Tracome Semi Tablet (Tramadol Hydrochloride, Acetaminophen)

Adult dose

Children aged 12 and older and adults: The dosage should be adjusted according to the degree of pain and the patient's response to treatment. An initial dose of 4 tablets is recommended, and thereafter, the dosing interval should be at least every 6 hours and not to exceed 16 tablets per day. Administer the minimum effective dose for the shortest duration possible. Avoid prolonged use beyond what is necessary, and if long-term administration is required due to the nature and severity of the disease, regular monitoring should be conducted to evaluate the continued need for this medication.

Child dose

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

This medication may put stress on the liver, so individuals who regularly consume more than three alcoholic drinks a day should consult with a physician or pharmacist before taking it. The acetaminophen ingredient can, although rarely, cause serious skin reactions; therefore, it is important to stop taking it immediately and notify medical personnel if any rash or hypersensitivity reactions appear on the skin. The tramadol ingredient can increase the risk of seizures if the recommended dosage is exceeded, and the risk of seizures can further increase if taken in conjunction with certain antidepressants or narcotics, so caution is warranted. Rarely, severe allergic reactions may occur during the use of this medication; therefore, if symptoms such as difficulty breathing or hives develop, immediate medical attention must be sought. Patients with severe respiratory disease may be at risk for respiratory depression when taking this medication; hence, it should be administered in an environment where medical staff can monitor them. Taking this medication with alcohol or central nervous system depressants can result in severe drowsiness, respiratory depression, or coma, so co-administration should be avoided. Patients with head trauma or brain diseases should be cautious as this medication may increase intracranial pressure. This medication may induce dependence similar to morphine; therefore, the duration and dosage should be adjusted considering the potential for dependence with long-term use. Patients with impaired liver function must consult a physician before taking this medication due to the risk of liver damage from acetaminophen. Especially for ultra-rapid metabolizers of CYP2D6, an excessive amount of active metabolites may be produced, increasing the risk of respiratory depression, so these individuals should consult their physician before taking it. This medication should not be given to children under 12 years old or adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy. Patients with sleep apnea or hypoxemia should be continuously monitored for symptom exacerbation while using this medication, and dosage adjustments or discontinuation should be made as necessary. Hyponatremia may occur while taking this medication; thus, particular attention should be paid to symptoms in the elderly or patients at risk of hyponatremia. This medication can interact with specific drugs; therefore, if there are other medications currently being taken, it is essential to inform healthcare professionals, and caution is required with co-administration. Pregnant or breastfeeding women should consult a physician before taking this medication, as it may affect the fetus or newborn. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating machinery. In case of overdose, severe side effects such as respiratory depression, seizures, or liver damage may arise; therefore, adherence to the prescribed dosage is crucial to avoid overdose. This medication should be stored in a safe place out of reach of children, and precautions should be taken to prevent misuse or accidental ingestion.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, difficulty or discomfort in breathing, asthma attack, cough and fever accompanied respiratory abnormalities, jaundice (yellowing of skin or eyes), extreme drowsiness, 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 sealed container to prevent air ingress and is best kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer time.

Appearance

Pale yellow rectangular film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle