TRADOREC XL® prolonged-release tablets
Treatment of moderate to severe pain.
One prolonged-release tablet contains 100mg, 200mg or 300mg tramadol hydrochloride
Prolonged-release tablet. White to off white, plain, bevelled edge, round biconvex tablet
Merck Sharp & Dohme Limited
05 March 2010
The dosage should be adjusted according to the severity of pain and the response of the individual patient.
The tablets should be swallowed whole, with a sufficient quantity of liquid and not divided or chewed. The tablets can be taken with or without food.
Alternative tablet strengths of TRADOREC XL® are available. Where necessary, appropriate tablet strengths should be used to achieve the required dose.
TRADOREC XL® should be taken once every 24 hours as follows:
Adults and adolescents (12 years and over):
The starting dose is one 100 mg prolonged-release tablet once daily. The usual dose is one 200 mg prolonged-release tablet once daily, to be taken preferably in the evening. If this does not provide sufficient pain relief, the dosage can be increased in 100 mg dose increments to 300 mg or to a maximum of 400 mg once daily.
In general, the lowest effective analgesic dose should be chosen. A daily dose of 400mg of tramadol should not be exceeded except in special clinical cases.
TRADOREC XL® should not be used for a period longer than absolutely necessary. If continued pain treatment is necessary due to the nature and severity of the illness, careful regular surveillance should be carried out (including periods without treatment, if necessary) in order to determine the need for continued treatment.
Children (under 12):
TRADOREC XL® is not recommended for the treatment of children (under 12 years of age).
Dose adjustment in elderly patients (up to 75 years of age) without clinically relevant hepatic or renal impairment is normally not necessary. In patients over 75 years, the elimination half-life of tramadol may be prolonged. Use in these patients is not recommended.
Renal impairment, dialysis and hepatic impairment:
TRADOREC XL® is not recommended for patients with severe hepatic impairment or with severe renal impairment (creatinine clearance <10 ml/min). Caution is advised in patients with moderate hepatic or moderate renal impairment (creatinine clearance <30 ml/min).
Consumption of alcohol is not recommended during treatment with tramadol. Concomitant treatment with carbamazepine is not recommended.
Tramadol has a low potential for dependence. However, with long-term use, tolerance and psychological and/or physical dependence may develop. At therapeutic doses, withdrawal symptoms have been reported with a frequency of 1 in 8,000 while reports of dependence and abuse have been less frequent.
Because of the potential for dependence or withdrawal to occur, the clinical need for continued analgesia should be reviewed regularly. In patients with a tendency to drug abuse or dependence, tramadol should only be used for short periods under strict medical surveillance.
Tramadol is not suitable as a substitute in opioid dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.
Respiratory depression or patient taking CNS depressants:
Caution is recommended with administration of tramadol in patients at risk for respiratory depression or receiving medicinal products likely to produce respiratory depression.
Tramadol should be used with caution in patients with head trauma, increased intracranial pressure, impairment of hepatic or renal function, in patients in shock, an altered state of consciousness (with no obvious cause), respiratory centre disorders or respiratory dysfunction.
There is an increased risk of seizures if the tramadol dose exceeds the maximum recommended daily dose (400 mg). Seizures have been reported at the therapeutic doses. Patients with controlled epilepsy or patients with a known risk of seizure should only be treated with tramadol in cases of absolute necessity. There is an increased risk of seizures in patients taking concomitant medications which lower the seizure threshold.
Uncommon (<1%): effects on cardiovascular regulation (palpitations, tachycardia, orthostatic hypotension or cardiovascular collapse). These undesirable effects occur in particular after intravenous administration and in patients undergoing physical exertion. Rare (<0.1%): bradycardia, Increase in blood pressure
Nervous system disorders
Very common (>10%): dizziness.
Common (1-10%): headaches, confusion.
Rare (<0.1%): changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform seizures.
Respiratory depression may occur if the quantities administered greatly exceed the recommended doses and in the case of concomitant administration of other CNS depressant medicinal products.
Epileptiform seizures primarily occurred following administration of high doses of tramadol or following concomitant treatment with medicinal products that lower the seizure threshold or trigger seizures.
Rare (<0.1%): hallucinations, confusion, sleep disturbance, nightmares.
After the administration of tramadol, in rare cases, various psychiatric adverse events may occur, the nature and severity of which vary between patients (depending on the individual reactivity and the duration of treatment). Mood disorders (usually euphoria, occasionally dysphoria), changes in activity (usually reduced activity, occasionally an increase) and, altered cognitive and sensory capacities (for example the ability to make decisions, perception problems) may be observed. Dependence may occur.
Rare (<0.1%): blurred vision.
Respiratory, thoracic and mediastinal disorders
An aggravation of asthma has been reported although a causal relationship was not confirmed.
Very common (>10%): nausea.
Common (1-10%): vomiting, constipation, dry mouth.
Uncommon (<1%): gastro-intestinal irritation (a feeling of gastric heaviness, flatulence).
Skin and subcutaneous tissue disorders
Common (1-10%): sweating.
Uncommon (<1%): dermal reactions (for example pruritus, rash, urticaria).
Musculoskeletal and connective tissue disorders
Rare (<0.1%): muscular weakness.
In some isolated cases, an increase in hepatic enzymes was reported during the therapeutic use of tramadol.
Renal and urinary disorders
Rare (<0.1%): micturation problems (difficulty in passing urine and urinary retention).
General disorders and administration site conditions
Rare (<0.1%): Allergic reactions (for example dyspnoea, bronchospasm, wheezing, Quincke's oedema) and anaphylaxis. Withdrawal symptoms similar to those observed during withdrawal of opiates may occur, such as agitation, anxiety, nervousness, insomnia, hyperkinesias, tremor and gastro-intestinal symptoms. Other symptoms of withdrawal have also been reported, including: panic attacks, severe anxiety, hallucinations, paraesthesia, tinnitus and other CNS problems.
Known hypersensitivity to tramadol or to any of the excipients.
Acute intoxication or overdose with CNS depressants (alcohol, hypnotics, other opioid analgesics, etc.).
Patients receiving concomitant treatment with MAO inhibitors or who have been treated with MAO inhibitors during the past 2 weeks.
Concomitant treatment with linezolid.
Severe hepatic or severe renal impairment (creatinine clearance < 10ml/min).
Epilepsy not adequately controlled by treatment.
Tramadol must not be administered during breastfeeding if long-term treatment, i.e. more than 2 to 3 days, is necessary