TAPENTADOL NEURAXPHARM

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. This medicine 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 50 mg Tapentadol Neuraxpharm twice daily. Initiation of therapy in patients currently taking opioid analgesics When switching from opioids to this medicine 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 Tapentadol Neuraxpharmfor patients currently taking opioids compared to those not having taken opioids before initiating therapy with this medicine. 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 prolonged-release tapentadol twice daily every 3 days was appropriate to achieve adequate pain control in most of the patients. Total daily doses of more than 500 mg prolonged-release tapentadol have not yet been studied and are therefore not recommended.

2). 2). 2). This medicine should be used with caution in patients with moderate hepatic impairment. e. Tapentadol Neuraxpharm 50 mg, and not be administered more frequently than once every 24 hours. 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 tapentadol in children and adolescents below 18 years of age has not yet been established. Therefore this medicine is not recommended for use in this population. Method of administration This medicine is for oral.

It can be taken with or without food. g. apple sauce) and taken immediately, and not stored for future use. g. water, should follow the intake of the sprinkles with apple sauce. The capsules and the capsule contents must not be crushed or chewed to ensure that the prolonged-release mechanism is maintained.

Treatment goals and discontinuation Before initiating treatment with Tapentadol, a treatment strategy including treatment duration and treatment goals, 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 [product name], it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4). Duration of treatment Tapentadol should not be used longer than necessary.

The adverse drug reactions that were experienced by patients in the placebo- controlled trials performed with tapentadol 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 tapentadol 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).

4) Delirium** Nervous system disorders Dizziness, Somnolence, Disturbance in attention, Depressed level of consciousness, Convulsion, Presyncope, Headache Tremor, Muscle contractions involuntary Memory impairment, Mental impairment, Syncope, Sedation, Balance disorder, Dysarthria, Hypoaesthesia, Paraesthesia 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 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 Feeling abnormal, Irritability Feeling drunk, Feeling of relaxation Drug withdrawal syndrome * Post-marketing rare events of angioedema, anaphylaxis and anaphylactic shock have been reported.

** Post marketing cases of delirium were observed in patients with additional risk factors such as cancer and advanced age. Clinical trials performed with tapentadol 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.

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 Tapentadol. 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.

A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on- line, and past and present medical and psychiatric conditions. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced.

Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death.

It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse, or addiction.

The clinical need for analgesic treatment should be reviewed regularly. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with tapentadol.

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.

The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.

This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.

Symptoms of hyperalgesia may resolve with a reduction of opioid dose. Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances Concomitant use of tapentadol 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 tapentadol 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, tapentadol may produce dose-related respiratory depression.

Therefore, tapentadol should be administered with caution to patients with impaired respiratory functions. Alternative non-mu-opioid receptor agonist analgesics should be considered and tapentadol should be employed only under careful medical supervision at the lowest effective dose in such patients.

9). Head Injury and Increased Intracranial Pressure Tapentadol 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. Tapentadol should be used with caution in patients with head injury and brain tumors. Seizures Prolonged-release tapentadol has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical trials.

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