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TEVA-LENOLTEC NO. 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.
SERIOUS WARNINGS AND PRECAUTIONS
Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the risks of overdose and death with immediate release opioid formulations, TEVA-LENOLTEC No. 2 and No. , 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 TEVA-LENOLTEC No. 2 and No. 3 poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Each patient’s risk should be assessed prior to prescribing TEVA-LENOLTEC No. 2 and No.
3, and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS). TEVA- LENOLTEC No. 2 and No. 3 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 TEVA- LENOLTEC No. 2 and No. 3. 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 TEVA-LENOLTEC No. 2 and No. 3 or following a dose increase. TEVA-LENOLTEC No. 2 and No. 3 must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving TEVA-LENOLTEC No.
2 and No. 3 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 TEVA-LENOLTEC No.
2 and No. 3, 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 TEVA-LENOLTEC No.
2 and No. 3 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 TEVA-LENOLTEC No. 2 and No. 3 should be avoided as it may result in dangerous additive effects, causing serious injury or death (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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TEVA-LENOLTEC No. 2 and No. 3 Page 6 of 41 SERIOUS WARNINGS AND PRECAUTIONS 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 prescribing of TEVA-LENOLTEC No. 2 and No. 3 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 Patients should be instructed not to give TEVA-LENOLTEC No. 2 and No. 3 (acetaminophen, caffeine and codeine phosphate) tablets to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
TEVA-LENOLTEC No. 2 and No. 3 should be stored securely to avoid theft or misuse. TEVA-LENOLTEC No. 2 and No. 3 should only be prescribed by persons knowledgeable in the administration of potent opioids, in the management of patients receiving potent opioids for the treatment of pain, and in the detection and management of respiratory depression, including the use of opioid antagonists.
Patients should be cautioned not to consume alcohol while taking TEVA-LENOLTEC No. 2 and No. 3 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. TEVA-LENOLTEC No. 2 and No. 3 Page 7 of 41 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, TEVA-LENOLTEC No. 2 and No. 3 are a potential drug of abuse and misuse, which can lead to overdose and death. Therefore, TEVA-LENOLTEC No. 2 and No. 3 should be prescribed and handled with caution. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being 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.
TEVA-LENOLTEC No. 2 and No. 3 are intended for oral use only. The tablets should be swallowed […]