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PALEXIA 4MG/ML ORAL SOLUTION

Active substance(s): TAPENTADOL HYDROCHLORIDE

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Package leaflet: Information for the user

PALEXIA 4 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 4 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 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:
• 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”)
• 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 may lead to addiction. In this case, you should
only take this medicine for short periods of time and under strict
medical supervision.

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 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 with products (e.g. rifampicin, phenobarbital or St
John’s Wort) that affect the enzymes required to remove PALEXIA
from the body, may affect how well PALEXIA works or may cause side
effects. The effects may occur especially when the other medication is
started or stopped.
• PALEXIA 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.
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 this
medicine 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 you become pregnant during treatment with PALEXIA. 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, 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.

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.
• 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. If
this happens tell your doctor.
• Your consciousness may be decreased, you may feel drowsier or
feel you might faint, if you take PALEXIA 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 as there have been cases of “serotonin syndrome”.
Serotonin syndrome is a rare, but life-threatening condition. The

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 painrelieving dose should be taken.

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
Not recommended for children and adolescents below the age of
18 years.
How and when should you take PALEXIA
PALEXIA is for oral use.
You may take the oral solution with or without food.
Use the oral syringe 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 oral syringe

• fast heartbeat
• altered consciousness, collapse or deep unconsciousness (coma)
• epileptic fits
• dangerously slow or shallow breathing or stopping breathing.

Adults
The usual dose every 4 to 6 hours is either:
- 50 mg tapentadol (12.5 ml oral solution), or
- 75 mg tapentadol (18.75 ml oral solution), or
- 100 mg tapentadol (25 ml oral solution).
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.
Perforation

Fig 1
• The bottle has a child resistant screw cap. To
remove the cap, push it down and turn it anticlockwise (Fig. 1). After the cap is removed, peel
off the safety seal from the top of the bottle. If the
safety seal is damaged, do not use this medicine
and talk to your pharmacist.
Fig 2
• Place the bottle on a stable flat surface. Open
the plastic bag containing the oral syringe and
adaptor at the perforated end and remove the oral
syringe (A) with the attached adaptor (B). Plug the
adaptor with the oral syringe firmly into the neck of
the bottle (Fig 2).
Fig 3
• To fill the oral syringe, turn the bottle upside down.
Whilst holding the oral syringe in place, gently
pull the plunger (C) down to the line that matches
the dose prescribed by your doctor (See section
„How to take PALEXIA”). Do not remove the oral
syringe at this point! (Fig 3)
Fig 4
• Turn the bottle upright and then carefully remove
the oral syringe from the bottle. After you have
removed the oral syringe, carefully check that you
have taken the right amount of the solution. The
adaptor (B) that was previously attached to the oral
syringe should now remain in the bottle (Fig. 4).
Fig 5
• Take your medicine by placing the oral syringe
into your mouth and gently pressing the plunger.
Press the plunger fully to ensure all solution
is dispensed. If you prefer, you can dilute the
medicine in a glass of water or a non-alcoholic
drink before you take it; in this case drink the
whole glass to ensure that you have taken the
correct dose of medicine (Fig.5)
• Leave the adaptor in the bottle. Replace the cap and tightly close the
bottle. Store the bottle in an upright position. After use, rinse the oral
syringe with water and allow it to dry. When you take your medicine
the next time, place the oral syringe into the adaptor in the neck of the
bottle and follow the instructions above.
How long should you take PALEXIA
Do not take this medicine for longer than your doctor has told you.
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:
• pin-point pupils in the eyes
• being sick (vomiting)
• drop in blood pressure

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:
• 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,
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:
• This medicine may cause allergic reactions including swelling beneath
the skin, hives, and in severe cases difficulty breathing, a fall in blood
pressure, collapse, or shock (rare). Symptoms may be wheeziness,
difficulty breathing, swelling of the eyelids, face or lips, or rash or
itching, which may cover your whole body.
• Another serious side effect is a condition where you breathe more
slowly or weakly than expected (uncommon). It mostly occurs in
elderly and weak patients.
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)
• feeling sick (nausea), being sick (vomiting)
• dizziness, drowsiness, headache.
Common (may affect up to 1 in 10 people)
• decreased appetite, constipation, diarrhoea, indigestion
• anxiety, confusion, hearing, seeing or sensing things that are not really
there (hallucinations), sleep problem, abnormal dreams
• trembling, feeling hot (flushing), dry mouth
• itching, increased sweating, rash
• muscle cramps, feeling of weakness, tiredness or exhaustion (fatigue),
feeling of body temperature change.
Uncommon (may affect up to 1 in 100 people)
• feeling depressed, very happy (euphoria), nervous, restless, or excitable
(agitated), low awareness of time, place or identity (disorientation)
• lack of attention, forgetfulness, almost fainting, sedation, uncoordinated
movements, muscle twitches, difficulty in speaking
• numbness, abnormal sensations of the skin (e.g. tingling, prickling)
• abnormal vision
• faster heartbeat, palpitations, decreased blood pressure, less oxygen
in the blood, shortness of breath
• stomach discomfort
• skin reactions (hives)
• feeling of heaviness
• delay in passing urine, passing urine more often than usual
• drug withdrawal effects (see ‘If you stop taking PALEXIA’)
• water retention (oedema)
• feeling strange, drunk, irritable or relaxed.
Rare (may affect up to 1 in 1,000 people)
• epileptic fits

• thinking abnormal, impaired consciousness, uncoordinated movements,
slower heart beat
• 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
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.

1 ml of PALEXIA 4 mg/ml oral solution contains 4 mg tapentadol (as
hydrochloride)
The other ingredients are:
Sodium benzoate (E211), Citric acid monohydrate, Sucralose (E955),
Raspberry flavour, Purified water.
What PALEXIA looks like and contents of the pack
PALEXIA 4 mg/ml oral solution is a clear, colourless oral solution.
In the UK, PALEXIA 4 mg/ml oral solution is available in plastic bottles
containing 100 millilitres of solution, including an oral syringe and an
adapter.
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.
Tel: +44(0)870 351 8960. E-mail: medicalinformationuk@grunenthal.com
Manufacturer:
Grünenthal GmbH, Zieglerstrasse 6, 52078, Aachen, Germany.
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:
• Product name: PALEXIA 4 mg/ml oral solution
• Reference number: PL 21727/0053
This leaflet was last revised in April 2014

6. Contents of the pack and other information
What PALEXIA contains
The active ingredient is tapentadol.

Perforation

R-AD-170812-16

50/044/08

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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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