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PALEXIA SR is a brand name for Tapentadol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PALEXIA SR is indicated for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosing regimen should be individualised according to the severity of pain being treated, the previous treatment experience and the ability to monitor the patient. PALEXIA SR should be taken twice daily, approximately every 12 hours.
Initiation of therapy Initiation of therapy in patients currently not taking opioid analgesics Patients should start treatment with single doses of 50 mg tapentadol as prolonged-release tablet administered twice daily. Initiation of therapy in patients currently taking opioid analgesics When switching from opioids to PALEXIA SR and choosing the initial dose, the nature of the previous medicinal product, administration and the mean daily dose should be taken into account.
This may require higher initial doses of PALEXIA SR for patients currently taking opioids compared to those not having taken opioids before initiating therapy with PALEXIA SR. Titration and maintenance After initiation of therapy the dose should be titrated individually to a level that provides adequate analgesia and minimises undesirable effects under the close supervision of the prescribing physician.
Experience from clinical trials has shown that a titration regimen in increments of 50 mg tapentadol as prolonged-release tablet twice daily every 3 days was appropriate to achieve adequate pain control in most of the patients. Total daily doses of PALEXIA SR greater than 500 mg tapentadol have not yet been studied and are therefore not recommended.
8). When a patient no longer requires therapy with tapentadol, it is advisable to taper the dose gradually to prevent symptoms of withdrawal. 2). 2). 2). PALEXIA SR should be used with caution in patients with moderate hepatic impairment.
e. 50 mg tapentadol as prolonged-release tablet, and not be administered more frequently than once every 24 hours. At initiation of therapy a daily dose greater than 50 mg tapentadol as prolonged-release tablet is not recommended. 2).
2). Elderly patients (persons aged 65 years and over) In general, a dose adaptation in elderly patients is not required. 2). Paediatric Patients The safety and efficacy of PALEXIA SR in children and adolescents below 18 years of age has not yet been established.
Therefore PALEXIA SR is not recommended for use in this population. Method of administration PALEXIA SR has to be taken whole, not divided or chewed, to ensure that the prolonged- release mechanism is maintained. PALEXIA SR should be taken with sufficient liquid.
The adverse drug reactions that were experienced by patients in the placebo controlled trials performed with PALEXIA SR were predominantly of mild and moderate severity. The most frequent adverse drug reactions were in the gastrointestinal and central nervous system (nausea, dizziness, constipation, headache and somnolence).
The table below lists adverse drug reactions that were identified from clinical trials performed with PALEXIA SR and from post-marketing environment. They are listed by class and frequency. Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
ADVERSE DRUG REACTIONS Frequency System Organ Class Very common Common Uncommon Rare Unknown Immune system disorders Drug hypersensitivity* Metabolism and nutrition disorders Decreased appetite Weight decreased Psychiatric disorders Anxiety, Depressed mood, Sleep disorder, Nervousness, Restlessness Disorientation, Confusional state, Agitation, Perception disturbances, Abnormal dreams, Euphoric mood Drug dependence, Thinking abnormal Delirium** Nervous system disorders Dizziness, Somnolence, Headache Disturbance in attention, Tremor, Muscle contractions involuntary Depressed level of consciousness, Memory impairment, Mental impairment, Syncope, Sedation, Balance disorder, Dysarthria, Hypoaesthesia, Paraesthesia Convulsion, Presyncope, Coordination abnormal Eye disorders Visual disturbance Cardiac disorders Heart rate increased, Heart rate decreased, Palpitations Vascular disorders Flushing Blood pressure decreased Respiratory, thoracic and mediastinal disorders Dyspnoea Respiratory depression Gastrointestinal disorders Nausea, Constipation Vomiting, Diarrhoea, Dyspepsia Abdominal discomfort Impaired gastric emptying Skin and subcutaneous tissue disorders Pruritus, Hyperhidrosis, Rash Urticaria Renal and Urinary hesitation, urinary disorders Pollakiuria Reproductive system and breast disorders Sexual dysfunction General disorders and administration site conditions Asthenia, Fatigue, Feeling of body temperature change, Mucosal dryness, Oedema Drug withdrawal syndrome, Feeling abnormal, Irritability Feeling drunk, Feeling of relaxation * Post-marketing rare events of angioedema, anaphylaxis and anaphylactic shock have been reported.
Potential for Abuse and Addiction/ Dependence Syndrome PALEXIA SR has a potential for abuse and addiction. This should be considered when prescribing or dispensing PALEXIA SR in situations where there is concern about an increased risk of misuse, abuse, addiction, or diversion.
All patients treated with active substances that have mu-opioid receptor agonist activity should be carefully monitored for signs of abuse and addiction. Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances Concomitant use of PALEXIA SR and sedating medicinal products such as benzodiazepines or related substances may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe PALEXIA SR concomitantly with sedating medicinal products, the reduction of dose of one or both agents should be considered and the duration of the concomitant treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Respiratory Depression At high doses or in mu-opioid receptor agonist sensitive patients, PALEXIA SR may produce dose-related respiratory depression.
Therefore, PALEXIA SR should be administered with caution to patients with impaired respiratory functions. Alternative non-mu-opioid receptor agonist analgesics should be considered and PALEXIA SR should be employed only under careful medical supervision at the lowest effective dose in such patients.
9). Head Injury and Increased Intracranial Pressure PALEXIA SR should not be used in patients who may be particularly susceptible to the intracranial effects of carbon dioxide retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma.
1. e. 5)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tapentadol in United Kingdom.
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PALEXIA SR can be taken with or without food. The shell (matrix) of the tapentadol tablet may not be digested completely and therefore it can be eliminated and seen in the patient’s stool. However, this finding has no clinical relevance, since the active substance of the tablet will have already been absorbed.
** Post marketing cases of delirium were observed in patients with additional risk factors such as cancer and advanced age. Clinical trials performed with PALEXIA SR with patient exposure up to 1 year have shown little evidence of withdrawal symptoms upon abrupt discontinuations and these were generally classified as mild, when they occurred.
2) and treat patients accordingly should they occur. The risk of suicidal ideation and suicides committed is known to be higher in patients suffering from chronic pain. In addition, substances with a pronounced influence on the monoaminergic system have been associated with an increased risk of suicidality in patients suffering from depression, especially at the beginning of treatment.
For tapentadol data from clinical trials and post-marketing reports do not provide evidence for an increased risk. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Analgesics with mu-opioid receptor agonist activity may obscure the clinical course of patients with head injury. PALEXIA SR should be used with caution in patients with head injury and brain tumors. Seizures PALEXIA SR has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical trials.
However, like other analgesics with mu- opioid agonist activity PALEXIA SR is not recommended in patients with a history of a seizure disorder or any condition that would put the patient at risk of seizures. 5). 2). 5-fold increase in systemic exposure, respectively, compared with subjects with normal hepatic function.
2), especially upon initiation of treatment. 2). Use in Pancreatic/Biliary Tract Disease Active substances with mu-opioid receptor agonist activity may cause spasm of the sphincter of Oddi. PALEXIA SR should be used with caution in patients with biliary tract disease, including acute pancreatitis.
Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
Mixed opioid agonists/antagonists Care should be taken when combining PALEXIA SR with mixed mu-opioid agonist/antagonists (like pentazocine, nalbuphine) or partial mu-opioid agonists (like buprenorphine). g. temporary buprenorphine discontinuation) should be considered, if administration of full mu-agonists (like tapentadol) becomes necessary in acute pain situations.
On combined use with buprenorphine, higher dose requirements for full mu-receptor agonists have been reported and close monitoring of adverse events such as respiratory depression is required in such circumstances. PALEXIA SR prolonged-release tablets contain lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product.