Santramol Special Precautions

General: The recommended dose of SANTRAMOL should not be exceeded.
Do not co-administer SANTRAMOL with other Tramadol or Paracetamol products. (See Use with other Paracetamol-containing products and Risk of Overdosage under WARNINGS).
Acute Abdominal Conditions: The administration of SANTRAMOL may complicate the clinical assessment of patients with acute abdominal conditions.
Information for Patients: SANTRAMOL may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
SANTRAMOL should not be taken with alcohol containing beverages.
The patients should be instructed not to take SANTRAMOL in combination with other Tramadol or Paracetamol containing products, including over-the counter preparations.
SANTRAMOL should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.
The patients should be instructed to inform the physician if they are pregnant, think they might become pregnant, or are trying to become pregnant.
The patients should understand the single-dose and 24-hour dose limit and the time interval between doses, since exceeding these recommendations can result in respiratory depression, seizures, hepatic toxicity and death.
Serious Skin Reaction: Serious skin reactions including Acute Generalized Exanthematous Pustulosis (AGEP), Steven-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), are reported to be very rare in patients receiving Paracetamol.
Patients should be informed about signs of a serious skin reaction, and if there is use of the drug should be stopped since the first signs of redness appear on the skin or other symptoms associated with hypersensitivity.
Effects on Ability to Drive and Use Machines: SANTRAMOL may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
Use in Renal Disease: SANTRAMOL has not been studied in patients with impaired renal function. Experience with Tramadol suggests that impaired renal function results in a decreased rate and extent of excretion of Tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of SANTRAMOL be increased not to exceed 2 caplets every 12 hours.
Use in Hepatic Disease: SANTRAMOL has not been studied in patients with impaired hepatic function. The use of SANTRAMOL in patients with hepatic impairment is not recommended. (See Use with Alcohol under WARNINGS).
Use in Children: The safety and effectiveness of SANTRAMOL has not been studied in the pediatric population.
Use in Elderly: In general, dose selection for an elderly patients should be cautions, reflecting the greater frequency of decreased hepatic, renal, or cardiac function; of concomitant disease and multiple drug therapy.