ULTRACET™

INTERNATIONAL NON-PROPRIETARY NAMES

Tramadol

Paracetamol

QUALITATIVE AND QUANTITATIVE COMPOSITION

ULTRACET™ is available as tablets for oral administration containing 37.5 mg tramadol hydrochloride and 325 mg paracetamol.

PHARMACEUTICAL FORM

A light yellow tablet with an off-white core, with debossing as follows: 'T/A' on one side and 'JANSSEN' on the other side.

CLINICAL PARTICULARS

Therapeutic Indications

ULTRACET™ is indicated for the management of moderate to severe pain.

Posology and Method of Administration

Oral use.

Tablets must be swallowed whole with a sufficient quantity of liquid. They must not be broken/chewed.

ULTRACET™ should under no circumstances be administered for longer than is strictly necessary. If repeated use or long-term treatment with ULTRACET™ is required as a result of the nature and severity of the illness, then careful and regular monitoring should take place (with breaks in treatment, where possible) to assess whether continuation of the treatment is necessary.

Adults and Children Over 16 Years

The maximum single dose of ULTRACET™ is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.

ULTRACET™ can be administered without regard to food.

Pediatric (Children Below 16 Years)

The safety and effectiveness of ULTRACET™ has not been established in the pediatric population.

Elderly (Geriatric)

It should he noted that in volunteers >75 years of age, elimination half-life was increased by 17% following oral administration. In patients >75 years of age the recommended minimum interval between doses is ≥ 6 hours.

Contraindications

ULTRACET™ should not be administered to patients who have previously demonstrated hypersensitivity to tramadol paracetamol, any other component of this product or opioids. It is also contraindicated in cases of acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opiods or psychotropic drugs.

ULTRACET™ should not be administered to patients who are receiving monoamine oxidase inhibitors or within 2 weeks of their withdrawal, patients with severe hepatic impairment and patients with epilepsy not well controlled by treatment.

Special Warnings and Special Precautions for Use

Seizures

Seizures have been reported in patients receiving tramadol within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of tramadol above the recommended range. Concomitant use of tramadol increases the seizure risk in patients taking: Selective serotonin reuptake inhibitors (SSRI antidepressants or anorectics), Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or Opioids.

Administration of tramadol may enhance the seizure risk in patients taking: MAO inhibitors, Neuroleptics or Other drugs that reduce the seizure threshold.

Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections). In tramadol overdose, naloxone administration may increase the risk of seizure.

Anaphylactoid Reactions

Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive ULTRACET™.

Respiratory Depression

Administer ULTRACET™ cautiously in patients at risk for respiratory depression. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Treat such cases as an overdose. It naloxone is to be administered, use cautiously because it may precipitate seizures.

Use with CNS Depressants

ULTRACET™ should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.

Increased Intracranial Pressure or Head Trauma

ULTRACET™ should be used with caution in patients with increased intracranial pressure or head injury.

Physical Dependence and Abuse

Tramadol may induce physical dependence of the morphine-type (µ-opioid). Tramadol should not be used in opioid-dependent patients. Tramadol has been shown to reinitiate physical dependence in some patients that have been previously dependent on other opioids. Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with prior history of opioid dependence. The risk in patients with substance abuse has been observed to be higher

Use with Alcohol

Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive paracetamol use.

Withdrawal

Withdrawal symptoms may occur if ULTRACET™ is discontinued abruptly. Panic attacks, severe anxiety, hallucinations, parathesia, tinnitus, and unusual CNS symptoms have also been very rarely reported with abrupt discontinuation of tramadol hydrochloride. Clinical experience suggests that withdrawal symptoms may be relieved by tapering the medication.

Use with MAO Inhibitors and Serotonin Reuptake Inhibitors

Use ULTRACET™ with great caution in patients taking monoamine oxidase inhibitors. Concomitant use of tramadol with MAO inhibitors or SSRI's increases the risk of adverse events, including seizure and serotonin syndrome diarrhea, tachycardia, sweating, trembling, confusion, coma).

Use in Renal Disease

ULTRACET™ has not beer studied in patents with impaired renal function. In patients with creatinine clearances of less than 30 mL/min, it s recommended that the dosing interval of ULTRACET™ be increased rut to exceed 2 tablets every 12 tours. ULTRACET™ is not recommended in patents with creatinine clearance of less Man 10 mL/min.

Use In Hepatic Disease

The use of ULTRACET™ in patients with severe hepatic impairment is not recommended.

Precautions General

The recommended dose of ULTRACET™ should not be exceeded.

ULTRACET™ should not be co-administered with other tramadol or paracetamol- containing products.

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