Uses of Pentazocine and Naloxone:

• It is used to ease pain.

What do I need to tell my doctor BEFORE I take Pentazocine and Naloxone?

• If you have an allergy to pentazocine, naloxone, or any other part of pentazocine and naloxone.
• If you are allergic to pentazocine and naloxone; any part of pentazocine and naloxone; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.

This is not a list of all drugs or health problems that interact with pentazocine and naloxone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take pentazocine and naloxone with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Pentazocine and Naloxone?

• Tell all of your health care providers that you take pentazocine and naloxone. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how pentazocine and naloxone affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you have been taking pentazocine and naloxone for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if pentazocine and naloxone stops working well. Do not take more than ordered.
• Long-term or regular use of opioid drugs like pentazocine and naloxone may lead to dependence. Lowering the dose or stopping pentazocine and naloxone all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your doctor before you lower the dose or stop pentazocine and naloxone. You will need to follow your doctor’s instructions. Tell your doctor if you have more pain, mood changes, thoughts of suicide, or any other bad effects.
• Do not take pentazocine and naloxone with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• If you are addicted to pain drugs and are given pentazocine and naloxone, you may have signs of withdrawal. Talk with your doctor.
• Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men).
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking pentazocine and naloxone.
• If you are 65 or older, use pentazocine and naloxone with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking pentazocine and naloxone, call your doctor right away.
• Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.

How is this medicine (Pentazocine and Naloxone) best taken?

Use pentazocine and naloxone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

• If you take pentazocine and naloxone on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times pentazocine and naloxone is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Trouble breathing, slow breathing, or shallow breathing.
• Feeling very sleepy.
• Feeling confused.
• Very bad belly pain.
• Very bad constipation.
• Feeling very tired or weak.
• Hallucinations (seeing or hearing things that are not there).
• Seizures.
• Chest pain or pressure or a fast heartbeat.
• Change in eyesight.
• Trouble passing urine.
• Mood changes.
• Fever or chills.
• Sore throat.
• A burning, numbness, or tingling feeling that is not normal.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take pentazocine and naloxone with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.
• Taking an opioid drug like pentazocine and naloxone may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.

What are some other side effects of Pentazocine and Naloxone?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Feeling sleepy.
• Dizziness.
• Sweating a lot.
• Diarrhea.
• Headache.
• Not hungry.
• Dry mouth.
• Belly pain.
• Constipation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Pentazocine and Naloxone?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time pentazocine and naloxone is refilled. If you have any questions about pentazocine and naloxone, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.