Codeine belongs to the class of medications known as narcotic analgesics (pain relievers). These pain relievers are also known as opioid analgesics. They are used to treat mild to moderate long-term (chronic) pain. Opioids decrease pain by blocking pain signals in the brain. Codeine controlled release is not fast-acting and is used only after an effective dose of short-acting pain relievers has been determined.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful and even fatal for people to take this medication if their doctor has not prescribed it.

The dose required depends on the cause and severity of the pain, as well as the previous history of narcotic analgesic use. The doctor will convert the dose of short-acting analgesics to an equivalent dose of codeine controlled release.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Codeine controlled release tablets should be taken every 12 hours in order to maintain pain relief. The tablets should be swallowed whole and should not be chewed, crushed, or dissolved. Doing so can cause serious harm or even death. All tablet strengths, except the 50 mg tablets, may be halved. Half tablets should also be swallowed intact.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Over time, this medication may produce tolerance and physical dependence as your body becomes used to the drug. Tolerance occurs when a dose that used to provide acceptable pain relief is no longer effective, and higher doses are required to achieve the same level of pain relief. Physical dependence is a state where the body will go into withdrawal if the medication is stopped suddenly. If you have been taking codeine on a regular basis for a long period of time, talk to your doctor before stopping the drug, as withdrawal effects can occur.

Tolerance and physical dependence are not the same as addiction. Addiction is defined as a psychological need to use the medication for reasons other than pain relief. Although people may become addicted to this medication, it is most common for people who have had addictions to other substances in the past.

This medication may be habit-forming if taken for long periods of time. You may experience withdrawal effects if you stop taking this medication suddenly after extended use. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to reduce the severity of withdrawal effects.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children. Accidental ingestion of this medication by a child can lead to serious harm or even death.

50 mg
Each blue, round, film-coated tablet with "PF" printed on one side and "CC 50" on the other contains 26.5 mg of codeine monohydrate and 31.35 mg of codeine sulfate trihydrate (each equivalent to 25 mg of codeine anhydrous). Nonmedicinal ingredients: hydroxyethyl cellulose, lactose, magnesium stearate, stearyl alcohol, and talc; film coating: opadry Blue Y-5-10544, FD&C Blue No. 2 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.

100 mg
Each yellow, round, scored, film-coated tablet with "PF" imprinted on one side and "CC 100" on the other contains 53 mg of codeine monohydrate and 62.7 mg of codeine sulfate trihydrate (each equivalent to 50 mg of codeine anhydrous). Nonmedicinal ingredients: hydroxyethyl cellulose, lactose, magnesium stearate, stearyl alcohol, and talc; film coating: opadry Yellow Y-5-2036, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 5 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.

150 mg
Each red, round, scored, film-coated tablet with "PF" imprinted on one side and "CC 150" on the other contains 79.5 mg of codeine monohydrate and 94.1 mg of codeine sulfate trihydrate (each equivalent to 75 mg of codeine anhydrous). Nonmedicinal ingredients: hydroxyethyl cellulose, lactose, magnesium stearate, stearyl alcohol, and talc; film coating: opadry Red Y-5-1842, FD&C Yellow No. 6 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.

200 mg
Each orange, caplet-shaped, scored, film-coated tablet with "PF" imprinted on one side and "CC 200" on the other contains 106 mg of codeine monohydrate and 125.4 mg of codeine sulfate trihydrate (each equivalent to 100 mg of codeine anhydrous). Nonmedicinal ingredients: hydroxyethyl cellulose, lactose, magnesium stearate, stearyl alcohol, and talc; film coating: opadry Orange Y-5-2467, FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.

Do not take this medication if you:

• are allergic to codeine or any ingredients of the medication
• are allergic to narcotic pain relievers
• are breast-feeding, pregnant, or going through labour or delivery
• are under 18 years of age, particularly after surgery to remove tonsils or adenoids for treatment of sleep apnea
• need a pain reliever for short term only
• have pain that can be treated by taking pain relievers occasionally
• have a head injury or increased pressure inside the head or spinal cord
• have acute alcoholism or are experiencing delirium tremens
• have acute asthma or other obstructive airway disease
• have acute respiratory depression
• have convulsive (seizure) disorders
• have cor pulmonale
• have severe central nervous system (CNS) depression (i.e., sedation)
• have surgical abdomen (a serious abdomen condition that usually requires surgery)
• have a blockage of the gastrointestinal tract, particularly paralytic ileus
• have taken monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine) within the past 14 days
• have been identified as an ultra-rapid metabolizer of codeine (your body breaks down codeine into its active form faster and more completely than other people)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• confusion
• constipation
• decreased sexual ability or interest
• dizziness, lightheadedness, or feeling faint
• drowsiness
• dry mouth
• headache
• itching
• nausea
• sweating
• trouble sleeping
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision
• decreased coordination
• fast, slow, or irregular heartbeat
• loss of appetite
• signs of a bowel blockage (e.g. abdominal pain, severe constipation, nausea)
• symptoms of withdrawal (e.g., nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (i.e., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• slow, shallow, or weak breathing
• symptoms of overdose (i.e., cold and clammy skin, abnormally slow or weak breathing, severe dizziness, confusion, slow heartbeat, or extreme drowsiness)
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abdominal (stomach) conditions: Codeine and other narcotic medications can reduce the movement of material through the digestive system, which may make diagnosing certain conditions more difficult. It may also worsen abdominal conditions. If you have any abdominal conditions or history of abdominal conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Adrenal gland problems: Adrenal glands produce chemical messengers that are responsible for the normal function of the body's organs, including how your body responds to injury or stress. On rare occasions, codeine may cause your adrenal glands to function improperly. Your doctor may monitor your adrenal gland condition especially if you have experienced stress such as surgery, injury, or severe infection.

Alcohol use: People taking this medication should not consume alcohol, or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness, since doing so can increase the risk of serious and potentially fatal side effects. This medication is not recommended for people with alcohol abuse problems.

Asthma/respiratory disease: Codeine and other narcotic pain relievers can reduce the body's drive to breathe. As a result, people with breathing problems are at increased risk of not getting enough oxygen. If you have asthma or another respiratory disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Blood pressure: Codeine and other narcotic pain relievers may cause a severe drop in blood pressure in some individuals. If you experience severe dizziness or fainting, contact your doctor as soon as possible.

Constipation: Constipation is a common side effect of taking narcotic pain relievers on a regular basis. One complication of constipation is fecal impaction, which is more likely to occur in the elderly or bedridden. This can result in a medical emergency if not treated promptly. For this reason, appropriate bowel habits are very important. Your doctor may prescribe the use of stimulant laxatives, stool softeners, and other measures to be used as required.

Dependence and withdrawal: This medication may become habit-forming if taken for long periods of time. Drug abuse is not a problem for people who require this medication for pain relief. Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with narcotic analgesics such as codeine. Withdrawal symptoms may be experienced if the dose is significantly reduced or suddenly discontinued. These symptoms include seizures, irritability, sleep problems, agitation, tremors, diarrhea, abdominal cramps, vomiting, headache, muscle cramps, extreme anxiety, tension, restlessness, sweating, and confusion. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms when this medication is no longer required for pain control.

Drowsiness/reduced alertness: Codeine may impair the mental or physical abilities needed for activities such as driving a car or operating machinery. Avoid activities that require alertness until you know how codeine affects you.

Head injury: Codeine can cause increased pressure inside the head and cause breathing to slow or even stop for people with head injury. If you have an acute head injury or other conditions which increase intracranial pressure (pressure inside the head), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Decreased kidney function and kidney disease may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: As with other narcotic medications, codeine may worsen pre-existing seizure disorders. If you have a seizure disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin syndrome: Severe reactions are possible when codeine is combined with medications used to treat depression. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are also possible. If you are taking medications for depression or migraine headache, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Sleep apnea: Sleep apnea is a condition where you stop breathing for short periods while asleep. This can be caused or made worse by medications that slow breathing such as codeine. If you or your partner notices episodes where you are not breathing then suddenly start to breathe again, contact your doctor as soon as possible.

Urinary tract conditions: Codeine and other narcotic pain relievers can contribute to reduced urine flow through the urinary tract. If you have an enlarged prostate or other urinary tract conditions such as urethral narrowing, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Thyroid disease: People with thyroid disease, such as underactive thyroid or Addison's disease may be more sensitive to the effects of codeine controlled release and may need lower doses.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Infants born to mothers who have taken codeine during pregnancy have been born with signs of narcotic withdrawal, which can be life-threatening. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. Some of the codeine dose is converted into morphine by the body, once it has been taken. For some people, this change happens much faster than for others. If this happens to a nursing mother, the baby is at risk of receiving a morphine overdose through the breast milk. Codeine controlled release is not recommended for women who are breast-feeding.

Children: The safety and effectiveness of this medication have not been established in children under the age of 18 years.

Seniors: Seniors may be more sensitive to the effects of this medication and may need lower doses.

There may be an interaction between codeine controlled release and any of the following:

• abiraterone
• aclidinium
• alcohol
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• antipsychotics (e.g., quetiapine, risperidone,  ziprasidone)
• antihistamines that cause drowsiness (e.g., azelastine, cetirizine, chlorpheniramine, diphenhydramine, hydroxyzine, rupatadine)
• apalutamide
• aprepitant
• "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
• barbiturates (e.g., phenobarbital)
• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• bosentan
• brimonidine
• buprenorphine
• bupropion
• buspirone
• cannabis
• chloral hydrate
• cinacalcet
• clidinium
• clonidine
• cobicistat
• darifenacin
• darunavir
• desmopressin
• diltiazem
• disopyramide
• diuretics (water pills; hydrochlorothiazide, indapamide)
• domperidone
• dronedarone
• eluxadoline
• entacapone
• enzalutamide
• general anaesthetics (medications to put you to sleep for surgery)
• glycopyrrolate
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., doravirine, efavirenz, etravirine, nevirapine, rilpivirine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir, tipranavir)
• ipratropium
• lanreotide
• lemborexant
• lidocaine
• lithium
• lumacaftor and ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
• methadone
• metoclopramide
• mirabegron
• mirtazapine
• modafinil
• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
• nalbuphine
• naltrexone
• octreotide
• other narcotic analgesics (e.g., fentanyl, morphine, tapentadol, tramadol)
• oxybutynin
• pasireotide
• pegvisomant
• pomalidomide
• pramipexole
• pregabalin
• protein kinase inhibitors (e.g., crizotinib, dabrafenib, imatinib, nilotinib, ribociclib)
• rifabutin
• rifampin
• ropinirole
• rotigotine
• quinidine
• St. John's wort
• scopolamine
• seizure medications (e.g., carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, phenytoin, rufinamide, topiramate)
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• solifenacin
• somatostatin
• terbinafine
• thalidomide
• tiotropium
• tizanidine
• tolterodine
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, imipramine)
• tryptophan
• umeclidinium
• verapamil
• zolpidem
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.