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YANTIL 20MG/ML ORAL SOLUTION

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PIL UK-National Phase

Aug 2012
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Package leaflet: Information for the user
YANTIL 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.

What is in this leaflet:
1.
What YANTIL is and what it is used for
2.
What you need to know before you take YANTIL
3.
How to take YANTIL
4.
Possible side effects
5.
How to store YANTIL
6.
Contents of the pack and other information

1.

What YANTIL is and what it is used for

The full name of your medicine is ‘YANTIL 20 mg/ml oral solution’. It is referred to as ‘YANTIL’ in the
rest of this leaflet.
Tapentadol - the active substance in YANTIL - is a strong painkiller which belongs to the class of opioids.
YANTIL 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 YANTIL

Do not take YANTIL
 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 YANTIL’)

Warnings and precautions
Talk to your doctor or pharmacist before taking YANTIL if you:



have slow or shallow breathing
suffer from increased pressure in the brain or are not fully conscious
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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 YANTIL”)
suffer from a pancreatic disease including inflammation of the pancreas (pancreatitis) or disease of
the bile duct (biliary tract disease)
have a tendency to abuse medicines or if you are dependent on medicines, as YANTIL may lead to
addiction. In this case, you should only take this medicine for short periods of time and under strict
medical supervision.

Other medicines and YANTIL
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 YANTIL.
 Do not take YANTIL with monoamine oxidase inhibitors (MAOIs – certain medicines for the
treatment of depression). Tell your doctor if you are taking a MAOI or have taken a MAOI during
the last 14 days.
 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 YANTIL. If this happens tell
your doctor.
 Your consciousness may be decreased, you may feel drowsier or feel you might faint, if you take
YANTIL 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 YANTIL 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.
 YANTIL may not work as well if taken with opioid like medicines (e.g. those containing nalbuphine
or buprenorphine). Tell your doctor if you are currently being treated with one of these medicines.
 Taking YANTIL with products (e.g. rifampicin, phenobarbital or St John’s Wort) that affect the
enzymes required to remove YANTIL from the body, may affect how well YANTIL works or may
cause side effects. The effects may occur especially when the other medication is started or stopped.
Please keep your doctor informed about all medicines you are taking.

Taking YANTIL with food, drink and alcohol
Do not drink alcohol whilst you are taking YANTIL, because some side effects such as drowsiness may be
increased. You can take YANTIL 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 YANTIL. 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.

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Driving and using machines
If you feel drowsy, dizzy, have blurred vision or a slow reaction time whilst taking YANTIL, then do not
drive, use tools or machinery.
Any such effects are more likely to occur when you start taking YANTIL, when the dose of YANTIL is
changed, or when you drink alcohol or take tranquilizers.
Please ask your doctor before driving a car or using machinery.

3.

How to take YANTIL

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 YANTIL 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).
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 YANTIL 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 YANTIL
YANTIL 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
Fig 1

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 The bottle has a child resistant screw cap. To remove the cap, push it down and turn it anti-clockwise
(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 YANTIL”). 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 YANTIL
Do not take this medicine for longer than your doctor has told you.

If you take more YANTIL than you should
Taking too much YANTIL 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 YANTIL may cause the following:
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pin-point pupils in the eyes
being sick (vomiting)
drop in blood pressure
fast heartbeat
altered consciousness, collapse or deep unconsciousness (coma)
epileptic fits
dangerously slow or shallow breathing or stopping breathing.

If you forget to take YANTIL
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 YANTIL
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 YANTIL, 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 (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)
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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, 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 YANTIL’)
 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.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet.

5.

How to store YANTIL

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.

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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 YANTIL contains
The active ingredient is tapentadol.
1 ml of YANTIL 20 mg/ml oral solution contains 20 mg tapentadol (as hydrochloride)
The other ingredients are:
Citric acid monohydrate, Sucralose (E955), Raspberry flavour, Sodium hydroxide (for pH adjustment),
Purified water.
What YANTIL looks like and contents of the pack
YANTIL 20 mg/ml oral solution is a clear, colourless oral solution.
In the UK, YANTIL 20 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: YANTIL 20 mg/ml oral solution
 Reference number: PL 21727/0056
This leaflet was last revised in 08/2012.

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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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