Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Zomig is well tolerated. Adverse reactions are typically mild/moderate, transient, not serious and resolve spontaneously without additional treatment.

Possible adverse reactions tend to occur within 4 hours of dosing and are no more frequent following repeated dosing. Tabulated list of adverse reactions Adverse reactions are classified according to frequency and system organ class.
Frequency categories are defined according to the following convention: 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).
The following undesirable effects have been reported following administration with zolmitriptan:

System Organ Class             Frequency     Undesirable Effect
Immune system disorders        Rare          Anaphylaxis/Anaphylactoid Reactions; Hypersensitivity reactions.
Nervous system disorder        Common        Abnormalities or disturbances of sensation;
Dizziness;
Headache;
Hyperaesthesia;
Paraesthesia;
Somnolence;
Warm sensation.
Cardiac disorders              Common        Palpitations.
Uncommon       Tachycardia.
Very rare     Angina pectoris;
Coronary vasospasm;
Myocardial infarction.
Vascular disorders             Uncommon      Transient increases in systemic blood pressure
Gastrointestinal disorders    Common      Abdominal pain;
Dry mouth;
Nausea;
Vomiting
Dysphagia.
Very rare   Bloody diarrhoea;
Gastrointestinal infarction or necrosis;
Gastrointestinal ischaemic events;
Ischaemic colitis;
Splenic infarction.
Skin and subcutaneous         Rare        Angioedema;
tissue disorders                          Urticaria.
Musculoskeletal and           Common      Muscle weakness;
connective tissue disorders               Myalgia.
Renal and urinary disorders   Uncommon    Polyuria;
Increased urinary frequency

Very rare   Urinary urgency.
General disorders and           Common         Asthenia;
administration site                            Heaviness, tightness, pain or pressure in conditions                                     throat, neck, limbs or chest.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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