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PALXIA SR 100MG PROLONGED-RELEASE TABLETS

Active substance(s): TAPENTADOL HYDROCHLORIDE

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Package leaflet: information for the user
Palexia® SR 100mg prolonged-release tablets
(tapentadol hydrochloride)
This product is available in multiple strengths and all strengths will
be referred to throughout this leaflet.
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 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 100mg prolongedrelease 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
 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 SR’)
Warnings and precautions
Talk to your doctor or pharmacist before taking PALEXIA SR if you:
 have slow or shallow breathing
 suffer from increased pressure in the brain or are not fully conscious
 have had a head injury or brain tumors
 have had an epileptic fit or if you are at risk of having epileptic fits
 suffer from liver or kidney problems (see ‘How to take PALEXIA
SR’)
 suffer from a pancreatic disease including inflammation of the
pancreas (pancreatitis) or disease of the bile duct (biliary tract
disease)
 are taking medicines referred to as mixed opioid agonist/antagonists
(e.g., pentazocine, nalbuphine) or partial mu-opioid agonists (e.g.
buprenorphine)
 have a tendency to abuse medicines or if you are dependent on
medicines, as PALEXIA SR may lead to addiction. In this case, you
should only take these tablets for short periods of time and under
strict medical supervision.
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.
 Your breathing may become dangerously slow or shallow
(respiratory depression) if you are taking certain sleeping pills or
tranquilizers (e.g. barbiturates, benzodiazepines), or pain relievers
such as morphine and codeine (also as cough medicine) in
combination with PALEXIA SR. If this happens tell your doctor.
 Your consciousness may be decreased, you may feel drowsier or
feel you might faint, if you take PALEXIA SR with sedatives (such as
benzodiazepines), antipsychotics (medicines that affect the state of
mind or emotions), H1-antihistamines, opioids or alcohol. If this
happens tell your doctor.
 If you are taking a type of medicine that affects serotonin levels (e.g.
certain medicines to treat depression), speak to your doctor before
taking PALEXIA SR as there have been cases of “serotonin
syndrome”. Serotonin syndrome is a rare, but life-threatening
condition. The signs include confusion, restlessness, fever,
sweating, uncoordinated movement of arms, legs or eyes,
uncontrollable jerking of muscles, muscle twitches and diarrhoea.
Your doctor can advise you on this.
 PALEXIA SR may not work as well if taken with opioid like
medicines (e.g. those containing pentazocine, nalbuphine or
buprenorphine). Tell your doctor if you are currently being treated
with one of these medicines.
 Taking PALEXIA SR with products (e.g. rifampicin, phenobarbital or
St John’s Wort) that affect the enzymes required to remove
PALEXIA SR from the body, may affect how well PALEXIA SR
works or may cause side effects. The effects may occur especially
when the other medication is started or stopped.
 PALEXIA SR should not be taken together with monoamine oxidase
inhibitors (MAOIs - certain medicines for the treatment of
depression). Tell your doctor if you are taking MAO inhibitors or
have taken these during the last 14 days.
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:

 if you are pregnant, unless your doctor has instructed you to do so
 if you become pregnant during treatment with PALEXIA SR. Check
with your doctor.

 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.
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.
The medicine can affect your ability to drive as it may make you
sleepy or dizzy.
 Do not drive while taking this medicine until you know how it affects
you.
 It is an offence to drive if this medicine affects your ability to drive.
 However, you would not be committing an offence if:
○ The medicine has been prescribed to treat a medical or dental
problem and
○ You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
○ It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.
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.
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.
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:
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.

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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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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