ULTRACET TABLET [SIN12432P]

Product Info

ULTRACET TABLET

[SIN12432P]

Indications
ULTRACET® is indicated for the treatment of moderate to severe pain.

Dosage and Administration
The tablets should be taken orally, whole, not divided or chewed, with sufficient liquid, without regard to food. ULTRACET® should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with ULTRACET® is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.

Dosage – Adults and children 16 years of age and over
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. The lowest effective dose should be used for the shortest period of time.

Treatment withdrawal
Do not stop use of ULTRACET® abruptly. Withdrawal symptoms may be relieved by tapering the medication (see Warnings and Precautions – Treatment withdrawal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children below 16 years of age
The use of ULTRACET® is contraindicated in children below 12 years of age (see Contraindications).

The safety and effectiveness of ULTRACET® in children aged 12 to below 16 years of age has not been established (see Contraindications and Warnings and Precautions – Other risk factors for life-threatening respiratory depression in children – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Therefore, treatment is not recommended in this population.

Elderly (75 years of age and older)
Elimination of the active components may be prolonged in elderly patients over 75 years of age. Therefore, if necessary the dosage interval may be extended according to the patients requirements.

Renal Insufficiency/Dialysis/Hepatic Insufficiency
The pharmacokinetics of the tramadol/paracetamol combination in patients with renal impairment has not been studied. Experience with tramadol suggests that impaired renal function results in a decreased rate and extent of excretion of tramadol. In patients with creatinine clearances of less than 30mL/min, it is recommended that the dosing interval of ULTRACET® be increased not to exceed 2 tablets every 12 hours. The pharmacokinetics and tolerability of ULTRACET® in patients with impaired hepatic function has not been studied. Tramadol and paracetamol are both extensively metabolized by the liver. The use of ULTRACET® in patients with severe hepatic impairment is not recommended.

Contraindications
ULTRACET® is contraindicated:

• in all children younger than 12 years of age.

• in post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.

• in patients who have previously demonstrated hypersensitivity to tramadol, paracetamol or any other components (see List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) of this product or opioids.

• in cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

• in patients using monoamine oxidase inhibitors (MAOI) concurrently or within the last 14 days. (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• in patients with significant respiratory depression (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).