- 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 included in your pack of tablets.2
Tapentadol – the active substance in Palexia IR – is a strong analgesic which belongs to the class of opioids. Palexia IR is used for the treatment of moderate to severe acute pain in adults that can only be adequately managed with an opioid analgesic.4
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 IR (for moderate to severe acute pain).4
Do not drink alcohol whilst taking Palexia IR (for moderate to severe acute pain) because some side effects such as drowsiness may be increased. Food does not influence the effect of this medicine.4
If you feel drowsy, dizzy, have blurred vision or a slow reaction time whilst taking Palexia IR (for moderate to severe acute pain), then do not drive, use tools or machinery. Any such effects are more likely to occur when you start taking Palexia IR, when the dose of Palexia IR is changed, or when you drink alcohol or take tranquilizers. Please ask your doctor before driving a car or using machinery.4
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 IR (for moderate to severe acute pain):
Palexia IR (for moderate to severe acute pain) is for oral use. Swallow the tablets with sufficient liquid. You may take the tablets on an empty stomach or with meals.4
Do not take the tablets for longer than your doctor has told you.4
After taking very high doses, the following may be experienced:
pin-point pupils, vomiting, drop in blood pressure, fast heart beat, collapse, disturbed consciousness or coma (deep unconsciousness), epileptic fits, dangerously slow or shallow breathing or stopping breathing may occur.4
If this happens a doctor should be called immediately!
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.4
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 after-effects when treatment is stopped, however, on uncommon occasions, people who have been taking the tablets for some time may feel unwell if they abruptly stop taking them.
Symptoms may be:
If you experience any of these complaints after stopping treatment, please consult your doctor.
You should not suddenly 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.
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.4
Yes, you can travel with Palexia IR (for moderate to severe acute 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 IR (for moderate to severe acute pain) in its original packaging.
Palexia IR (for moderate to severe acute pain) may lead to physical and psychological addiction. If you have a tendency to abuse medicines or if you are dependent on medicines, you should only take these tablets for short periods and under strict medical supervision.4