Trapen Extended Release Tablets

Adult dose

Administer 1 tablet as the initial dose, with the subsequent dosing interval being at least 12 hours apart, not exceeding 4 tablets per day. Do not administer for longer than necessary, and if prolonged use is required, regular monitoring should be implemented. For the elderly, the standard adult dosage is recommended, but for those over 75 years, administration should be at intervals of at least 12 hours.

This medication should be discussed with a doctor or pharmacist before use by individuals who regularly consume more than three drinks of alcohol per day, as it can pose a risk of liver damage when taken with alcohol. If a rash or hypersensitivity reaction occurs during treatment, discontinue use immediately and consult a doctor, as severe skin reactions can occur rarely. Tramadol, one of the components of this medication, may increase the risk of seizures if taken in doses exceeding the recommended amount or with certain medications, particularly antidepressants or other opioids. In patients with severe respiratory diseases, this medication can cause respiratory depression that may threaten life, so it should be administered in an environment with appropriate equipment. Taking this medication with alcohol or central nervous system depressants can cause severe drowsiness, respiratory depression, and coma, so co-administration should be avoided or used with extreme caution. Patients with head injuries or brain disorders should be cautious, as this medication may increase intracranial pressure during use. This drug can cause dependencies similar to morphine, so careful consideration of dependence risk is necessary with long-term use. Patients with impaired liver function may experience a risk of liver damage due to the acetaminophen component, so consultation with a doctor is essential before use. Especially for individuals with a rapid-acting form of the enzyme CYP2D6, the concentration of the active ingredient in this medication may increase, thus elevating the risk of respiratory depression. This medication is not to be given to children under 12 years old or to adolescents under 18 years old who have undergone tonsillectomy and adenoidectomy, as life-threatening respiratory depression may occur in this age group. Rarely, during treatment, hyponatremia, which is a decrease in blood sodium levels, may occur; therefore, elderly patients or those with risk factors should be monitored closely for symptoms. This drug is not to be used in patients with hypersensitivity to its components, those with central nervous system drug dependence, severe respiratory depression, head injuries, those taking MAO inhibitors, or those with severe liver or kidney impairment. Ensure the recommended dosage is not exceeded, and avoid combining with other tramadol or acetaminophen-containing products for safety. Sudden discontinuation during treatment can lead to withdrawal symptoms, so doses should be tapered off gradually per doctor's instructions. Women who are pregnant or may become pregnant must carefully consider the risk and benefits of administering this medication, and breastfeeding women should avoid using it. Caution is required while driving or operating machinery, as drowsiness or dizziness may occur with this medication. In case of overdose, immediate emergency treatment is required as it may lead to severe respiratory depression or liver damage; appropriate treatment must be provided according to doctor's orders.

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in the oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough+fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination issues

Mild side effects

• Weakness
• fatigue
• flushing
• stiffness
• fainting
• withdrawal symptoms
• high blood pressure
• worsening of hypertension
• low blood pressure
• arrhythmia

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Additionally, it is recommended to store it at room temperature, specifically between 1 to 30 degrees Celsius, avoiding extreme heat or cold.

Appearance

Pale yellow oblong film-coated extended release tablet

Package unit

30 tablets/bottle, 100 tablets/bottle