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 SR is indicated for the management of severe chronic 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.
PALEXIA SR should be taken twice daily, approximately every 12 hours.
Patients should start treatment with single doses of 50 mg tapentadol as prolonged-release tablet administered twice daily.
When switching from opioids to PALEXIA SR and choosing the initial dose, the nature of the previous medicinal product, administration and the mean daily dose should be taken into account. This may require higher initial doses of PALEXIA SR for patients currently taking opioids compared to those not having taken opioids before initiating therapy with PALEXIA SR.
After initiation of therapy the dose should be titrated individually to a level that provides adequate analgesia and minimises undesirable effects under the close supervision of the prescribing physician.
Experience from clinical trials has shown that a titration regimen in increments of 50 mg tapentadol as prolonged-release tablet twice daily every 3 days was appropriate to achieve adequate pain control in most of the patients.
Total daily doses of PALEXIA SR greater than 500 mg tapentadol have not yet been studied and are therefore not recommended.
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 is 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 SR 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 SR 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 prolonged-release tablet, and not be administered more frequently than once every 24 hours. At initiation of therapy a daily dose greater than 50 mg tapentadol as prolonged-release tablet is not recommended. Further treatment should reflect maintenance of analgesia with acceptable tolerability (see sections 4.4 and 5.2).
PALEXIA SR 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 elderly patients is not required. However, as elderly patients 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 SR in children and adolescents below 18 years of age has not yet been established. Therefore PALEXIA SR is not recommended for use in this population.
PALEXIA SR has to be taken whole, not divided or chewed, to ensure that the prolonged-release mechanism is maintained. PALEXIA SR should be taken with sufficient liquid. PALEXIA SR can be taken with or without food.
The shell (matrix) of the tapentadol tablet may not be digested completely and therefore it can be eliminated and seen in the patient’s stool. However, this finding has no clinical relevance, since the active substance of the tablet will have already been absorbed.
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/paper/PET blisters: Packs with 7, 10, 14, 20, 24, 28, 30, 40, 50, 54, 56, 60, 90, 100 prolonged-release tablets.
PVC/PVDC aluminium/paper/PET perforated unit-dose blisters: Packs with 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 prolonged-release tablets.
Not all pack sizes may be marketed.
No special requirements.
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