Expain ER Extended-Release Tablet

Adult dose

For initial dose, 1 tablet is recommended, with subsequent dosing intervals of at least 12 hours. Do not exceed 4 tablets per day. In cases requiring prolonged treatment, regular monitoring should be conducted to assess the continuation of therapy. For elderly patients, the usual adult dose is administered, but for those over 75, dosing intervals should be at least 12 hours apart.

This medication should be consulted with a doctor or pharmacist before use by individuals who regularly consume more than three alcoholic beverages a day, as this can lead to liver damage. This medication can rarely cause serious skin reactions, and if skin rash or hypersensitivity occurs, discontinue use immediately. The tramadol component in this medication may increase the risk of seizures; caution is required when used by individuals with a history of seizures or alongside other medications that may induce seizures. Rarely, life-threatening anaphylaxis reactions may occur in patients taking this medication, so be cautious of allergic symptoms. When administered to patients with acute and severe bronchial asthma, there is a high risk of respiratory depression. It should be administered only in settings with adequate medical equipment. Taking this medication with alcohol or benzodiazepines can increase the risk of severe sedation, respiratory depression, coma, and death, so concurrent use should be avoided. Patients with increased intracranial pressure or head injuries should use this medication with caution, as symptoms may worsen due to respiratory depression. Tramadol can lead to both psychological and physical dependence, so the risk of dependence should be considered with prolonged use. The acetaminophen ingredient in this medication can burden the liver, so those with liver dysfunction or who are using other acetaminophen products should be cautious. Particularly, ultra-rapid metabolizers of CYP2D6 may rapidly metabolize this medication's components, increasing the risk of respiratory depression; therefore, dose adjustment and monitoring are necessary. This medication should not be administered to children under 12 years old or adolescents under 18 years old who have undergone tonsillectomy and adenoidectomy, and it should be avoided in patients aged 12 to 18 years with specific risks. Hyponatremia may occur during treatment with this medication, so elderly patients or those with risk factors should be monitored closely for symptoms. This medication is contraindicated in individuals with hypersensitivity to its components, severe respiratory depression, central nervous system drug intoxication, severe liver, kidney, or heart dysfunction, breastfeeding mothers, and certain pediatric patients. Drowsiness or dizziness may occur during treatment, which requires caution when driving or operating machinery. In case of overdose, severe respiratory depression and liver damage may occur, so it is important to adhere to the recommended dosage, and in case of overdose, contact a medical institution immediately. This medication can interact with multiple drugs, and it is essential to consult a doctor or pharmacist when taking other medications. Pregnant or breastfeeding women should consult healthcare professionals before taking this medication, especially breastfeeding mothers should be attentive to adverse reactions in breastfed infants. Elderly patients need careful observation when using this medication due to the potential decline in liver, kidney, and heart function.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, breathing difficulties accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Pale yellow rectangular film-coated extended-release tablet

Package unit

30 tablets, 100 tablets/bottle