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ACETAMINOPHEN WITH CODEINE is a brand name for Acetaminophen (also known as Paracetamol), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................................... 3 CONTRAINDICATIONS ................................................................................................................ 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Adverse effects of ACETAMINOPHEN WITH CODEINE – CAPLET (acetaminophen, caffeine and codeine phosphate) tablets are similar to those of other opioid analgesics and represent an extension of pharmacological effects of the drug class.
The major hazards of opioids include respiratory and central nervous system depression and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest. The most frequently observed adverse effects of acetaminophen, caffeine and codeine phosphate tablets are drowsiness, light-headedness, dizziness, sedation, shortness of breath, nausea, and vomiting.
These effects seem to be more prominent in ambulatory patients than in non- ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, dry mouth, hyperhidrosis, somnolence and agranulocytosis.
The incidence and severity of gastrointestinal upset is less than that after salicylate administration. The classic gastrointestinal irritation associated with non-steroidal anti-inflammatory drugs, including acetylsalicylic acid (ASA), does not occur with acetaminophen.
Sensitivity reactions are rare and may manifest as rash or urticaria. Cross-reactivity in ASA-sensitive persons has been rarely reported. If sensitivity is suspected, discontinue use of the drug. Higher doses of caffeine lead to overstimulation of the higher centres of the CNS.
Adverse CNS effects may include insomnia, restlessness, nervousness and mild delirium. Adverse gastrointestinal effects of caffeine may include nausea, vomiting, and gastric irritation. Although chronic administration of caffeine in animals has been associated with gastric ulceration, such a causal relationship in humans has not been adequately established to date.
Sedation:
Sedation is a common side effect of opioid analgesics, especially in opioid naïve individuals. Sedation may also occur partly because patients often recuperate from prolonged fatigue after the relief of persistent pain. Most patients develop tolerance to the sedative effects of opioids within three to five days and, if the sedation is not severe, will not require any treatment except reassurance.
SERIOUS WARNINGS AND PRECAUTIONS
, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate management of pain (see DOSAGE AND ADMINISTRATION). Addiction, Abuse, and Misuse ACETAMINOPHEN WITH CODEINE – CAPLET poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
ACETAMINOPHEN WITH CODEINE – CAPLET should be stored securely to avoid theft or misuse.
Life-Threatening Respiratory Depression:
OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of ACETAMINOPHEN WITH CODEINE – CAPLET. Infants exposed in-utero or through breast milk are at risk of life-threatening respiratory depression upon delivery or when being nursed.
Patients should be monitored for respiratory depression, especially during initiation of ACETAMINOPHEN WITH CODEINE – CAPLET or following a dose increase. ACETAMINOPHEN WITH CODEINE – CAPLET must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving ACETAMINOPHEN WITH CODEINE – CAPLET can lead to dangerous adverse events including death (see WARNINGS AND PRECAUTIONS).
Further, instruct patients of the hazards related to taking opioids including fatal overdose. Accidental Exposure Accidental ingestion of even one dose of ACETAMINOPHEN WITH CODEINE – CAPLET, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome (NOWS) Prolonged maternal use of ACETAMINOPHEN WITH CODEINE – CAPLET during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life- threatening (see WARNINGS AND PRECAUTIONS).
Interaction with Alcohol The co-ingestion of alcohol with ACETAMINOPHEN WITH CODEINE – CAPLET should be avoided as it may result in dangerous additive effects, causing serious injury or death (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).
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STORAGE AND STABILITY ACETAMINOPHEN WITH CODEINE – CAPLET:
Keep bottle tightly closed. Protect from light. Store between 15ºC - 30ºC. Do not use if neckband is damaged. Keep out of the sight and reach of children. SPECIAL HANDLING INSTRUCTIONS Not applicable. DOSAGE FORMS, COMPOSITION AND PACKAGING ACETAMINOPHEN WITH CODEINE – CAPLET caplets: Each white, oblong, biconvex caplet, imprinted TEC 1 on one side, reverse side plain, contains: acetaminophen 300 mg, caffeine 15 mg and codeine phosphate 8 mg.
Also contains as non-medicinal ingredients:
Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Silica Colloidal anhydrous. Alcohol-, Sucrose, Tartrazine-, Sulfite-, Paraben- and Gluten-free. 123 kcal. Available in bottles of 30, 100 and 200 caplets. 19 g/mol Structural formula: _________________________________________________________________________________________ ACETAMINOPHEN WITH CODEINE – CAPLET – Prescribing Information Page 28 of 39 REFERENCES Product Monograph for TYLENOL with Codeine No.
2 and TYLENOL with Codeine No. 3, Control No. 258437, Date of revision December 1, 2021. _________________________________________________________________________________________ ACETAMINOPHEN WITH CODEINE – CAPLET – Prescribing Information Page 29 of 39 READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION N ACETAMINOPHEN WITH CODEINE – CAPLET Acetaminophen, Caffeine and Codeine Phosphate Tablets 300 mg / 15 mg / 8 mg Read this carefully before you start taking ACETAMINOPHEN WITH CODEINE – CAPLET and each time you get a refill.
This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about ACETAMINOPHEN WITH CODEINE – CAPLET.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If excessive sedation persists beyond a few days, the dose of the opioid should be reduced and alternate causes investigated. Some of these are: concurrent CNS depressant medication, hepatic or renal dysfunction, brain metastases, hypercalcemia and respiratory failure.
If it is necessary to reduce the dose, it can be carefully increased again after three or four days if it is obvious that the pain is not being well controlled. Dizziness and unsteadiness may be caused by postural hypotension, particularly in elderly or debilitated patients, and may be alleviated if the patient lies down.
Nausea and Vomiting:
Nausea is a common side effect on initiation of therapy with opioid analgesics and is thought to occur by activation of the chemoreceptor trigger zone, stimulation of the vestibular apparatus and through delayed gastric emptying. The prevalence of nausea declines following continued treatment with opioid analgesics.
When instituting therapy with an _________________________________________________________________________________________ ACETAMINOPHEN WITH CODEINE – CAPLET – Prescribing Information Page 16 of 39 opioid for chronic pain, the routine prescription of an antiemetic should be considered.
In the cancer patient, investigation of nausea should include such causes as constipation, bowel obstruction, uremia, hypercalcemia, hepatomegaly, tumor invasion of celiac plexus and concurrent use of drugs with emetogenic properties.
Persistent nausea which does not respond to dosage reduction may be caused by opioid-induced gastric stasis and may be accompanied by other symptoms including anorexia, early satiety, vomiting and abdominal fullness. These symptoms respond to chronic treatment with gastrointestinal prokinetic agents.
Constipation:
Practically all patients become constipated while taking opioids on a persistent basis. In some patients, particularly the elderly or bedridden, fecal impaction may result. It is essential to caution the patients in this regard and to institute an appropriate regimen of bowel management at the start of prolonged opioid therapy.
Stimulant laxatives, stool softeners, and other appropriate measures should be used as required. As fecal impaction may present as overflow diarrhea, the presence of constipation should be excluded in patients on opioid therapy prior to initiating treatment for diarrhea.
Post-marketing Experience Adverse drug reactions (ADRs) identified during post-marketing experience with codeine, acetaminophen or the combination are shown below according to their System Organ Class (SOC). The frequencies are estimated from spontaneous reports and sales data.
Cardiac Disorders: (very rare) palpitations, tachycardia Gastrointestinal Disorders: (very rare) abdominal pain, dyspepsia. Immune System Disorders: (very rare) anaphylactic reaction, hypersensitivity, Investigations: (very rare) transaminases increased.
Nervous System Disorders: (very rare) headache, insomnia, sedation Psychiatric Disorders: (very rare) agitation, dependence, drug withdrawal syndrome, euphoric mood Respiratory, Thoracic and Mediastinal Disorders: (very rare) bronchospasm, dyspnoea, respiratory depression Vascular Disorders: (very rare) flushing Skin and Subcutaneous Tissue Disorders: (very rare) angioedema, dermatitis, fixed eruption, pruritus, rash, rash pruritus, urticaria Androgen deficiency: Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
The causal role of opioids in the clinical syndrome of hypogonadism is […]
_________________________________________________________________________________________ ACETAMINOPHEN WITH CODEINE – CAPLET – Prescribing Information Page 6 of 39 Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see WARNINGS AND PRECAUTIONS, Neurologic and DRUG INTERACTIONS).
• Reserve concomitant usage of ACETAMINOPHEN WITH CODEINE – CAPLET and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression and sedation. General ACETAMINOPHEN WITH CODEINE – CAPLET should be stored securely to avoid theft or misuse. Patients should be cautioned not to consume alcohol while taking ACETAMINOPHEN WITH CODEINE – CAPLET as it may increase the chance of experiencing serious adverse events, including death.
Patients on any opioid for pain should be counselled to consult a physician before using this product. Patients should be counselled to consult a physician if redness or swelling is 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, as these may be signs of a condition which requires medical attention.
Acetaminophen should not be taken for pain for more than 5 days or for fever for more than 3 days, unless directed by a physician. Do not take continuously without medical review. Patients should be counselled to contact a physician if pain or fever persists or gets worse, or if new symptoms occur.
Patients should be counselled not to use with other products containing acetaminophen, an opioid, or codeine. Patients should be counselled to discontinue codeine products and to seek urgent medical help at the earliest sign of codeine toxicity including symptoms such as extreme sleepiness, confusion or shallow breathing, which may be life threatening.
Abuse and Misuse Like all opioids, ACETAMINOPHEN WITH CODEINE – CAPLET are a potential drug of abuse and misuse, which can lead to overdose and death. Therefore, ACETAMINOPHEN WITH CODEINE – CAPLET should be used and handled with caution.
Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being _________________________________________________________________________________________ ACETAMINOPHEN WITH CODEINE – CAPLET – Prescribing Information Page 7 of 39 prescribed opioids.
All patients receiving opioids should be routinely monitored for signs of misuse and abuse. Opioids, such as codeine, should be used with particular care in patients with a history of alcohol and illicit/prescription drug abuse. However, concerns about abuse, addiction, and diversion should not prevent the proper management of pain.
ACETAMINOPHEN WITH CODEINE – CAPLET are intended for oral use only. The tablets should be swallowed whole. Abuse of oral dosage forms can be expected to result in serious adverse events, including death. Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals on whether acetaminophen or codeine have a potential for carcinogenesis or mutagenesis.
No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for impairment of fertility. Acetaminophen and codeine have been found to have no mutagenic potential using […]
Serious Warnings and Precautions • Even if you take ACETAMINOPHEN WITH CODEINE – CAPLET as directed, you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death. • When you take ACETAMINOPHEN WITH CODEINE – CAPLET, it must be swallowed whole.
Do not cut, break, crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you. • You may get life-threatening breathing problems while taking ACETAMINOPHEN WITH CODEINE – CAPLET. This is less likely to happen if you take it as directed.
Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing. • If you took ACETAMINOPHEN WITH CODEINE – CAPLET while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth.
This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms: o has changes in their breathing (such as weak, difficult or fast breathing) o is unusually difficult to comfort o has tremors (shakiness) o has increased stools, sneezing, yawning, vomiting, or fever Seek immediate medical help for your baby.
• Taking ACETAMINOPHEN WITH CODEINE – CAPLET with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
_________________________________________________________________________________________ ACETAMINOPHEN WITH CODEINE – CAPLET – Prescribing Information Page 30 of 39 What is ACETAMINOPHEN WITH CODEINE-CAPLET used for? • the short-term relief of mild to moderate pain.
ACETAMINOPHEN WITH CODEINE – CAPLET should not be taken for pain for more than 5 days, unless directed by your healthcare professional. How does ACETAMINOPHEN WITH CODEINE – CAPLET work? ACETAMINOPHEN WITH CODEINE – CAPLET combines the effects of the pain reliever, codeine, which acts on the brain and spinal cord, with the pain reliever, acetaminophen.
ACETAMINOPHEN WITH CODEINE – CAPLET also contains caffeine. Caffeine is a stimulant that increases activity in the brain and generally makes people feel more alert. It also affects the kidneys by causing an increased production of urine, and can increase your heart rate.
What are the ingredients in ACETAMINOPHEN WITH CODEINE – CAPLET? Medicinal ingredients: acetaminophen, caffeine and codeine phosphate. Non-medicinal ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silica colloidal anhydrous.
ACETAMINOPHEN WITH CODEINE – CAPLET comes in the following dosage forms:
Acetaminophen 300 mg, Caffeine 15 mg and Codeine Phosphate 8 mg, caplets. Do not use ACETAMINOPHEN WITH CODEINE – CAPLET if: • you are allergic to acetaminophen, caffeine, codeine or other opioids or any of the other ingredients in ACETAMINOPHEN WITH CODEINE – CAPLET • you can control your pain by the occasional use of other pain medications.
This includes those available without a prescription • you have asthma, trouble breathing, chronic lung disease or […]