Revaset Semi Tablet (Tramadol Hydrochloride, Acetaminophen)

Adult dose

For children over 12 years and adults: The dose should be adjusted according to the patient's level of pain and treatment response. An initial dose of 4 tablets is recommended, and after that, the dosing interval should be at least 6 hours apart, not exceeding 16 tablets per day. As low as effective doses should be administered for the shortest duration necessary. Avoid using this medication for longer than necessary; if prolonged usage is required due to the nature and severity of the condition, regular monitoring should be conducted to confirm the need for continued use of this medication. Elderly Administer the usual adult dose. However, for elderly patients over 75 years who take tramadol orally, the elimination half-life of tramadol increases by 17%, so the medication should be administered at least 6 hours apart. Renal impairment For moderate renal impairment (creatinine clearance of 10-30 ml/min), extend the dosing interval to 12 hours. It is not recommended for patients with severe renal impairment (creatinine clearance of less than 10 ml/min). Tramadol is eliminated very slowly during dialysis and filtration, so there is no need to redose this medication after dialysis to maintain analgesic effects. Liver impairment For moderate liver impairment, consider extending the dosing interval cautiously. Do not prescribe this medication for patients with severe liver impairment.

This medication carries a risk of liver damage, so individuals who regularly consume more than three glasses of alcohol daily must consult a doctor or pharmacist before taking it. Additionally, although rare, serious skin reactions may occur; if a rash or allergy symptoms develop, discontinue use immediately and inform healthcare providers. Tramadol, one of the components of this medication, may increase the risk of seizures, so patients with a history of seizures or those at high risk of seizures should take it cautiously. Particularly, when taken with selective serotonin reuptake inhibitors or tricyclic antidepressants, the risk of seizures may increase, necessitating caution. In patients with severe respiratory diseases, this medication may cause respiratory depression and should only be administered in a properly equipped medical environment. Also, co-administration with alcohol or benzodiazepine medications may result in severe sedation, respiratory depression, or coma, so concomitant use should be avoided. Patients with brain injuries or elevated intracranial pressure should be cautious, as the symptoms may worsen with this medication. This medication can cause psychological and physical dependence; therefore, long-term use requires close monitoring for potential dependence. Patients with impaired liver function must consult a doctor before taking this medication, as there is a risk of liver damage due to the acetaminophen component. Especially in cases where the individual possesses the genetic trait of being a CYP2D6 ultra-rapid metabolizer, excessive accumulation of the active ingredient may lead to severe respiratory depression, so caution is required. This medication should not be given to children under 12 years old or to adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy. Patients with sleep apnea or hypoxemia should have their condition regularly monitored, as symptoms may worsen after taking this medication. Moreover, there is a risk of hyponatremia, so elderly patients or those with relevant risk factors should monitor their blood sodium levels. Avoid concomitant use with other narcotic analgesics or acetaminophen preparations, and do not exceed the recommended dosage. Abrupt cessation of use may lead to withdrawal symptoms such as anxiety, insomnia, nausea, sweating; therefore, it is advisable to taper off gradually under a doctor's guidance. Rarely, serious allergic reactions such as anaphylaxis may occur; if allergy symptoms appear, inform healthcare providers immediately. This medication may interact with various drugs; thus, anyone taking other medications should inform their healthcare providers, especially when used in conjunction with MAO inhibitors, serotonergic agents, or drugs related to CYP3A4 and CYP2D6. Elderly patients may have various diseases alongside reduced liver, kidney, and heart function, warranting more careful monitoring during administration of this medication. During pregnancy, safety for the fetus has not been established; therefore, it should only be given when the benefits outweigh the risks. During breastfeeding, it is preferable not to administer this medication as it may be secreted in breast milk and cause sedation or respiratory depression in nursing infants. When taking this medication, drowsiness or dizziness may occur, necessitating caution while driving or operating machinery. In cases of overdose, severe symptoms such as respiratory depression, seizures, or liver failure may occur; hence, strictly adhere to the dosage and seek immediate medical attention if suspected. This medication should be stored out of reach of children and precautions taken to prevent abuse and accidental ingestion.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

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

This medication should be stored in a tightly closed container to prevent air or moisture ingress, ideally at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the medication's efficacy and ensure safe use.

Appearance

Pale yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle