Mighty Set Semicapsule (Tramadol Hydrochloride, Acetaminophen)

Adult dose

For children aged 12 and older and adults: The dosage should be adjusted based on the patient's level of pain and therapeutic response. An initial dose of 4 tablets is recommended, with subsequent doses administered with a minimum interval of 6 hours, ensuring not to exceed 16 tablets per day. The effective lowest dose should be administered for the shortest duration possible. Avoid prolonged use of this medication beyond what is necessary, and if long-term administration is required due to the characteristics and severity of the disease, regular monitoring should confirm the continued use of this medication. Elderly Administer the usual adult dosage. However, it should be noted that the elimination half-life of tramadol increases by 17% in elderly individuals over 75 years old, thus administering this medication with a minimum interval of more than 6 hours is recommended. Renal Impairment In cases of moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the administration interval to 12 hours. In cases of severe renal impairment (creatinine clearance of less than 10 mL/min), administration is not recommended. Tramadol is eliminated very slowly during blood dialysis and filtration, so there is no need for re-administration of this medication post-dialysis to maintain analgesic effects. Hepatic Impairment In patients with moderate hepatic impairment, careful consideration should be given to extending the administration interval. In patients with severe hepatic impairment, this medication should not be administered.

Child dose

Children aged 12 and older should follow the same dosage and administration interval as adults.

This medication may burden the liver, so individuals who regularly consume more than three drinks of alcohol per day must consult their doctor or pharmacist. The acetaminophen component can rarely cause serious skin reactions, so if skin rashes or hypersensitivity reactions occur, discontinue use immediately. The tramadol component may increase the risk of seizures if taken above the recommended dose, and the risk of seizures may further increase when taken with certain antidepressants or narcotics. For patients with severe respiratory diseases, this medication may cause respiratory depression, which can be life-threatening, so it must be administered in an adequately equipped facility. Combining this medication with alcohol or central nervous system depressants can lead to severe sedation, respiratory depression, or coma, so caution is advised. Patients with increased intracranial pressure or head injuries may experience worsened symptoms when taking this medication. The tramadol component can cause psychological and physical dependence; therefore, careful monitoring of dependence should be conducted during long-term use. Patients with impaired liver function should consult their doctor before taking this medication, as excessive intake of acetaminophen can lead to severe liver damage. Particularly for ultra-rapid metabolizers of CYP2D6, the concentration of the active metabolite can increase, raising the risk of respiratory depression, requiring caution. This medication should not be administered to children, especially those under 12 years of age or teenagers under 18 who have undergone tonsillectomy and adenoidectomy. It may induce sleep apnea or hypoxia, so continuous monitoring for these symptoms, or any worsening of them, is necessary. Patients at risk for hyponatremia should monitor for symptoms of hyponatremia while taking this medication. This medication is contraindicated in certain patient populations, for example, those with hypersensitivity to the components, severe respiratory depression, head injuries, or those taking MAO inhibitors should not take this medication. Patients taking narcotic analgesics or central nervous system depressants, those with severe liver or kidney dysfunction, and those with alcohol dependence should use caution when taking it. This medication may cause drowsiness or dizziness, so caution should be exercised when driving or operating machinery. In case of overdose, serious side effects such as respiratory depression, seizures, or liver damage may occur; therefore, the dosage must be strictly adhered to, and in case of overdose, medical attention should be sought immediately. Women who are pregnant or breastfeeding should consult their doctor before taking this medication, and breastfeeding mothers should avoid this medication as it is safer not to take it. During the use of this medication, if abnormal symptoms such as seizures, allergic reactions, or difficulty breathing appear, inform healthcare personnel immediately.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

Mild side effects

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

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. Additionally, avoid extremely hot or cold locations, and it is advisable to store it at a temperature between 1 to 30 degrees Celsius, which is typical room temperature.

Appearance

Pale yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle