MEDICATION GUIDE

It is not known if propoxyphene napsylate and acetaminophen tablets USP are safe and effective in children under age 18.

Who should not take propoxyphene napsylate and acetaminophen tablets USP?

Do not take propoxyphene napsylate and acetaminophen tablets USP if you:

• are allergic to propoxyphene or acetaminophen. Ask your doctor if you are not sure. See the end of this Medication Guide for a list of the ingredients in propoxyphene napsylate and acetaminophen tablets USP.
• are having an asthma attack or have severe asthma, trouble breathing, or lung problems.
• have a bowel blockage called paralytic ileus.

What should I tell my doctor before taking propoxyphene napsylate and acetaminophen tablets USP?

Before taking propoxyphen napsylate and acetaminophen tablets USP, tell your doctor:

• if you have any of the conditions listed in the section "What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?"
• if you are allergic to propoxyphene or acetaminophen
• if you plan to have surgery with general anesthesia
• if you are pregnant or plan to become pregnant.
• if you take propoxyphene napsylate and acetaminophen tablets USP regularly before your baby is born, your newborn baby may have withdrawal symptoms because their body has become used to the medicine. Symptoms of withdrawal in a newborn baby may include:
  • irritability
  • shaking (tremors)
  • jitteriness
  • breathing faster than normal
  • crying more than usual
  • diarrhea or more stools than normal
  • vomiting
  • fever
• if you take propoxyphene napsylate and acetaminophen tablets USP right before your baby is born, your baby could have breathing problems.
• if you are breast-feeding or plan to breast-feed. Some propoxyphene napsylate and acetaminophen passes into breast milk.

Tell your doctor about all the medicines you take, including prescription, and non-prescription medicines, vitamins, and herbal supplements. Propoxyphene napsylate and acetaminophen tablets USP interact with many medicines and may lead to serious side effects. The doses of certain medicines may need to be changed.

Especially tell your doctor if you take:

See "What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?"

• certain medicines that can affect how your liver breaks down other medicines.
• a monoamine oxidase inhibitor (MAOI) medicine
• other medicines that make you sleepy, such as: other medicines for pain, including other opioid medicines, anti-depressant medicines, sleeping pills, anti-anxiety medicines, muscle relaxants, anti-nausea medicines, or tranquilizers
• an anticholinergic medicine
• a water pill (diuretic)
• a medicine for high blood pressure or irregular heart beat
• birth control pills taken by mouth
• lamotrigine (Lamictal®, Lamictal® CD™, Lamictal® XR™, Lamictal® ODT™)
• probenecid (Probalan®)
• a blood-thinner medicine. You may have an increased risk of bleeding while also taking propoxyphene napsylate and acetaminophen tablets USP.
• zidovudine (Trizivir®, Combivir®, Retrovir®)

Do not take other medicines that contain acetaminophen while taking propoxyphene napsylate and acetaminophen tablets USP. See "What are the possible side effects of propoxyphene napsylate and acetaminophen tablets USP?"

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

How should I take propoxyphene napsylate and acetaminophen tablets USP?

See "What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?"

• Take propoxyphene napsylate and acetaminophen tablets USP exactly as prescribed.
• If you take too many propoxyphene napsylate and acetaminophen tablets USP, or take it with alcohol or other medicines, you may overdose. See "What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?". You will need medical help right away if you think you have taken an overdose of propoxyphene napsylate and acetaminophen tablets USP. A large overdose can cause you to become unconscious and die.

Signs and symptoms of an overdose of propoxyphene napsylate and acetaminophen tablets USP include:

• you are very sleepy or do not respond to others
• confusion
• have trouble breathing or stop breathing
• changes in blood pressure and heart rate
• nausea
• vomiting
• loss of appetite
• stomach-area (abdominal pain)

What are the possible side effects of propoxyphene napsylate and acetaminophen tablets USP?

Propoxyphene napsylate and acetaminophen tablets USP can cause serious side effects, including:

See "What is the most important information I should know about propoxyphene napsylate and acetaminophen tablets USP?"

• Serious breathing problems that can become life-threatening. This is especially true if you already have a serious lung or breathing problem, or your body is not used to opioid pain medicines. This can happen even if you take propoxyphene napsylate and acetaminophen tablets USP exactly as prescribed by your doctor. Call your doctor or get medical help right away if:
  • your breathing slows down
  • you have shallow breathing (little chest movement with breathing)
  • you feel faint, dizzy, confused, or
  • you have any other unusual symptoms
• Propoxyphene napsylate and acetaminophen tablets USP can cause your blood pressure to drop. This can make you feel dizzy and faint if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lose blood or take certain other medicines.
• Liver problems. Propoxyphene napsylate and acetaminophen tablets USP contain acetaminophen. Acetaminophen can cause serious liver problems if you take more than the recommended dose. Do not take more propoxyphene napsylate and acetaminophen tablets USP than prescribed. See "How should I take propoxyphene napsylate and acetaminophen tablets USP?" Do not take any other medicines that contain acetaminophen while also taking propoxyphene napsylate and acetaminophen tablets USP. Many products contain acetaminophen. Ask your doctor or pharmacist if you are not sure. Liver damage may happen even after symptoms go away. You can die from liver failure days later. Tell your doctor if you have any of these symptoms of a liver problem while taking propoxyphene napsylate and acetaminophen tablets USP:
  • nausea
  • vomiting
  • loss of appetite
  • stomach area (abdominal pain)
• Sleepiness. Propoxyphene napsylate and acetaminophen tablets USP can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how propoxyphene napsylate and acetaminophen tablets USP affect you.
• Propoxyphene napsylate and acetaminophen tablets USP can cause physical dependence if you take them for more than a few weeks. Do not stop taking propoxyphene napsylate and acetaminophen tablets USP all of a sudden. You could become sick with uncomfortable withdrawal symptoms (for example, nausea, vomiting, diarrhea, anxiety, and shivering) because your body has become used to the medicine. Talk to your doctor about slowly stopping propoxyphene napsylate and acetaminophen tablets USP to avoid getting sick with withdrawal symptoms. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction.

  Tell your doctor if you have any of these withdrawal symptoms while you slowly stop taking propoxyphene napsylate and acetaminophen tablets USP. You may need to stop propoxyphene napsylate and acetaminophen tablets USP more slowly.

Common side effects of propoxyphene napsylate and acetaminophen tablets USP include:

• • dizziness
  • feeling sleepy
  • nausea and vomiting
  • constipation
  • stomach area (abdominal) pain
  • skin rashes
  • lightheadedness
  • headache
  • weakness
  • feeling of excitement (elation) or discomfort
  • seeing, hearing, or sensing things that are not really there (hallucinations)
  • blurred vision

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872, X6351.

How should I store propoxyphene napsylate and acetaminophen tablets USP?

• Store propoxyphene napsylate and acetaminophen tablets USP at 20° to 25°C (68° to 77°F).

Keep propoxyphene napsylate and acetaminophen tablets USP and all medicines out of the reach of children.

General information about propoxyphene napsylate and acetaminophen tablets USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use propoxyphene napsylate and acetaminophen tablets USP for a purpose for which they were not prescribed. Do not give propoxyphene napsylate and acetaminophen tablets USP to others even if they have the same symptoms you have. It may harm them and is against the law. This Medication Guide summarizes the most important information about propoxyphene napsylate and acetaminophen tablets USP. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about propoxyphene napsylate and acetaminophen tablets USP that is written for health professionals. For more information, call 1-888-838-2872, MEDICAL AFFAIRS.

What are the ingredients in propoxyphene napsylate and acetaminophen tablets USP?

Active ingredients: propoxyphene napsylate and acetaminophen

Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients: colloidal silicon dioxide, D&C Red No. 27 aluminum lake, D&C Yellow No. 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.

Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (WHITE) contain the following inactive ingredients: castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and crospovidone.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Iss. 10/2009