Interactions: The concomitant use with sedating medicinal products such as benzodiazepines or other respiratory or CNS depressants (other opioids, antitussives or substitution treatments, barbiturates, antipsychotics, H1-antihistamines, alcohol) increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. When combined therapy with a respiratory or CNS depressant is contemplated, the reduction of dose of one or both agents should be considered and the duration of the concomitant use should be limited. Can induce convulsions and increase the potential for selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics and other medicinal products that lower the seizure threshold to cause convulsions. There have been reports of serotonin syndrome in a temporal connection with the therapeutic use of tapentadol in combination with serotoninergic medicinal products such as SSRIs, SNRIs and tricyclic antidepressants. Use with strong inhibitors of uridine diphosphate transferase isoenzymes (involved in glucuronidation) may increase systemic exposure of Palexia SR. Caution if concomitant administration of strong enzyme inducing drugs (e.g. rifampicin, phenobarbital, St John’s Wort) starts or stops as this may lead to decreased efficacy or risk for adverse events, respectively. Avoid use in patients who have taken monoamine oxidase inhibitors (MAOIs) within the last 14 days, due to cardiovascular events. Pregnancy and Breast-feeding: Use in pregnancy only if the potential benefit justifies the potential risk to the foetus. Long term maternal opioid use during pregnancy may cause neonatal withdrawal syndrome (NOWS). NOWS can be life threatening. Not recommended during and immediately before labour and delivery. Do not use during breast feeding. New-born infants whose mothers have been taking tapentadol should be monitored for respiratory depression. Driving and using machines: May have major effect on ability to drive and use machines, especially at the beginning or change in dosage, in connection with alcohol or tranquilisers. Undesirable effects: Very common (≥1/10): dizziness, somnolence, headache, nausea, constipation. Common (≥1/100, <1/10): decreased appetite, anxiety, depressed mood, sleep disorder, nervousness, restlessness, disturbance in attention, tremor, involuntary muscle contractions, flushing, dyspnoea, vomiting, diarrhoea, dyspepsia, pruritus, hyperhidrosis, rash, asthenia, fatigue, feeling of body temperature change, mucosal dryness, oedema. Other important undesirable/ serious effects observed in clinical trials and/or post-marketing: drug hypersensitivity, depressed level of consciousness, mental impairment, syncope (uncommon ≥1/1000, <1/100), angioedema, anaphylaxis and anaphylactic shock, respiratory depression, convulsion, impaired gastric emptying, drug dependence (rare ≥1/10,000, <1/1000), delirium (unknown). No evidence of increased risk of suicidal ideation or suicide with Palexia SR. Prescribers should consult the SmPC in relation to all adverse reactions. Overdose: Seek specialist treatment (see SmPC). Legal classification: POM, CD (Schedule II). Marketing Authorisation numbers, pack sizes and basic NHS cost: 50 mg: PL 50414/0014, 28 pack (£12.46) and 56 pack (£24.91); 100 mg: PL 50414/0015, 56 pack (£49.82); 150 mg: PL 50141/0016, 56 pack (£74.73); 200 mg: PL 50414/0017, 56 pack (£99.64) and 250 mg: PL 50414/0018, 56 pack (£124.55). Marketing Authorisation Holder: Grunenthal Pharma Ltd. 4045 Kingswood Road, Citywest Business Park, Citywest, Co.Dublin, Ireland.
DOP: June 2021. Job Bag: M-PLX-UK-06-21-0025