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About Palexia® IR

Palexia® IR (for moderate to severe acute pain) is the brand name of tapentadol immediate release, which is a strong pain medication. Palexia® IR is used in adults for the relief of moderate to severe acute pain in adults which can only be adequately managed with opioid analgesics.1

Palexia® IR is administered in film-coated tablets or oral solution.2 Find out how it works, how it will help you control your moderate to severe acute pain, and what you can expect from your treatment with Palexia® IR.

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What can I expect from my treatment?

You have been prescribed Palexia® IR (for moderate to severe acute pain) 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.3

Your doctor will prescribe you an appropriate dose of Palexia® IR (for moderate to severe acute pain) and assess the level of pain relief you are receiving with that dose.

Your doctor will want to give you the lowest dose of Palexia® IR that effectively treats your pain.2,3

Recording your changes in pain as well as using an activity diary will help you and your doctor monitoring your 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® IR (for moderate to severe acute pain) for you.

To get the full benefit of Palexia® IR (for moderate to severe acute pain) it is important that you 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® IR (for severe acute pain) may cause side effects, although not everyone gets them. 3

The most common (may affect more than 1 in 10 people) side effects experienced with Palexia® IR (for moderate to severe acute pain) are feeling sick (nausea), vomiting, dizziness, drowsiness and headaches. 3

Common side effects (may affect up to 1 in 10 people) include decreased appetite, anxiety, confusion, hallucination, sleep problem, abnormal dreams, trembling, flushing, constipation, diarrhoea, indigestion, dry mouth, itching, increased sweating, rash, muscle cramps, feeling of weakness, fatigue and feeling of body temperature change.3

A full list of side effects can be found in the Patient Information Leaflet (PIL) that is included in your Palexia® IR (for moderate to severe acute pain) pack of tablets.

If you experience any side effects while taking Palexia® IR (for moderate to severe acute pain), it is important that you 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 side effects?

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

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

They 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. [ref]

Paleixa Patient

How do I take Palexia IR (for severe acute pain)?

Always take Palexia® IR (for moderate to severe acute pain) exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will adjust the dosage according to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.

In adults, the usual dose of Palexia® IR (for moderate to severe acute pain) is 1 dose every 4 to 6 hours. Daily doses greater than 700 mg tapentadol on the first day of treatment and daily doses greater than 600 mg tapentadol on the following days of treatment are not recommended.3

Palexia® IR (for moderate to severe acute pain) is an oral tablet that can be swallowed with water on an empty stomach or with food.3

If you miss a dose of Palexia® IR (for moderate to severe acute pain), do not double up on your medication to make up for the forgotten dose; simply continue taking the tablets as before.3

If you feel that the effects of these tablets are too strong or weak, talk to your doctor or pharmacist.

FAQs

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

    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.[ref]

  • Can I take Palexia® IR (for moderate to severe acute 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® IR (for moderate to severe acute pain).[ref]

  • Can I take Palexia® IR (for moderate to severe acute pain) with food, drink and alcohol?

    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.[ref]

  • Can I drive whilst taking Palexia® IR (for moderate to severe acute pain)?

    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.[ref]

  • Can I take Palexia® IR (for moderate to severe acute 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® IR (for moderate to severe acute pain):

    • 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 and when do I take my 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.[ref]

  • How long should you take Palexia® IR (for moderate to severe acute pain)?

    Do not take the tablets for longer than your doctor has told you.[ref]

  • What should I do if I take more Palexia® IR (for moderate to severe acute pain) than I should?

    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.[ref]

    If this happens a doctor should be called immediately!

  • What should I do if I forget to take my Palexia® IR (for moderate to severe acute 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® IR (for moderate to severe acute pain) if I am 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 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:

    • Restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle pain and dilated pupils,
    • Irritability, anxiety, backache, joint pain, weakness, abdominal cramps, difficulty in sleeping, nausea, loss of appetite, vomiting, diarrhea, and increases in blood pressure, breathing or heart rate.[ref]
    • 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.

  • How do I store Palexia® IR (for moderate to severe acute 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® IR (for moderate to severe acute pain)?

    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.

  • Is Palexia® IR (for moderate to severe acute pain) addictive?

    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.[ref]

  • References

    1. Palexia® PR SmPC, July 2016.

    2. Mehra M et al. The burden of chronic low back pain with and without a neuropathic component: a healthcare resource use and cost analysis. J Med Econ. 2012; 15(2):245-52.

    3. Baron R et al. Tolerability, Safety, and Quality of Life with Tapentadol Prolonged Release (PR) Compared with Oxycodone/Naloxone PR in Patients with Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-Label, Phase 3b/4 Trial. Pain Practice 2016; 16(5):600-619.