Adverse reactions : תופעות לוואי

4.8.   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)

Blood and lymphatic system disorders
Uncommon:
Haemolytic anaemia and thrombocytopenia have been reported in patients treated with apomorphine.
Rare:
Eosinophilia has rarely occurred during treatment with apomorphine HCl.

Immune system disorders
Rare:
Due to the presence of sodium bisulphite, allergic reactions (including anaphylaxis and bronchospasm) may occur.

Psychiatric disorders
Very common:
Hallucinations

Common:
Neuropsychiatric disturbances (including transient mild confusion and visual hallucinations) have occurred during apomorphine HCl therapy.
Not known:
Impulse control disorders: pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including apomorphine (see section 4.4).

Aggression, agitation.

Nervous system disorders
Common:
Transient sedation with each dose of apomorphine HCl at the start of therapy may occur; this usually resolves over the first few weeks.

Apomorphine is associated with somnolence.

Dizziness/light-headedness have also been reported.
Uncommon:
Apomorphine may induce dyskinesias during ‘on’ periods, which can be severe in some cases, and in a few patients may result in cessation of therapy.

Apomorphine has been associated with sudden sleep onset episodes (see section 4.4).
       Not known:
Syncope
Headache

Vascular disorders
Uncommon:
Postural hypotension is seen infrequently and is usually transient (see section 4.4).
Respiratory, thoracic and mediastinal disorders
Common:
Yawning has been reported during apomorphine therapy.

Uncommon:
Breathing difficulties have been reported.

Gastrointestinal disorders
Common:
Nausea and vomiting, particularly when apomorphine treatment is first initiated, usually as a result of the omission of domperidone (see section 4.2).

Skin and subcutaneous tissue disorders
Uncommon:
Local and generalised rashes have been reported.

General disorders and administration site conditions
Very common:
Most patients experience injection site reactions, particularly with continuous use. These may include subcutaneous nodules, induration, erythema, tenderness and panniculitis. Various other local reactions (such as irritation, itching, bruising and pain) may also occur.

Uncommon:
Injection site necrosis and ulceration have been reported.

Not known:
Peripheral oedema has been reported.
Investigations
Uncommon:
Positive Coombs' tests have been reported for patients receiving apomorphine.
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.