IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PENTAZOCINE/NALOXONE - ORAL

(pen-TAZZ-oh-seen/nal-OX-own)

COMMON BRAND NAME(S): Talwin NX

WARNING: This medication should only be taken by mouth. Do not try to dissolve and inject the tablets. Injecting this product, alone or with other substances, may cause serious, possibly fatal, side effects.

USES: This product is used to treat moderate to severe pain. It contains 2 medications, pentazocine and naloxone. Pentazocine is a narcotic pain reliever (opiate-type). It acts on certain centers in the brain to give you pain relief. Naloxone helps to prevent misuse of this product. It blocks the effect of pentazocine and may cause withdrawal reactions if this product is dissolved and injected. Naloxone does not have any effect when taken by mouth.

HOW TO USE: Take this medication by mouth with or without food, usually every 3 to 4 hours or as directed by your doctor. If you have nausea, it may help to take this drug with food. Consult your doctor or pharmacist about other ways to decrease nausea (such as taking antihistamines, lying down for 1 to 2 hours with as little head movement as possible). The dosage is based on your medical condition and response to treatment. Do not take more than 600 milligrams of pentazocine in a 24-hour period. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well. If you have been regularly using other narcotic pain medications (for example, morphine, methadone), withdrawal reactions (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur when you start this product. Consult with your doctor or pharmacist for more details. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well. Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction. Tell your doctor if your pain persists or worsens.

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, increased sweating, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener). Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, vision changes, fast heartbeat. Tell your doctor immediately if these rare but very serious side effects occur: slow/shallow breathing, severe stomach/abdominal pain, change in the amount of urine, signs of infection (such as fever, persistent sore throat), seizures. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to pentazocine or naloxone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain bowel diseases (paralytic ileus, infectious diarrhea). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung disease (such as asthma, chronic obstructive pulmonary disease-COPD), a certain spinal problem (kyphoscoliosis), breathing problems (such as slow/shallow breathing, sleep apnea), certain heart problems (irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol, brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), gallbladder disease, adrenal gland problem (such as Addison's disease), intestinal disorders (such as colitis, blockage). This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Before having surgery, tell your doctor or dentist that you are using this medication. To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Older adults may be more sensitive to the effects of this drug, especially slow/shallow breathing and drowsiness. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. It is unknown if this product passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medications because very serious interactions may occur: naltrexone, sibutramine. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting pentazocine/naloxone. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: fluoxetine, MAO inhibitors (for example, isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine). The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or their doses may need to be changed. Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, severe drowsiness, severe dizziness, pinpoint pupils.

NOTES: Do not share this medication with others. It is against the law. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you take this product regularly and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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