50 mg, 75 mg, 100 mg film-coated tablets
tapentadol
What Palexia is and what it is used for
Tapentadol, the active substance in Palexia, is a strong painkiller that belongs to the class of opioids.
Palexia is used to relieve moderate to severe acute pain in adults who are only getting enough effect from opioid painkillers.
Tapentadol contained in Palexia may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist ,or other healthcare professional if you have any further questions ,and always follow their instructions.
What you need to know before you take Palexia
Do not take Palexia if you
- is 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 intestinal tract
- if you are acutely poisoned by alcohol, sleeping pills, painkillers ,or other psychotropic drugs (drugs that affect mood and emotional life) (see “Other drugs and Palexia”).
Warnings and cautions
Talk to your doctor or pharmacist before taking Palexia if you:
- have slow or light breathing
- suffers from increased pressure in the brain or has decreased consciousness or coma
- have had a head injury or brain tumor
- suffers from liver or kidney disease (see “How to take Palexia”)
- suffers from a disease of the pancreas or bile ducts, including inflammation of the pancreas
- take medicines called mixed opioid aagonists/antagonists(eg pentazocine, nnalbuphine or partial opioid agonists (eg buprenorphine).
- if you have a tendency to have epileptic seizures or seizures, or if you are taking other medicines that may increase the risk of seizures, ahe risk of seizures may increase.
Palexia can lead to physical and mental dependence. If you htendto abuse drugs or if you are addicted to drugs, you should only take these tablets for short periods and under strict medical supervision.
Sleep-related respiratory disorders
Palexia contains an active substance that belongs to the group oof pioids . Opioids can cause sleep-related respiratory disorders, e.g. central sleep apnea (shallow breathing or respiratory arrest during sleep) and sleep-related hypoxemia (too low oxygen content in the blood).
The risk of experiencing central sleep apnea depends on the dose of one of the opioids Your doctor may consider reducing your total opioid dose 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.
The risk of side effects is increased if you take medicines that can cause seizures (seizures), such as ca ertain antidepressant or antipsychotic medicines. The risk of having a seizure may increase if you take Palexia at the same time. Your doctor will tell you if Palexia is right for you.
Concomitant use of Palexia and sedatives or sleeping pills such as benzodiazepines or similar medicines (certain sleeping pills or sedatives (eg barbiturates ) or painkillers such as opioids morphine and codeine (including cough medicines), antipsychotics, H1- antihistamines alcohol) increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Palexia with sedatives, the dose and treatment time should be limited by your doctor.
Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It can be good to inform friends and relatives to pay attention to the signs and symptoms described above. Contact your doctor if you experience any of these symptoms.
Talk to your doctor before taking Palexia if you are taking a type of medicine that affects serotonin levels (such as certain medicines used to treat depression) as there have been cases of serotonin syndrome. Serotonin syndrome is an unusual but life-threatening condition. You may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control eye movements, anxiety, sweating, tremors, excessive reflexes, increased muscle tension ,and body temperature above 38 ° C. Your doctor can advise you on this.
The use of Palexia with other types of medicines called mixed µ-opioid aagonists/antagonists(eg pentazocine, nnalbuphine or partial µ- opioid agonists (eg buprenorphine) has not been studied. Palexia may not work as well if given with any of these medicines. Tell your doctor if you are being treated with any of these medicines at the same time.
Using Palexia with strong inhibitors or inducers (eg rifampicin, phenobarbital, St. John’s wort ) of certain enzymes that are necessary to eliminate tapentadol from your body, may affect how well tapentadol works or may cause side effects This is especially true when the second treatment starts or ends. Tell your doctor about all the medicines you take.
Palexia should not be taken with MAOIs (a type of antidepressant). Talk to your doctor if you are taking MAO inhibitors or have been taking them for the last 14 days.
Palexia with food, drink ,and alcohol
Do not drink alcohol while taking Palexia as some side effects such as drowsiness may increase. Food does not affect the eeffectivenessof this medicine.
Pregnancy and breastfeeding
If you are pregnant or bbreastfeeding 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 tells you to. Long-term use of tapentadol during pregnancy can lead to withdrawal symptoms in the newborn, which can be life-threatening for the infant if not detected and treated by a doctor.
- during childbirth as it may lead to dangerously slow or shallow breathing ( respiratory depression ) in the newborn
- when bbreastfeedingas it may be excreted in human milk.
Driving and using machines
Palexia can cause drowsiness, dizziness ,and blurred vision and may impair your ability to react. This can especially happen when you start taking Palexia, when your doctor changes your dose or when you drink alcohol or take sedatives. Ask your doctor if it is allowed to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects aand/orside effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Palexia contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Palexia
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will adjust the dose one by intensity one on your pain and your iain sensitivity. As a rule, the lowest pain-relieving dose should be taken.
Adults The
uthe sual dose is 1 tablet every 4 to 6 hours. Total daily doses higher than 700 mg tapentadol on the first day of treatment and daily doses higher than 600 mg tapentadol during subsequent treatment days aisnot recommended.
Your doctor may prescribe another more appropriate dose or dosing interval if necessary for you. If you have the impression that the effect of these tablets is too strong or too weak, talk to your doctor or pharmacist.
Elderly patients
No dose adjustment is usually necessary iforelderly patients (over 65 years of age). However, the secretion of tapentadol may be delayed in some patients in this age group. If this applies to you, your doctor may recommend a different dosing interval.
Liver and kidney disease ( insufficiency )
Patients with severe liver problems should not take these tablets. If you have moderate problems, your doctor will recommend a different dosing interval. For mild liver problems, no dose adjustment is required.
Patients with severe kidney problems should not take these tablets. For mild or moderate kidney problems, no dose adjustment is required.
Children and young people
Palexia is not suitable for children and adolescents under 18 years of age.
How and when to take Palexia
Palexia should be taken by mouth.
Swallow the tablets with a sufficient amount of liquid. You can take these tablets on an empty stomach or with a meal.
How long should you take Palexia?
Do not take the tablets for longer than your doctor has told you.
If you take more Palexia than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital ,or the Poison Information Center (tel. 112) for risk assessment and advice.
After taking very high doses you may experience the following:
- pupil decrease, vomiting, drop in blood pressure, palpitations, collapse, loss of consciousness or coma (deep unconsciousness), epileptic seizures, dangerously slow or shallow breathing ,or respiratory arrest may occur.
If this happens to you, call a doctor immediately!
If you forget to take Palexia
If you forget to take the tablets, ithe pain will likelyreturn. Do not take a double dose to make up for a forgotten dose just keep taking the tablets as before.
If you stop taking Palexia
If you stop or stop treatment too soon, your pain is likely to return. If you want to stop treatment, talk to your doctor first before stopping treatment.
As a rule, it has no side effects when the treatment is stopped, but in rare cases, people who have taken the tablets for a while have felt bad about suddenly stopping taking them. Symptoms can be:
- restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle aches ,and enlarged pupils
- irritation, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, decreased appetite, vomiting, diarrhea, increased blood pressure increased breathing ,or increased heart rate
If you experience any of these symptoms after stopping treatment, consult your doctor. You should not abruptly stop your treatment unless your doctor tells you to. If your doctor wants you to stop taking your tablets, hhe/shewill tell you how to do it, which may include a gradual rdose reduction
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Important side effects or symptoms to be aware of and measures to take if you are affected:
This medicine may cause allergic reactions. Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching especially those that cover your entire body.
Another serious side effect is a condition where you breathe slower or weaker than expected. This mainly affects elderly and weak patients.
If you are experiencing these important side effects consult a doctor immediately.
Other side effects that may occur:
| Very common: (may affect more than 1 in 10 people) | nausea, vomiting, dizziness, drowsiness, headache. |
| Common: (may affect up to 1 in 10 people) | decreased appetiteconcernconfusionhallucinationssleeping problems abnormal dreamsshakingredness isconstipationdiarrheaindigestiondry mouthitchingincreased sweatingrashmuscle cramp feeling of weaknessfatiguefeeling of changed body temperature |
| Uncommon:(may affect up to 1 in 100 people) | Depressionorientation difficultiesagitation _ _nervousnessrestlessnesselated mmood disturbedattentionmemory impairmentfainting sensationdrowsiness ( sedation )difficulties in controlling mmovements difficultyspeakingnumbnessabnormal sensations in the skin (eg tickling tingling)muscle twitchingabnormal ssin increasedheart ratepalpitationdecreased blood ppressure dangerouslyslow or shallow breathing ( respiratory depression )decreased oxygen in the bblood respiratorydistressfeeling of discomfort in the abdomenhivesfeeling of heavinessdelay in emptying the bladder, frequent urinationwithdrawal symptoms ( abstinence ) of drugs (see “If you stop taking Palexia”)accumulation of water in the tissues ( edema )feel aabnormal feelingof intoxication, iirritability feelingof relaxation |
| Rare:(affects 1-10 of10,000 users) | allergic reactions of the drug including swelling under the skin, hives,and in severe cases difficulty breathing, drop in blood pressure, collapse or shock )abnormal thoughtsepileptiska anfallnedsatt medvetandegradonormal koordinationminskad pulsförsämrad tömning av magsäcken |
| Inte känd: | delirium |
Generellt är sannolikheten att få självmordstankar och självmordsbeteende större hos patienter som lider av kronisk smärta. Dessutom kan vissa mediciner som används mot depression (vilka påverkar signalsubstanser i hjärnan) öka denna risk, speciellt i början av behandlingen. Även om tapentadol också påverkar signalsubstanser så ger inte data från användning av tapentadol hos människor några bevis för en ökad risk.
Rapportering av biverkningar
Om du får biverkningar, tala med läkare, apotekspersonal eller sjuksköterska. Detta gäller även eventuella biverkningar som inte nämns i denna information. Du kan också rapportera biverkningar direkt till Läkemedelsverket, www.lakemedelsverket.se. Genom att rapportera biverkningar kan du bidra till att öka informationen om läkemedels säkerhet. Postadress
Hur Palexia ska förvaras
Förvara detta läkemedel utom syn- och räckhåll för barn.
Används före utgångsdatum som anges på kartongen efter ”Utg.dat.” och på blistret efter ”EXP”.
Utgångsdatumet är den sista dagen i angiven månad.
Inga särskilda förvaringsanvisningar.
Läkemedel ska inte kastas i avloppet eller bland hushållsavfall. Fråga apotekspersonalen hur man kastar läkemedel som inte längre används. Dessa åtgärder är till för att skydda miljön.
6. Förpackningens innehåll och övriga upplysningar
Innehållsdeklaration
Den aktiva substansen är tapentadol
Varje tablett innehåller 50 mg tapentadol (som 58,24 mg tapentadolhydroklorid).
Varje tablett innehåller 75 mg tapentadol (som 87,36 mg tapentadolhydroklorid).
Varje tablett innehåller 100 mg tapentadol (som 116,48 mg tapentadolhydroklorid).
Övriga innehållsämnen är:
Palexia 50 mg filmdragerade tabletter:
Tablettkärna: mikrokristallin cellulosa, laktosmonohydrat, kroskarmellosnatrium, povidon K30, magnesiumstearat. Tabletthölje: polyvinylalkohol, titandioxid (E 171), makrogol 3350, talk.
Palexia 75 mg filmdragerade tabletter:
Tablettkärna: mikrokristallin cellulosa, laktosmonohydrat, kroskarmellosnatrium, povidon K30, magnesiumstearat. Tabletthölje: polyvinylalkohol, titandioxid (E 171), makrogol 3350, talk, järnoxid, gul (E172), järnoxid, röd (E172).
Palexia 100 mg film-coated tablets:
Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K30, magnesium stearate. Tablet cover: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide, yellow (E172), iron oxide, red (E172), iron oxide, black (E172).
What the medicine looks like and the contents of the pack
Palexia 50 mg film-coated tablets:
white round film-coated tablets 7 mm in diameter marked with the Grünenthal logo on one side and “H6” on the other side.
Palexia 75 mg film-coated tablets:
pale yellow round 8-mm film-coated tablets marked with the Grünenthal logo on one side and “H7” on the other side.
Palexia 100 mg film-coated tablets
light pink round film-coated tablets 9 mm marked with the Grünenthal logo on one side and “H8” on the other side.
Palexia film-coated tablets are packaged in blisters and are supplied in cartons of 5, 10, 10×1, 14, 14×1, 20, 20×1, 24, 28, 28×1, 30, 30×1, 40, 50, 50×1, 54, 56, 56×1, 60, 60×1, 90, 90×1, 100 and 100×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany