Therapen Semi-Tablet

Adult dose

For children aged 12 and older and adults: The dosage should be adjusted according to the patient's level of pain and treatment response. It is recommended to start with a dose of 4 tablets, and thereafter the interval between doses should be at least 6 hours, not exceeding 16 tablets per day. The lowest effective dose should be administered for the shortest duration possible. Do not administer this medication for longer than necessary, and if long-term administration is required due to the nature and severity of the disease, regular monitoring should be conducted to assess the need for continued treatment. Elderly Administer the usual adult dosage. However, for elderly patients over 75 years old, the elimination half-life of tramadol has been increased by 17%, so it should be administered with at least a 6-hour interval. Renal impairment In moderate renal impairment patients (creatinine clearance of 10-30ml/min), extend the dosing interval to 12 hours. In severe renal impairment patients (creatinine clearance less than 10ml/min), administration is not recommended. Tramadol is eliminated very slowly during hemodialysis and filtration; hence, there is no need to readminister this medication post-dialysis to maintain analgesic effects. Hepatic impairment In moderate hepatic impairment patients, carefully consider extending the dosing interval. In patients with severe hepatic impairment, do not administer this medication.

Child dose

There is no separate dosage specified for children as they are included in the category of those aged 12 and older.

This medication may put strain on the liver; therefore, individuals who regularly consume more than three glasses of alcohol per day should definitely consult with a doctor or pharmacist before taking this medication. If you experience serious skin reactions such as a rash, itching, or blisters during the course of taking this medication, you should immediately discontinue use and seek medical attention. The tramadol component in this medication can induce seizures, thus caution is required for patients with a history of seizures or those at high risk for seizures. Particularly, taking this medication in combination with certain antidepressants or other narcotic analgesics and neuroleptic agents may increase the risk of seizures, and therefore, consultation with a professional is essential. For patients with severe respiratory diseases, this medication carries a risk of suppressing respiration; thus, severe asthma patients should only use this medication in a monitored environment. Additionally, as this medication can affect the central nervous system, it may cause drowsiness or dizziness; caution is advised when driving or operating hazardous machinery. Combining narcotic analgesics with benzodiazepines or alcohol can lead to severe sedation, respiratory depression, or coma; therefore, extreme caution is warranted in such cases. Patients with liver dysfunction or impaired liver function must consult with a doctor before taking this medication and ensure not to exceed the recommended dosage. This medication should not be administered to children under 12 years old or to adolescents under 18 years old who have undergone tonsillectomy or adenoidectomy, particularly in children due to the risk of life-threatening respiratory depression. Women who are pregnant or breastfeeding must consult a doctor before taking this medication, and nursing mothers are advised to discontinue breastfeeding while taking this medication. Suddenly stopping this medication may result in withdrawal symptoms such as anxiety, insomnia, or sweating, so it should be tapered off under a doctor's guidance when discontinuing. In the case of overdose, serious side effects such as respiratory depression, seizures, or liver damage may occur, so it is crucial to adhere to the prescribed dosage and seek immediate medical attention in an emergency. During treatment, care should be taken not to concurrently take other analgesics or medications containing acetaminophen, and it is necessary to notify the doctor or pharmacist of any other medications being taken due to possible drug interactions. Lastly, this medication should be stored out of the reach of children, and it should be kept securely to prevent misuse or accidental ingestion.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, seizures, fatal anaphylactic reaction, life-threatening respiratory depression, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, yellowing of skin or eyes (jaundice), extreme drowsiness, hepatitis, sudden and severe symptoms

Mild side effects

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

This medication should be stored in an airtight container and kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication and prevent degradation.

Appearance

Pale yellow oblong film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle