Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Undesirable effects frequencies are defined as: very common (≥1/10), common (≥1/100 <1/10), uncommon (≥1/1,000 <1/100), rare (≥1/10,000 <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

During administration of Monolong the following undesirable effects may be observed: 
Nervous system disorders:

•       very common: headache
•       common: dizziness (including dizziness postural), somnolence Cardiac disorders:

•   common: tachycardia
•   uncommon: angina pectoris aggravated

Vascular disorders:
•   common: orthostatic hypotension
•   uncommon: circulatory collapse (sometimes accompanied by bradyarrhythmia and syncope) •   not known: hypotension

Gastrointestinal disorders:

•   uncommon: nausea, vomiting
•   very rare: heartburn
Skin and subcutaneous tissue disorders:

•   uncommon: allergic skin reactions (e.g. rash), flushing
•   not known: dermatitis exfoliative

Immune system disorders:
•   not known: angioedema

General disorders and administration site conditions:

•   common: asthenia


Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration.

During treatment with Monolong, a temporary hypoxemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas. Particularly in patients with coronary artery disease this may lead to a myocardial hypoxia.

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