SIDE EFFECTS: Nausea, vomiting, constipation, headache, mild itching, drowsiness, dry mouth, lightheadedness, or weakness may occur. Some of these side effects may decrease after continued use of the medication. If any of these effects persist or worsen, notify 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 the use of a laxative (e.g., stimulant-type, stool softener). Remember that your doctor has prescribed this medication because 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: slow/irregular/shallow breathing, dizziness upon standing, slow/fast/irregular heartbeat, mental/mood changes, uncontrolled muscle movements (tremors), vision changes. Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain relievers (e.g., morphine, oxymorphone); or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: serious breathing problems (e.g., severe asthma, respiratory depression), certain bowel diseases (e.g., paralytic ileus), intoxication with medications which depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives). Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizure, head injury, increased intracranial pressure), adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., enlarged prostate, urethral stricture), personal or family history of regular use/abuse of drugs/alcohol/other substances, kidney or liver disease, heart problems (e.g., low blood pressure, irregular heartbeat), lung diseases (e.g., chronic obstructive pulmonary disease, hypercapnia, hypoxia), metabolic disorders (e.g., low sodium, dehydration), disease of the pancreas (pancreatitis), psychiatric problems (e.g., major depression, toxic psychosis), spinal problems (kyphoscoliosis), stomach/intestinal problems (e.g., gallbladder disease, severe diarrhea or constipation), underactive thyroid (hypothyroidism). This drug may make you dizzy or drowsy; do not drive or operate machinery until you know how this medication affects you. Avoid alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Tell your doctor or dentist you are taking this medication prior to having surgery. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects (e.g., slow/shallow breathing and drowsiness effects). This medication should be used only when clearly needed during pregnancy. Inform your doctor immediately if you are or think you are pregnant. Discuss the risks and benefits with your doctor. This medication should not be started near or at the time of delivery because of possible side effects in the newborn (e.g., slow/shallow breathing). If prescribed, follow your doctor's instructions closely and do not suddenly stop taking this drug. Infants born to mothers who have been using this medication for an extended time, may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended . Consult your doctor before breast-feeding.

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