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Ultradol
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Ultradol contains tramadol, an opioid analgesic that acts on the central nervous system, and paracetamol, an analgesia and antipyresis agent.`

Pack size Box of 20 tablets, 30 tablets
Shelf-life 24 months
Composition Paracetamol, Tramadol hydrochloride
Dosage forms and strengths Film-coated tablet: Paracetamol 325 mg, Tramadol hydrochloride 37.5 mg
Product code :

PRESCRIBING INFORMATION

Indications:

Ultradol is indicated for the symptomatic treatment of moderate to severe pain.

Dosage:

2 tablets every 4 to 6 hours as needed for relief, up to a maximum of 8 tablets per day.

In patients with creatinine clearances of less than 30 ml/min: Not to exceed 2 tablets every 12 hours.

Usage:

Ultradol is orally administered.

Hypersensitivity to tramadol or opioid, paracetamol or to any of the excipients of the medicinal product.

Patients with anemia or cardiac, pulmonary, renal, or hepatic disease.

Patients with deficiency of glucose – 6 – phosphate dehydrogenase.

Acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs.

Patients are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal.

Severe hepatic impairment.

Severe respiratory depression.

Epilepsy not controlled by treatment.

Children under 15 years of age.

Opioid addiction.

Common: Malaise. Vasodilation (hypotension). Anxiety, restlessness, confusion, coordination disorders, euphoria, nervousness, sleep disturbances. Vomiting, nausea, abdominal pain, loss of appetite, distension, constipation. Hypertonia. Vision disorders. Menopausal symptoms, micturition, urinary retention.

Uncommon: Rash, blood dyscrasias (neutropenia, pancytopenia, leukopenia), anemia, nephropathy, nephrotoxicity with chronic abuse.

Excessive intake of alcohol may increase the risk of induced hepatotoxicity; avoid or limit alcohol intake.

Caution is recommended when giving Ultradol to:

Patients with preexisting anemia;

Patients with hepatic or renal impairment, susceptible individuals, alcohol dependence;

Patients at risk for respiratory depression, patients with increased intracranial pressure or head injury;

Patients with epilepsy, those with a history of seizures, or patients with a recognized risk for seizure (e.g., head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections);

Patients dependent on opiate agonists or in patients who are chronically using opiate agonists;

Patients taking other CNS depressants (e.g., alcohol, anesthetic agents, phenothiazines, sedatives and hypnotics, other centrally acting analgesics, opiate agonists); selective serotonin-reuptake inhibitors (SSRIs), tricyclic antidepressants, other tricyclic compounds, or other opiate agonists, monoamine oxidase (MAO) inhibitors, antipsychotic agents, or other drugs that decrease the seizure threshold.

Naloxone administration in patients with tramadol overdose also may increase the risk of seizure.

Withdrawal symptoms may occur if Ultradol is discontinued abruptly.

The physicians need to warn the patients of the signs of serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).

Ultradol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This drug is not recommended for nursing mothers.

Ultradol reduces alertness, therefore, Ultradol should not been taken when driving, operating machinery and working on high.