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YANTIL SR 25MG PROLONGED-RELEASE TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Yantil SR 25 mg prolonged-release tablets

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 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.

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

1.

WHAT YANTIL SR IS AND WHAT IT IS USED FOR

The full name of your medicine is ‘Yantil SR 25 mg prolonged-release tablets’. It is referred to as ‘Yantil
SR’ in the rest of this leaflet.
Tapentadol - the active substance in Yantil SR - is a strong painkiller which belongs to the class of opioids.
Yantil 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 YANTIL SR

Do not take Yantil SR if you
 are allergic (hypersensitive) to tapentadol or any of the other ingredients (see Section 6) of Yantil SR
 have asthma or if your breathing is dangerously slow or shallow (respiratory depression,
hypercapnia)
 have no bowel movement as shown by severe constipation and bloating which may be accompanied
by pain or discomfort in the lower stomach
 have poisoning with alcohol, sleeping pills, pain relievers or medicines that affect mood and
emotions (see ‘Other medicines and Yantil SR’).

Warnings and precautions
Talk to your doctor or pharmacist before taking Yantil SR.
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Take special care with Yantil 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 Section 3)
 suffer from a pancreatic disease including inflammation of the pancreas (pancreatitis) or disease of
the bile duct (biliary tract disease)
 are taking or have taken a type of medicine known as a monoamine oxidase inhibitor (MAOI) during
the last 14 days. MAOIs are used in the treatment of depression (see ‘Other medicines and Yantil
SR’).
 if you have a tendency to abuse medicines or if you are dependent on medicines, as Yantil SR may
lead to addiction. In this case you should only take these tablets for short periods of time and under
strict medical supervision.
If any of the above applies to you, talk to your doctor before you take this medicine.

Other medicines and Yantil SR
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. Your doctor will tell you which medicines are safe to take with
Yantil SR.
 Do not take Yantil SR 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), pain relievers such as
morphine and codeine (also as cough medicine) in combination with Yantil SR. If this happens tell
your doctor.
 Your consciousness may be decreased, you may feel drowsier or feel you might faint, if you take
Yantil 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 Yantil 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.
 Yantil SR 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 SR with products (e.g. rifampicin, phenobarbital or St John’s Wort) that affect the
enzymes required to remove Yantil SR from the body, may affect how well Yantil SR 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.

Yantil SR with food, drink and alcohol
Do not drink alcohol whilst you are taking Yantil SR, because some side effects such as drowsiness may be
increased. You can take Yantil SR with or without food.

Pregnancy and breast-feeding
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Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Yantil SR:
 if you are pregnant, unless your doctor has instructed you to do so
 if you become pregnant during treatment with Yantil 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 Yantil SR, then do not
drive, use tools or machinery.
Any such effects are more likely to occur when you start taking Yantil SR, if the dose of Yantil SR is
changed, or if you are drinking alcohol or taking tranquilizers.
Please ask your doctor before driving a car or using machinery.

Yantil 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 YANTIL SR

Always take Yantil SR exactly as your doctor 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 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 Yantil 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 Yantil SR
Yantil 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 Yantil SR
Do not take the tablets for longer than your doctor has told you.

Children
Not recommended for children and adolescents below the age of 18 years.

Elderly patients
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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 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.

If you take more Yantil SR than you should
Taking too much Yantil 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 Yantil 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.

If you forget to take Yantil 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 Yantil 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 Yantil 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
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Like all medicines, Yantil 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 (uncommon). 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
(rare). 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 (affects more than 1 in 10 patients)
 feeling sick (nausea)
 constipation
 dizziness, drowsiness, headache.
Common (affects less than 1 in 10 patients)
 decreased appetite, anxiety, being sick (vomiting), diarrhoea, indigestion
 sleep problem, tiredness or exhaustion (fatigue), feeling of weakness, trembling, muscle 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 heart beat, 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 Yantil 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
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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 SR

Keep out of the sight and reach of children.
Do not use Yantil 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.
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 Yantil SR contains
The active substance is tapentadol.
One (1) Yantil 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 Yantil SR looks like and contents of the pack
Yantil 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.
Yantil SR are packed in blisters.
In the UK, Yantil 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.

Other formats of this leaflet

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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 SR 25 mg prolonged-release tablets
 Reference number: PL 21727/0052
This leaflet was last approved in
04/2012.

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