Tapentadol extended-release tablets

What is this medicine?

TAPENTADOL (ta PEN ta dol) is a pain reliever. It is used to treat moderate to severe pain that lasts for more than a few days. It is also used to treat nerve pain caused by diabetes.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not cut, crush, or chew this medicine. Do not take a tablet that is not whole. A broken or crushed tablet can be very dangerous. You may get too much medicine. 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 medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor'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 pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• seizures

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• trouble passing urine or change in the amount of urine

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

• constipation

• dry mouth

• nausea, vomiting

• tiredness

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

• alcohol or any product that contains alcohol

• antihistamines for allergy, cough and cold

• atropine

• certain medicines for anxiety or sleep

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for depression like amitriptyline, fluoxetine, sertraline

• certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• certain medicines for seizures like phenobarbital, primidone

• certain medicines for stomach problems like dicyclomine, hyoscyamine

• certain medicines for travel sickness like scopolamine

• general anesthetics like halothane, isoflurane, methoxyflurane, propofol

• ipratropium

• local anesthetics like lidocaine, pramoxine, tetracaine

• medicines that relax muscles for surgery

• other narcotic medicines for pain or cough

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

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.

Where should I keep my medicine?

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

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture.

This medicine may cause harm and death if it is taken by other adults, children, or pets. Return medicine that has not been used to an official disposal site. Contact the DEA at 1-800-882-9539 or your city/county government to find a site. If you cannot return the medicine, flush it down the toilet. Do not use the medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

• Addison's disease

• gallbladder disease

• head injury

• history of a drug or alcohol abuse problem

• if you often drink alcohol

• kidney disease

• liver disease

• low blood pressure

• lung or breathing disease, like asthma

• mental illness

• prostate disease

• seizures

• stomach or intestine problems

• thyroid disease

• an unusual or allergic reaction to tapentadol, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or health care professional 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 the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

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

There are different types of narcotic medicines (opiates). If you take more than one type at the same time or if you are taking another medicine that also causes drowsiness, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing or unusual sleepiness.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

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