Adverse reactions : תופעות לוואי

4.8     Undesirable effects
At therapeutic doses of naratriptan the incidence of side effects reported in clinical trials was similar to placebo. Some of the symptoms may be part of the migraine attack.


Undesirable effects are ranked under headings of frequency using the following convention: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000).

Immune system disorders
Rare:       Hypersensitivity reactions ranging from cutaneous hypersensitivity to rare cases of anaphylaxis.

Nervous system disorders
Common:      Tingling. This is usually of short duration, may be severe and may affect any part of the body including the chest or throat. Dizziness and somnolence.

Eye disorders
Uncommon: Visual disturbance.

Cardiac disorders
Uncommon: Bradycardia, tachycardia, palpitations.
Very Rare:   Coronary artery vasospasm, transient ischaemic ECG changes, angina and myocardial infarction (see sections 4.3 and 4.4).

Vascular disorders
Very rare:   Peripheral vascular ischaemia.

Gastrointestinal
Common:       Nausea and vomiting.
Rare:         Ischaemic colitis.
Skin and subcutaneous tissue disorders
Rare:        Rash, Urticaria, Pruritis, facial oedema.

General disorders and administration site conditions:
The following symptoms are usually of short duration, may be severe and may affect any part of the body including the chest or throat:

Common:          Sensations of heat, malaise/fatigue.
Uncommon:        Pain, sensations of heaviness, pressure or tightness.

Investigations
Uncommon:        Increase in blood pressure of approximately 5mmHg (systolic) and 3 mmHg (diastolic) in a period of up to 12 hours after administration.

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).