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 M.I.R. 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 disorders                                                                                  reaction Anaphylactoid reaction
Psychiatric disorders                          Confusion               Agitation           Drug dependence Insomnia                Euphoria             (see 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 contractions            Syncope
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    Central sleep apnoea disorders                                                              Respiratory         syndrome depression
Gastrointestinal        Constipation           Abdominal pain          Dyspepsia            Pancreatitis disorders               Nausea                 Anorexia                Ileus Dry mouth               Taste perversion
Vomiting
Hepatobiliary                                                          Increased hepatic   Biliary pain disorders                                                              enzymes             Exacerbation of pancreatitis
Sphincter of Oddi dysfunction
Skin and                                       Rash                    Urticaria           Acute generalised subcutaneous tissue                                                                        exanthematous disorders                                                                                  pustulosis (AGEP) Renal and urinary                                                      Urinary retention   Ureteric spasm disorders
Reproductive system                                                                        Amenorrhoea and breast disorders                                                                       Decreased libido Erectile dysfunction
General disorders                              Asthenia                Peripheral oedema   Drug tolerance 
and administration                              Fatigue                 Drug withdrawal         Drug withdrawal site conditions                                 Malaise                 syndrome                (abstinence) Pruritus                                        syndrome neonatal


Drug dependence and withdrawal (abstinence) syndrome
Repeated use of M.I.R tablets can lead to drug dependence, even at therapeutic doses. The risk of drug dependence may vary depending on a patient’s individual risk factors, dosage, and duration of opioid treatment (see section 4.4).

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/