Acetaminophen (a-seet-a-MIN-oh-fen), Pentazocine Hydrochloride (pen-TAZ-oh-seen hye-droe-KLOR-ide)

Relieves mild to moderate pain. This medicine contains a narcotic pain medicine.

Brand Name(s):

Talacen, APAP/Pentazocine HCl

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• This combination medicine contains acetaminophen (Tylenol(R)). Carefully check the labels of all other medicines you are using because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Make sure you store the medicine in a safe and secure place to prevent others from getting it.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you have received an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Tell your doctor if you are also using an anticholinergic medicine (such as glycopyrrolate, ipratropium, or Atrovent®) or a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®).
• Tell your doctor if you smoke tobacco. Smoking may change how well this medicine works.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine. Large doses of acetaminophen can damage your liver. If you regularly drink 3 or more alcoholic drinks every day, do not take acetaminophen without asking your doctor.
• Do not also use other medicines that contain acetaminophen (Tylenol®), or you may be getting more than a safe amount of this medicine.
• Many combination medicines contain acetaminophen, including products with brand names such as Alka-Seltzer Plus®, Comtrex®, Drixoral®, Excedrin Migraine®, Midol®, Sinutab®, Sudafed®, Theraflu®, and Vanquish®. Carefully check the labels of all other medicines you are using to be sure they do not contain acetaminophen.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart or blood vessel disease, high blood pressure, a recent heart attack, or a history of head injury, seizures, or recent surgery. Tell your doctor if you have adrenal problems, asthma or other lung problems (such as COPD, respiratory depression), gallbladder problems, kyphoscoliosis (severe curvature of the spine with breathing problems), mental illness, pancreas problems, porphyria (an enzyme problem), an enlarged prostate, bowel blockage, stomach problems, or an underactive thyroid. Tell your doctor if you have been addicted to alcohol or drugs.
• Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
• This medicine may cause allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• Make sure your doctor knows if you or your child have received narcotic medicines (such as methadone) in the past. Some patients receiving narcotic pain medicines, have experienced withdrawal symptoms after receiving pentazocine.
• Check with your doctor if you or your child have confusion about identity, place, and time; mood or mental changes; or seeing things that are not there while taking this medicine.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine may cause constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Dark-colored urine or pale stools.
• Decrease in how much or how often you urinate.
• Extreme weakness, shallow breathing, sweating, or cold or clammy skin.
• Fast, slow, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Seizures.
• Severe confusion or hallucinations (seeing things that are not there).
• Severe stomach pain.
• Sleepiness or unusual drowsiness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Blurred vision.
• Constipation, diarrhea, nausea, vomiting, or upset stomach.
• Dry mouth.
• Feeling depressed or irritable.
• Headache or trouble sleeping.
• Mild skin rash or itching.
• Warmth or redness in your face, neck, arms, or upper chest.
• Weakness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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