Ultra New Tablets

Adult dose

Children aged 12 and older and adults: The dosage should be adjusted based on the patient's pain level and treatment response. An initial dose of 2 tablets is recommended, thereafter, the dosing interval should be at least 6 hours apart, and not to exceed 8 tablets per day. The lowest effective dose should be administered for as short a duration as possible. This medication should not be taken for longer than necessary, and in cases where prolonged use is needed due to the nature and severity of the disease, regular monitoring should be conducted to determine the need for ongoing use of this medication. Elderly patients: The standard adult dosage will be administered; however, in those over 75 years of age, oral administration of tramadol increases the elimination half-life by 17%, so intervals of at least 6 hours should be observed. Patients with kidney impairment: For moderate kidney impairment (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. Severe kidney impairment patients (creatinine clearance of less than 10 ml/min) are not recommended to take the medication. Tramadol is very slowly removed during hemodialysis and thus, there is no need to re-administer this medication post-dialysis for pain relief. Patients with liver impairment: For those with moderate liver impairment, the extending of the dosing interval should be carefully considered. This medication is not to be administered to patients with severe liver impairment.

This medication may cause liver damage if taken by someone who regularly consumes three or more alcoholic drinks a day, so consultation with a doctor or pharmacist is necessary. Due to the acetaminophen component, serious skin reactions may occur rarely, and if a rash or hypersensitivity reaction appears, use should be stopped immediately. The tramadol component may increase the risk of seizures, particularly when taken with certain antidepressants or narcotics, which further elevates the seizure risk. Rarely, serious allergic reactions such as anaphylaxis can occur, requiring caution. Patients with severe respiratory diseases should take this medication under the supervision of healthcare personnel due to the risk of respiratory depression. Using this medication in combination with alcohol or central nervous system depressants can cause severe sedation or respiratory depression, necessitating caution. Patients with elevated intracranial pressure or head injuries must be careful as symptoms may worsen upon taking this medication. The tramadol component may cause mental and physical dependence; thus, prolonged use requires attention to dependency development. Patients with impaired liver function must consult a doctor before taking this medication and should not exceed the recommended dose. In particular, those who are ultra-rapid metabolizers of CYP2D6 should be cautious due to a higher risk of respiratory depression. Children under 12 years old and those under 18 who have undergone tonsillectomy or adenoidectomy should not take this medication. Patients with sleep apnea or hypoxemia should be carefully monitored for symptom worsening while taking this medication. Elderly patients or those at risk of hyponatremia should monitor for the occurrence of hyponatremia. Patients with hypersensitivity to the components of this medication, those with central nervous system drug addiction, or those in a severe state of respiratory depression should not take it. Pregnant or breastfeeding women must consult healthcare personnel when taking this medication due to the risks to the fetus or infant. Drowsiness or dizziness may occur; therefore, caution is necessary when driving or operating machinery. In case of overdose, serious respiratory depression, seizures, liver damage, etc., may occur, so strict adherence to dosage is necessary. This medication interacts with various drugs, so it's crucial to inform a doctor or pharmacist about other medications being taken; careful monitoring is required during concurrent use. While using this medication, do not exceed the recommended dose and do not take it with other acetaminophen or tramadol formulations. Discontinuing suddenly may cause withdrawal symptoms; therefore, it should be gradually tapered off according to the physician's instructions. This medication should be kept out of the reach of children and precautions should be taken to prevent misuse.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, 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 air or moisture from entering. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to preserve the efficacy of the medication for a long time.

Appearance

Light yellow, rectangular, film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle