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How should this medicine be used?

Tramadol comes as a tablet and an extended-release (long-acting) tablet to take by mouth. The regular tablet is usually taken with or without food every 4-6 hours as needed. The extended-release tablet should be taken once a day. Take the extended-release tablet at about the same time of day every day, and either always take it with food or always take it without food. Take tramadol exactly as directed. Do not take more medication as a single dose or take more doses per day than prescribed by your doctor. Taking more tramadol than prescribed by your doctor may cause serious side effects or death.

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 regular tablets or every 5 days if you are taking the extended-release tablets.

Swallow the extended-release tablets whole; do not split, chew, or crush them. Do not snort (inhale powder from crushed tablet) or inject the dissolved extended-release tablets. Taking this medication in a way that is not recommended may cause serious side effects or death.

Tramadol can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor. Call your doctor if you find that you want to take extra medication or if you notice any other unusual changes in your behavior or mood.

Do not stop taking tramadol without talking to your doctor. Your doctor will probably 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; numbness, pain, burning, or tingling in your hands or feet; 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).

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking tramadol,

• tell your doctor and pharmacist if you are allergic to tramadol or other opiate pain or cough medications such as meperidine (Demerol), morphine (Avinza, Kadian, MS Contin), codeine (in some pain medications and cough syrups), hydrocodone (in Vicodin), hydromorphone (Dilaudid), oxycodone (OxyContin, in Percocet), propoxyphene (Darvon, Darvon N, in Darvocet), any other medications, or any of the ingredients in tramadol tablets or extended-release tablets. Ask your pharmacist for a list of ingredients in tramadol tablets or extended release tablets.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: antifungal medications such as ketoconazole (Nizoral); digoxin (Lanoxin); erythromycin (E.E.S., E-Mycin, Erythrocin); monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); medications for anxiety, mental illness, nausea, and pain; medications for seizures, such as carbamazepine (Tegretol); muscle relaxants such as cyclobenzaprine (Flexeril); promethazine (Phenergan); quinidine; rifampin (Rifadin, Rifamate, Rimactane, others); sedatives; sleeping pills; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); tranquilizers; tricyclic antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil);and warfarin (Coumadin). Many other medications may also interact with tramadol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have or have ever had seizures; an infection in your brain or spine; a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull; depression or thoughts about harming or killing yourself or planning or trying to do so; diabetes; breathing problems or lung disease; or kidney or liver disease. Also tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tramadol, call your doctor.
• 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.
• talk to your doctor about the safe use of alcohol while you are taking this medication. Alcohol can make the side effects from tramadol worse.
• 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.

What special dietary instructions should I follow?

Talk to your doctor about drinking grapefruit juice while you are taking this medication.

What should I do if I forget a dose?

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.

What side effects can this medication cause?

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

• dizziness
• weakness
• sleepiness
• difficulty falling asleep or staying asleep
• headache
• nervousness
• agitation
• uncontrollable shaking of a part of the body
• muscle tightness
• changes in mood
• drowsiness
• heartburn or indigestion
• nausea
• vomiting
• diarrhea
• constipation
• itching
• sweating
• chills
• dry mouth

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately. If you experience any of the first 7 symptoms on this list, do not take any more simvastatin without talking to your doctor:

• seizures
• sores on the inside of your mouth, nose, eyes, or throat
• flu-like symptoms
• hives
• rash
• difficulty swallowing or breathing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• hallucinations (seeing things or hearing voices that do not exist)

Tramadol may cause other side effects. Tell your doctor if you have any unusual problems while you are 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 [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• decreased size of the pupil (the black circle in the center of the eye)
• difficulty breathing
• extreme drowsiness
• unconsciousness
• coma
• seizure
• heart attack

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand Names

• Conzip®
• Ryzolt®
• Ultram®
• Ultram® ER

Brand names of combination products

• Ultracet® (containing Acetaminophen, Tramadol)