Dolcet Mini

Tramadol HCl 18.75 mg, paracetamol 162.50 mg

Moderate to severe acute & chronic pain.

Adult & childn ≥12 yr Initially 4 tab every 6 hr & additional doses can be taken as needed. Max: 16 tab daily. Moderate renal insufficiency (CrCl 10-30 mL/min) Increase dosing interval to 12 hr.

May be taken with or without food.

Hypersensitivity. Patients w/ severe resp depression; risk of reduced level of consciousness due to head injury; gastric ulcer, severe blood disorders; severe liver/renal damages, severe cardiac function disorders; asthma exacerbation induced by NSAIDs or those who previously suffered from it; epilepsy which cannot be controlled by treatment. Intoxication w/ CNS acting drugs eg, alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs. Intake of MAOIs or w/in 2 wk of w/drawal.

Discontinue use at the 1st appearance of skin rash or any other sign of hypersensitivity. Tolerance w/ long-term use, psychological & physical dependence may develop. Patients w/ tendency to drug abuse or dependence (use only for short periods). W/drawal symptoms may occur if discontinued abruptly. Patient consumes ≥3 alcoholic drinks every day. Hepatotoxicity. Monitor during treatment for signs & symptoms of hyponatremia for patients w/ predisposing factors. Patients at risk for resp depression; consider use of alternative non-opioid analgesics. Biliary tract diseases. State of shock of an altered state of consciousness for unknown reasons. Perform periodic evaluation of prothrombin time when concurrently used w/ warfarin like compd. Co-administration or repeated administration of morphine. Patients receiving CNS depressants eg, alcohol, opioids, anesth agents, narcotics, phenothiazines, tranquilizers, sedative hypnotics/antidepressants/antihistamines, neuroleptics, centrally-acting antihypertensive drugs, thalidomide or baclofen. Not recommended in patients w/ severe renal insufficiency (CrCl <10 mL/min) or severe hepatic impairment. Pregnancy. Not recommended for use during lactation. Childn <12 yr. Elderly. Tramadol: Increased risk in patients w/ history of anaphylactoid reactions to codeine & other opioids. Increased risk of convulsions in patients w/ epilepsy, history of seizures, or those w/ recognized risk for seizure (eg, head trauma, metabolic disorders, alcohol & drug w/drawal, CNS infections). Patients w/ increased ICP or head injury. Patients known to be CYP2D6 ultra-rapid metabolizers. Not a suitable substitute in opioid-dependent patients. Concomitant use w/ SSRIs, TCAs & other tricyclic compd (eg, cyclobenzaprine, promethazine), or other opioids; MAOIs, neuroleptics or other drugs that reduce seizure threshold. Concomitant use w/ opioid agonists-antagonists (buprenorphine, nalbuphine, pentazocine) is not recommended. Avoid use w/ enflurane & nitrous oxide. May impair ability to drive or operate machinery.

Hypersensitivity; asthenia, fatigue, hot flushes; dizziness, headache, tremor; abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting; anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence; pruritus, rash, increased sweating; urticaria; abnormal hepatic function, decrease wt, tinnitus, abnormal vision, shivers. Occasionally, chest pain, rigors, syncope, w/drawal syndrome; HTN, aggravated HTN, hypotension, arrhythmia, palpitation, tachycardia; ataxia, convulsion, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paresthesia, stupor, vertigo; dysphagia, melena, tongue edema; amnesia, depersonalization, depression, drug abuse & dependence, emotional instability, hallucination, impotence, nightmare, abnormal thinking; anemia; dyspnea; albuminuria, micturition disorder, oliguria, urinary retention.

Tramadol: Increased risk of seizure w/ SSRIs, TCAs, & other tricyclic compd (eg, promethazine), or other opioids. Enhanced risk of seizure w/ MAOIs, neuroleptics, or other drugs that reduce seizure threshold. Reduced analgesic effect & shorten duration w/ carbamazepine. Increased conc w/ quinidine. Inhibited metabolism w/ fluoxetine, paroxetine, & amitriptyline; ketoconazole & erythromycin. Paracetamol: Increased absorption w/ metoclopramide or domperidone. Reduced absorption w/ cholestyramine.

Analgesics (Opioid)

N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.

Rx