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Seizures: Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range. Concomitant use of tramadol increases the seizure risk in patients taking: Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics), tricyclic antidepressants (TCAs), and other tricyclic compounds (eg, cyclobenzaprine, promethazine, etc.), or Opioids.
Administration of tramadol may enhance the seizure risk in patients taking: MAO inhibitors, neuroleptics or 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 (eg, head trauma, metabolic disorders, alcohol and drug withdrawal, central nervous system infections). In tramadol overdose, naloxone administration may increase the risk of seizure.
Anaphylactic Reactions: Patients with a history of anaphylactic reactions to codeine and other opioids may be at increased risk and therefore should not receive Tramadol + Paracetamol (Dolcet).
Serious and rarely fatal anaphylactic reactions have been reported in patients receiving therapy with tramadol.Advise patients to seek medical attention if they experience any symptoms of a hypersensitivity reaction.
Respiratory depression: Patients with significant respiratory depression (see Contraindications) or acute, severe bronchial asthma are at increased risk of life-threatening respiratory depression when treated with opioids.
Administer Tramadol + Paracetamol (Dolcet) cautiously in patients at risk for respiratory depression. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Treat such cases as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
Opioids can cause sleep-related breathing disorders such as sleep apnea syndromes (including central sleep apnea [CSA]) and hypoxia (including sleep-related hypoxia) (see Adverse Reactions). 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, considering reducing or stopping the opioid treatment if appropriate, using best practices for tapering of opioids. ( Treatment withdrawal under Dosage & Administration, Precautions).
CYP2D6 Ultra-rapid Metabolism of Tramadol: 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 (see Overdosage). 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 (see Pharmacology: Pharmacokinetic under Actions). Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing) (see Overdosage).
Other risk factors for life-threatening respiratory depression in children: Life-threatening respiratory depression and death have occurred in children who received tramadol. Tramadol is subject to variability in metabolism based upon CYP2D6 genotype, which can lead to increased exposure to an active metabolite. Based upon postmarketing reports with tramadol, children younger than 12 years of age may be more susceptible to the respiratory depressant effects of tramadol (see Contraindications). Furthermore, children with obstructive sleep apnea who are treated with opioids for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to their respiratory depressant effect (see Contraindications). Because of the risk of life-threatening respiratory depression and death, avoid the use of Tramadol + Paracetamol (Dolcet) in adolescents younger than 18 years of age who have other risk factors include conditions associated with hypoventilation such as postoperative status, obstructive sleep apnea and concomitant use of other medications that cause respiratory depression. As with adults, when prescribing opioids for adolescents, healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of opioid overdose.
Use with Central Nervous System Depressants, including alcohol: The concomitant use of tramadol (an active ingredient in Tramadol + Paracetamol (Dolcet)) with CNS depressants, including alcohol, may cause additive CNS depressant effects, including profound sedation and respiratory depression. Tramadol + Paracetamol (Dolcet) should be used with caution and in reduced dosages when administered to patients receiving CNS depressants.
Increased Intracranial Pressure or Head Trauma: Tramadol + Paracetamol (Dolcet) should be used with caution in patients with increased intracranial pressure or head injury.
Drug dependence and potential for abuse: Tramadol + Paracetamol (Dolcet) contains tramadol as an active ingredient. A portion of the analgesic effect of Tramadol + Paracetamol (Dolcet) is attributable to the binding of the active ingredient, tramadol, to the mu-opioid receptor. Upon repeated administration of opioids, tolerance, physical dependence and psychological dependence may develop, even at the recommended dosages. Assess each patient's risk for opioid dependence and abuse prior to prescribing Tramadol + Paracetamol (Dolcet) and monitor all patients with personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g. major depression). Tramadol + Paracetamol (Dolcet) should not be used in opioid-dependent patients. Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids.
Increased risk of Hepatotoxicity with alcohol use: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive paracetamol use.
Treatment Withdrawal: Withdrawal symptoms may occur if Dolcet is discontinued abruptly. Panic attacks, severe anxiety, hallucinations, paresthesia, tinnitus and unusual CNS symptoms have also been rarely reported with abrupt discontinuation of tramadol hydrochloride. Clinical experience suggests that withdrawal symptoms may be relieved by tapering the medication.
Use with serotonergic drugs: Use Tramadol + Paracetamol (Dolcet) with great caution in patients taking serotonergic drugs including SSRIs. Concomitant use of tramadol with serotonergic drugs including SSRI's increases the risk of adverse events, including seizure and serotonin syndrome.
Renal Impairment: Tramadol + Paracetamol (Dolcet) has not been studied in patients with impaired renal function. In patients with creatinine clearances of <30 mL/min, it is recommended that the dosing interval of Dolcet be increased not to exceed 2 tablets every 12 hrs.
Hepatic Impairment: The use of Tramadol + Paracetamol (Dolcet) in patients with severe hepatic impairment is not recommended.
Serious Skin Reactions: Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported very rarely in patients receiving paracetamol.
Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Hyponatremia: Hyponatremia has been reported very rarely with the use of Tramadol + Paracetamol (Dolcet), 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 Tramadol + Paracetamol (Dolcet) and appropriate treatment (e.g. fluid restriction). During Tramadol + Paracetamol (Dolcet) treatment, monitoring for signs and symptoms of hyponatremia is recommended for patients with predisposing risk factors.
General: The recommended dose of Dolcet should not be exceeded. Dolcet should not be co-administered with other tramadol or paracetamol-containing products.
Effects on the Ability to Drive or Operate Machinery: Dolcet may impair mental and physical abilities required for the performance of potentially hazardous tasks eg, driving a car or operating machinery.
