Adverse reactions : תופעות לוואי

4.8        Undesirable effects
The frequency of adverse reactions is low at the recommended dose. Terbutaline given by inhalation is unlikely to produce significant systemic effects when given in recommended doses.

Most of the adverse reactions are characteristic of sympathomimetic amines. The majority of these effects have reversed spontaneously within the first 1-2 weeks of treatment.

The frequency of side-effects is low at the recommended doses.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: 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), very rare (<1/10,000) and not known (cannot be estimated from the available data).


BRICALIN                                    1. 1.   2015, RH                  Page 4 of 8 
Frequency                 Adverse Drug Reaction
Classification
System Organ Class           Preferred term (PT)
(SOC)
Very Common (>1/10)       Nervous System               Tremor
Disorders                    Headache
Common (>1/100,           Cardiac Disorders            Tachycardia
<1/10)                                                 Palpitations

Musculoskeletal and          Muscle spasms
Connective Tissue
Disorders #


Metabolism and Nutrition     Hypokalaemia (See section 4.4)
Disorders
Not Known ^               Cardiac Disorders            Arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia and
extrasystoles
Myocardial ischaemia (See section 4.4)


Vascular Disorders           Peripheral vasodilation

Immune System                Hypersensitivity reactions including
Disorders                    angioedema, bronchospasm, hypotension
and collapse

Gastrointestinal Disorders Nausea
Mouth and throat irritation


Psychiatric Disorders        Sleep disorder and Behavioural
disturbances, such as agitation and
restlessness
Metabolism and                                 1
Lactic acidosis
Nutritional Disorders
Respiratory, Thoracic and    Paradoxical bronchospasm *
Mediastinal Disorders
Skin and Subcutaneous        Urticaria
Tissue Disorders             Rash

# A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation.
BRICALIN                                      1. 1.   2015, RH                       Page 5 of 8 ^ Reported spontaneously in post-marketing data and therefore frequency regarded as unknown * In rare cases, through unspecified mechanisms, paradoxical bronchospasm may occur, with wheezing immediately after inhalation. This should be immediately treated with a rapid-onset bronchodilator. Bricalin therapy should be discontinued and after assessment, an alternative therapy initiated.
1
For Bricalin Respirator Solution only