Tramadol

Tramadol may be habit-forming. Take tramadol exactly as directed. Do not take more of it, take it more often, stop taking it suddenly, or take it differently than directed by your doctor. 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.

Tramadol 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. 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 medications, drinking alcohol, or using street drugs while you are taking tramadol may increase the risks that you will experience breathing problems, sedation, coma, or other life-threatening side effects. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully.

Tell your doctor if you are pregnant or plan to become pregnant. If you take tramadol regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth.

Swallow tramadol extended-release tablet or capsule whole. Do not chew, break, divide, crush, or dissolve them. If you swallow broken, chewed, crushed, or dissolved extended-release preparations, you may receive too much tramadol at once.

Do not allow anyone else to take your medication. Tramadol may harm or cause death to other people who take your medication, especially children.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Tramadol is used to relieve certain types of pain. Tramadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Tramadol comes as an immediate-release tablet, a solution (liquid), an extended-release (long-acting) tablet, and an extended-release (long-acting) capsule to take by mouth.  

The immediate-release tablet and solution are taken with or without food every 4 to 6 hours as needed. 

The extended-release tablet and extended-release capsule are taken with or without food once a day. Take the extended-release tablet and the extended-release capsule at about the same time of day every day. If you are taking the extended-release tablet or extended-release capsule, you should take it consistently, either always with or always without food.

Take tramadol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Tell your doctor if your pain increases, gets worse, or if you have new pain or an increased sensitivity to pain, especially after taking tramadol.

Your doctor may start you on a low dose of tramadol and gradually increase the amount of medication you take, not more often than every 3 days if you are taking the solution or regular tablets or every 5 days if you are taking the extended-release tablets or extended-release capsules.

If you are taking the solution, use an oral syringe or measuring spoon or cup to measure the correct amount of liquid needed for each dose. Do not use a regular household spoon to measure your dose. Ask your doctor or pharmacist if you need help getting or using a measuring device,

Do not stop taking tramadol without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop taking tramadol, you may experience withdrawal symptoms such as nervousness; panic; sweating; difficulty falling asleep or staying asleep; runny nose, sneezing, or cough; pain; hair standing on end; chills; nausea; uncontrollable shaking of a part of your body; diarrhea; or rarely, hallucinations (seeing things or hearing voices that do not exist).

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking tramadol,

• tell your doctor and pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor or pharmacist if you are taking or receiving the following medications or if you have stopped taking them within the past 2 weeks: isocarboxazid (Marplan^®), linezolid (Zyvox^®), methylene blue, phenelzine (Nardil^®), selegiline (Emsam^®, Zelapar^®), or tranylcypromine (Parnate^®).  
• you should know the following nonprescription or herbal products may interact with tramadol: St. John's wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking tramadol. Do not start these medications while taking tramadol without discussing it with your healthcare provider.
• tell your doctor if you have or have ever had a blockage or narrowing of your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take tramadol
• tell your doctor if you have or have ever had slowed breathing, asthma, chronic pulmonary disease (COPD), or other lung problems; a brain tumor, head injury, or history of seizures; an infection in your brain or spine; difficulty urinating; low blood levels of sodium; thoughts about harming or killing yourself or planning or trying to do so; diabetes; pancreas, gall bladder, or thyroid problems; or kidney or liver disease.
• tell your doctor if you are breastfeeding. You should not breastfeed while taking tramadol.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking tramadol.
• you should know that this medication may not be recommended in people 65 years or older. There may be other treatment options that are safer or work better. Talk to your doctor about the risks and benefits of taking this medication.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tramadol.
• you should know that this medication may make you drowsy and may affect your coordination. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that tramadol may cause dizziness, lightheadedness, and fainting when you get up from a lying position. To avoid this, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that tramadol may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.

Unless your doctor tells you otherwise, continue your normal diet.

If your doctor has told you to take tramadol regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Tramadol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• sleepiness
• headache
• nervousness
• uncontrollable shaking of a part of the body
• changes in mood
• heartburn or indigestion
• dry mouth
• constipation

Some side effects can be serious. If you experience any of these symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• hives, rash, blisters
• hoarseness, difficulty swallowing or breathing
• chest pain
• swelling of the eyes, face, throat, tongue, lips, hands, feet, ankles, or lower legs
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea
• nausea, vomiting, loss of appetite, fatigue, weakness, or dizziness
• changes in heartbeat
• headache, confusion, loss of energy, drowsiness, restlessness, muscle weakness, spasms or cramps
• hunger, shaking of a part of your body that you cannot control, irritability, or difficulty concentrating
• loss of consciousness
• seizures

Tramadol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Talk to your doctor or pharmacist about access to a rescue medication called naloxone or nalmefene. Rescue medications can reverse the life-threatening effects of an opioid overdose and are available from a community-based program,over the counter, or with a prescription. Make sure that you and your family members and people usually around you know how to recognize an overdose, how to use naloxone or nalmefene and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and others how to use it. If symptoms of an overdose occur, they should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. If your symptoms return, the person should give you another dose of the rescue medication. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include the following:

• decreased size of the pupil (the black circle in the center of the eye)
• difficulty breathing
• slow or shallowing breathing
• extreme drowsiness or sleepiness
• unable to respond or wake up
• slowed heartbeat
• muscle weakness
• cold, clammy skin

Keep all appointments with your doctor and laboratory. Your doctor may order certain lab tests to check your body's response to tramadol.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking tramadol.

Do not let anyone else take your medication. Tramadol is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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• Ultracet^® (containing Acetaminophen, Tramadol)^¶
• Seglentis^® (containing Celecoxib, Tramadol)^¶