Details for: ACETAMINOPHEN WITH CODEINE - CAPLET

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ACETAMINOPHEN WITH CODEINE – CAPLET. Talk about any health conditions or problems you may have, including if you:

• have a history of illicit or prescription drug or consume 3 or more alcoholic beverages per day
• have severe kidney, liver or lung disease
• have low blood pressure
• have past or current depression
• suffer from chronic or severe constipation
• have problems with your thyroid, adrenal or prostate gland
• have difficulty urinating
• have, or had in the past hallucinations or other severe mental problems
• develop allergic reactions such as wheezing, rash or itching
• feel sedated or drowsy, are confused or have slow, shallow breathing
• have redness or swelling present in an area of pain, if symptoms do not improve or if they worsen, or if new symptoms such as high fever, rash, itching, wheezing or persistent
• headache occur
• have pain that lasts more than 5 days or for fever more than 3 days
• have difficulty breathing, asthma or chronic lung disease
• are pregnant or are planning to get pregnant
• suffer from migraines
• are elderly or debilitated
• take tranquilizers, sedatives, sedating antihistamines or other depressants, salicylates, other pain and fever relief medications or nonsteroidal anti-inflammatory drugs (NSAIDs)
• take, or plan to take a serotonergic drug, or are not sure whether you are taking a serotonergic drug (e.g. anti-depressants, migraine medications)
• have recently had surgery under general anesthesia

Other warnings you should know about

ACETAMINOPHEN WITH CODEINE – CAPLET can cause low levels of oxygen in the blood and a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your doctor if you have a history of sleep apnea or if anyone notices you stop breathing from time to time while sleeping.

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery:
Do not use ACETAMINOPHEN WITH CODEINE – CAPLET while nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while it is still in the womb. ACETAMINOPHEN WITH CODEINE – CAPLET can then cause life-threatening breathing problems in your unborn baby or nursing infant.

If you are pregnant, your doctor will determine if the benefits of using ACETAMINOPHEN WITH CODEINE – CAPLET outweigh the risks to your unborn baby. In addition, if you are pregnant and are taking this medication, it is important that you don’t stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking ACETAMINOPHEN WITH CODEINE – CAPLET. This may help avoid serious harm to your unborn baby.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to ACETAMINOPHEN WITH CODEINE – CAPLET.

ACETAMINOPHEN WITH CODEINE – CAPLET can cause:

• drowsiness
• dizziness or
• lightheadedness

This can usually occur after you take your first dose and when your dose is increased.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:

• nausea, vomiting
• feeling tired, weak or dizzy
• decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. If you develop any of the above symptoms, seek medical help right away.

Serotonin Syndrome: ACETAMINOPHEN WITH CODEINE – CAPLET can cause Serotonin Syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take ACETAMINOPHEN WITH CODEINE – CAPLET with certain anti-depressants or migraine medications.

Serotonin Syndrome symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Ultra-Rapid Metabolizers of Codeine:

Some individuals process codeine more rapidly and completely than others. This rapid processing in the body results in higher than expected drug levels. Even at the recommended doses, people whose bodies are ultra-rapid processors may have life-threatening or fatal effects on their breathing or experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing.

Drug Abuse and Dependence

Codeine can produce drug dependence and has the potential for being abused. Tolerance, psychological and physical dependence may develop over time with repeated use of ACETAMINOPHEN WITH CODEINE – CAPLET. Using this product for a prolonged period of time is not recommended.

Serious skin reactions (Stevens - Johnson Syndrome, Toxic Epidermal Necrolysis, Hypersensitivity Syndrome)

Acetaminophen can cause serious skin reactions that can spread to your mouth, lips, face, hands, trunk, arms and legs. This condition is life-threatening. Stop taking ACETAMINOPHEN WITH CODEINE – CAPLET and contact your healthcare professional immediately if you develop a rash during treatment (see table of Serious side effects and what to do about them, below).

Liver injury

Taking acetaminophen in doses higher than recommended may result in liver injury, including the risk of severe liver disease and death. Do not exceed the maximum recommended daily dose of acetaminophen including all routes of administration (intravenous, oral and rectal) and all products containing acetaminophen (oral solutions/drops, syrup, pills, capsules, suppositories etc.).