Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Undesirable effects are listed below by system organ class and frequency.
Frequencies are defined as follows: very common ≥1/10 (≥10%); common ≥1/100 and <1/10 (≥1% and <10%); uncommon ≥1/1000 and <1/100 (≥0.1% and <1%); rare ≥1/10,000 and <1/1000 ( ≥0.01% and <0.1%); very rare <1/10,000 (< 0.01%); not known (cannot be estimated from the available data).


Blood and lymphatic system disorders
Very rare
Methaemoglobinaemia
Psychiatric disorders
Very rare
Restlessness

Nervous system disorders
Headache
Very common
Dizziness
Common
Drowsiness
Uncommon
Syncope
Very rare
Cerebral ischaemias

Cardiac disorders
Common                                     Tachycardia
Uncommon
Enhanced angina pectoris symptoms Bradycardia
Cyanosis


Vascular disorders
Common
Orthostatic hypotension*
Facial flushing
Uncommon                                   Circulatory collapse

Gastrointestinal disorders
Uncommon
Nausea
Vomiting

Not known                                 Tongue swelling**
Tongue blistering
Respiratory, thoracic and mediastinal disorders
Impairment of respiration
Very Rare
Skin and subcutaneous tissue disorders
Allergic dermatitis**
Uncommon
Exfoliative dermatitis
Very rare
Drug rash

General disorders and administration site conditions
Asthenia
Common
Investigations
Common
Blood pressure decreased*

*Particularly upon initiation of therapy and following an increase in dose.
**Symptoms which are known in conjunction with hypersensitivity reactions Large doses of glyceryl trinitrate may cause vomiting, cyanosis, restlessness, methaemoglobinaemia and impairment of respiration.
During treatment with glyceryl trinitrate, temporary hypoxemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas.


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