- Palexia® PR SmPC, September 2013.
- Palexia® IR SmPC, September 2013.
- Palexia® PR, Patient Information Leaflet. August 2013.
- Palexia® IR, Patient Information Leaflet. August 2013.
More information can be found in the Patient Information Leaflet (PIL) included in your pack of tablets.
Tapentadol – the active substance in Palexia PR – is a strong pain medication which belongs to the class of opioids. Palexia PR is used in adults for the treatment of severe long-term pain that can only be adequately managed with an opioid pain medication.3
You may take the tablets either on an empty stomach or with food.3
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor will tell you which medicines are safe to take with Palexia PR (for severe chronic pain).3
Do not drink alcohol whilst taking Palexia PR (for severe chronic pain), because some side effects such as drowsiness may be increased.3
If you feel drowsy, dizzy, have blurred vision or a slow reaction time whilst taking Palexia PR, then do not drive, use tools or machinery. Any such effects are more likely to occur when you start taking Palexia PR, when the dose of Palexia PR is changed, or when you drink alcohol or take tranquilizers. Please ask your doctor before driving a car or using machinery.3
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Palexia PR:
When you take your Palexia PR (for severe chronic pain), make sure that you swallow your tablet whole with a liquid. Do not chew, break or crush the tablet, as it may result in overdose due to quick release of tapentadol in your body. The tablet needs to stay intact for it to work effectively over time.1,3
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose of Palexia PR (for severe chronic pain) is one tablet every 12 hours, however, if you are unsure about when you should take your Palexia PR (for severe chronic pain) you should contact your doctor3.
Take the tablets for as long as your doctor has told you.3
Taking too much Palexia PR may be life-threatening.
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Very high doses of Palexia PR may cause the following:
If you forget to take the tablets, your pain is likely to return. Do not take a double dose to make up for a forgotten dose; simply continue taking the tablets as before.3
If you interrupt or stop treatment too soon, your pain is likely to return. If you wish to stop treatment, please tell your doctor first before stopping treatment.
Generally there will be no withdrawal effects when treatment is stopped. However, on uncommon occasions, people who have been taking the tablets for some time may feel unwell if they suddenly stop taking them.
Symptoms may be:
If you experience any of these complaints after stopping treatment, please consult your doctor. Do not stop taking this medicine unless your doctor tells you to. If your doctor wants you to stop taking your tablets, he/she will tell you how to do this. This may include a gradual reduction of the dose.3
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.3
Yes, you can travel with Palexia PR (for severe chronic pain). Check the country you are traveling to, to see if there are any restrictions or special regulations regarding opioids. Make sure that you keep your Palexia PR (for severe chronic pain) in its original packaging.3
Although Palexia PR has the potential for abuse and addiction, drug dependence is only a rare side effect of Palexia PR therapy.3