Package leaflet: Information for the user
PALEXIA 20 mg/ml oral solution
Tapentadol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
· Keep this leaflet. You may need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
· If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).
What is in this leaflet:
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
1. What PALEXIA is and what it is used for
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.
2. What you need to know before you take PALEXIA
Do not take PALEXIA
· if you are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6)
· if you have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia)
· if you have no bowel movement as shown by severe constipation and bloating which may be accompanied by pain or discomfort in the lower stomach
· if you have poisoning with alcohol, sleeping pills, pain relievers or medicines that affect mood and emotions (see ‘Other medicines and PALEXIA’)
Warnings and precautions
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.
Other medicines and PALEXIA
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.
· The risk of side effects increases if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take PALEXIA at the same time. Your doctor will tell you whether PALEXIA is suitable for you.
· Concomitant use of PALEXIA and sedative medicines such as benzodiazepines or related drugs (certain sleeping pills or tranquillizers (e.g. barbiturates) or pain relievers such as opioids, morphine and codeine (also as cough medicine), antipsychotics, H1-antihistamines, alcohol) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe PALEXIA together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
The concomitant use of opioids and drugs used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and may be life-threatening.
Please tell your doctor if you are taking gabapentin or pregabalin or any sedative medicines, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Please keep your doctor informed about all medicines you are taking.
Taking PALEXIA with food, drink and alcohol
Do not drink alcohol whilst you are taking PALEXIA, because some side effects such as drowsiness may be increased. You can take PALEXIA with or without food.
Pregnancy and 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 this medicine:
· if you are pregnant, unless your doctor has instructed you to do so, if used over prolonged periods during pregnancy, tapentadol may lead to withdrawal symptoms in the newborn baby, which might be life-threatening for the newborn if not recognized and treated by a doctor.
· if you become pregnant during treatment with PALEXIA. Check with your doctor.
Use of PALEXIA is not recommended:
· during childbirth, as it could lead to dangerously slow or shallow breathing (respiratory depression) in the newborn
· if you are breast-feeding, as tapentadol may pass into the breast milk.
Driving and using machines
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.
PALEXIA 20 mg/ml contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per maximum single dose, that is to say essentially ‘sodium-free’.
PALEXIA 20 mg/ml contains sodium benzoate
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).
PALEXIA 20 mg/ml contains propylene glycol
This medicine contains 10 mg propylene glycol per 5 ml solution (maximum single dose) which is equivalent to 2 mg/ml.
3. How to take PALEXIA
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.
Adults
The usual dose every 4 to 6 hours is either:
- 50 mg tapentadol (2.5 ml oral solution), or
- 75 mg tapentadol (3.75 ml oral solution), or
- 100 mg tapentadol (5 ml oral solution).
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.
Elderly patients
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.
Patients with liver or kidney problems (insufficiency)
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.
Children and adolescents
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.
How and when should you take PALEXIA
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.
Directions for opening the bottle and using the dosing pipette
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How long should you take PALEXIA
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.
If you take more PALEXIA than you should
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 PALEXIA
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 stop taking PALEXIA
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects or symptoms to look out for and what to do if you are affected:
If you are affected by these important side effects contact a doctor immediately.
Other side effects that may occur:
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)
Unknown
· Delirium
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.
Reporting of side effects
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 via HPRA Pharmacovigilance Website: www.hpra.ie.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store PALEXIA
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.
6. Contents of the pack and other information
What PALEXIA contains
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.
What PALEXIA looks like and contents of the pack
PALEXIA 20 mg/ml oral solution is a clear, colourless oral solution.
In Ireland, 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 and Manufacturer
Marketing Authorisation Holder:
Grünenthal Pharma Ltd., 4045 Kingswood Road, Citywest Business Park, Citywest, Co. Dublin, Ireland. Tel: +44(0)870 351 8960. E-mail: medicalinformationie@grunenthal.com
Manufacturer:
Grünenthal GmbH, Zieglerstrasse 6, 52078, Aachen, Germany.
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Croatia, Cyprus, Czech Republic, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, United Kingdom (Northern Ireland): PALEXIA
Other formats of this leaflet
A service is available to request a copy of this leaflet in Braille, large print or audio.
Please call: +44 173 3375 370
Please be ready to give the following information:
· Product name: PALEXIA 20 mg/ml oral solution
· Reference number: PA 2242/12/11
This leaflet was last revised in December 2022