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In case a person who drinks daily three glasses of alcohol or more at regular basis has to take this drug or other antipyretic analgesic, he/she should discuss with doctors or pharmacists. If these patients take this drug, liver damage can be caused.
In patients administered with paracetamol, serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) very rarely have been reported and these serious skin reactions can be fatal. Therefore, these signs of serious cutaneous reactions should be informed sufficiently to the patients, and if any signs of skin rash or other hypersensitivity reactions following administration of this drug occur, administration should be discontinued immediately.
Seizures have been reported in patients receiving tramadol within the recommended dosage range and it has shown that the seizure risk is increased with doses of tramadol above the recommended range.
Concomitant use of tramadol increases the seizure risk in patients taking with the drugs including the following: Selective serotonin reuptake inhibitor (SSRI antidepressants or anorectics); Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.); Other opioids.
Concomitant use of tramadol may increase the seizure risk in patients taking with the following drugs: MAO (Monoamine Oxidase) inhibitor; Neuroleptics; Other drugs that reduce the seizure threshold.
Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol or drug withdrawal, CNS infections).
Rarely fatal anaphylactoid reactions have been reported in patients administered with tramadol.
Patients with acute, severe bronchial asthma are at increased risk of life-threatening respiratory depression when treated with opioids. This drug should only be used in this patient population in a monitored setting and with the availability of resuscitative equipment. When administering this drug in patients who may be at risk for respiratory depression, caution should be taken, and the use other non-opioid analgesics should be considered.
Concomitant use of tramadol with central nervous system (CNS) depressants including alcohol or benzodiazepines, may result in profound sedation, respiratory depression, coma, and death. Due to these risks, reserve concomitant prescribing for use of this drug and CNS depressants in patients for whom there is no alternative treatment options. If concomitant use of this drug and CNS depressants is determined, limit dosages and durations to the minimum required, and closely follow patients for signs and symptoms of respiratory depression and sedation.
If this drug is administered to patients with increased intracranial pressure or head injury, these symptoms may be exaggerated in these patients by the respiratory depressant effects of opioids and include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure.
Tramadol may lead to physical and psychological dependence in μ-opioid type.
Hepatotoxicity: This drug contains paracetamol and tramadol. Occasionally, paracetamol is associated with liver transplantation and acute hepatic failure resulting in death, and most of liver damage is involved with use of over 4,000 mg per day in combination with other paracetamol products, thus it should be used with caution. Especially, patients with hepatic impairment should consult physician before administration.
Patients who are CYP2D6 ultra-rapid metabolizers may convert tramadol to its active metabolite (M1) more rapidly and completely than other patients. This rapid conversion may result in higher than expected serum M1 levels which could lead to an increased risk of respiratory depression. Alternative medication, dose reduction and/or increased monitoring for signs of tramadol overdose, such as respiratory depression is recommended in patients known to be CYP2D6 ultra-rapid metabolizers. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (see Symptoms and signs: Tramadol under Overdosage).
Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children: Life-threatening respiratory depression and death have occurred in children who received tramadol. Some of the reported cases occurred following tonsillectomy and/or adenoidectomy, and the child had evidence of being an ultra-rapid metabolizer of tramadol due to a CYP2D6 polymorphism. This drug is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of Paracetamol + Tramadol (Dolcet mini) in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol.
This drug can cause sleep-related breathing disorders such as sleep apnea syndromes (including central sleep apnea [CSA]) and hypoxia (including sleep-related hypoxia). Opioid use increases the risk of CSA in a dose-dependent fashion. Evaluate patients on an ongoing basis for the onset of a new sleep apnea, or a worsening of an existing sleep apnea. In these patients, consider reducing or stopping the opioid treatment if appropriate, using best practices for tapering of this drug.
Hyponatremia has been reported very rarely with the use of this drug, usually in patients with predisposing risk factors, such as elderly patients and/or patients using concomitant medications that may cause hyponatremia. In some reports, this hyponatremia appeared to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and resolved with discontinuation of this drug and appropriate treatment (e.g. fluid restriction). During this drug treatment, monitoring for signs and symptoms of hyponatremia is recommended for patients with predisposing risk factors.
