TAPENTADOL CELIX

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. Tapentadol Celix Prolonged-release Tablets should be taken twice daily, approximately every 12 hours.

Adults Initiation of therapy Initiation of therapy in patients currently not taking opioid analgesics Patients should start treatment with 50 mg Tapentadol Celix Prolonged-release Tablets administered twice daily. Initiation of therapy in patients currently taking opioid analgesics When switching from opioids to Tapentadol Celix Prolonged-release Tablets 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 Celix Prolonged-release Tablets for patients currently taking opioids compared to those not having taken opioids before initiating therapy with Tapentadol Celix Prolonged-release Tablets.

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 prolonged-release tapentadol greater than 500 mg tapentadol have not yet been studied and are therefore not recommended. 2). 2). 2). Tapentadol Celix Prolonged-release Tablets should be used with caution in patients with moderate hepatic impairment.

e. Tapentadol Celix 50 mg Prolonged-release Tablets, 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 population Dose recommendation for children is dependent on age and body weight. 5 mg per kg body weight given every 12 hours. Nevertheless, a starting dose of 50 mg should not be exceeded. From the available tablet strengths, 50 mg should be considered as starting doses.

Initiation of therapy in patients currently taking opioid analgesics When switching from opioids to Tapentadol Celix Prolonged-release Tablets and choosing the initial dose, the nature of the previous medicinal product, administration and the mean daily dose should be taken into account.

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

ADVERSE DRUG REACTIONS FrequencySystem Organ Class Very common Common Uncommon Rare Not known Immune system disorders Drug hypersensitiv ity* ADVERSE DRUG REACTIONS FrequencySystem Organ Class Very common Common Uncommon Rare Not known 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, 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, Hyperhidro sis, Rash Urticaria Renal and urinary disorders Urinary hesitation, Pollakiuria Reproductive system and breast disorders Sexual dysfunction General disorders and administration Asthenia, Fatigue, Feeling of Drug withdrawal syndrome, Feeling drunk, Feeling of ADVERSE DRUG REACTIONS FrequencySystem Organ Class Very common Common Uncommon Rare Not known site conditions body temperature change, Mucosal dryness, Oedema Feeling abnormal, Irritability relaxation * Post-marketing rare events of angioedema, anaphylaxis and anaphylactic shock have been reported.

Do not use for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI). 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 Celix Prolonged-release Tablets.

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 psychoactive drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.

8). Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances Concomitant use of Tapentadol Celix Prolonged-release Tablets 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 Celix Prolonged-release Tablets 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 Celix Prolonged-release Tablets may produce dose-related respiratory depression.

e. 5).