Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Undesirable effects typical of opioids are to be expected with Abstral; they tend to decrease in intensity with continued use. The most serious potential adverse reactions associated with opioid use are respiratory depression (which could lead to respiratory arrest), hypotension and shock.

The clinical trials of Abstral were designed to evaluate safety and efficacy in treating patients with breakthrough cancer pain; all patients were taking concomitant opioids, such as sustained- release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent pain.
Therefore it is not possible to definitively separate the effects of Abstral alone.

The most frequently observed adverse reactions with Abstral include typical opioid adverse reactions, such as nausea, constipation, somnolence and headache.

Tabulated Summary of Adverse Reactions with Abstral and/or other fentanyl-containing compounds:
The following adverse reactions have been reported with Abstral and/or other fentanyl- containing compounds during clinical studies and from post-marketing experience. They are listed below by system organ class and frequency (very common ≥ 1/10; common ≥ 1/100 to < 1/10; uncommon ≥1/1,000 to <1/100; not known (cannot be estimated from available data)).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ                                 Adverse Reaction by Frequency Class
Very common         Common                 Uncommon             Not known (cannot ≥ 1/10       ≥ 1/100 to < 1/10       ≥1/1,000 to <1/100      be estimated from available data)
Immune system                                             Hypersensitivity disorders
Metabolism and                                            Anorexia nutrition disorders                                       Decreased appetite Psychiatric                                               Depression                  Hallucination disorders                                                 Paranoia                    Drug dependence Confusional state           (addiction)
Disorientation              Drug abuse
Mental status changes       Delirium
Anxiety
Euphoric mood
Dysphoria
Emotional lability
Disturbance in attention
Insomnia
Nervous system                      Dizziness             Amnesia                     Convulsion disorders                           Headache              Parosmia                    Depressed level of Somnolence            Dysgeusia                   consciousness
Tremor                      Loss of
Lethargy                    consciousness
Hypoaesthesia
Sleep disorder
Eye disorders                                             Vision blurred Cardiac disorders                                         Tachycardia Bradycardia
Vascular disorders                                        Hypotension Respiratory,                        Dyspnoea              Oropharyngeal pain          Respiratory thoracic                                                  Throat tightness            depression and mediastinal disorders
Gastrointestinal   Nausea           Stomatitis            Mouth ulceration            Swollen tongue disorders                           Vomiting              Gingival ulceration         Diarrhoea Constipation          Lip ulceration
Dry mouth             Impaired gastric emptying
Abdominal pain
Dyspepsia
Stomach discomfort
Tongue disorder
Aphthous stomatitis
Skin and                            Hyperhidrosis         Skin lesion                 Urticaria subcutaneous                                              Rash tissue disorders                                          Pruritus allergic Pruritus
Night sweats
Increased tendency to bruise
Musculoskeletal                                           Arthralgia and connective                                            Musculoskeletal stiffness tissue disorders                                          Joint stiffness System Organ                                 Adverse Reaction by Frequency Class
Very common        Common                 Uncommon          Not known (cannot ≥ 1/10      ≥ 1/100 to < 1/10       ≥1/1,000 to <1/100   be estimated from available data)
Reproductive                                            Erectile dysfunction system and breast disorders
General disorders                  Fatigue              *Drug withdrawal         Flushing and hot and administration                                      syndrome                 flush site conditions                                         Asthenia                 Peripheral oedema Malaise                  Pyrexia
Neonatal withdrawal syndrome
Injury, poisoning                                       Accidental overdose      Fall and procedural complications
* 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 https://sideeffects.health.gov.il/ and      emailed     to     the    Registration   Holder’s     Patient    Safety     Unit    at: drugsafety@neopharmgroup.com