Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: 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 (cannot be estimated from the available data). Some of the symptoms reported as undesirable effects may be associated symptoms of migraine.
Immune system disorders
Not known:                 Hypersensitivity reactions ranging from cutaneous hypersensitivity (such as urticaria) to anaphylaxis.
Nervous system disorders
Very common:               Dysgeusia/unpleasant taste.


Common:                    Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.
Not known:                 Seizures, although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures.
There are also reports in patients where no such predisposing factors are apparent; Tremor, dystonia, nystagmus, scotoma.
Eye disorders
Not known:                 Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects. However, visual disorders may also occur during a migraine attack itself.
Cardiac disorders
Not known:                 Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina,
myocardial infarction (see sections 4.3 and 4.4).
Vascular disorders
Common:                    Transient increases in blood pressure arising soon after treatment.
Flushing.
Not known:                 Hypotension, Raynaud’s phenomenon.


Respiratory, thoracic and mediastinal disorders
Common:                      Following administration of sumatriptan nasal spray mild, transient irritation or burning sensation in the nose or throat or epistaxis have been reported. Dyspnoea.


Gastrointestinal disorders
Common:                      Nausea and vomiting occurred in some patients but it is unclear if this is related to sumatriptan or the underlying condition.
Not known:                   Ischaemic colitis, diarrhoea, dysphagia.


Musculoskeletal and connective tissue disorders
Common:                      Sensations of heaviness (usually transient and may be intense and can affect any part of the body including the chest and throat). Myalgia.
Not known:                   Neck stiffness.
Arthralgia


General disorders and administration site conditions
Common:                      Pain, sensations of heat or cold, pressure or tightness (these events are usually transient and may be intense and can affect any part of the body including the chest and throat); feelings of weakness, fatigue
(both events are mostly mild to moderate in intensity and transient).
Not known:                   Pain trauma activated, pain inflammation activated.


Investigations
Very rare:                   Minor disturbances in liver function tests have occasionally been observed.

Psychiatric disorders
Not known:                   Anxiety.

Skin and subcutaneous tissue disorders
Not known:                Hyperhidrosis.

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/.
Additionally, you should also report to GSK Israel (il.safety@gsk.com).