Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, United Kingdom
PALEXIA is indicated for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics.
The dosing regimen should be individualised according to the severity of pain being treated, the previous treatment experience and the ability to monitor the patient.
Patients should start treatment with single doses of 50 mg tapentadol as film-coated tablet administered every 4 to 6 hours. Higher starting doses may be necessary depending on the pain intensity and the patient’s previous history of analgesic requirements.
On the first day of dosing, an additional dose may be taken as soon as one hour after the initial dose, if pain control is not achieved. The dose should then be titrated individually to a level that provides adequate analgesia and minimises undesirable effects under the close supervision of the prescribing physician.
Daily doses greater than 700 mg tapentadol on the first day of treatment and maintenance daily doses greater than 600 mg tapentadol have not been studied and are therefore not recommended.
The film-coated tablets are intended for acute pain situations. If longer term treatment is anticipated or becomes necessary and effective pain relief in the absence of intolerable adverse events was achieved with PALEXIA, the possibility of switching the patient to therapy with PALEXIA prolonged release tablets should be considered.
As with all symptomatic treatments, the continued use of tapentadol must be evaluated on an ongoing basis.
Withdrawal symptoms could occur after abrupt discontinuation of treatment with tapentadol (see section 4.8). When a patient no longer requires therapy with tapentadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
In patients with mild or moderate renal impairment a dosage adjustment is not required (see section 5.2).
PALEXIA has not been studied in controlled efficacy trials in patients with severe renal impairment, therefore the use in this population is not recommended (see sections 4.4 and 5.2).
In patients with mild hepatic impairment a dosage adjustment is not required (see section 5.2).
PALEXIA should be used with caution in patients with moderate hepatic impairment. Treatment in these patients should be initiated at the lowest available dose strength, i.e. 50 mg tapentadol as film-coated tablet, and not be administered more frequently than once every 8 hours. At initiation of therapy a daily dose greater than 150 mg tapentadol as film-coated tablet is not recommended. Further treatment should reflect maintenance of analgesia with acceptable tolerability, to be achieved by either shortening or lengthening the dosing interval (see sections 4.4 and 5.2).
PALEXIA has not been studied in patients with severe hepatic impairment and therefore, use in this population is not recommended (see sections 4.4 and 5.2).
In general, a dose adaptation in older people is not required. However, as older people are more likely to have decreased renal and hepatic function, care should be taken in dose selection as recommended (see sections 4.2 and 5.2).
The safety and efficacy of PALEXIA in children and adolescents below 18 years of age has not yet been established. Therefore PALEXIA is not recommended for use in this population.
PALEXIA should be taken with sufficient liquid. PALEXIA can be taken with or without food.
Human experience with overdose of tapentadol is very limited. Preclinical data suggest that symptoms similar to those of other centrally acting analgesics with mu-opioid receptor agonist activity are to be expected upon intoxication with tapentadol. In principle, these symptoms include, referring to the clinical setting, in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest.
Management of overdose should be focused on treating symptoms of mu-opioid agonism. Primary attention should be given to re-establishment of a patent airway and institution of assisted or controlled ventilation when overdose of tapentadol is suspected.
Pure opioid receptor antagonists such as naloxone are specific antidotes to respiratory depression resulting from opioid overdose. Respiratory depression following an overdose may outlast the duration of action of the opioid receptor antagonist. Administration of an opioid receptor antagonist is not a substitute for continuous monitoring of airway, breathing, and circulation following an opioid overdose. If the response to opioid receptor antagonists is suboptimal or only brief in nature, an additional dose of antagonist (e.g. naloxone) should be administered as directed by the manufacturer of the product.
Gastrointestinal decontamination may be considered in order to eliminate unabsorbed active substance. Gastrointestinal decontamination with activated charcoal or by gastric lavage may be considered within 2 hours after intake. Before attempting gastrointestinal decontamination, care should be taken to secure the airway.
3 years.
This medicinal product does not require any special storage conditions.
PVC/PVDC aluminium blisters: Packs with 5, 10, 14, 20, 24, 28, 30, 40, 50, 54, 56, 60, 90, 100 film-coated tablets.
PVC/PVDC aluminium perforated unit-dose blisters: Packs with 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 90x1, 100x1 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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