Adverse reactions : תופעות לוואי

4.8 Undesirable effects

In normal doses, the commonest side effects of morphine are nausea, vomiting, constipation and drowsiness. With chronic therapy, nausea and vomiting are unusual with MCR tablets but should they occur the tablets can be readily combined with an anti-emetic if required. Constipation may be treated with appropriate laxatives.
The following frequencies are the basis for assessing undesirable effects: 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)
Very common             Common                   Uncommon                  Not known Immune system                                                              Hypersensitivity          Anaphylactic reaction disorders                                                                                            Anaphylactoid reaction Psychiatric disorders                             Confusion                Agitation                 Drug dependence (see Insomnia                 Euphoria                  section 4.4)
Hallucinations            Dysphoria
Mood altered              Thinking disturbances
Nervous system                                    Dizziness                Convulsions               Allodynia disorders                                         Headache                 Hypertonia                Hyperalgesia (see Hyperhidrosis            Myoclonus                 section 4.4)
Involuntary muscle       Paraesthesia              Sleep apnoea contractions             Syncope                   syndrome
Somnolence
Eye disorders                                                              Visual impairment         Miosis Ear and labyrinth                                                          Vertigo disorders
Cardiac disorders                                                          Palpitations              Bradycardia Tachycardia
Vascular disorders                                                         Facial flushing           Hypertension Hypotension
Respiratory thoracic                                                       Bronchospasm              Cough decreased and mediastinal                                                            Pulmonary oedema disorders                                                                  Respiratory depression Gastrointestinal          Constipation            Abdominal pain           Dyspepsia disorders                 Nausea                  Anorexia                 Ileus Dry mouth                Taste perversion
Vomiting
Hepatobiliary disorders                                                    Increased hepatic         Biliary pain enzymes                   Exacerbation of pancreatitis
Skin and subcutaneous                             Rash                     Urticaria tissue disorders
Renal and urinary                                                          Urinary retention         Ureteric spasm disorders
Reproductive system                                                                                  Amenorrhoea and breast disorders                                                                                 Decreased libido Erectile dysfunction
General disorders and                             Asthenia                 Peripheral oedema         Drug tolerance administration site                               Fatigue                  Drug withdrawal           Drug withdrawal conditions                                        Malaise                  syndrome                  (abstinence) syndrome Pruritus                                           neonatal

Drug dependence and withdrawal (abstinence) syndrome
Use of opioid analgesics may be associated with the development of physical and/or psychological dependence or tolerance. An abstinence syndrome may be precipitated when opioid administration is suddenly discontinued or opioid antagonists administered, or can sometimes be experienced between doses. For management, see section 4.4.
Physiological withdrawal symptoms include: Body aches, tremors, restless legs syndrome, diarrhoea, abdominal colic, nausea, flu-like symptoms, tachycardia and mydriasis. Psychological symptoms include dysphoric mood, anxiety and irritability. In drug dependence, “drug craving” is often involved.
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 accordin go the National Regulation by using an online form  https://sideeffects.health.gov.il/