Suprafen Sustained-release Tablets (Tramadol, Acetaminophen)

Adult dose

Administer 1 tablet as an initial dose, ensuring a minimum interval of 12 hours before subsequent doses. Do not exceed 4 tablets in one day and do not use for an extended period unnecessarily. In severe cases requiring long-term use, regular monitoring should be performed. Side effects such as nausea, vomiting, itching, constipation, dizziness, and drowsiness may occur, thus close observation of patient responses is necessary.

This medication can impose a burden on the liver, so individuals who regularly consume more than three drinks per day should consult a physician or pharmacist before taking it. The acetaminophen component can rarely lead to serious skin reactions, and if skin rashes or hypersensitivity reactions occur after taking this medication, usage should be immediately discontinued. The tramadol component may increase the risk of seizures if taken above the recommended dosage, and the risk may be further elevated when taken with certain antidepressants or other central nervous system agents. Patients with severe respiratory diseases may experience life-threatening respiratory depression when taking this medication and should use it under medical supervision. Co-administration of this medication with alcohol or benzodiazepines can lead to severe drowsiness, respiratory depression, and coma; therefore, such combinations should be avoided. Patients with increased intracranial pressure or head injuries need to be cautious as respiratory depression from this medication can worsen their symptoms. This medication can cause dependency similar to morphine, so if taken for a long duration, dependency should be periodically evaluated. Patients with poor liver function must consult with a doctor before taking this medication, as the acetaminophen component can cause liver damage. Particularly, those with very rapid CYP2D6 enzyme metabolism should be careful as they may produce excess active metabolites, increasing the risk of respiratory depression. This medication should not be given to children under the age of 12 or teenagers under the age of 18 who have undergone tonsillectomy or adenoidectomy. Hyponatremia may occur during the use of this medication, so elderly patients or those at risk of hyponatremia need to be monitored for symptoms. This medication should be contraindicated or used with caution in patients with certain diseases or conditions, such as severe respiratory depression, head injuries, or severe liver or kidney disorders. Drowsiness or dizziness may occur during administration, so caution is advised when driving or operating machinery. In cases of overdose, serious respiratory depression or liver damage can occur; thus, do not exceed the prescribed dosage, and contact a medical facility immediately in case of abnormal symptoms. The risk of side effects may increase when this medication is combined with other analgesics or central nervous system depressants, so follow the guidance of professionals during concurrent administration. Pregnant or breastfeeding women should consult with a doctor before using this medication, especially during breastfeeding, as the components of this medication can be transmitted through breast milk and affect the infant. Various side effects, such as dependency, withdrawal symptoms, seizures, and allergic reactions, can occur while taking this medication, so it is vital to inform the healthcare provider immediately in case of any abnormal symptoms.

Serious side effects

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

Mild side effects

• Weakness
• fatigue
• flushing
• rigidity
• fainting
• withdrawal symptoms
• hypertension
• exacerbation of hypertension
• hypotension
• arrhythmia

This medication must be stored in a tightly sealed container to avoid exposure to air or humidity. Additionally, keep the medication at room temperature between 1°C and 30°C, avoiding very hot or very cold places.

Appearance

Light yellow oval sustained-release film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle