Adverse reactions : תופעות לוואי

4.8. Undesirable effects

Serious adverse reactions that may be associated with BuTrans therapy in clinical use are similar to those observed with other opioid analgesics, including respiratory depression (especially when used with other CNS depressants) (see section 4.4).

The following undesirable effects have occurred:
Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

System organ     Very common      Common            Uncommon           Rare (≥1/10,000,   Very rare      Not known (cannot class            (≥1/10)          (≥1/100, <1/10)   (≥1/1000,          <1/1000)           (<1/10,000)    be estimated from MedDRA                                              <1/100)                                              the available data) Immune system                                       Hypersensitivity   Anaphylactic                      Anaphylactoid disorders                                                              reaction                          reaction Metabolic and                     Anorexia                             Dehydration nutritional disorders
Psychiatric                       Confusion         Affect liability   Psychotic          Mood swings    Depersonalisation disorders                         Depression        Sleep disorder     disorder                          Drug dependence Insomnia          Restlessness                                         (see section 4.4) Nervousness       Agitation
Anxiety           Euphoric mood
Hallucinations
Decreased libido
Nightmares
Aggression

Nervous system   Headache         Tremor            Sedation           Balance disorder   Involuntary    Seizures disorders        Dizziness                          Dysgeusia          Speech disorder    muscle         Hyperalgesia, Somnolence                         Dysarthria                            contractions   Sleep apnoea Hypoaesthesia                                        syndrome.
Memory impairment
Migraine
Syncope
Abnormal co-ordination
Disturbance in attention
Paraesthesia
Eye disorders                                           Dry eye             Visual Blurred vision      disturbance
Eyelid oedema
Miosis
Ear and labyrinth                                       Tinnitus                               Ear pain disorders                                               Vertigo

Cardiac disorders                                       Palpitations        Angina pectoris Tachycardia
Vascular                                                Hypotension         Vasodilatation disorders                                               Circulatory         Orthostatic collapse            hypotension
Hypertension
Flushing
Respiratory,                           Dyspnoea         Cough               Respiratory thoracic and                                            Wheezing            depression mediastinal                                             Hiccups             Respiratory disorders                                                                   failure Asthma aggravated
Hyperventilation
Rhinitis

Gastrointestinal    Constipation       Abdominal pain   Flatulence          Dysphagia                     Diverticulitis disorders           Nausea             Diarrhoea                            Ileus Vomiting           Dyspepsia
Dry mouth

Hepatobiliary                                                                                             Biliary colic disorders
Skin and            Pruritus           Rash             Dry skin            Face oedema        Pustules   Dermatitis contact subcutaneous        Erythema           Sweating         Urticaria                              Vesicles   Skin discolouration tissue disorders                       Exanthema
Musculoskeletal                        Muscular         Myalgia and connective                         weakness         Muscle spasms tissue disorders

Renal and                                               Urinary urinary disorders                                       incontinence
Urinary retention
Urinary hesitation

Reproductive                                                                Erectile system and breast                                                           dysfunction disorders                                                                   Sexual dysfunction
General disorders   Application site   Tiredness        Fatigue             Influenza like                Neonatal drug and                 skin reactions*    Asthenic         Pyrexia             illness                       withdrawal administration                         conditions       Rigors                                            syndrome site conditions                        Peripheral       Oedema                                            Drug tolerance oedema           Drug withdrawal syndrome
Chest pain

Investigations                                          Alanine aminotransferase increased
Weight decreased
Injury, poisoning                                       Accidental and procedural                                          injury complications                                           Fall


* Includes common signs and symptoms of contact dermatitis (irritative or allergic): erythema, oedema, pruritis, rash, vesicles and pain/burning sensation at the application site. In some cases late onset allergic 
contact dermatitis has occurred with marked signs of inflammation. In such cases treatment with BuTrans patches should be terminated.

After discontinuation of BuTrans, withdrawal symptoms are uncommon. This may be due to the very slow dissociation of buprenorphine from the opioid receptors and to the gradual decrease of buprenorphine plasma concentrations (usually over a period of 30 hours after removal of the last patch).

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/