Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Descriptions Codeine is used to relieve mild to moderately severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). This medicine acts on the central nervous system (CNS) to relieve pain. When codeine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely. This medicine is available only with your doctor’s prescription. This product is available in the following dosage forms: • Solution • Tablet, Extended Release • Syrup • Tablet In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of codeine in the pediatric population. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of codeine in the elderly. However, elderly patients are more likely to have confusion and drowsiness, and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving codeine. Pregnancy Information about this codeine-oral-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding. Drug Interactions Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. • Naltrexone Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. • Adinazolam • Alfentanil • Alprazolam • Anileridine • Bromazepam • Brotizolam • Buprenorphine • Bupropion • Butalbital • Butorphanol • Carbinoxamine • Carisoprodol • Chloral Hydrate • Chlordiazepoxide • Chlorzoxazone • Clobazam • Clonazepam • Clorazepate • Codeine • Dantrolene • Dezocine • Diazepam • Estazolam • Ethchlorvynol • Fentanyl • Flunitrazepam • Fluoxetine • Flurazepam • Halazepam • Hydrocodone • Hydromorphone • Ketazolam • Levorphanol • Lorazepam • Lormetazepam • Meclizine • Medazepam • Meperidine • Mephenesin • Mephobarbital • Meprobamate • Meptazinol • Metaxalone • Methocarbamol • Methohexital • Midazolam • Morphine • Morphine Sulfate Liposome • Nalbuphine • Nitrazepam • Nordazepam • Opium • Oxazepam • Oxycodone • Oxymorphone • Pentazocine • Prazepam • Propoxyphene • Quazepam • Remifentanil • Sodium Oxybate • Sufentanil • Tapentadol • Temazepam • Thiopental • Triazolam Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. • Perampanel Other Interactions Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. • Ethanol Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: • Addison’s disease (adrenal gland problem) or • Alcohol abuse, history of or • Breathing or lung problems (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia) or • CNS depression or • Drug dependence, especially narcotic abuse or dependence, or history of or • Enlarged prostate (BPH, prostatic hypertrophy) or • Hypothyroidism (an underactive thyroid) or • Kyphoscoliosis (curvature of spine that can cause breathing problems) or • Mental illness or • Problems with passing urine—Use with caution. May increase risk for more serious side effects. • Brain tumor or • Head injuries or • Increased pressure in your head—Some of the side effects of codeine can cause serious problems in people who have these medical problems. • Breathing problems (e.g., asthma, hypercapnia), severe or • Paralytic ileus (intestinal blockage) or • Respiratory depression (hypoventilation or slow breathing)—Should not be used in patients with these conditions. • Hypotension (low blood pressure) or • Pancreatitis (inflammation of the pancreas) or • Seizures, history of—Use with caution. May make these conditions worse. • Kidney disease or • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Stomach or digestion problems—This medicine may mask the diagnosis of these conditions. Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Dosing The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. • For oral dosage form (tablets): For mild to moderately severe pain: Adults—15 to 60 milligrams (mg) every 4 hours as needed. However, the dose is usually not more than 360 mg per day. Children—Use and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using 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. Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness. This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems. For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine): • Contact your doctor right away if you have extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an “ultra-rapid metabolizer of codeine”. Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual. Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping. Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Incidence not known • Bloating • blurred vision • chills • cold, clammy skin • confusion • constipation • darkened urine • difficult or troubled breathing • dizziness • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position • fainting • fast, irregular, pounding, or racing heartbeat or pulse • fast, weak pulse • feeling of warmth • fever • indigestion • irregular, fast or slow, or shallow breathing • lightheadedness • loss of appetite • nausea • no blood pressure or pulse • no breathing • pains in the stomach, side, or abdomen, possibly radiating to the back • pale or blue lips, fingernails, or skin • redness of the face, neck, arms, and occasionally, upper chest • shortness of breath • stopping of the heart • sweating • unconsciousness • unusual tiredness or weakness • vomiting • wheezing • yellow eyes or skin Get emergency help immediately if any of the following symptoms of overdose occur: Symptoms of overdose • Bluish lips or skin • change in consciousness • chest pain or discomfort • constricted, pinpoint, or small pupils (black part of the eye) • decreased awareness or responsiveness • extreme sleepiness or unusual drowsiness • loss of consciousness • no blood pressure or pulse • severe sleepiness • slow or irregular heartbeat Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common • Drowsiness • relaxed and calm Incidence not known • Abdominal or stomach pain or cramps • blurred or loss of vision • diarrhea • disturbed color perception • double vision • dry mouth • false or unusual sense of well-being • fear or nervousness • feeling of constant movement of self or surroundings • halos around lights • headache • hives or welts • itching skin • night blindness • overbright appearance of lights • redness of the skin • sensation of spinning • shakiness • skin rash • sleeplessness • trouble sleeping • tunnel vision • unable to sleep • weight loss Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.