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Patient Info Service - information for patients
1. What is PALEXIA retard and what is it used for?
Tapentadol - the active ingredient in Palexia retard - is a strong pain reliever that belongs to the group of opioids.
Palexia retard is used to treat severe, chronic pain in adults that can only be adequately managed with opioid pain relievers.
2. What you need to know before you take PALEXIA retard.
Do not take PALEXIA retard
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 threateningly slow or shallow (respiratory depression, hypercapnia).
if you suffer from intestinal paralysis.
if you have acute poisoning from alcohol, sleeping pills, painkillers or other psychotropic drugs (medicines that affect mood and emotional life) (see "Other medicines and Palexia retard").
Warnings and Precautions
Talk to your doctor or pharmacist before taking PALEXIA retard:
if your breathing is slow or shallow.
if you suffer from increased intracranial pressure or impaired consciousness or even coma.
after a head injury or a brain tumor.
if you have liver or kidney problems (see 'How to take PALEXIA retard').
if you have a disease of the pancreas or bile ducts, including inflammation of the pancreas.
if you are taking medicines that belong to the group of so-called mixed µ-opioid receptor agonists / antagonists (e.g. pentazocine, nalbuphine) or the so-called partial µ-opioid receptor agonists (e.g. buprenorphine).
if you are prone to epilepsy or seizures as the risk of having a seizure is increased. The risk of having a seizure may increase if you are also taking medicines that in turn increase the risk of having a seizure.
Palexia retard can be physically and mentally addictive. If you are prone to drug abuse or are drug dependent, you may only take the tablets for a short time and under strict medical supervision.
Sleep-related breathing disorders
Palexia retard contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders such as central sleep apnea (shallow breathing or cessation of breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood).
The risk of developing central sleep apnea depends on the opioid dose. If you develop central sleep apnea, your doctor may consider reducing your total opioid dose.
Other medicines and Palexia retard
Tell your doctor or pharmacist if you are taking / using, have recently taken / used, or may take / use any other medicines.
The risk of side effects increases if you are taking medicines that can cause seizures, such as certain medicines for depression or psychosis. The risk of seizures may increase if you are taking PALEXIA retard at the same time. Your doctor will tell you if PALEXIA retard is right for you.
Simultaneous use of Palexia retard and sedative drugs such as benzodiazepines or similar drugs (certain sleeping pills or sedatives [e.g. barbiturates] or pain relievers such as opioids, morphine and codeine [also as a drug against coughs], antipsychotics, H1 antihistamines, alcohol), increases the risk of drowsiness, difficulty breathing (respiratory depression) and coma and can be life-threatening. For this reason, concomitant use should only be considered if no other treatment options are available.
However, if your doctor prescribes Palexia retard together with sedative medicinal products, the dose and duration of concomitant treatment should be limited by your doctor.
Please inform your doctor about all sedating medicines you are taking and strictly follow your doctor’s dose recommendations. It might be helpful to let friends or relatives know to look out for you for the signs and symptoms listed above. Contact your doctor if you experience these symptoms.
If you are taking certain medicines that affect serotonin levels (e.g. certain medicines used to treat depression), talk to your doctor before taking PALEXIA, as there have been reports of a so-called serotonin syndrome. Serotonin syndrome is a rare but life-threatening condition. Signs include involuntary, rhythmic muscle twitching, including the eye muscles, restlessness, profuse sweating, tremors, increased reflexes, increased muscle tension and a body temperature of over 38 ° C. Your doctor can advise you on this.
Palexia retard must not be taken together with other medicinal products belonging to the group of mixed µ-opioid receptor agonists / antagonists (e.g. pentazocine, nalbuphine) or partial µ-opioid receptor agonists (e.g. buprenorphine) been investigated. It is possible that PALEXIA retard will not work well if it is taken with any of these medicines. Tell your doctor if you are currently being treated with any of these medicines.
Taking Palexia retard together with strong inhibitors or enhancers (e.g. rifampicin, phenobarbital, St. John's wort) of certain endogenous enzymes that are important for the elimination of tapentadol from your body can influence the effects of tapentadol or cause side effects. This can happen especially when you start or stop using these other medicines. Please tell your doctor about all medicines you are taking.
Palexia retard should not be taken at the same time as MAOIs (certain medicines used to treat depression). Tell your doctor if you are taking or have taken MAOIs within the last 14 days.
Taking PALEXIA retard with food, drink and alcohol
Do not drink alcohol during treatment with Palexia retard, as some side effects, such as drowsiness, may be increased. Food does not affect the way this medicine works.
pregnancy and breast feeding period
Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.
Do not take this medicine
if you are pregnant, unless your doctor tells you to
during childbirth, as it can lead to threateningly slow or shallow breathing in the newborn (respiratory depression)
during breastfeeding, as the active substance could get into breast milk.
Driving and using machines
PALEXIA retard can cause sleepiness, dizziness and blurred vision and affect your ability to react. This may be the case especially when you start taking PALEXIA retard, if your doctor changes your dose, if you drink alcohol or take sedatives. Please ask your doctor whether you can drive a car or use machines.
Palexia retard contains lactose
This medicine contains lactose. Therefore, please only take Palexia retard after consulting your doctor if you know that you suffer from an intolerance to certain sugars.
3. How to take PALEXIA retard
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 adjust the dosage according to the severity of your pain (pain intensity) and your personal pain perception. In general, the lowest pain reliever dose should be used.
The recommended dose is 1 tablet every 12 hours. Taking a total of more than 500 mg tapentadol per day is not recommended.
Your doctor may prescribe a different, more appropriate dose and / or suggest different dosing intervals. Contact your doctor or pharmacist if you have the impression that the effect of these tablets is too strong or too weak.
No dose adjustment is usually required in elderly patients (over 65 years of age). The active ingredient tapentadol may be excreted with a delay in some patients in this age group. If this applies to you, your doctor may recommend a different intake schedule.
Liver and kidney dysfunction (insufficiency)
Patients with severe hepatic impairment should not take these tablets. If you have moderate liver problems, your doctor may recommend a different intake schedule. In the case of mild liver dysfunction, it is not necessary to adjust the dosage.
Patients with severe kidney impairment should not take these tablets. No dose adjustment is required for mild to moderate renal impairment.
Use in children and adolescents
Palexia retard is not suitable for children and adolescents under 18 years of age.
How and when should you take PALEXIA retard?
Palexia retard is for oral use.
Always take the tablets whole with sufficient liquid.
The tablets must not be chewed, broken or crushed - this can lead to an overdose because the active substance is released too quickly in your body.
The tablets can be taken on an empty stomach or with meals.
The tablet matrix of the tablet may not have been completely digested and maycan be found completely or partially in the chair, apparently intact. This is not a cause for concern as the active ingredient in the tablet has already been absorbed into the body and what you see is just the tablet matrix, which appears to be intact.
How long should you take PALEXIA retard?
Do not take the tablets longer than prescribed by your doctor.
If you take more PALEXIA retard than you should
The following may occur after taking very high doses:
Pupil constriction (pupils the size of a pinhead), vomiting, drop in blood pressure, increased heartbeat, circulatory collapse, impaired consciousness up to coma (deep unconsciousness), epileptic seizures, threateningly slow or shallow breathing or respiratory arrest.
Call a doctor for help immediately if these symptoms occur!
If you forget to take PALEXIA retard
If you forget to take the tablets, your pain is likely to come back. Do not take a double dose to make up for the forgotten dose, just carry on as before.
If you stop taking PALEXIA retard
If you interrupt or stop treatment early, the pain is likely to come back. If you want to stop the treatment, please contact your doctor beforehand.
In general, stopping treatment will have no after-effects. Occasionally, however, people who have been taking the tablets for some time may feel unwell if they suddenly stop taking them.
The following symptoms can occur:
Restlessness, watery eyes, runny nose, yawning, sweating, shivering, muscle pain and dilated pupils.
Irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, sleep disorders, nausea, loss of appetite, vomiting, diarrhea, increased blood pressure, increased breathing rate and accelerated heartbeat.
If you get any of these symptoms after stopping treatment, please contact your doctor.
You should not suddenly stop taking the medicine without your doctor's advice. If the doctor tells you to stop taking the tablets, he will explain the procedure to you. This may include reducing the dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. What side effects are possible?
Like all medicines, this medicine can have side effects, although not everybody gets them.
Important side effects or symptoms to look out for and how to respond:
This medicine can cause allergic reactions. Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, especially those that can affect the whole body.
Another serious side effect is having a condition where breathing is slower or weaker than expected. This is most common in elderly and debilitated 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):
Nausea, constipation, dizziness, drowsiness, headache.
Common (may affect up to 1 in 10 people):
decreased appetite, anxiety, depressive mood, sleep disorders, nervousness, restlessness, attention disorder, tremors, muscle twitching, blushing, shortness of breath, vomiting, diarrhea, indigestion, itching, increased sweating, rash, weakness, tiredness, sensation of fluctuations in body temperature, dry mucous membranes, Build-up of fluid in the tissues (edema).
Uncommon (may affect up to 1 in 100 people):
Drug allergy (including swelling of the face and the mucous membranes of the mouth and throat [angioedema] and, in severe cases, difficulty breathing, drop in blood pressure, collapse or shock), weight loss, disorientation, confusion, irritability (agitation), abnormal perception, unusual dreams, euphoric mood, Impaired consciousness, impaired memory, mental impairment, fainting, sedation, balance disorders, speech disorders, numbness, abnormal skin sensations (e.g. tingling, prickling), visual disturbances, accelerated heartbeat, slow heartbeat, palpitations, decreased blood pressure, abdominal discomfort, hives, frequent urination, urination , sexual dysfunction, drug withdrawal syndrome (see “If you stop taking PALEXIA retard”), general well-being, irritability.
Rare (may affect up to 1 in 1,000 people):
Drug addiction, abnormal thinking, epileptic seizures, fainting, abnormal coordination, threateningly slow or shallow breathing (respiratory depression), disturbed gastric emptying, feeling drunk, feeling relaxed.
In general, those who experience chronic pain are more likely to develop suicidal thoughts and behaviors. In addition, medicines used to treat depression (which affect the neurotransmitters in the brain) can increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters in the brain, the data on the use of tapentadol in humans do not indicate the existence of such an increased risk.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly via the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger- Allee 3, D-53175 Bonn, website: http://www.bfarm.de Show. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store PALEXIA retard
Keep this medicine out of the sight and reach of children.
You can put this medicine on the box and the blister pack "EXP" Do not use the stated expiry date. The expiry date refers to the last day of the month indicated.
This medicinal product does not require special storage conditions.
Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.
6. Contents of the pack and other information
What PALEXIA retard contains
The Active ingredient is: tapentadol.
Each prolonged-release tablet contains 250 mg tapentadol (as hydrochloride).
The other Components are:
Magnesium stearate (Ph.Eur.).
Titanium dioxide (E171),
Iron (III) hydroxide oxide x H2O (E172),
Iron (III) oxide (E172),
Iron (II, III) oxide (E172).
What PALEXIA retard looks like and contents of the pack
Brown-red, film-coated, elongated prolonged-release tablets (7 mm x 17 mm), marked on one side with the Grünenthal logo and on the other side with “H5”.
Palexia retard prolonged-release tablets are packed in blister packs and available in cardboard boxes with 20, 24, 50, 54 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Grünenthal GmbH • Zieglerstraße 6 • 52078 Aachen
Postal address: Grünenthal GmbH • 52099 Aachen
Tel .: 0241 569-1111
Fax: 0241 569-1112
Email: [email protected]
This medicinal product is authorized in the member states of the European Economic Area (EEA) under the following names:
Belgium, Bulgaria, Estonia, Greece, Latvia, Lithuania, Luxembourg, Croatia, Malta, Netherlands, Austria, Poland, Portugal, Romania, Slovakia, Spain, Czech Republic, Cyprus: PALEXIA retard
Denmark, Finland, Iceland, Norway, Sweden: PALEXIA Depot
France: PALEXIA LP
Ireland, Slovenia, United Kingdom: PALEXIA SR
This leaflet was last revised in January 2020.
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