PALEXIA

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 adult patients in the placebo controlled trials performed with PALEXIA were predominantly of mild and moderate severity. The most frequent adverse drug reactions were in the gastrointestinal and central nervous system (nausea, vomiting, somnolence, dizziness and headache).

The most severe adverse drug reactions are sedation, respiratory depression and allergic reactions. The table below lists adverse drug reactions that were identified from clinical trials performed in adults with another immediate release formulation of tapentadol (PALEXIA film-coated tablets) and from post-marketing data in adults.

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 Psychiatric disorders Anxiety, Confusional state, Hallucination, Sleep disorder, Depressed mood, Disorientation, Agitation, Nervousness, Thinking abnormal Delirium** Abnormal dreams Restlessness, Euphoric mood Nervous system disorders Dizziness, Somnolence, Headache Tremor Disturbance in attention, Memory impairment, Presyncope, Sedation, Ataxia, Dysarthria, Hypoaesthesia, Paraesthesia, Muscle contractions involuntary Convulsion, Depressed level of consciousness, Coordination abnormal Eye disorders Visual disturbance Cardiac disorders Heart rate increased, Palpitations Heart rate decreased Vascular disorders Flushing Blood pressure decreased Respiratory, thoracic and mediastinal disorders Respiratory depression, Oxygen saturation decreased, Dyspnoea Gastrointestinal disorders Nausea, Vomiting Constipation, Diarrhoea, Dyspepsia, Dry mouth Abdominal discomfort Impaired gastric emptying Skin and subcutaneous tissue disorders Pruritus, Hyperhidrosis, Rash Urticaria Musculoskeletal and connective tissue disorder Muscle spasms Sensation of heaviness Renal and urinary disorders Urinary hesitation, Pollakiuria General disorders and administration site conditions Asthenia, Fatigue, Feeling of body temperature change Drug withdrawal syndrome, Oedema, Feeling abnormal, Feeling drunk, Irritability, Feeling of relaxation *Post-marketing rare events of angioedema, anaphylaxis and anaphylactic shock have been reported.

1. 1 Therapeutic indications PALEXIA is indicated for the relief of moderate to severe acute pain in children and adolescents from 2 years of age with a body weight of more than 16 kg and in adults, which can be adequately managed only with opioid analgesics.

2 Posology and method of administration 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.

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