Older patients A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements. Renal insufficiency/dialysis and hepatic impairment In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage interval should be carefully considered according to the patients requirements. In cases of severe renal and/or severe hepatic insufficiency ZYDOL SR prolonged-release tablets are not recommended. Method of administration The tablets are to be taken whole, not divided or chewed, with sufficient liquid, with or without food. Duration of administration Tramadol should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary. 4.3 Contraindications ZYDOL SR is contraindicated in hypersensitivity to the active substance or any of the excipients listed in section 6.1, in acute intoxication with alcohol, hypnotics, analgesics, opioids or other psychotropic medicinal products, in patients who are receiving MAO inhibitors or who have taken them within the last 14 days (see section 4.5), in patients with epilepsy not adequately controlled by treatment, for use in narcotic withdrawal treatment. 4.4 Special warnings and precautions for use ZYDOL SR may only be used with particular caution in opioid-dependent patients, patients with head injury, shock, a reduced level of consciousness of uncertain origin, disorders of the respiratory centre or function, increased intracranial pressure. In patients sensitive to opiates the medicinal product should only be used with caution. Care should be taken when treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered (see section 4.5), or if the recommended dosage is significantly exceeded (see section 4.9) as the possibility of respiratory depression cannot be excluded in these situations.
Older patients A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements. Renal insufficiency/dialysis and hepatic impairment In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage interval should be carefully considered according to the patients requirements. In cases of severe renal and/or severe hepatic insufficiency ZYDOL SR prolonged-release tablets are not recommended. Method of administration The tablets are to be taken whole, not divided or chewed, with sufficient liquid, with or without food. Duration of administration Tramadol should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary. 4.3 Contraindications ZYDOL SR is contraindicated in hypersensitivity to the active substance or any of the excipients listed in section 6.1, in acute intoxication with alcohol, hypnotics, analgesics, opioids or other psychotropic medicinal products, in patients who are receiving MAO inhibitors or who have taken them within the last 14 days (see section 4.5), in patients with epilepsy not adequately controlled by treatment, for use in narcotic withdrawal treatment. 4.4 Special warnings and precautions for use ZYDOL SR may only be used with particular caution in opioid-dependent patients, patients with head injury, shock, a reduced level of consciousness of uncertain origin, disorders of the respiratory centre or function, increased intracranial pressure. In patients sensitive to opiates the medicinal product should only be used with caution. Care should be taken when treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered (see section 4.5), or if the recommended dosage is significantly exceeded (see section 4.9) as the possibility of respiratory depression cannot be excluded in these situations.
ie-spc-1189-1-7-sr150mg-tabs-clean.docx