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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. • severe chronic pain in children above 6 years and adolescents, which can be adequately managed only with opioid analgesics.
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment goals and discontinuation Before initiating treatment with PALEXIA, a treatment strategy including treatment goals and treatment duration, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with PALEXIA, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). 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. Patients should start treatment with single doses of 50 mg tapentadol as film-coated tablet administered every 4 to 6 hours.
Higher starting doses may be necessary depending on the pain intensity and the patient’s previous history of analgesic requirements. On the first day of dosing, an additional dose may be taken as soon as one hour after the initial dose, if pain control is not achieved.
The dose should then be titrated individually to a level that provides adequate analgesia and minimises undesirable effects under the close supervision of the prescribing physician. Total daily doses greater than 700 mg tapentadol on the first day of treatment and maintenance daily doses greater than 600 mg tapentadol have not been studied and are therefore not recommended.
Duration of treatment The film-coated tablets are intended for acute pain situations. If longer term treatment is anticipated or becomes necessary and effective pain relief in the absence of intolerable adverse events was achieved with PALEXIA, the possibility of switching the patient to therapy with PALEXIA prolonged release tablets should be considered.
As with all symptomatic treatments, the continued use of tapentadol must be evaluated on an ongoing basis. PALEXIA should not be used longer than necessary. 2). 2). 2). PALEXIA should be used with caution in patients with moderate hepatic impairment.
e. 50 mg tapentadol as film- coated tablet, and not be administered more frequently than once every 8 hours. At initiation of therapy a daily dose greater than 150 mg tapentadol as film-coated 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.
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, Drug dependence, Thinking abnormal Delirium* * Abnormal dreams, Euphoric mood 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, Coordinatio n 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 disorders Urinary hesitation, 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.
Tolerance and Opioid Use Disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as PALEXIA. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD.
Abuse or intentional misuse of opioids may result in overdose and/or death. g. major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician.
g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances Concomitant use of PALEXIA 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 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 may produce dose-related respiratory depression.
Therefore, PALEXIA should be administered with caution to patients with impaired respiratory functions. Alternative non-mu-opioid receptor agonist analgesics should be considered and PALEXIA should be employed only under careful medical supervision at the lowest effective dose in such patients.
1. e. 5)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2). Paediatric Patients The safety and efficacy of PALEXIA in children and adolescents below 18 years of age has not yet been established. Therefore PALEXIA is not recommended for use in this population. Method of administration PALEXIA is for oral use.
The tablet should be taken with sufficient liquid. PALEXIA can be taken with or without food.
** 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 Paediatric population Frequency, type and severity of adverse reactions in children and adolescents treated with PALEXIA SR are expected to be the same as in adults treated with PALEXIA SR.
No new safety issues have been identified from completed paediatric trial for any of the age subgroups investigated. Limited clinical trial data on withdrawal symptoms in children using PR formulation of tapentadol are available. 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.
9). Head Injury and Increased Intracranial Pressure PALEXIA 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.
Analgesics with mu-opioid receptor agonist activity may obscure the clinical course of patients with head injury. PALEXIA should be used with caution in patients with head injury and brain tumours. Seizures PALEXIA 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 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 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 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 film-coated tablets contain lactose.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take this […]