Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Summary of the safety profile
Typical opioid adverse reactions are to be expected with PecFent. Frequently, these will cease or decrease in intensity with continued use of the medicinal product, as the patient is titrated to the most appropriate dose. However, the most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be monitored for these.

The clinical studies of PecFent were designed to evaluate safety and efficacy in treating BTP and all patients were also on background opioid therapies, such as sustained-release morphine or transdermal fentanyl, for their persistent pain. Therefore it is not possible to definitively separate the effects of PecFent alone.

Tabulated list of adverse reactions
The following adverse reactions have been reported with PecFent and/or other fentanyl-containing compounds during clinical studies and post marketing experience (frequencies 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); unknown (cannot be estimated from available data)).

Common                Uncommon                     Unknown
Infections and                                   Pneumonia infestations                                     Nasopharyngitis
Pharyngitis
Rhinitis
Blood and lymphatic                              Neutropenia system disorders
Immune system                                    Hypersensitivity disorders
Metabolism and                                   Dehydration nutrition disorders                              Hyperglycaemia
Decreased appetite
Increased appetite
Psychiatric disorders      Disorientation        Delirium                     Insomnia Hallucination                Drug dependence
Confusional state            (addiction)
Depression                   Drug abuse
Attention deficit/hyperactivity disorder
Anxiety
Euphoric mood
Nervousness


Common             Uncommon                   Unknown
Nervous system          Dysgeusia          Loss of consciousness disorders               Dizziness          Depressed level of
Somnolence         consciousness
Headache           Convulsion
Ageusia
Anosmia
Memory impairment
Parosmia
Speech disorder
Sedation
Lethargy
Tremor
Ear and labyrinth                          Vertigo disorders
Cardiac disorders                          Cyanosis
Vascular disorders                         Cardiovascular             Flushing insufficiency
Lymphoedema
Hypotension
Hot flush
Respiratory, thoracic   Epistaxis          Upper airway               Respiratory depression and mediastinal         Rhinorrhoea        obstruction disorders               Nasal discomfort   Pharyngolaryngeal pain
(such as “nasal    Rhinalgia burning”)          Nasal mucosal disorder
Cough
Dyspnoea
Sneezing
Upper respiratory tract congestion
Nasal congestion
Intranasal hypoaesthesia
Throat irritiation
Postnasal drip
Nasal dryness
Gastrointestinal        Vomiting           Intestinal perforation disorders               Nausea             Peritonitis
Constipation       Oral hypoaesthesia
Oral paraesthesia
Diarrhoea
Retching
Abdominal pain
Tongue disorder
Mouth ulceration
Dyspepsia
Dry mouth
Skin and subcutaneous   Pruritus           Hyperhydrosis tissue disorders                           Urticaria
Musculoskeletal and                        Arthralgia connective tissue                          Muscle twitching disorders
Renal and urinary                          Anuria disorders                                  Dysuria
Proteinuria
Urinary hesitation

Common                Uncommon                     Unknown
Reproductive system                              Vaginal haemorrhage and breast disorders
General disorders and                            Non-cardiac chest pain       Withdrawal syndrome* administration site                              Asthenia                     Neonatal withdrawal conditions                                       Chills                       syndrome Face oedema
Peripheral oedema
Gait disturbance
Pyrexia
Fatigue
Malaise
Thirst
Investigations                                   Platelet count decreased Weight increased
Injury, poisoning and                            Fall procedural                                       Intentional drug misuse complications                                    Medication error
*See next section below

Description of selected adverse reactions
Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating have been observed with transmucosal fentanyl.

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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form Healthcare professionals are asked to report https://sideeffects.health.gov.il/