Phenacet Tablet (Tramadol Hydrochloride, Acetaminophen)

Adult dose

Children over 12 years and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. A starting dose of 4 tablets is recommended, and subsequent intervals should be at least 6 hours apart but not exceed 16 tablets per day. The lowest effective dose should be administered for the shortest duration possible. Avoid prolonged use of this medication beyond necessity, and in cases requiring long-term use due to the disease's characteristics and severity, regular monitoring should be conducted to confirm the continued necessity for this medication. Elderly Administer the usual adult dosage. However, in elderly patients over 75 years of age receiving oral tramadol, the elimination half-life of tramadol increased by 17%, so doses should be administered at intervals of at least 6 hours. Patients with renal impairment For moderately impaired renal patients (creatinine clearance of 10-30 ml/min), extend administration intervals to 12 hours. For severely impaired renal patients (creatinine clearance less than 10 ml/min), this medication is not recommended. Tramadol is eliminated very slowly during hemodialysis and filtration, so there is no need to re-administer this medication after dialysis for the maintenance of analgesic effect. Patients with hepatic impairment For moderately impaired hepatic patients, careful consideration should be given to extending the administration interval. This medication should not be administered to patients with severe hepatic impairment.

Child dose

Children over 12 years and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. A starting dose of 4 tablets is recommended, and subsequent intervals should be at least 6 hours apart, but not exceed 16 tablets per day.

This medication may strain the liver, so individuals who regularly consume more than three drinks per day should consult a doctor or pharmacist before use. The acetaminophen included in this medication can rarely cause serious skin reactions; therefore, if a skin rash or hypersensitivity reaction occurs, discontinue use immediately and consult healthcare personnel. The main component, tramadol, may increase the risk of seizures if taken in doses higher than recommended, and the risk of seizures can be further increased if taken with certain antidepressants or other narcotic analgesics. Patients with impaired respiratory function or those with acute and severe bronchial asthma should use this medication with extra caution and should be in an environment where resuscitation equipment is available. Combining this medication with alcohol or central nervous system depressants may lead to severe sedation or respiratory depression, so this should be avoided. Patients with elevated intracranial pressure or head injury should be cautious when using this medication, as symptoms may worsen. This drug may cause psychological and physical dependence, so careful observation is needed for dependency when used for an extended period. Patients with compromised liver function must consult a doctor before taking this medication, and overdosing on acetaminophen should be avoided. Patients with certain genetic metabolic characteristics may produce excessive active metabolites, increasing the risk of serious side effects such as respiratory depression, so caution is advised. This medication should not be given to children under 12 years of age or teenagers under 18 who have undergone tonsillectomy or adenoidectomy, and it is advisable to avoid administering this drug to those aged 12 to 18 with risk factors. Patients with sleep apnea or hypoxemia should continuously monitor symptoms during use of this medication and consider dosage adjustments or discontinuation if necessary. Hyponatremia may occur while using this medication; therefore, particularly elderly patients or those at risk for hyponatremia should monitor symptoms. Individuals with a history of allergy to this medication’s components, central nervous system drug addiction, severe respiratory depression, head injury, or those currently taking MAO inhibitors should not receive this medication. This medication may cause drowsiness or dizziness; caution should be taken when driving or operating machinery. In case of overdose, serious respiratory depression or liver damage may occur, and immediate contact with a medical institution and appropriate treatment should be sought. This medication should be stored in a safe place out of the reach of children, and care should be taken to prevent drug misuse or accidents.

Serious side effects

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

Mild side effects

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

Store this medication in a tightly sealed container to prevent air ingress, maintaining a storage temperature between 1 degree and 30 degrees Celsius room temperature. This will help maintain the medication's effectiveness and safety.

Appearance

Light yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle