Active ingredient
- tapentadol hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 21727/0041.
Palexia SR 50, 100, 150, 200, 250 mg prolonged-release tablets
Package leaflet: Information for the user
PALEXIA SR 50 mg, 100 mg, 150 mg, 200 mg and 250 mg prolonged-release tablets
Tapentadol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What PALEXIA SR is and what it is used for
2. What you need to know before you take PALEXIA SR
3. How to take PALEXIA SR
4. Possible side effects
5. How to store PALEXIA SR
6. Contents of the pack and other information
1. What PALEXIA SR is and what it is used for
The full name of your medicine is ‘PALEXIA SR 50 mg, 100 mg, 150 mg, 200 mg or 250 mg prolonged-release tablets’. It is referred to as ‘PALEXIA SR’ in the rest of this leaflet.
Tapentadol - the active substance in PALEXIA SR - is a strong painkiller which belongs to the class of opioids. PALEXIA SR is used in adults for the treatment of severe long-term pain that can only be adequately managed with an opioid painkiller.
2. What you need to know before you take PALEXIA SR
Do not take PALEXIA SR
Warnings and precautions
Talk to your doctor or pharmacist before taking PALEXIA SR if you:
Sleep-related breathing disorders
PALEXIA SR contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example central sleep apnea (shallow/pause of breathing during sleep) and sleep-related hypoxemia (low level of oxygen in the blood).
The risk of experiencing central sleep apnea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnea.
Other medicines and PALEXIA SR
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 SR.
Please keep your doctor informed about all medicines you are taking.
Taking PALEXIA SR with food, drink and alcohol
Do not drink alcohol whilst you are taking PALEXIA SR, because some side effects such as drowsiness may be increased. You can take PALEXIA SR 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 PALEXIA SR:
Driving and using machines
If you feel drowsy, dizzy, have blurred vision or a slow reaction time whilst taking PALEXIA SR, then do not drive, use tools or machinery.
Any such effects are more likely to occur when you start taking PALEXIA SR, when the dose of PALEXIA SR is changed, or when you drink alcohol or take tranquilizers.
Please ask your doctor before driving a car or using machinery.
PALEXIA SR contains lactose.
Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
3. How to take PALEXIA SR
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 SR according to your pain level and your needs. Generally, the lowest pain-relieving dose should be taken.
Adults
The usual dose is 1 tablet every 12 hours.
Total daily doses of PALEXIA SR greater than 500 mg tapentadol 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 these tablets is too strong or weak, talk to your doctor or pharmacist.
How and when should you take PALEXIA SR
PALEXIA SR is for oral use.
Swallow the tablets with a glass of water. You may take the tablets either on an empty stomach or with food. Do not chew, break or crush the tablet, as it may result in overdose due to quick release of tapentadol in your body.
The empty shell of the tablet may not be digested completely and thus be seen in stool. This should not worry you, since the drug (active substance) of the tablet has already been absorbed in your body and what you see is just the empty shell.
How long should you take PALEXIA SR
Do not take the tablets for longer than your doctor has told you.
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 SR 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 SR is not recommended for children and adolescents below the age of 18 years.
If you take more PALEXIA SR than you should
Taking too much PALEXIA SR 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 SR may cause the following:
If you forget to take PALEXIA SR
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.
If you stop taking PALEXIA SR
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:
If you experience any of these complaints after stopping PALEXIA SR, please contact 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.
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
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.
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 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.
5. How to store PALEXIA SR
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.
6. Contents of the pack and other information
What PALEXIA SR contains
The active ingredient is tapentadol.
One (1) PALEXIA SR 50 mg prolonged-release tablet contains 50 mg tapentadol (as hydrochloride).
One (1) PALEXIA SR 100 mg prolonged-release tablet contains 100 mg tapentadol (as hydrochloride).
One (1) PALEXIA SR 150 mg prolonged-release tablet contains 150 mg tapentadol (as hydrochloride).
One (1) PALEXIA SR 200 mg prolonged-release tablet contains 200 mg tapentadol (as hydrochloride).
One (1) PALEXIA SR 250 mg prolonged-release tablet contains 250 mg tapentadol (as hydrochloride).
The other ingredients are:
What PALEXIA SR looks like and contents of the pack
PALEXIA SR are packed in blisters.
In the UK, PALEXIA SR is available in boxes of 28 and 56 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
Other formats of this leaflet
A service is available to listen to or request a copy of this leaflet in Braille, large print or audio.
Please call free of charge: 0800 198 5000 (UK only)
Please be ready to give the following information:
This leaflet was last revised in October 2019
Unit 1 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK
+44 (0)870 351 8960