Tapentadol extended-release form is for around-the-clock treatment of pain that is not controlled by other medicines. The extended-release form of tapentadol is not for use on an as-needed basis for pain.

SKU: DP10061 Category:


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.

Should be taken twice daily, approximately every 12 hours.

Initiation of therapy

Initiation of therapy in patients currently not taking opioid analgesics

Patients should start treatment with single doses of 50 mg tapentadol as prolonged-release tablet administered twice daily.

Initiation of therapy in patients currently taking opioid analgesics.

When switching from opioids  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  for patients currently taking opioids compared to those not having taken opioids before initiating therapy with PALEXIA SR.

Titration and maintenance

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.


constipation, nausea, vomiting, stomach pain;

headache, feeling tired; or

drowsiness, dizziness.

noisy breathing, sighing, shallow breathing, breathing that stops;

a light-headed feeling, like you might pass out;

agitation, feeling hot;

severe drowsiness or dizziness, confusion, problems with speech or balance;

a seizure;

serotonin syndrome – agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea; or

low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.