This medicine is a narcotic analgesic used to treat certain types of severe pain.
Follow the directions for using this medicine provided by your doctor. This medicine may be taken on an empty stomach or with food. If stomach upset occurs, take with food to reduce stomach irritation. IF THIS MEDICINE IS NO LONGER NEEDED, check with your pharmacist for ways to properly dispose of this medicine. DO NOT throw it in the trash. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking a mixed agonist/antagonist analgesic medicines (eg, pentazocine, nalbuphine, butorphanol), sodium oxybate (GHB), a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or you have taken an MAOI within the past 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticholinergics (eg, scopolamine, bethanechol); HIV protease inhibitors (eg, ritonavir); other narcotic pain medicines, phenothiazines (eg, chlorpromazine); tricyclic antidepressants (eg, amitriptyline); cimetidine; naltrexone; quinidine; or rifampin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including a history of heart problems, low blood pressure, stomach or bowel problems (eg, inflammation, ulcer), pancreas problems (eg, inflammation), gallbladder problems (eg, gallstones), an enlarged prostate gland or other prostate problems, a blockage of your bladder or bowel, kidney or liver problems, adrenal gland problems (eg, Addison disease), an underactive thyroid, trouble breathing, a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), scoliosis, chronic obstructive pulmonary disease (COPD), a cough that occurs with large amounts of mucus, allergies, pregnancy, or breast-feeding. Tell your doctor if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures. Tell your doctor if you are going through alcohol withdrawal, have a history of alcohol or other substance abuse, mental or mood problems, or suicidal thoughts or behavior. Tell your doctor if you are dehydrated, are in very poor health, or have had recent abdominal surgery. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a lack of muscle movement in the bowel (paralytic ileus); high levels of carbon dioxide in the blood; a history of severe asthma or you are having an asthma attack; or if you have slow or shallow breathing. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include constipation; dizziness; drowsiness; lightheadedness; nausea; sweating; tiredness; or vomiting. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain; confusion; fainting; fast or irregular heartbeat; mental or mood changes; numbness or pain of an arm or leg; seizures; severe drowsiness or dizziness; severe or persistent constipation or stomach pain; shortness of breath; slow or shallow breathing; sudden severe headache or vomiting; or trouble urinating. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include blue lips or nails; cold and clammy skin; coma; confusion; hallucinations; limp muscles; loss of consciousness; mood or mental changes; seizures; severe dizziness or drowsiness; slow heartbeat; slow or shallow breathing; sluggishness; or small or large pupils.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.