Palexia 75 mg film-coated tablets

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

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
• 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 PALEXIA with medicines referred to as mixed opioid agonist/agntagonists (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.
• 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 these tablets for short periods of time and under strict medical supervision.

Sleep-related breathing disorders.

PALEXIA contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example central sleep apnea (shallow/pause of breathing during sleep) and sleep-related hypoxemia (low level of oxygen in the blood).

The risk of experiencing central sleep apnea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnea.

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.

• 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 at the same time. Your doctor will tell you whether PALEXIA is suitable for you.
• Concomitant use of PALEXIA 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 together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, 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 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.
• 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 monoamine oxidase inhibitors (MAOIs - certain medicines for the treatment of depression). Tell your doctor if you are taking or have taken MAO inhibitors 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 PALEXIA 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 PALEXIA:

• 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.

PALEXIA 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.

Adults

The usual dose is 1 tablet every 4 to 6 hours.

Total 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 these tablets is too strong or weak, talk to your doctor or pharmacist.

How and when should you take PALEXIA

PALEXIA 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.

How long should you take PALEXIA

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

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 and adolescents

PALEXIA is not recommended for children and adolescents below the age of 18 years.

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
• 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 PALEXIA

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 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 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, 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.

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 heart beat, 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).

Unknown

• 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.

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 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.

What PALEXIA contains

The active ingredient is tapentadol.

One (1) tablet contains 75 mg tapentadol (as hydrochloride).

The other ingredients are:

• Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K30, magnesium stearate.
• Tablet coat: polyvinylalcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What PALEXIA looks like and contents of the pack

PALEXIA 75 mg film-coated tablets are pale yellow round shaped film-coated tablets of 8 mm diameter, marked with Grünenthal logo on one side and “H7” on the other side.

PALEXIA film-coated tablets are packed in blisters.

In the UK, PALEXIA is available in boxes of 28 and 56 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Manufacturer: