Ultra Metsemi Tablet (Tramadol Hydrochloride, Acetaminophen)

Adult dose

Children aged 12 and older, and adults: The dosage should be adjusted according to the patient's pain intensity and response to treatment. A recommended initial dose is 4 tablets, and thereafter, the dosing interval should be at least 6 hours, but not exceed 16 tablets in one day. Administer the lowest effective dose for the shortest duration possible. Avoid unnecessary prolonged use of this medication, and if prolonged use is necessary due to the nature and severity of the disease, regular monitoring should be conducted to assess the continuation of this medication. Elderly Administer the usual adult dose. However, for elderly patients over 75 years, the elimination half-life of tramadol increased by 17% when taken orally, therefore maintain an interval of at least 6 hours between doses. Renal impairment patients For patients with moderate renal impairment (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. Severe renal impairment patients (creatinine clearance of less than 10 ml/min) should not receive this medication. Tramadol is eliminated very slowly during hemodialysis and filtration; therefore, there is no need to re-administer this medication after dialysis to maintain analgesic effects. Hepatic impairment patients For patients with moderate hepatic impairment, careful consideration should be given to extending the dosing interval. Patients with severe hepatic impairment should not receive this medication.

Child dose

Children aged 12 and older, and adults: The dosage should be adjusted according to the patient's pain intensity and response to treatment. A recommended initial dose is 4 tablets, and thereafter, the dosing interval should be at least 6 hours, but not exceed 16 tablets in one day.

This medication may cause liver damage, so those who regularly consume more than three drinks a day must consult a doctor or pharmacist before use. Due to the acetaminophen component, there is a rare possibility of serious skin rash or allergic reactions. If a rash or hypersensitivity symptoms appear, discontinue use immediately and consult with a healthcare professional. Taking tramadol above the recommended dosage may increase the risk of seizures and the risk may be higher when taken with certain antidepressants or narcotic analgesics, so caution is required with medication combinations. Patients with severe respiratory conditions may require monitoring in a location equipped with cardiopulmonary resuscitation equipment due to the risk of respiratory depression caused by this medication. When taken with alcohol or benzodiazepines, severe sedation, respiratory depression, or loss of consciousness may occur, so avoid combining these medications. Patients with increased intracranial pressure or head injury may have worsening symptoms due to the respiratory depressant effect of this medication, so caution is required. This medication can induce dependence similar to morphine, so careful observation for dependency should be conducted during prolonged use. Patients with impaired liver function may face a risk of liver damage when taking this medication, so usage should be discussed with a doctor, considering the acetaminophen content to avoid duplicate dosing with other antipyretic analgesics. Especially, depending on the CYP2D6 genotype, an increased drug metabolism rate may raise the risk of respiratory depression, requiring dosage adjustment or alternative medication for those affected. This medication should not be administered to children under the age of 12 or adolescents under 18 who have undergone tonsillectomy or adenoidectomy, and it is advisable for patients with sleep apnea to avoid this medication. This medication can cause hyponatremia, so elderly patients or those taking related medications should periodically check their blood sodium levels. Pregnant or breastfeeding women must consult a doctor before using this medication, particularly breastfeeding mothers should consider discontinuing breastfeeding or alternative treatments due to the possibility of this medication passing into breast milk and causing respiratory depression in the infant. While taking this medication, drowsiness or dizziness may occur; thus, avoiding dangerous activities like driving or operating machinery is advisable. In case of overdose, there is a risk of severe respiratory depression, seizures, and liver damage, necessitating immediate visits to emergency medical facilities and treatment like administration of antidotes if necessary. This medication may interact with various drugs; therefore, patients taking other medications must inform healthcare professionals, especially when combining with MAO inhibitors, antidepressants, or central nervous system depressants. This medication should be stored out of reach of children and securely managed to prevent misuse or abuse.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), profound systemic lethargy, sudden and severe headache, thunderclap headache, seizures, altered 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 sealed container that is well ventilated and ideally kept at room temperature between 1 to 30 degrees Celsius.

Appearance

Pale yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle