Phenacet Tablets (Tramadol Hydrochloride, Acetaminophen)

Adult dose

It is recommended to start with a dose of 2 tablets, with subsequent dosing intervals of at least 6 hours, but not exceeding 8 tablets per day. Elderly patients may receive the usual adult dose, but those aged 75 and older should be dosed at intervals of at least 6 hours. Moderate renal impairment patients should extend dosing intervals to 12 hours, and this medication should not be given to patients with severe renal impairment. Patients with moderate liver impairment may require caution in extending dosing intervals.

Child dose

Children aged 12 years and older should be dosed the same as adults, adjusted according to the patient's pain level and treatment response. The dosing interval should be at least 6 hours, and not exceed 8 tablets per day.

This medication may impose stress on the liver, so those who regularly consume more than three drinks a day should consult a doctor or pharmacist before use. The acetaminophen component may rarely cause serious skin reactions, so if a rash or hypersensitivity occurs after taking the medication, discontinue use immediately and consult medical professionals. The tramadol component may increase the risk of seizures if the recommended dose is exceeded, and the risk may further increase if taken with certain antidepressants or opioid analgesics. Patients with compromised respiratory function, especially those with acute or severe bronchial asthma, may experience serious respiratory depression while taking this medication and should use it in a monitored medical environment. Taking this medication with alcohol or central nervous system depressants such as benzodiazepines may result in severe drowsiness, respiratory depression, or coma, so co-administration should be avoided or approached with caution. Patients with head injuries or brain diseases should be cautious when taking this medication as it may exacerbate increased intracranial pressure or respiratory depression. The tramadol component may induce psychological or physical dependence, so dependency should be carefully monitored during long-term use. Patients with impaired liver function may risk liver damage due to the acetaminophen component and should consult a doctor before use. Especially for those who are ultra-rapid metabolizers of CYP2D6, there is a risk of excessive production of the active metabolite leading to severe respiratory depression, so caution is required. This medication should not be administered to children, particularly those under 12 years old or adolescents under 18 who have undergone tonsillectomy or adenoidectomy, and it is advisable to avoid use in those aged 12 to 18 with risk factors. This medication may induce sleep apnea or hypoxia, so continuous observation for worsening symptoms is necessary. There may be a risk of hyponatremia, so especially elderly patients or those at risk for hyponatremia should closely monitor symptoms while using it. This medication may interact with multiple drugs, so if other medications are being taken, it is essential to inform healthcare providers. Women who are pregnant or may become pregnant should consult a doctor before taking this medication, and it is advisable to avoid it while breastfeeding. Drowsiness or dizziness may occur during use, so caution is needed when driving or operating machinery. In case of overdose, severe respiratory depression or liver damage may occur, so strict adherence to dosing is necessary, and immediate medical attention should be sought in case of overdose. This medication should be stored in a safe place out of the reach of children, and care should be taken to prevent misuse and accidental ingestion.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, vision changes, paralysis, urinary retention.

Mild side effects

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

This medication should be kept in an airtight container and stored at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness over time.

Appearance

Pale yellow, oval film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle