medication may interact with the following:

• Alcohol or any product containing alcohol
• Antihistamines for allergy, cough, and cold
• Atropine
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for Parkinson's disease like benztropine, trihexyphenidyl
• Certain medications for seizures like phenobarbital, primidone
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Diuretics
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Ipratropium
• Medications that relax muscles for surgery
• Other narcotic medications for pain
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take this medication for a long time.

There are different types of medications for pain. If you take more than one type at the same time, you may have more side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Call emergency services if you have problems breathing.

Do not suddenly stop taking your medication because you may develop a severe reaction. Your body becomes used to the medication. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a medication for a nonmedical reason. If you have pain, you have a medical reason to take pain medication. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

Naloxone is an emergency medication used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other medications or substances such as alcohol. Know the symptoms of an overdose, like trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where your naloxone stored. Make sure they know how to use it. After naloxone is given, the person giving it must call emergency services. Naloxone is a temporary treatment. Repeat doses may be needed.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, flush it down the toilet.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.