Tracetase Tablets (Acetaminophen, Tramadol)

Adult dose

Children aged 12 years and older and adults: Dosage should be adjusted according to the level of pain and treatment response. An initial dose of 4 tablets is recommended, with subsequent dosing intervals being at least 6 hours apart and not exceeding 16 tablets in 1 day. Administer the effective minimum dose for the shortest duration possible. Ensure that this medication is not used for an extended period unnecessarily, and if long-term use is needed due to the nature and severity of the illness, regular monitoring should be performed to assess the need for continued use of this medication. Elderly patients Administer the standard adult dosage. However, for elderly patients over 75 years, the elimination half-life of tramadol increases by 17% when taken orally; thus, this medication should be given at least 6 hours apart. Renal impairment patients For moderate renal impairment (creatinine clearance 10-30ml/min), extend the dosing interval to 12 hours. For patients with severe renal impairment (creatinine clearance below 10ml/min), administration is not recommended. Tramadol is removed very slowly during dialysis and filtration; hence, there is no need to re-administer this medication after dialysis to maintain analgesic effects. Liver impairment patients For patients with moderate liver impairment, consider carefully the extension of the dosing interval. Do not administer this medication to patients with severe liver impairment.

Child dose

Children aged 12 years and older: Dosage should be adjusted according to the level of pain and treatment response, and an initial dose of 4 tablets is recommended. Dosing intervals should be at least 6 hours apart, but not exceed 1 day.

This medication may put a burden on the liver, so individuals who regularly consume more than three glasses of alcohol daily should consult a doctor or pharmacist before use. The acetaminophen component may rarely cause serious skin reactions, so discontinue use immediately and consult a specialist if skin rash or allergic symptoms occur. The tramadol component may increase the risk of seizures, thus caution is needed for patients with a history of seizures or those taking other medications that increase seizure risk. This medication may rarely cause serious allergic reactions, so notify medical personnel immediately if hypersensitivity symptoms occur. Patients with acute or severe bronchial asthma are at risk of respiratory depression; administer only where appropriate facilities are available, if necessary. Taking this medication with alcohol or central nervous system depressants may result in severe drowsiness, respiratory depression, and coma; avoid such combinations or follow a healthcare professional's instructions. Patients with elevated intracranial pressure or head injuries should be cautious as symptoms may worsen with this medication. Tramadol may cause psychological and physical dependence; monitor for dependency when used long-term. Patients with compromised liver function should consult a doctor before use and should avoid taking other acetaminophen products concurrently. Genetically fast metabolizers of tramadol have an increased risk of respiratory depression; dose adjustments and careful monitoring may be necessary. This medication should not be administered to children under 12 years old and to adolescents under 18 who have undergone tonsillectomy or adenoidectomy. Patients with sleep apnea or hypoxemia should continuously assess whether symptoms worsen during treatment, and consider dose adjustments or cessation if necessary. Elderly patients or those at risk for hyponatremia should be closely monitored for the occurrence of hyponatremia. During treatment, do not exceed the recommended dose or take other medications containing tramadol or acetaminophen. Patients with a risk of dependence or abuse of narcotic analgesics should be carefully monitored and administered for the shortest period possible. Abrupt discontinuation of use may result in withdrawal symptoms; therefore, it is advisable to taper off as per a doctor's instructions. This medication may interact with numerous other drugs, so if taking other medications, it is essential to inform healthcare personnel. Pregnant or nursing women should consult a doctor before taking this medication; especially breastfeeding women should avoid taking it for safety. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating machinery. In case of overdose, severe respiratory depression, seizures, liver damage, etc. may occur; strictly adhere to the prescribed dosage and seek medical attention immediately in case of overdose. Store in a safe place out of reach of children to prevent accidental ingestion.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by coughing and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues.

Mild side effects

• Loss of appetite
• insomnia
• depression
• dizziness
• headache
• drowsiness
• nausea
• vomiting
• constipation
• dry mouth

Store this medication in a sealed container to prevent exposure to air or moisture and keep it at a temperature between 1 to 30 degrees Celsius for optimal preservation. Proper storage will help maintain the medication's efficacy and prevent deterioration.

Appearance

Pale yellow rectangular film-coated tablets

Package unit

30 tablets/bottle, 500 tablets/bottle