Enshitra Tablets (Tramadol Hydrochloride, Acetaminophen)

Adult dose

For children aged 12 years and older and adults: The dosage should be adjusted according to the patient's level of pain and therapeutic response. An initial dose of 2 tablets is recommended, and thereafter the interval between doses should be at least 6 hours, with no more than 8 tablets taken in a day. The lowest effective dose should be given for the shortest duration possible. Avoid using this medication for longer than necessary, and if prolonged use is needed due to the nature and severity of the illness, regular monitoring should be conducted to confirm the continued use of this medication. Elderly Administer the usual adult dosage. However, in individuals over 75 years of age, the elimination half-life of tramadol increases by 17%, so doses should be spaced a minimum of 6 hours apart. Renal Impairment For patients with moderate renal impairment (creatinine clearance of 10-30 mL/min), extend the dosing interval to 12 hours. Use is not recommended for patients with severe renal impairment (creatinine clearance of less than 10 mL/min). Tramadol is eliminated very slowly during hemodialysis and filtration, so there is no need to readminister this medication after dialysis to maintain analgesia. Hepatic Impairment For patients with moderate hepatic impairment, consider extending the dosing interval with caution. This medication is not to be administered to patients with severe hepatic impairment.

This medication may put a strain on the liver, so individuals who consume a lot of alcohol daily should consult a doctor or pharmacist before taking it. Acetaminophen included in this medication may rarely cause serious skin reactions, so if skin rashes or hypersensitivity symptoms occur, discontinue use immediately and consult a doctor. The tramadol component may increase the risk of seizures, so caution is required when taken with certain antidepressants or narcotic analgesics. Serious allergic reactions may occur rarely while taking this medication, so if symptoms such as difficulty breathing or hives appear, seek medical attention immediately. Patients with acute bronchial asthma may have difficulty breathing when taking this medication, so it should only be administered in a healthcare environment where staff are prepared. Taking this medication with alcohol or central nervous system depressants may result in severe drowsiness or respiratory suppression, so strict adherence to a physician's instructions is necessary when taking these together. Patients with head injuries or elevated intracranial pressure should be cautious as the respiratory suppression effect of this medication may worsen symptoms. The tramadol component may lead to dependency, and long-term use should be managed according to a doctor's guidance regarding dosage and duration. Patients with impaired liver function should consult a doctor before taking this medication because its components may affect the liver. Particularly, this medication is not to be administered to children under the age of 12 or adolescents under 18 who have undergone certain surgeries, and caution is needed for patients with sleep apnea. This medication may cause drowsiness or dizziness, so it is safest to avoid driving or operating machinery after use. In the event of overdose, severe respiratory suppression or liver damage may occur, so follow the prescribed dosage and contact a medical facility immediately if any suspicious symptoms appear.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, abnormal breathing accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, changes in urination

Mild side effects

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

This medication should be stored in a sealed container to prevent exposure to air, and it is best kept at a temperature below 25 degrees Celsius. Proper storage will help maintain the medication's effectiveness for longer.

Appearance

Pale yellow rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle