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codeine phosphate - injection (cont.)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, tiredness, or dry mouth may occur. Less common side effects may include pain/redness at the injection site and sweating. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To prevent constipation, maintain a diet adequate in fiber, and drink plenty of water. If you become constipated while using this drug, consult your pharmacist for help with selecting a laxative (e.g., 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: slow/shallow breathing, difficulty staying awake, mental/mood changes (e.g., nervousness, agitation, hallucinations, confusion), vision problems, flushing of the face, slow/irregular heartbeat, fast heartbeat, dizziness when standing, fainting, trouble starting the flow of urine, decreased sexual interest/ability.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 rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 using codeine phosphate injection, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications; or to sulfites; 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: severe breathing problems (e.g., respiratory depression, asthma attack), certain bowel diseases (e.g., paralytic ileus, toxic megacolon, acute abdomen), intoxication with medications that depress the nervous system or your breathing (e.g., brain/respiratory depressants such as alcohol or tranquilizers/sedatives), heart rhythm problems, heart failure due to long-term lung disease, brain disorders (e.g., head injury/tumor, increased intracranial pressure), uncontrolled seizures, a certain type of infectious diarrhea (Clostridium difficile-associated diarrhea).Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, low oxygen in the blood, high carbon dioxide in the blood), low blood pressure, alcohol withdrawal, disease of the pancreas (e.g., pancreatitis), mental/mood disorders (e.g., toxic psychosis), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, adrenal gland problems (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), a severe loss of body water (dehydration), sleep apnea.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. Avoid alcoholic beverages.To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing, low blood pressure, and drowsiness.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who have used 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 drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell your doctor immediately if your infant develops increased sleepiness, difficulty feeding, or trouble breathing. Discuss the risks and benefits with your doctor before breast-feeding.



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