TRAMAPAR Tablet

For the short-term treatment (i.e., 3 days or less) of mild to moderate acute pain.

Dosage and directions for use

To be used in adults and children over 16 years of age. Do not exceed the recommended dose.

Acute Pain:

2 tablets every 4-6 hours as needed for pain relief. Do not exceed 8 tablets per day.

Renal impairment

For patients with creatinine clearance <30mL/min, the dosing interval should be increased not to exceed 2 tablets every to 12 hours.

- In patients with a known hypersensitivity to tramadol HCl, paracetamol or other opioids such as codeine.

- In cases of severe liver function impairment and in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic medicines.

- Patients who are receiving monoamine oxidase inhibitors or within 2 weeks of their withdrawal.

- For narcotic withdrawal treatment.

- Patients with respiratory depression especially in the presence of cyanosis and excessive bronchial secretions.

- Patients with increased intracranial pressure or central nervous system depression due to head injury or cerebral disease.

- Safety during pregnancy and lactation has not been established.

- Tramadol HCl has been shown to cross the placenta.

The most frequently reported side effects were of the gastrointestinal and central nervous systems. These include:

Central Nervous System and Psychiatric

Dizziness, headache, nervousness, anxiety, agitation, euphoria, emotional ability, hallucinations, hypertonia and tremor. Somnolence, insomnia, anorexia, anxiety, confusion, euphoria and nervousness.

Other reported side-effects include pruritus, fatigue, upper respiratory tract infection, increased sweating, hot flushes, rashes and asthenia.

Other side-effects reported with the use of Tramadol HCl Include:

Anaphylaxis, increased liver enzyme values, postural hypotension or cardiovascular collapse and the potential for Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome.

Paracetamol may cause Allergic Reactions and Skin Rash.

The rash usually appears as red areas or allergic wheals, and may be accompanied by fever and involvement of the mucous membranes. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.

See the package insert about the details below.

- Carbamazepine

- Inhibitors of CYP2D6 such as fluoxetine, paroxetine, quinidine and amitriptyline

- MAO-inhibitor

- Digoxin, warfarin

- Diflunisal

- Safety during pregnancy and lactation has not been established.

- Tramadol HCl has been shown to cross the placenta.

Do not co-administer this medicine with other Tramadol HCl or paracetamol containing products. This medicine should not be taken with alcohol containing beverages.

The administration of this medicine concurrently with central nervous system (CNS) depressants such as alcohol, opioids, anaesthetic agents, phenothiazines, tranquilizers or sedative hypnotics is likely to intensify and prolong CNS effects. This medicine should be used with caution in patients with impaired renal function and in patients prone to convulsive disorders or in shock.

Dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol containing products under medical supervision.

Tramadol HCl may only be taken with special care in opioid dependence, reduced level of consciousness of uncertain origin, disorders of the respiratory function and increased intracranial pressure.

See the package insert about the details below:

- Seizures

- Drug abuse and Dependence

- Effects on ability to drive or operate machinery

Tramadol HCl is a centrally acting synthetic analgesic compound whose analgesic profile can be attributed to the binding of parent and 0-demethylated metabolite to µ-opioid receptors as well as the weak inhibition of neuronal re-uptake of noradrenaline and serotonin.

Paracetamol also has centrally acting analgesic effects.