Tapentadol may be habit forming, especially with prolonged use. Take tapentadol exactly as directed. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. While taking tapentadol, discuss with your healthcare provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse tapentadol if you have or have ever had any of these conditions. Talk to your healthcare provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Tapentadol may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will adjust your dose to control your pain and decrease the risk that you will experience serious breathing problems. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to take tapentadol. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema), a head injury, a brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weakened or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking certain other medications during your treatment with tapentadol may increase the risk that you will experience breathing problems or other serious, life threatening breathing problems, sedation, or coma. Tell your doctor if you are taking or plan to take any of the following medications: benzodiazepines such as alprazolam (Xanax), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), and triazolam (Halcion); other narcotic pain medications; medications for mental illness or nausea; muscle relaxants; sedatives; sleeping pills; or tranquilizers. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take tapentadol with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with tapentadol increases the risk that you will experience serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment with tapentadol.

Do not allow anyone else to take your medication. Tapentadol may harm or cause death to other people who take your medication, especially children. Keep tapentadol in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep tapentadol out of the reach of children. Keep track of how many tablets or extended-release tablets are left so you will know if any medication is missing. Flush any tablets or extended-release tablets that are outdated or no longer needed down the toilet so that others will not take them.

If you are taking the extended-release tablets, swallow them whole; do not chew, break, divide, crush, or dissolve them. If you swallow broken, chewed, crushed, or dissolved extended-release tablets, you may receive too much tapentadol at once instead of slowly over 12 hours. This may cause serious problems, including overdose and death.

Tell your doctor if you are pregnant or plan to become pregnant. If you take tapentadol regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Talk to your doctor about the risks of taking tapentadol.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin your treatment with tapentadol and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Why is this medication prescribed?
Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes. Tapentadol extended-release tablets are only used to treat people who are expected to need medication around-the-clock to relieve pain that cannot be controlled by the use of other pain medications. Tapentadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

How should this medicine be used?
Tapentadol comes as a tablet and an extended-release (long acting) tablet to take by mouth. The tablets are usually taken with or without food every 4 to 6 hours as needed. If you are taking tapentadol tablets, your doctor may tell you that you may take a second dose as soon as 1 hour after the first dose on your first day of treatment if needed to treat your pain. Do not take extra doses at any other time during your treatment and do not ever take extra doses of the extended-release tablets. The extended-release tablets are taken once every 12 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tapentadol exactly as directed.