• 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).

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 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 paralysis of the gut
• If you have acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions) (see “Other medicines and PALEXIA SR”)

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 disturbed consciousness up to coma,
• have had a head injury or brain tumours,
• suffer from a liver or kidney disease (see ‘How to take PALEXIA SR’),
• suffer from a pancreatic or biliary tract disease including pancreatitis,
• 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 towards epilepsy or fits or if you are taking other medicines known to increase the risk of seizures because the risk of a fit may increase.
• or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• are a smoker.
• have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

This medicine contains tapentadol which is an opioid medicine. Repeated use of opioid painkillers may result in the drug being less effective (you become accustomed to it). It may also lead to dependence and abuse which may result in life-threatening overdose. If you have concern that you may become dependent on PALEXIA SR, it is important that you consult your doctor. Use (even at therapeutic doses) may lead to physical dependence, which may result in you suffering withdrawal effects and a recurrence of your problems if you suddenly stop taking this medicine treatment.

PALEXIA SR may lead to physical and psychological addiction. If you have a tendency to abuse medicines or if you are dependent on medicines, you should only take these tablets for short periods and under strict medical supervision.

Children and adolescents

Children and adolescents with obesity should be monitored closely and the recommended maximum dose should not be exceeded.

Do not give this medicine to children below the age of 6 years.

Sleep-related breathing disorders

PALEXIA SR can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The risk of side effects increases if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take PALEXIA SR at the same time. Your doctor will tell you whether PALEXIA SR is suitable for you.

Concomitant use of PALEXIA SR and sedative medicines such as benzodiazepines or related drugs (certain sleeping pills or tranquillizers (e.g., barbiturates) or pain relievers such as opioids, morphine and codeine (also as cough medicine), antipsychotics, H1-antihistamines, alcohol) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe PALEXIA SR together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

The concomitant use of opioids and drugs used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and may be life-threatening.

Please tell your doctor if you are taking gabapentin or pregabalin or any sedative medicines, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

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 involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension and body temperature above 38°C.

Your doctor can advise you on this.

Taking PALEXIA SR together with other types of medicines referred to as mixed mu-opioid agonist/antagonists (e.g. pentazocine, nalbuphine) or partial mu-opioid agonists (e.g., buprenorphine) has not been studied. It is possible that PALEXIA SR will not work as well if given together with one of these medicines. Tell your doctor in case you are currently treated with one of these medicines.

Taking PALEXIA SR together with strong inhibitors or inducers (e.g. rifampicin, phenobarbital, St John’s Wort) of certain enzymes that are necessary to eliminate tapentadol from your body, may influence how well tapentadol works or may cause side effects, especially when this other medication is started or stopped. Please keep your doctor informed about all medicines you are taking.

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.

Do not drink alcohol whilst taking PALEXIA SR, because some side effects such as drowsiness may be increased. Food does not influence the effect of this medicine.

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 these tablets:

• if you are pregnant, unless your doctor has instructed you to do so, if used over prolonged periods during pregnancy, tapentadol may lead to withdrawal symptoms in the newborn baby, which might be life-threatening for the newborn if not recognized and treated by a doctor.
• during childbirth, because it could lead to dangerously slow or shallow breathing (respiratory depression) in the newborn,
• during breast-feeding, because it may be excreted in the breast milk.

PALEXIA SR may cause drowsiness, dizziness and blurred vision and may impair your reactions. This may especially happen when you start taking PALEXIA SR, when your doctor changes your dosage or when you drink alcohol or take tranquilizers. Please ask your doctor whether it is permitted to drive a car or use machines.

This medicine can affect your ability to drive.

Do not drive whilst taking this medicine until you know how this medicine affects you.

It may be an offence to drive if your ability to drive safely is affected.

There is further information for patients who are intending to drive in Great Britain - go to https://www.gov.uk/drug-driving-law.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The usual starting dose is 50 mg every 12 hours.

Your doctor may prescribe a different, more appropriate dose or interval of dosing, if this is necessary for you. If you feel that the effect of these tablets is too strong or too weak, talk to your doctor or pharmacist.

Total daily doses of PALEXIA SR greater than 500 mg tapentadol are not recommended.

In elderly patients (above 65 years) usually no dose adjustment is necessary. However, the excretion of tapentadol may be delayed in some patients of this age group. If this applies to you, your doctor may recommend a different dosage regimen.

Patients with severe liver problems should not take these tablets. If you have moderate problems, your doctor will recommend a different dosage regimen. In case of mild liver problems, a dosage adjustment is not required.

Patients with severe kidney problems should not take these tablets. In case of mild or moderate kidney problems, a dosage adjustment is not required.

The dose of PALEXIA SR for children and adolescents aged 6 years to less than 18 years is dependent on age and body weight.

The correct dose will be determined by your doctor. A total dose of 500 mg per day, i.e. 250 mg given every 12 hours should not be exceeded.

Children and adolescents with kidney or liver problems should not take these tablets.

PALEXIA SR is not suitable for children below the age of 6 years.

PALEXIA SR is for oral use.

Always swallow the tablets whole, with sufficient liquid. Don’t chew it, break it or crush it – this could lead to overdosing, because the drug will be released into your body too quickly. You may take the tablets on an empty stomach or with meals.

The empty shell of the tablet may not be digested completely and thus be seen in stool. This should not worry you, since the active substance of the tablet has already been absorbed in your body and what you see is just the empty shell.

Do not take the tablets for longer than your doctor has told you.

After taking very high doses, the following may be experienced:

• pin-point pupils, vomiting, drop in blood pressure, fast heartbeat, collapse, disturbed consciousness or coma (deep unconsciousness), epileptic fits, dangerously slow or shallow breathing or stopping breathing may occur.

If this happens a doctor should be called immediately!

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 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 after-effects when treatment is stopped, however, on uncommon occasions, people who have been taking the tablets for some time may feel unwell if they abruptly stop taking them.

Symptoms may be:

• restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle pain and dilated pupils,
• irritability, anxiety, backache, joint pain, weakness, abdominal cramps, difficulty in sleeping, nausea, loss of appetite, vomiting, diarrhoea, and increases in blood pressure, breathing or heart rate.

If you experience any of these complaints after stopping treatment, please consult your doctor.

You should not suddenly 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.

This medicine may cause allergic reactions. Symptoms may be wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching, especially those covering your whole body.

Another serious side effect is a condition where you breathe more slowly or weakly than expected. It mostly occurs in elderly and weak patients.

If you are affected by these important side effects contact a doctor immediately.

Very common (may affect more than 1 in 10 people): nausea, constipation, dizziness, drowsiness, headache.

Common (may affect up to 1 in 10 people): decreased appetite, anxiety, depressed mood, sleep problem, nervousness, restlessness, disturbance in attention, trembling, muscle twitches, flushing, shortness of breath, vomiting, diarrhoea, indigestion, itching, increased sweating, rash, feeling of weakness, fatigue, feeling of body temperature change, mucosal dryness, accumulation of water in the tissue (oedema).

Uncommon (may affect up to 1 in 100 people): allergic reaction to medicines (including swelling beneath the skin, hives, and in severe cases difficulty breathing, a fall in blood pressure, collapse, or shock),weight loss, disorientation, confusion, excitability (agitation), perception disturbances, abnormal dreams, euphoric mood, depressed level of consciousness, memory impairment, mental impairment, fainting, sedation, balance disorder, difficulty in speaking, numbness, abnormal sensations of the skin (e.g. tingling, prickling), abnormal vision, faster heartbeat, slower heartbeat, palpitations, decreased blood pressure, abdominal discomfort, hives, delay in passing urine, frequent urination, sexual dysfunction, drug withdrawal syndrome (see ‘If you stop taking PALEXIA SR’), feeling abnormal, irritability.

Rare (may affect up to 1 in 1,000 people): drug dependence, thinking abnormal, epileptic fits, near fainting, coordination abnormal, dangerously slow or shallow breathing (respiratory depression), impaired gastric emptying, feeling drunk, feeling of relaxation.

Not known (frequency cannot be estimated from the available data): Delirium.

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. You can also report side effects directly via:

Ireland

UK

the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is tapentadol.

Each tablet contains 50 mg tapentadol (as 58.24 mg tapentadol hydrochloride).

Each tablet contains 100 mg tapentadol (as 116.48 mg tapentadol hydrochloride).

Each tablet contains 150 mg tapentadol (as 174.72 mg tapentadol hydrochloride).

Each tablet contains 200 mg tapentadol (as 232.96 mg tapentadol hydrochloride).

Each tablet contains 250 mg tapentadol (as 291.20 mg tapentadol hydrochloride).

The other ingredients are:

• Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
• 50mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171).
• 100 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172).
• 150 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).
• 200 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).
• 250 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172), black iron oxide (E 172).

• [50 mg]: White film-coated oblong shaped prolonged-release tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H1” on the other side.
• [100 mg]: Pale yellow film-coated oblong shaped prolonged-release tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H2” on the other side.
• [150 mg]: Pale pink film-coated oblong shaped prolonged-release tablets (6.5 mm x 15 mm) marked with Grünenthal logo on one side and “H3” on the other side.
• [200 mg]: Pale orange film-coated oblong shaped prolonged-release tablets (7 mm x 17 mm) marked with Grünenthal logo on one side and “H4” on the other side.
• [250 mg]: Brownish red film-coated oblong shaped prolonged-release tablets (7 mm x 17 mm) marked with Grünenthal logo on one side and “H5” on the other side.

PALEXIA SR prolonged-release tablets are packed in blisters and are supplied in boxes of 7, 10, 10x1, 14, 14x1, 20, 20x1, 24, 28, 28x1, 30, 30x1, 40, 50, 50x1, 54, 56, 56x1, 60, 60x1, 90, 90x1, 100 and 100x1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer: