Adverse reactions : תופעות לוואי

4.8   Undesirable effects
In normal doses, the commonest side effects of morphine are nausea, vomiting, constipation and drowsiness and confusion. With chronic therapy, nausea and vomiting are unusual but should they occur the morphine dosage can be readily combined with an anti-emetic if required. Constipation may be treated with appropriate laxatives.
For the evaluation of undesirable effects the following incidences are defined: Very common                  1/10
Common                       1/100 to < 1/10
Uncommon                     1/1000 to < 1/100
Rare                         1/10000 to < 1/1000
Very rare                   < 1/10000
Not known                   Can't be estimated from the available data 


Category                   Very             Common              Uncommon             Not known Immune system              Common                              Allergic reaction    Anaphylactic reaction disorders
Anaphylactoid reaction


Psychiatric disorders      Very            Confusion           Agitation Euphoria   Drug dependence Morphine shows various common:             Insomnia            Hallucinations psychiatric undesirable           mood     Common:             Mood altered         Dysphoria effects which with         changes,        changes in regard to severity and     mostly          activity (mostly    Very rare:dependence Thinking disturbances nature present differently euphoria, but   sedation, but       (see section 4.4), (depending on the          also            also enhanced       decreased libido and personality and duration dysphoria         activity or         impaired potency of therapy).                               agitation),
insomnia,
alterations of cognitive and sensory functions (e. g.
disturbances in thinking, altered apprehensivenes s/hallucinations,
confusion)



Nervous system             Dizziness      Convulsions             Hyperalgesia (see section 4.4) disorders - Depending on                  Hypertonia Myoclonus    Not known: hyperhidrosis the dose, morphine leads   Headache       Paraesthesia            Especially in high doses to various extents of                     Syncope                 hyperalgesia or allodynia (see respiratory depression                    Very rare:tremor,       section 4.4), which do not and sedation ranging       Involuntary muscle         involuntary muscle      respond to a further increase in from slight fatigue to                    twitching, epileptic    morphine doses (possibly dose contractions giddiness.                                seizures                reduction or opioid rotation is necessary).
Somnolence



Eye disorders                             Visual disturbance      Miosis, Miosis is a typical Very rare:      blurred accompanying symptom vision, diplopia,
nystagmus



Ear and labyrinth                         Vertigo disorders
Cardiac disorders                         Palpitations, Heart     Uncommon: clinically failure                 relevant decrease or increase in blood pressure and heart rate
Facial flushing, palpitations,
generalised weakness up to loss of consciousness and heart failure can occur.
Bradycardia
Tachycardia
Vascular disorders                        Facial flushing         Hypertension 
Hypotension



Respiratory thoracic and                                   Bronchospasm              Cough decreased mediastinal disorders
Pulmonary oedema

Respiratory depression

Very rare: dyspnoea
Non-cardiogenic pulmonary oedemas have been reported in patients treated under intensive-care conditions.
Gastrointestinal         Constipation Abdominal pain       Dyspepsia                 Very rare:       ileus, abdominal disorders                             Anorexia Dry                                   pain Depending on the dose, Nausea         mouth Vomiting       Ileus nausea and dry mouth                  Common: can occur.                            vomiting             Taste perversion Obstipation is a typical              (especially at the   Rare: elevation of accompanying symptom                  beginning of         pancreatic enzymes of long-term treatment.               therapy),            and pancreatitis anorexia,            respectively dyspepsia and taste alterations


Hepatobiliary disorders                                    Increased hepatic         Biliary pain enzymes                   Exacerbation of pancreatitis
Rare: biliary colics
Very rare:       elevation of liver-specific enzymes


Skin and subcutaneous                  Hyperhidrosis       Urticaria tissue disorders
Rash                Very rare:      other skin reactions such as
Common:             exanthema and sweating,           peripheral oedema hypersensitivity (reversible upon reactions such as termination of therapy) urticaria, pruritus Anaphylactic and anaphylactoid reactions can occur.
Renal and urinary                      Common:         Urinary retention             Ureteric spasm disorders                              disturbances of Rare: renal colic micturition



Reproductive system and                                                         Amenorrhoea breast disorders
Decreased libido

Erectile dysfunction

General disorders and                  Asthenic         Peripheral oedema       Tolerance can develop.
administration site                    conditions conditions
Pruritus                                 Rare: drug withdrawal
(abstinence) syndrome
Very rare:       asthenia,
malaise, chills, amenorrhoea



Musculoskeletal and                                                             Very rare:      muscle cramps, connective tissue                                                               muscle rigidity disorders


Endocrine disorders                                                             Very rare:    syndrome of inadequate ADH secretion
(SIADH, with hyponatraemia as the main symptom).



Very rare: Diplopia, nystagmus, Chills, Hyponatraemia.



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 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 according to the National Regulation by using an online form /https://sideeffects.health.gov.il