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PALEXIA SR 25 MG PROLONGED-RELEASE TABLETS

Active substance(s): TAPENTADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PALEXIA SR 25 mg prolonged-release tablets
Tapentadol
• PALEXIA SR should not be taken together with MAO inhibitors (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.
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 this medicine with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any 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
1. WHAT PALEXIA SR IS AND WHAT IT IS USED FOR
The full name of your medicine is ‘PALEXIA SR 25 mg prolonged-release tablets’. It is 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.
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 Any such effects are more likely to occur when you start taking PALEXIA SR, if the dose of
the class of opioids. PALEXIA SR is used in adults for the treatment of severe long-term PALEXIA SR is changed, or when you are drinking alcohol or taking tranquilizers.
Please ask your doctor before driving a car or using machinery.
pain that can only be adequately managed with an opioid painkiller.
PALEXIA SR contains lactose
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance
PALEXIA SR
to some sugars, talk to your doctor before taking this medicine.
Do not take PALEXIA SR
• if you are allergic (hypersensitive) to tapentadol or any of the other ingredients (see 3. HOW TO TAKE PALEXIA SR
Always take PALEXIA SR exactly as your doctor has told you. Check with your doctor or
Section 6) of PALEXIA SR
• if you have asthma or if your breathing is dangerously slow or shallow (respiratory pharmacist if you are not sure.
Your doctor will change the dose and time between doses of PALEXIA SR according to
depression, hypercapnia)
• if you have no bowel movement as shown by severe constipation and bloating which may your pain level and your needs. Generally, the lowest pain-relieving dose should be taken.
be accompanied by pain or discomfort in the lower stomach
Adults
• if you have poisoning with alcohol, sleeping pills, pain relievers or medicines that affect The usual dose is 1 tablet every 12 hours.
mood and emotions (see ‘Other medicines and PALEXIA SR’).
Daily doses of PALEXIA SR greater than 500 mg tapentadol are not recommended.
Warnings and precautions
Your doctor may prescribe a different, more appropriate dose or timing of dosing, if this is
Talk to your doctor or pharmacist before taking PALEXIA SR if you
necessary for you. If you feel that the effect of these tablets is too strong or weak, talk to
• have slow or shallow breathing
your doctor or pharmacist.
• suffer from increased pressure in the brain or are not fully conscious
How and when should you take PALEXIA SR
• have had a head injury or brain tumors
PALEXIA SR is for oral use.
• have had an epileptic fit or if you are at risk of having epileptic fits
Swallow the tablets with a glass of water. You may take the tablets either on an empty
• suffer from liver or kidney problems (see “How to take PALEXIA SR”)
• suffer from a pancreatic disease including inflammation of the pancreas (pancreatitis) or 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.
disease of the bile duct (biliary tract disease)
• are taking medicines referred to as mixed opioid agonist/antagonists (e.g., pentazocine, How long should you take PALEXIA SR
Do not take the tablets for longer than your doctor has told you.
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 Children
may lead to addiction. In this case you should only take these tablets for short periods of Not recommended for children and adolescents below the age of 18 years.
time and under strict medical supervision.
Elderly patients
Other medicines and PALEXIA SR
In elderly patients (above 65 years) usually no dose adjustment is necessary. However,
Please tell your doctor or pharmacist if you are taking or have recently taken any other your doctor may adjust your dose or time between doses if required.
medicines, including medicines obtained without a prescription. Your doctor will tell you
Patients with liver or kidney problems (insufficiency)
which medicines are safe to take with PALEXIA SR.
• Your breathing may become dangerously slow or shallow (respiratory depression) if you Do not take PALEXIA SR if you have severe liver or kidney problems.
are taking certain sleeping pills or tranquilizers (e.g. barbiturates, benzodiazepines), pain If you have moderate liver problems, your doctor will adjust your dose or time between doses.
relievers such as morphine and codeine (also as cough medicine) in combination with If you have mild liver problems or mild to moderate kidney problems, a dose adjustment
is not required.
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 more PALEXIA SR than you should
if you take PALEXIA SR with sedatives (such as benzodiazepines), antipsychotics Taking too much PALEXIA SR may be life-threatening.
(medicines that affect the state of mind or emotions), H1-antihistamines, opioids or Immediate medical advice should be sought in the event of an overdose, even if
alcohol. If this happens tell your doctor.
you feel well.
• If you are taking a type of medicine that affects serotonin levels (e.g. certain medicines Very high doses of PALEXIA SR may cause the following:
to treat depression), speak to your doctor before taking PALEXIA SR as there have • pin-point pupils in the eyes
been cases of “serotonin syndrome”. Serotonin syndrome is a rare, but life-threatening • being sick (vomiting)
condition. The signs include confusion, restlessness, fever, sweating, uncoordinated • drop in blood pressure
movement of arms, legs or eyes, uncontrollable jerking of muscles, muscle twitches and
• fast heart beat
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 • altered consciousness, collapse or deep unconsciousness (coma)
pentazocine, nalbuphine or buprenorphine). Tell your doctor if you are currently being • epileptic fits
• dangerously slow or shallow breathing or stopping breathing.
treated with one of these medicines.
• Taking PALEXIA SR with products (e.g. rifampicin, phenobarbital or St John’s Wort) that If you forget to take PALEXIA SR
affect the enzymes required to remove PALEXIA SR from the body, may affect how well If you forget to take the tablets, your pain is likely to return.
PALEXIA SR works or may cause side effects. The effects may occur especially when the Do not take a double dose to make up for a forgotten dose; simply continue taking the
other medication is started or stopped.
tablets as before.
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 your 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).
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

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:
• feeling restless, irritable, anxious, weak or sick (nausea), loss of appetite, being sick
(vomiting), diarrhoea
• watery eyes, runny nose, increase in size of the pupils in the eyes (dilated pupils)
• difficulty in sleeping, yawning
• sweating, shivering
• muscle or joint pain, backache, abdominal cramps
• increase in blood pressure, breathing or heart rate.
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

This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What PALEXIA SR contains
The active substance is tapentadol.
One (1) PALEXIA SR 25 mg prolonged-release tablet contains 25 mg tapentadol (as
hydrochloride).
The other ingredients are:
Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica,
magnesium stearate.
25 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 400, macrogol
6000, titanium dioxide (E 171), yellow iron oxide (E 172) and red iron oxide (E 172).
What PALEXIA SR looks like and contents of the pack
PALEXIA SR 25 mg prolonged-release tablets are slightly brownish-orange film-coated
oblong shaped prolonged-release tablets, measuring 5.5 mm x 10 mm, marked with
Grünenthal logo on one side and “H9” on the other side.
PALEXIA SR are packed in blisters.
In the UK, PALEXIA SR are available in boxes of 28 and 56 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge,
Middlesex UB11 1BD, United Kingdom.
Manufacturer:
Grünenthal GmbH, Zieglerstrasse 6, 52078, Aachen, Germany.

Like all medicines, PALEXIA SR 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:
• This medicine may cause allergic reactions including swelling beneath the skin,
hives, in severe cases difficulty breathing, a fall in blood pressure, collapse, or shock
(uncommon). Symptoms may be wheeziness, difficulty breathing, swelling of the eyelids,
face or lips, or rash or itching, which may cover your whole body.
Other formats of this leaflet
• Another serious side effect is a condition where you breathe more slowly or weakly than
A service is available to listen to or request a copy of this leaflet
expected (rare). It mostly occurs in elderly and weak patients.
in Braille, large print or audio.
If you are affected by these important side effects contact a doctor immediately.
Other side effects that may occur:
Please call free of charge: 0800 198 5000 (UK only).
Very common (affects more than 1 in 10 patients)
Please be ready to give the following information:
• feeling sick (nausea)
• Product name: PALEXIA SR 25 mg prolonged-release
• constipation
tablets
• dizziness, drowsiness, headache.

Reference number: PL 21727/0051
Common (affects less than 1 in 10 patients)
• decreased appetite, anxiety, being sick (vomiting), diarrhoea, indigestion
This leaflet was last revised in
• sleep problem, tiredness or exhaustion (fatigue), feeling of weakness, trembling, muscle April 2014
twitches, shortness of breath
• feeling depressed, nervousness, restlessness, lack of attention
• feeling hot (flushing), increased sweating, feeling of body temperature change, dry areas
like nostrils, mouth, lips, eyelids, ears, genitals and anus
• itching, rash
• water retention (oedema).
Uncommon (affects less than 1 in 100 patients)
• weight loss
• low awareness of time, place or identity (disorientation), confusion, excitable (agitated),
disturbances in perception, abnormal dreams, forgetfulness, mental impairment
• very happy (euphoria), less consciousness, fainting, sedation, feeling unsteady, difficulty
in speaking, numbness
• abnormal sensations of the skin (e.g. tingling, prickling), skin reactions (hives)
• abnormal vision
• faster or slower heartbeat, palpitations, low blood pressure
• stomach discomfort, delay in passing urine, passing urine more often than usual
• sexual dysfunction
• drug withdrawal effects (see ‘If you stop taking PALEXIA SR’)
• feeling strange, irritable.
Rare side effects (affect less than 1 in 1,000 patients)
• addiction
• thinking abnormal, epileptic fits, near fainting, uncoordinated, feeling drunk or relaxed
• delayed emptying of the stomach (impaired gastric emptying).
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. By reporting side effects you can help
provide more information on the safety of this medicine.

5. HOW TO STORE PALEXIA SR
Keep out of the sight and reach of children.
Do not use PALEXIA SR after the expiry date which is stated on the carton and the blister.
The expiry date refers to the last day of that month.

R-JJ-100412-01

50/030/23

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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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