Adverse reactions : תופעות לוואי

4.8 Undesirable effects
These side effects are generally mild, of short duration (usually less than 1 minute) and well tolerated by the patient. However, severe reactions can occur.
Methylxanthines, such as IV aminophylline or theophylline have been used to terminate persistent side effects (50 – 125 mg by slow intravenous injection).
Adverse events are ranked under the heading of the frequency:
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 available data).
•   Immune system disorders
Not known: anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash)
•   Cardiac disorders
Very common: bradycardia, sinus pause, skipped beats, atrial extrasystoles, Atrio-Ventricular block, ventricular excitability disorders such as ventricular extrasystoles, non-sustained ventricular tachycardia
Uncommon: sinus tachycardia, palpitations
Very rare: atrial fibrillation, severe bradycardia not corrected by atropine and possibly requiring temporary pacing, ventricular excitability disorders, including ventricular fibrillation and torsade de pointes (see section 4.4)
Not known: asystole/cardiac arrest, sometimes fatal especially in patients with underlying ischaemic heart disease/cardiac disorder (see section 4.4), arteriospasm coronary which may lead to myocardial infarction.
•   Vascular disorders
Very common: flushing
Not known: hypotension (sometimes severe) (see section 4.4)
•   Nervous system disorders Common: headache, dizziness, light-headedness, paraesthesia
Uncommon: head pressure
Very rare: transient and spontaneously rapidly reversible worsening of intracranial hypertension Not known: loss of consciousness/syncope, convulsions, especially in predisposed patients (see section 4.4)
•    Eye disorders
Uncommon: blurred vision
•    Respiratory, thoracic and mediastinal disorders Very common: dyspnoea (or the urge to take a deep breath)
Uncommon: hyperventilation
Very rare: bronchospasm (see section 4.4)
Not known: respiratory failure (see section 4.4), apnoea/respiratory arrest Cases of respiratory failure, bronchospasm, apnoea and respiratory arrest with fatal outcome have been reported.
•    Gastrointestinal disorders
Common: nausea
Uncommon: metallic taste
Not known: vomiting
•    Psychiatric disorders
Common: nervousness
•    General disorders and administration site conditions Very common: chest pain or pressure, feeling of thoracic constriction/oppression Uncommon: sweating, discomfort in the leg, arm or back, feeling of general discomfort, weakness/pain
Very rare: injection site 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