Paracetamol Tramadol Extended Release Tablets

Adult dose

Adjust the dosage according to the patient's level of pain and therapeutic response. Administer 2 tablets as the initial dose, and maintain a minimum interval of 12 hours between doses. Do not exceed 8 tablets in one day. Regular monitoring should be performed if long-term administration is required. For the elderly, administer the usual adult dose, but for those over 75 years old, a minimum interval of 12 hours should be observed.

This medication should be discussed with a doctor or pharmacist if the patient consumes alcohol in excess daily, as it may cause liver damage. The acetaminophen component can rarely cause serious skin reactions, so if a rash or hypersensitivity reaction occurs, use should be discontinued immediately. The tramadol included in this medication may increase the risk of seizure in case of overdose, and the risk may be higher if combined with certain antidepressants or other central nervous system medications. Rarely, severe allergic reactions such as anaphylaxis may occur, so any unusual symptoms should be reported to medical personnel immediately. Care should be taken when administering this drug to patients with bronchial asthma due to the risk of respiratory depression; appropriate equipment and monitoring are necessary. Caution should be exercised when combining this medication with alcohol or central nervous system depressants, as severe sedation, respiratory depression, or coma may occur. Patients with brain injuries or elevated intracranial pressure may experience worsening conditions from respiratory depression due to this medication, necessitating caution. The tramadol component may lead to psychological and physical dependence, thus careful observation for dependence is needed during long-term use. Acetaminophen can cause liver damage if overdosed, so it is important to not exceed a total daily dosage of 4,000 mg, and patients with impaired liver function must consult a doctor. Patients with a rapid metabolism of this medication should be closely monitored for respiratory depression as they have a higher risk. This medication should not be used in children under 12 years of age or in certain pediatric patients after surgery, and it is advisable to avoid administering it to adolescents aged 12 to 18 years who may be at risk of respiratory depression. This medication may cause hyponatremia, so patients with risk factors should have their serum sodium levels checked periodically. This medication should not be administered to patients with certain allergies, severe respiratory depression, central nervous system drug abuse, severe liver, kidney, or heart disease, breastfeeding mothers, or children under 12 years of age. Drowsiness or dizziness may occur while taking this medication, so caution is needed when driving or operating hazardous machinery. In case of overdose, respiratory depression, liver damage, and severe toxicity symptoms may occur, so it is crucial to contact a medical institution for appropriate treatment immediately. If this medication is taken for an extended period, dependence or withdrawal symptoms may appear; therefore, dosage should be gradually adjusted per doctor's instructions. Women who are pregnant or may become pregnant should carefully consider the effects of this medication on the fetus, and breastfeeding women should be cautious as this medication can be transferred to the baby through breast milk. Because there are many drug interactions, it is essential to inform a doctor or pharmacist of any other medications being taken, especially caution is required when combined with antidepressants, anticonvulsants, and opioid analgesics.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweating, pallor, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness

Mild side effects

• Dizziness
• drowsiness
• headache
• itching
• nausea
• vomiting
• constipation
• dyspepsia
• cold sweat
• decreased appetite

This medication should be stored in a tightly sealed container to avoid contact with air or moisture, maintaining a storage temperature between 1 and 30 degrees Celsius at room temperature. It is important to avoid direct sunlight or high temperatures and to store it in a place out of reach of children.

Appearance

Pale yellow round extended-release film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle