Tapentadol belongs to a class of pain relievers known as opioid analgesics (also known as narcotic analgesics) that act on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

It is used to treat severe pain for adults who need treatment for several days or more.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended starting dose (for people who are not currently taking opioid pain relievers) is 50 mg every 12 hours. The dose may then be increased to the usual daily dose of 100 mg to 250 mg twice daily, depending on how the medication is tolerated and how well it works for your pain.

If you have been taking another opioid medication, the starting dose of tapentadol may be higher, depending on the dose of the other medication. Your doctor will determine the most appropriate starting dose.

Always swallow the tablet whole. Do not crush, divide, dissolve, or chew tapentadol tablets. Taking broken or crushed tablets may result in too much of the medication being absorbed at one time. This is dangerous, and can be fatal.

You may take the tablets on an empty stomach or with meals.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Stopping the medication suddenly may cause withdrawal symptoms (such as restlessness, irritability, nausea and vomiting, diarrhea, sweating, chills, muscle aches, or watery eyes and nose). Do not stop taking this medication without checking with your doctor first. Your doctor will advise you on how to stop the medication safely.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children and pets. Accidental use by a child is a medical emergency and may result in death.

Do not take tapentadol if you:

• are allergic to tapentadol, or any ingredients of the medication
• are allergic to opioids
• are also taking MAO inhibitors (certain medications used for treatment of depression) or have taken them in the last 14 days before treatment with tapentadol
• are pregnant, in labour, or breast-feeding
• have a head injury, increased intracranial pressure (pressure inside the head), or severe central nervous system depression (a slowing of the central nervous system leading to decreased heart rate, decreased breathing rate, or loss of consciousness)
• have asthma or dangerously slow or shallow breathing (respiratory depression, hypercapnia)
• have convulsions or a seizure disorder
• have pain that can be controlled by occasional use of painkillers or pain around the time of surgery
• have paralysis of the gut or a bowel obstruction
• have severe kidney or liver dysfunction
• are addicted to alcohol

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• dizziness
• drowsiness
• headache
• nausea
• vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• opioid withdrawal symptoms such as nausea, vomiting, diarrhea, anxiety, and shivering (these may occur after converting from your previous opioid analgesic to tapentadol or converting from tapentadol to another opioid)
• severe dizziness when getting up from a sitting or lying position

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)
• symptoms of too much medication (e.g., extreme sleepiness, a slow heartbeat, cold, clammy skin, feeling faint, confused, or being unable walk or talk normally)
• trouble breathing or slow or shallow breathing

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abdominal (stomach) conditions: As with other narcotic medications, tapentadol may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have abdominal problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Addiction: Tapentadol may lead to physical and psychological addiction. Tell your doctor if you (or a family member) have ever abused or been dependent on alcohol, prescription medications, or street drugs.

Alcohol use: People taking this medication should not consume alcohol since doing so can reduce the effectiveness of this medication and increase the risk of side effects. It is not recommended for people with alcohol abuse problems.

Breathing: Tapentadol can suppress breathing. This effect on breathing may be more pronounced for people with breathing problems, brain damage, or who are taking other medications that suppress breathing (e.g., codeine, morphine). If you have breathing problems, such as COPD, asthma or respiratory depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with this medication. Severe withdrawal symptoms may be experienced (e.g., seizures) if the dose is significantly reduced or suddenly stopped. Withdrawal symptoms include irritability, nervousness, sleep problems, agitation, tremors, diarrhea, abdominal cramps, vomiting, memory impairment, headache, muscle pain, extreme anxiety, tension, restlessness, and confusion. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms.

Drowsiness/reduced alertness: This medication may cause drowsiness or reduced alertness. Avoid driving or engaging in other activities requiring alertness unless and until you know how the medication affects you. Alcohol and antianxiety medications can increase the drowsiness caused by this medication.

Head injury: Tapentadol can cause increased pressure inside the head. If you have acute head injuries or other conditions which increase intracranial pressure (pressure inside the head) discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: The safety and effectiveness of tapentadol has not been established for people with reduced kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function:  Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Overdose: If you experience the following symptoms after taking very high doses, seek medical help immediately:

• breathing that is stopped or dangerously slow or shallow
• collapse
• disturbed consciousness or coma (deep unconsciousness)
• drop in blood pressure
• fast heart beat
• pin-point pupils
• vomiting
• seizures

Pancreatitis: If you have a history of pancreatitis (inflammation of the pancreas), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Seizures: There have been reports of seizures occurring with tapentadol. Seizures are more likely to occur when higher doses of this medication are taken. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed..

Serotonin Syndrome: Severe reactions are possible when tapentadol is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. These combinations must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

Pregnancy: This medication should not be used during pregnancy, prior to or during labour. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if tapentadol passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. Tapentadol is not recommended for use by people under 18 years of age.

There may be an interaction between tapentadol and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.