Itrafen Tablets

Adult dose

For children over 12 years and adults, administer an initial dose of 2 tablets. Thereafter, the dosing interval should be at least 6 hours, and do not exceed 8 tablets per day. Administer the lowest effective dose for the shortest duration possible, and do not use for longer than necessary. Elderly individuals are to be administered the usual adult dose, but those aged 75 years and older should have a minimum interval of 6 hours between doses. Patients with moderate renal impairment:

Child dose

For children over 12 years, administer an initial dose of 2 tablets. Thereafter, the dosing interval should be at least 6 hours, and do not exceed 8 tablets per day. Administer the lowest effective dose for the shortest duration possible.

This medication can put strain on the liver, so individuals who regularly consume more than three drinks a day should consult with their doctor or pharmacist before taking it. Due to the acetaminophen component, serious skin reactions may occur very rarely, so if skin rashes or allergic reactions occur, use should be discontinued immediately. The tramadol component can increase the risk of seizures, so patients with a history of seizures or risk factors for seizures should exercise special caution. Additionally, taking this medication along with certain antidepressants, opioid analgesics, or MAO inhibitors can further increase the risk of seizures, so concurrent use should be avoided or discussed with a doctor. There is a rare possibility of serious allergic reactions, so any symptoms like difficulty breathing or hives should be reported to medical personnel immediately. Patients with acute and severe bronchial asthma may experience severe respiratory depression when taking this medication, so it should be administered with monitoring in a medical facility. This medication can cause severe drowsiness, respiratory depression, and coma when taken with central nervous system depressants or alcohol, so caution is needed. Patients with increased intracranial pressure or head injuries may experience worsening symptoms due to respiratory depression, so usage should be cautious. This medication can cause dependency similar to morphine, thus long-term use requires careful monitoring of potential dependency. Patients with poor liver function or liver disorders may face risks of liver damage, thus consulting with a doctor before use is necessary. Especially for ultra-rapid CYP2D6 metabolizers, the medication may metabolize faster than expected, increasing the risk of respiratory depression, thus caution is warranted. Children under 12 years or individuals under 18 who have undergone tonsillectomy or adenoidectomy should not be administered this medication. Patients with sleep apnea or at risk for hypoxia need continuous assessment as their symptoms may worsen with this medication. Elderly patients or those at risk for hyponatremia may experience symptoms of hyponatremia, thus monitoring is necessary. This medication should not be administered to those with hypersensitivity to specific components, severe respiratory depression, central nervous system drug poisoning, or severe dysfunction of liver, kidney, or heart. The recommended dosage must be strictly adhered to, and it should not be taken with other tramadol or acetaminophen products. Abruptly discontinuing the medication may result in withdrawal symptoms, so it should be tapered down according to a doctor's instructions. This medication can induce drowsiness or dizziness when driving or operating machinery, so caution is required. In case of overdose, serious side effects like respiratory depression, seizures, or liver damage can occur, and immediate emergency treatment should be sought. During the course of this medication, it is important to consult with a physician and promptly report any abnormal symptoms to receive treatment.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, severe abnormal skin reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, liver abnormalities (jaundice), sudden severe headache, lightning-like headache, seizures

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 air and moisture from entering. Additionally, it is best to keep the medication at room temperature between 1 to 30 degrees Celsius. This helps maintain the effectiveness of the medication over time.

Appearance

Pale yellow oblong film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle