The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 50414/0020.
Palexia Oral Solution 20 mg/ml
PALEXIA 20 mg/ml oral solution
1. What PALEXIA is and what it is used for
2. What you need to know before you take PALEXIA
3. How to take PALEXIA
4. Possible side effects
5. How to store PALEXIA
6. Contents of the pack and other information
The full name of your medicine is ‘PALEXIA 20 mg/ml oral solution’. It is referred to as ‘PALEXIA’ in the rest of this leaflet.
Tapentadol - the active substance in PALEXIA - is a strong painkiller which belongs to the class of opioids. PALEXIA is used in children from 2 years of age and a body weight of more than 16 kg and in adults for the treatment of moderate to severe pain of recent onset that can only be adequately managed with an opioid painkiller.
Talk to your doctor or pharmacist before taking PALEXIA if you:
This medicine contains tapentadol which is an opioid medicine. Repeated use of opioid painkillers may result in the drug being less effective (you become accustomed to it). It may also lead to dependence and abuse which may result in life-threatening overdose. If you have concern that you may become dependent on PALEXIA it is important that you consult your doctor. Use (even at therapeutic doses) may lead to physical dependence, which may result in you suffering withdrawal effects and a recurrence of your problems if you suddenly stop taking this medicine treatment.
PALEXIA has not been systematically evaluated in children and adolescent with obesity, therefore, paediatric patients with obesity should be extensively monitored and the recommended maximum dose for the age should not be exceeded.
Do not give this medicine to children below the age of 2 years.
Sleep-related breathing disorders
PALEXIA can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.
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.
Please keep your doctor informed about all medicines you are taking.
Do not drink alcohol whilst you are taking PALEXIA, because some side effects such as drowsiness may be increased. You can take this medicine with or without food.
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 this medicine:
Use of PALEXIA is not recommended:
If you feel drowsy, dizzy, have blurred vision or a slow reaction time whilst taking PALEXIA, then do not drive, use tools or machinery.
Any such effects are more likely to occur when you start taking PALEXIA, when the dose of PALEXIA is changed, or when you drink alcohol or take tranquilizers.
Please ask your doctor before driving a car or using machinery.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per maximum single dose, that is to say essentially ‘sodium-free’.
This medicine contains 5.9 mg benzoate salt per 5 ml solution (maximum single dose) which is equivalent to 1.18 mg/ml.
Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
This medicine contains 10 mg propylene glycol per 5 ml solution (maximum single dose) which is equivalent to 2 mg/ml.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will change the dose and time between doses of PALEXIA according to your pain level and your needs. Generally, the lowest pain-relieving dose should be taken.
The usual dose every 4 to 6 hours is either:
Total 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.
Your doctor may prescribe a different, more appropriate dose or timing of dosing, if this is necessary for you. If you feel that the effect of this medicine is too strong or weak, talk to your doctor or pharmacist.
In elderly patients (above 65 years) usually no dose adjustment is necessary. However, your doctor may adjust your dose or time between doses if required.
Do not take PALEXIA if you have severe liver or kidney problems.
If you have moderate liver problems, your doctor will adjust your dose or time between doses.
If you have mild liver problems or mild to moderate kidney problems, a dose adjustment is not required.
PALEXIA should only be given to children in the hospital.
PALEXIA should only be given to children with a body weight of more than 16 kg.
The dose of PALEXIA for children and adolescents aged 2 to less than 18 years is 1.25mg/kg every 4 hours. The correct dose will be given to you by your doctor or nurse.
Always wait 4 hours before giving the next dose. The dose may be decreased as the acute pain decreases.
PALEXIA is for oral use.
You may take the oral solution with or without food.
Use the dosing pipette and the adaptor provided in the pack to take the exact volume of the solution from the bottle as prescribed by your doctor. The volume corresponds to the prescribed dose.
Do not take this medicine for longer than your doctor has told you. In children the duration of treatment should be no longer than 3 days.
Taking too much PALEXIA 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 may cause the following:
If you forget to take this medicine, your pain is likely to return. Do not take a double dose to make up for a forgotten dose; simply continue taking this medicine as before.
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 this medicine for some time may feel unwell if they suddenly stop taking it.
Symptoms may be:
If you experience any of these complaints after stopping PALEXIA, please contact your doctor.
Do not stop taking this medicine unless your doctor tells you to. If your doctor wants you to stop taking this medicine, he/she will tell you how to do this. This may include a gradual reduction of the dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you are affected by these important side effects contact a doctor immediately.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
In general, the likelihood of having suicidal thoughts and behaviour is increased in patients suffering from chronic pain. In addition, certain medicines for the treatment of depression (which have an impact on the neurotransmitter system in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, data from human use of tapentadol do not provide evidence for an increased risk.
No Additional side effects were observed in children and adolescents.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 bottle. The expiry date refers to the last day of that month.
Unopened: This medicinal product does not require any special storage conditions.
After first opening: The solution should not be used for longer than 6 weeks. Store in an upright position.
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.
The active ingredient is tapentadol.
1 ml of PALEXIA 20 mg/ml oral solution contains 20 mg tapentadol (as hydrochloride)
The other ingredients are:
Sodium benzoate (E 211), Citric acid monohydrate, Sucralose (E 955), Raspberry flavour containing propylene glycol (E 1520), Sodium hydroxide (for pH adjustment), Purified water.
PALEXIA 20 mg/ml oral solution is a clear, colourless oral solution.
In the UK, PALEXIA 20 mg/ml oral solution is available in plastic bottles containing 100 millilitres or 200 millilitres of solution, including a 5 ml dosing pipette with 0.1 ml intervals and an adapter attached to the dosing pipette. Additionally, the right scale shows the single doses for adults.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
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This leaflet was last revised in December 2022