Hypersensitivity to tramadol, paracetamol, or to any component in the product.
Acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs.
Patients on monoamine oxidase inhibitor (MAOI) therapy or if patients have taken such medications within the last 14 days before treatment with tramadol. (See Interactions.)
Severe hepatic or renal impairment.
Severely impaired kidney function (creatinine clearance < 10 mL/min).
Severe respiratory impairment (e.g., acute or severe bronchial asthma, bronchial asthma, chronic obstructive airway, or status asthmaticus) in an unmonitored setting or in the absence of resuscitative equipment.
Acute alcoholism, delirium tremens, and convulsive disorders.
Suspected or known mechanical gastrointestinal (GI) obstruction, (e.g., bowel obstruction or strictures); any conditions affecting bowel transit (e.g., ileus of any type); or in patients with suspected surgical abdomen (e.g., acute appendicitis or pancreatitis).
Significant acute respiratory depression, elevated carbon dioxide levels in the blood, and cor pulmonale.
Patients suffering from uncontrolled epilepsy or epilepsy not adequately controlled by treatment.
Severe central nervous system (CNS) depression, increased cerebrospinal or intracranial pressure, and head injury.
Children who are younger than 12 years old and to patients younger than 18 years old who have tonsillectomy and/or adenoidectomy.