Acetaminophen; Tramadol tablets

What is this medicine?

ACETAMINOPHEN; TRAMADOL (a set a MEE noe fen; TRA ma dole) is a pain reliever. It is used to treat short term moderate pain.

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. If the medicine upsets your stomach, take it with food or milk. Do not take your medicine more often than directed.

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. This medicine is not for use in children less than 12 years of age. Do not give this medicine to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.

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

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• 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

• yellowing of the eyes or skin

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 medication with any of the following medicines:

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

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• certain medicines for anxiety or sleep

• certain medicines for depression like amitriptyline, fluoxetine, sertraline

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

• certain medicines for seizures like carbamazepine, oxcarbazepine, phenobarbital, primidone

• certain medicines that treat or prevent blood clots like warfarin

• digoxin

• furazolidone

• general anesthetics like halothane, isoflurane, methoxyflurane, propofol

• linezolid

• 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

• procarbazine

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. Tramadol is a morphine-like drug that 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 is against the law.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

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

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

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

• brain tumor

• depression

• drug abuse or addiction

• head injury

• if you often drink alcohol

• kidney disease or trouble passing urine

• liver disease

• lung disease, asthma, or breathing problems

• seizures or epilepsy

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to acetaminophen, tramadol, codeine, other opioid analgesics, 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 health care provider 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 this drug. Tolerance means that you will need a higher dose of the drug for pain relief. Tolerance is normal and is expected if you take this drug for a long time.

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

If you take other drugs that also cause drowsiness like other narcotic pain drugs, benzodiazepines, or other drugs for sleep, you may have more side effects. Give your health care provider a list of all drugs you use. He or she will tell you how much drug to take. Do not take more drug than directed. Get emergency help right away if you have trouble breathing or are unusually tired or sleepy.

Talk to your health care provider about naloxone and how to get it. Naloxone is an emergency drug used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other drugs or substances, like alcohol. Know the symptoms of an overdose, like trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.

Do not take other drugs that contain acetaminophen with this drug. Many non-prescription drugs contain acetaminophen. Always read labels carefully. If you have questions, ask your health care provider.

If you take too much acetaminophen, get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

This drug may cause serious skin reactions. They can happen weeks to months after starting the drug. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand up 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 drug. Avoid alcoholic drinks.

This drug will cause constipation. If you do not have a bowel movement for 3 days, call your health care provider.

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