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About Palexia® PR

Palexia® PR (for severe chronic pain) is the brand name for tapentadol prolonged release, which is a strong pain medication. Palexia® PR is used for the treatment of severe chronic pain in adults that can only be adequately managed with an opioid analgesic.1

Palexia® PR may be effective in both types of pain because of its two synergistic mechanisms of action.1

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What can I expect from my treatment?

You have been prescribed Palexia® PR (for severe chronic pain) treatment to decrease your feeling of pain. Taking your medication as prescribed by your doctor in conjunction with a few lifestyle changes should help you to manage your pain effectively.

Your doctor will start you on an appropriate dose of Palexia® PR (for severe chronic pain) based on the type of pain medication and the dose you were taking previously. This dosage may then be adjusted depending on the amount of pain that you have and/or considering the side effects you may experience.1 Recording your changes in pain as well as using an activity diary will help you and your doctor monitoring your chronic pain. You should record any side effects you may be experiencing and note down how your pain is responding to your treatment. This is all useful information that can help your doctor adjusting the right dose of Palexia® PR (for severe chronic pain) for you.

To get the full benefit of Palexia® PR it is important that you try to stay on treatment and work with your doctor to find the best dose for you.

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What are the most common side effects?

Like all medicines, Palexia® PR (for severe chronic pain) may cause side effects, although not everyone gets them.2

The most common side effects (may affect more than 1 in 10 people) experienced with Palexia® PR (for severe chronic pain) are feeling sick (nausea), constipation, dizziness, drowsiness and headaches.2

Common side effects (may affect up to 1 in 10 people) include decreased appetite, anxiety, depressed mood, sleep problem, nervousness, restlessness, disturbance in attention, trembling, muscle twitches, flushing, shortness of breath, vomiting, diarrhoea, indigestion, itching, increased sweating, rash, feeling of weakness, fatigue, feeling of body temperature change, mucosal dryness, accumulation of water in the tissue (oedema).2

A full list of side effects can be found in the Patient Information Leaflet (PIL) included in your pack of tablets.

If you do experience any side effects whilst taking Palexia® PR (for severe chronic pain), it is important to discuss them with your doctor or pharmacist. By reporting side effects you can help provide more information on the safety of this medicine.

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How do I manage my side effects?

If you experience any side effects whilst taking Palexia® PR (for severe chronic pain) you should discuss them with your doctor.

Your doctor may also review your dose to try and achieve a balance between effective pain relief and the side effects you are experiencing.

Your doctor and pharmacist can also offer you practical advice, such as changes you could make to your diet or daily routine, which can help relieve pain in some cases.

Staying on Palexia® PR (for severe chronic pain) treatment

To get the full benefit of Palexia®; PR it is important that you try to stay on treatment and work with your doctor to find the best dose for you.

If you experience any side effects it is important that you discuss them with your doctor.

If you wish to stop taking Palexia® PR (for severe chronic pain) for any reason you should discuss this with your doctor before stopping treatment.

Switching from other treatments

If you are coming off another strong pain medication, you may feel withdrawal symptoms for a short time. You should discuss any symptoms with your doctor.1

Paleixa Patient

How do I take Palexia PR (for severe chronic pain)?

You should always take Palexia® PR (for severe chronic pain) as directed by your doctor.2

The usual dose is one tablet taken every 12 hours (or as directed by your doctor). It should be swallowed whole and not chewed, because this could lead to overdosing, due to the drug being released into your body too quickly. The tablet needs to stay intact for it to work effectively over time. Palexia® PR (for severe chronic pain) can be taken with or without food and should be taken with a liquid (not alcohol) to make it easier to swallow.1,2

If you miss a dose of Palexia® PR (for severe chronic pain), do not double dose to make up for a forgotten dose; simply continue taking the tablets as before.2

Like most pain medication, it may take some time for you to get the right balance of treatment for you. Therefore it is important that you talk to your doctor about how you are feeling so that you can work together to get the correct dose.

FAQs

  • What is Palexia® PR and what is it used for?

    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.[ref]

  • Should I take Palexia® PR (for severe chronic pain) with food?

    You may take the tablets either on an empty stomach or with food.[ref]

  • Can I take Palexia® PR (for severe chronic pain) with other medicines?

    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).[ref]

  • Can I drink alcohol whilst taking Palexia® PR (for severe chronic pain)?

    Do not drink alcohol whilst taking Palexia® PR (for severe chronic pain), because some side effects such as drowsiness may be increased.[ref]

  • Can I drive whilst taking Palexia® PR (for severe chronic pain)?

    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.[ref]

  • Can I take Palexia® PR (for severe chronic pain) if I am pregnant or breast-feeding?

    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:

    • if you are pregnant, unless your doctor has instructed you to do so.
    • during childbirth, as it could lead to dangerously slow or shallow breathing (respiratory depression) in the newborn.
    • if you are breast-feeding, as it may pass into the breast milk.[ref]
  • How do I take my Palexia® PR (for severe chronic pain)?

    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.[ref] ,[ref]

  • When should I take Palexia® PR (for severe chronic pain)?

    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 doctor.[ref]

  • How long should you take Palexia® PR (for severe chronic pain)?

    Take the tablets for as long as your doctor has told you.[ref]

  • What should I do if I take more Palexia® PR (for severe chronic pain) than I should?

    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:

    • pin-point pupils in the eyes
    • being sick (vomiting)
    • drop in blood pressure
    • fast heart beat
    • altered consciousness, collapse or deep unconsciousness (coma)
    • epileptic fits
    • dangerously slow or shallow breathing or stopping breathing.[ref]
  • What should I do if I forget to take my Palexia® PR (for severe chronic pain)?

    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.[ref]

  • Should I stop taking Palexia® PR (for severe chronic pain) it if I'm feeling better?

    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:

    • feeling restless, irritable, anxious, weak or sick (nausea), loss of appetite, being sick (vomiting), diarrhoea
    • watery eyes, runny nose, increase in size of the pupils in the eyes (dilated pupils)
    • difficulty in sleeping, yawning
    • sweating, shivering
    • muscle or joint pain, backache, abdominal cramps
    • increase in blood pressure, breathing or heart rate.

    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.[ref]

  • How do I store Palexia® PR (for severe chronic pain)?

    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.[ref]

  • Can I travel with Palexia® PR (for severe chronic pain)?

    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.[ref]

  • Is Palexia® PR (for severe chronic pain) addictive?

    Although Palexia® PR has the potential for abuse and addiction, drug dependence is only a rare side effect of Palexia® PR therapy.[ref]

  • References

    1. Palexia® PR SmPC, July 2016.

    2. Baron R, et al. Effectiveness of Tapentadol Prolonged Release (PR) Compared with Oxycodone/Naloxone PR for the Management of Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-Label, Phase 3b/4 Study. Pain Pract. 2016; 16(5):580-99.